Questions? Contact FDA/CDRH/OCE/DID at CDRH · PDF filethe STERRAD®100S sterilizer. ......

Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Confidential

3MTM AttestTM 1295

Biological Indicator

510(k)

Performance Testing-Animal

19. Animal Testing

The submission device does not include animal testing. This page is included

for ease of submission packet review.

K152060 Amendment 1 Page 1



Confidential

3MTM AttestTM 1295


510(k)

Performance Testing-Clinical

20. Clinical testing

The submission device does not include clinical testing. This page is included

for ease of submission packet review.

K152060 Amendment 1 Page 2









3M Health Care Business 3M Center

2510 Conway Ave., Bldg. 275-5W-06

St. Paul, MN 55144 U.S.A

Monday July 13th, 2015

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation [510(K)]

Document Mail Center - WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Re: Cover letter for traditional 510(k) notification for the 3M™ Attest™ Rapid

Readout Biological Indicator 1295 expanded indications for use

Dear Sir or Madam:

In compliance with the Federal Food, Drug and Cosmetic Act (as amended) and as required

in 21 CFR § 807, Subpart E, 3M Health Care submits this Premarket Notification for your

review. In accordance with 21 CFR §807.90(c), this document is submitted in duplicate, with

one paper copy and one electronic copy. The eCopy is an exact duplicate of the paper copy.

The purpose of the submission is to notify the Agency of the intent of 3M to market the

3M™ Attest™ Rapid Readout Biological Indicator 1295 with a new indication for use with

the STERRAD®100S sterilizer. This product was previously cleared by the Agency

(K140392) for use in STERRAD® 100NX and STERRAD® NX sterilizers.

Trade Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295

Classification Name: Indicator, Biological Sterilization Process

Common Name: Biological Indicator

Device Classification: Class II, 21 CFR 880.2800(a)

Product Code: FRC

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the

previously cleared device of the same model number. The device has the same materials,

performance specifications, and fundamental scientific technology.

Page 1






The table below summarizes the principal factors of the design and use of the device.

Question YES NO

Is the device intended for prescription use (21 CFR 801 Subpart D)?

X

Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? X

Does the device contain components derived from a tissue or other

biologic source? X

Is the device provided sterile?

X

Is the device intended for single use? X

Is the device a reprocessed single use device?

X

If yes, does this device type require reprocessed validation data?

X

Does the device contain a drug?

X

Does the device contain a biologic? X

Does the device use software?

X

Does the submission include clinical information?

X

Is the device implanted?

X

Recent communications with ODE Infection Control Branch reviewers, both during the review of the

predicate K140392 and during unrelated product reviews, have suggested the following organization

of this particular submission as appropriate:

1) This submission includes original results of testing necessary to include additional

cycles in the Indications for Use. Discussions held with INCB during teleconferences on

June 17 and June 24, 2104 indicated the necessary testing to be Full Cycle, Half Cycle

and Recovery Protocols (Carrier and Primary Packaging Materials Evaluation & Effect

of Sterilization Process on Recovery Medium) for each additional cycle. This testing is

provided in Section 18 – Bench Testing.

2) This submission additionally includes test documentation reproduced from K140392.

Review staff have communicated that reproducing documentation from previous

premarket notifications, where possible, allows for maintaining a complete review file

within FDA systems. To that end, we have included Full Cycle, Half Cycle, and

Recovery Protocols for the previously cleared sterilizer cycles, as well as non-cycle-

specific BI resistance (D-value and Survive/Kill) and Hold Time testing which supports

both the predicate and current submission. This testing is provided as Appendices

within this submission.

3M considers the intent to market this device as confidential commercial information.

Therefore, 3M considers the information provided under this submission to be a trade secret

and confidential commercial information under 21 CFR §20.61 and requests that the Food

Page 2






and Drug Administration not disclose this information either in response to a Freedom of

Information Request or by any other means.

An electronic payment of was made to FDA on June 23, 2015 in support of this

submission, and 3M’s Medical Device User Fee Payment Identification Number for this

submission is . Should you have any questions regarding this submission, please

contact me at the phone number or email listed below. In the event that I cannot be reached,

please contact Hilary Hovde at (651) 736-0364.

Sincerely,

Matthew S. Mortensen, PhD, RAC

3M Health Care Regulatory Affairs

3M Center

2510 Conway Avenue, Bldg. 275-5W-06

St. Paul, MN 55144-1000 U.S.A.

Phone (651) 737-2670 Fax: (651) 737-5320

[email protected]

Page 3

(b)(4)

(b)(4)







Page 1 of 5 Pages

Supplement

CDRH PREMARKET REVIEW SUBMISSION COVER SHEET

Form Approval OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on page 5.

Date of Submission

(If Yes, please complete Section I, Page 5)

Division Name (if applicable) Phone Number (including area code)

Street Address FAX Number (including area code)

City

Contact Name

Contact E-mail Address

Company / Institution Name

Contact Title

ZIP/Postal CodeState / Province

Division Name (if applicable) Phone Number (including area code)

Street Address FAX Number (including area code)

City

Contact Name

Contact E-mail Address

Evaluation of Automatic Class III Designation

(De Novo)

APPLICATION CORRESPONDENT (e.g., consultant, if different from above)

FORM FDA 3514 (1/13)

PMA PMA & HDE Supplement

Establishment Registration Number (if known)

Original Submission

PDP 510(k)

Other SubmissionHumanitarian Device Exemption (HDE)

Amendment

Class II Exemption Petition

Original SubmissionAdditional Information

Original Submission Original Submission

Additional InformationOriginal Submission

Amendment

No

Supplement

SUBMITTER, APPLICANT OR SPONSOR

IDE

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Report Amendment

TYPE OF SUBMISSION

State / Province ZIP Code Country

Country

Additional Information

Other (describe submission):

Contact Title

FDA Submission Document Number (if known)User Fee Payment ID Number

513(g)

Notice of CompletionAmendment to PDP

Original PDPRegular (180 day)SpecialPanel Track (PMA Only)30-day Supplement30-day Notice135-day SupplementReal-time Review

Abbreviated (Complete section I, Page 5)

SpecialTraditional

Original Submission:

Modular Submission

Other

AmendmentReportReport Amendment

Premarket Report

Licensing Agreement Third Party

Amendment to PMA & HDE Supplement

Company / Institution Name

Have you used or cited Standards in your submission?

Report

Yes

07/13/2015

3M Company 2110898

3M Health Care 651-737-2670

3M Center, Building 275-5W-06 651-737-5320

St. Paul MN 55144 USA

Matt Mortensen

Regulatory Affairs Specialist [email protected]

SECTION A

SECTION C

SECTION B

PSC Publishing Services (301) 443-6740 EF

Request for Feedback

Informational Meeting

Study Risk Determination

Pre-Submission

Day 100 MeetingAgreement MeetingDetermination Meeting

Submision Issue Meeting

Other (specify):

Page 6

(b)(4)



Page 2 of 5 Pages

Additional or Expanded Indications

Request for Applicant Hold

Withdrawal

Post-approval Study Protocol

Request to Remove or Add Manufacturing Site

Request for Extension

Request for Removal of Applicant Hold

New Device

Manufacturing PackagingSterilization

Other (specify below)

Post-approval Study

Packager

Process change:

Response to FDA correspondence: Change of Applicant Address

Location change:

SterilizerManufacturer

New Indication

Request Hearing

Other Reason (specify):

Adverse ReactionDevice DefectAmendment

Change in design, component, or specification:

Report Submission:Annual or Periodic

Color AdditiveMaterial

Software / Hardware

Change in OwnershipChange in Correspondent

SpecificationsOther (specify below)

Labeling change:Indications

Performance CharacteristicsInstructions

Shelf LifeTrade NameOther (specify below)


Change in TechnologyNew Device

REASON FOR APPLICATION - PMA, PDP, OR HDE

REASON FOR SUBMISSION - 510(k)

FORM FDA 3514 (1/13)

REASON FOR APPLICATION - IDE

New Device

Expansion / Extension of StudyIRB Certification

Addition of Institution

Termination of StudyWithdrawal of Application

Continued Access

Unanticipated Adverse Effect

Compassionate Use RequestTreatment IDE

Notification of Emergency Use

Change in:

Design / DeviceInformed Consent

Correspondent / Applicant

Manufacturer

Protocol - FeasibilityProtocol - Other

Manufacturing Process

Response to FDA Letter Concerning:

Sponsor

Deemed ApprovedDeficient Final Report

Conditional Approval

Site Waiver Report

Current InvestigatorAnnual Progress Report

Report submission:

Deficient Progress Report

DisapprovalRequest Extension of Time to Respond to FDA

Deficient Investigator Report

Request Meeting

Final


Additional or Expanded Indications

SECTION D1

SECTION D3

SECTION D2

Page 7



Page 3 of 5 Pages

Trade or Proprietary or Model Name510(k) Number

Product codes of devices to which substantial equivalence is claimed

5

Manufacturer

Information on devices to which substantial equivalence is claimed (if known)

1

PRODUCT INFORMATION - APPLICATION TO ALL APPLICATIONS

2

PRODUCT CLASSIFICATION - APPLICATION TO ALL APPLICATIONS

Common or usual name or classification name

Trade or Proprietary or Model Name for This Device

3

Model Number

3

FDA document numbers of all prior related submissions (regardless of outcome)

8

2

9

3

10

Data Included in SubmissionLaboratory Testing Animal Trials Human Trials

Device ClassProduct Code C.F.R. Section (if applicable)

Classification Panel

Indications (from labeling)

Class I Class II

Class III Unclassified

Summary of, or statement concerning, safety and effectiveness information

510 (k) summary attached510 (k) statement

ADDITIONAL INFORMATION ON 510(K) SUBMISSIONS

FORM FDA 3514 (1/13)

7

3

4

8

4

2

3

6

2

7

1

11

5

12

6

3

1 1

4

5

6

4

5

6

2

3

1

4

5

6

4

1

2

5

4

1

2

5

FRC

K140392 3M™ Attest™ Rapid Readout Biological Indicator 1295

3M Company

Biological indicator

3M™ Attest™ Rapid Readout Biological Indicator 1295

FRC 880.2800

General Hospital

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

SECTION F

SECTION G

SECTION E

Page 8





Page 5 of 5 Pages

UTILIZATION OF STANDARDS

FORM FDA 3514 (1/13)

Standards Organization

Please include any additional standards to be cited on a separate page.

The burden time for this collection of information is estimated to average 0.5 hour per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 1350 Piccard Drive, Room 400 Rockville, MD 20850

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

7

Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement.

1

2

3

4

5

6

DateStandards No. Standards Title Version













SECTION I

Page 10



FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use510(k) Number (if known)

Device Name

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.


Indications for Use (Describe)Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

Page 11



Premarket Notification (510(k)) Summary

Sponsor Information:

3M Health Care

3M Center, Bldg. 275-5W-06

St. Paul, MN 55144-1000

Contact Person: Matt S. Mortensen, Ph.D., RAC

Regulatory Affairs

Phone Number: (651) 737-2670

FAX Number: (651) 737-5320

Date of Summary: July 13, 2015

Device Name and Classification:

Common or Usual Name: Biological Indicator

Proprietary Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295



Product Code: FRC

Predicate Devices:


Description of Device:

The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological

indicator specifically designed for rapid and reliable routine monitoring of STERRAD®

vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M

Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate

sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A

chemical process indicator printed with stripes which change from blue to pink upon exposure to

vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same

fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid

Page 12



Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-

reader indicates a sterilization failure.

Nonclinical Comparison to the Predicate Device

This submission is addressing clearance for use in an additional sterilizer. The 3M™ Attest™

Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of

the same model number. There device has the same materials, performance specifications, and

fundamental scientific technology.

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M

Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized hydrogen

peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and

Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

Comparison to Predicate Device

Feature Submission Device: 3MTM

AttestTM 1295 Biological Indicator

Predicate Device (K140392):

3MTM AttestTM 1295 Biological

Indicator

Indications for use

Use the 3M™ Attest™ Rapid Readout

Biological Indicator 1295 in

conjunction with the 3M Attest™

Auto‑reader 490H as a standard method

of routine monitoring of vaporized

hydrogen peroxide sterilization

processes in STERRAD® 100S,

STERRAD® NX (Standard and

Advanced cycles) and 100NX

(Standard, Flex, Express and Duo

cycles) systems.

Use the 3M Attest™ Rapid

Readout Biological Indicator

1295 in conjunction with the 3M

Attest™ Auto‑reader 490H as a

standard method of routine

monitoring of vaporized hydrogen

peroxide sterilization processes in

STERRAD® NX and 100NX

systems.

Organism Geobacillus stearothermophilus

traceable to ATCC™ 7953 Same

Viable spore

population ≥1x106 Same

Resistance

Characteristics

D-value

(Tested at 10 mg/L vaporized hydrogen

peroxide)

D10 mg/L ≥ 1 second

Survival Time ≥ 5 seconds

Same

Page 13



Survival/Kill

Window

Kill Time = 7 minutes

Shelf-life Will be based on results of completed

testing at time of marketing. 18 months

Conclusion

The 3MTM AttestTM 1295 Biological Indicator is substantially equivalent to the predicate device

in terms of their intended use, physical properties and technological characteristics. The non-

clinical testing demonstrates that the 3MTM AttestTM 1295 Biological Indicator is as safe, as

effective, and performs as well as the predicate device.

Page 14



Confidential

3MTM AttestTM 1295


510(k)

Premarket Notification

Truthful and Accurate

Statement

6. Premarket Notification Truthful and Accurate Statement

Pursuant to 21 CFR §807.87(k), I certify that, in my capacity as the position

within 3M Infection Prevention Division noted below, I believe to the best of

my knowledge, that all data and information submitted in the premarket

notification are truthful and accurate and that no material fact has been

omitted.

7/13/2015

Matthew S. Mortensen PhD, RAC, (Date)

Regulatory Affairs

Page 15



Confidential

3MTM AttestTM 1295


510(k)

Premarket Notification Class

III Certification and Summary

7. Premarket Notification Class III Certification and Summary

This is a submission of a Class II device; therefore, the following statement is

not required but is intentionally left here for ease of submission packet review.

I certify that, in my capacity as (the position held in company) of (company name) that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and/or effectiveness problems that have been reported for the (device name). I further certify that I am aware of the types of problems to which the (device name) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety and/or effectiveness problems about the (device name) is complete and accurate. (Attach the summary of problem data, bibliography or other citations upon which the summary is based.)

___Not Applicable___________ (Signature of Certifier) ___ Not Applicable ____________ (Typed Name) ___ Not Applicable ___________ (Date) ____________________________ (Premarket Notification [510(k)] Number)

Page 16



Confidential

3MTM AttestTM 1295


510(k)

Financial Certification or

Disclosure Statement

8. Financial Certification or Disclosure Statement

This submission does not include information from clinical studies; therefore,

per 21 CFR 807.87(i) this section is not required. This page is included for

ease of submission packet review.

Page 17



Confidential

3MTM AttestTM 1295


510(k)

Standards Data Report for

510(k)s

9. Standards Data Report for 510(k)

This submission does not reference any national or international standards,

therefore the Standards Data Report Form (FORM FDA 3654) is not

required. This page is included for ease of submission packet review.

Page 18



Confidential

3MTM AttestTM 1295


510(k)

Executive Summary

10 Executive Summary

10.1 Overview of Design

The 3M Attest™ 1295 Rapid Readout Biological Indicator (1295 BI) is a self-

contained biological indicator that contains greater than 1x106 Geobacillus

stearothermophilus spores on a carrier within the device.

The 1295 BIs have a 4 hour fluorescence response with an optional 168 hour (7 day)

visual result and are intended for use in STERRAD® hydrogen peroxide sterilization

cycles (see Section 4, Indications for Use). The biological indicator resistance

characteristics are: D10mg/L-value greater than or equal to 1 second, a Survival time of

5 seconds and a Kill time of 7 minutes. There are no calculated survival or kill

times.

10.2 Overview of Performance testing

With the exception of performance in the 100S sterilizer, the 1295 BI performance

was described in the predicate submission K140392. As described in the cover letter

to this submission, we have divided test data herein into original results for 100S

(provided in Section 18) and reproduced results from K140392 (provided as

Appendices). This was done based on ODE reviewer feedback to maintain a better

administrative record within Agency systems. A summary of the performance

Page 19



Confidential

3MTM AttestTM 1295


510(k)

Executive Summary

characteristics of 1295 BI, along with location of supporting data, is provided in the

sections below.

10.3 Substantial Equivalence

Feature

Submission Device: 3MTM

AttestTM 1295 Biological

Indicator

Predicate Device

(K140392): 3MTM


Indicator

Indications for

use

Use the 3M™ Attest™ Rapid


1295 in conjunction with the

3M Attest™ Auto-reader 490H

as a standard method of routine

monitoring of vaporized


processes in STERRAD®

100S, STERRAD® NX

(Standard and Advanced cycles)

and 100NX (Standard, Flex,

Express and Duo cycles)

systems.


Readout Biological

Indicator

1295 in conjunction with

the 3M

Attest™ Auto-reader 490H

as a



hydrogen

peroxide sterilization

processes in

STERRAD® NX and

100NX systems.



Viable spore


Resistance

Characteristics

D-value

Survival/Kill

Window

(Tested at 10 mg/L vaporized

hydrogen peroxide)




Same

Shelf-life

Will be based on results of

completed testing at time of

marketing.

18 months

Page 20

(b)(4)







Confidential

3MTM AttestTM 1295


510(k)

Device Description

bromocresol purple, and a fluorescent enzyme substrate 4-methylumbelliferyl-alpha-D-

glucoside.

11.2 Performance Characteristics

With the exception of performance in the 100S sterilizer, the 1295 BI performance was described

in the predicate submission K140392. As described in the cover letter to this submission, we

have divided test data herein into original results for 100S (provided in Section 18) and

reproduced results from K140392 (provided as Appendices). This was done based on ODE

reviewer feedback to maintain a better administrative record within Agency systems. A

summary of the performance characteristics of 1295 BI, along with location of supporting data,

is provided in the sections below.

1 Cycle independent therefore not testing using any of method 1-3

Page 23

(b)(4) Performance Characteristcs



Confidential

3MTM AttestTM 1295


510(k)

Device Description

Page 24

(b)(4) Performance Characteristcs

(b)(4) Performance Characteristcs(b)(4)



Confidential

3MTM AttestTM 1295


510(k)

Substantial Equivalence

Discussion

12 Substantial Equivalence Discussion

This submission is addressing an expansion in the indications for use (i.e. additional

sterilizer) over what was cleared in K140392. The 3M™ Attest™ Rapid Readout

Biological Indicator 1295 is the same design as the previously cleared device of the

same model number. There device has the same materials, performance

specifications, and fundamental scientific technology.

Feature

Submission Device: 3MTM


Indicator

Predicate Device

(K140392): 3MTM


Indicator

Indications for

use

Use the 3M™ Attest™ Rapid


1295 in conjunction with the

3M Attest™ Auto‑reader 490H

as a standard method of routine



processes in STERRAD®

100S, STERRAD® NX

(Standard and Advanced cycles)

and 100NX (Standard, Flex,

Express and Duo cycles)

systems.


Readout Biological

Indicator

1295 in conjunction with

the 3M

Attest™ Auto‑reader 490H

as a



hydrogen

peroxide sterilization

processes in

STERRAD® NX and

100NX systems.



Viable spore


Resistance

Characteristics

D-value

Survival/Kill

Window

(Tested at 10 mg/L vaporized

hydrogen peroxide)




Same

Shelf-life

Will be based on results of

completed testing at time of

marketing.

18 months

Page 25



Confidential

3MTM AttestTM 1295


510(k)

Labeling

13. Labeling

A draft of the English language portion of the IFU, the primary label and certificate of analysis

are provided below.

13.1. IFU

Product Description

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 (pink cap, referred to hereinafter as the 1295

BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of

STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™

Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use

device.

A schematic illustrating the design of the 1295 BI is provided in Figure 1. The

self-contained design includes a carrier with spores of Geobacillus

stearothermophilus and a media ampoule containing bacteriological growth

medium which meets the requirements for growth promoting ability specified in

ANSI/AAMI/ISO 11138-1:2006/(R)2010. The spore carrier and media ampoule

are contained in a plastic vial topped with a pink cap. A chemical process

indicator printed with stripes which change from blue to pink upon exposure to

vaporized hydrogen peroxide is located on the top of the cap.

The 1295 BI utilizes the α-glucosidase enzyme system, which is

generated naturally within growing cells of Geobacillus stearothermophilus. The α-glucosidase in its

active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-

fluorescent substrate, 4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent by-product,

4-methylumbelliferone (MU), is detected in the 490H Auto-reader. The presence of fluorescence within 4

hours of incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization process failure.

The 1295 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change

reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by-products that

cause the media to change color from purple to yellow which also indicates a sterilization process failure.

Use of this indication method is optional and is typically restricted to special studies.

Figure 1: Design of the 3M™ Attest™

Rapid Readout Biological Indicator 1295

Page 26



Confidential

3MTM AttestTM 1295


510(k)

Labeling

Readout Time

The 4-hour rapid readout has been correlated with a 7-day visual pH color change result

following the FDA’s Reduced Incubation Time protocol.

4-hour Fluorescent Result

1295 BIs have a 4 hour reduced incubation time result that correlates to the 7

day (168 hours) visual readout result ≥ 97% of the time.

Due to the high reliability of the 4-hour fluorescent result there is no advantage to incubating 1295 BIs

beyond 4 hours.

1295 BIs meet ANSI/AAMI/ISO 11138-1:2006/(R)2010 and EN/ISO 11138-1:2006.

Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the

3M Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized

hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX

(Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles)

systems.

Contraindications

None.

Warnings

There is a glass ampoule inside the plastic vial of the biological indicator (BI). To avoid the risk of serious

injury from peroxide burns:

Wear safety glasses and gloves when removing the 1295 BI from the sterilizer.

Wear safety glasses and gloves when activating the 1295 BI.

Handle the 1295 BI by the cap when crushing or flicking.

Residual hydrogen peroxide may be trapped within the 1295 BI if the media ampoule is damaged during

the sterilization process. If a broken ampoule is observed after processing, avoid direct contact with the

Page 27



Confidential

3MTM AttestTM 1295


510(k)

Labeling

1295 BI as it may result in hydrogen peroxide burns. Follow the disposal instructions provided at the end

of this document.

Precautions

1. Do not use the 1295 BI to monitor sterilization cycles which it is not designed to challenge:

a. Steam sterilization cycles;

b. Dry heat sterilization cycles; or

c. Ethylene oxide sterilization processes.

2. To reduce the risk associated with incorrect results:

Before sterilization, inspect 1295 BI to verify media ampoule is intact and process indicator

stripes are blue. Do not use any 1295 BIs which have a broken media ampoule or process

indicator stripes which are not blue.

Do not place tape or labels on 1295 BI prior to sterilization or incubation in the 490H Auto-reader.

Activate and incubate the 1295 BI within 1 hour after the completion of the sterilization cycle.

Do not incubate a 1295 BI if, after processing and before BI activation, it is observed to have a

broken media ampoule. Retest the sterilizer with a new biological indicator.

After 1295 BI activation, ensure media has flowed to the spore growth chamber.

3. To ensure the product functions as intended throughout the labeled shelf life, store

1295 BIs in the resealable foil pouch until use.

4. The 1295 BI is not designed for use in STERRAD® test packs, including the

STERRAD® 100NX® System DUO Test Pack.

Monitoring Frequency

Follow facility Policies and Procedures which should specify a biological indicator monitoring

frequency compliant with professional association recommended practices and/or national

guidelines and standards. As a best practice and to provide optimal patient safety, 3M

recommends that every sterilization load be monitored with a biological indicator.

Directions for Use

1. Remove 1295 BI from sealed foil pouch, then reseal pouch if other 1295 BIs remain

in pouch. Do not place any labels or indicator tape on the vial or on the cap.

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Labeling

Whether the media ampoule is crushed using method a) or b),

immediately remove the BI and flick it (see picture at right). Visually

verify that media has flowed into the growth chamber at the bottom of

the vial. If the media hasn’t filled the growth chamber, hold the BI by

the cap and flick it until media fills the growth chamber. Place the activated 1295 BI in a

490H Auto-reader incubation well which is color-coded pink and wait for the result. See

the 490H Auto-reader Operator’s Manual for further information related to its use.

NOTE: Activate and incubate the 1295 BI within 1 hour of the completion of the

sterilization cycle.

9. Each day that a processed 1295 BI is incubated, activate and incubate at least one

non-processed 1295 BI to use as a positive control. Follow the activation instructions

provided in Step 8 above. Write a "C" (for "control") and the date on the BI label. The

positive control should be from the same lot code as the processed biological indicator.

The positive control BI helps confirm:

correct incubation temperatures are met,

viability of spores has not been altered due to improper storage temperature, humidity or

proximity to chemicals,

capability of media to promote rapid growth, and

proper functioning of the 490H Auto-reader.

10. Incubation and Reading:

Incubate the positive control and processed 1295 BIs at 60 ± 2°C in a 490H Auto-

reader. See the 490H Auto-reader Operator’s Manual for the proper use of this

equipment. Positive results are available within 4 hours. The 490H Auto-reader will

indicate a positive result as soon as it is obtained. The final negative 1295 BI reading is

made at 4 hours. After the results are displayed and recorded, the 1295 BIs may be

discarded.

Interpretation of Results

Fluorescent Result

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The positive control (unprocessed) 1295 BI must provide a positive fluorescent result (+

symbol on the 490H Auto-reader LCD display). Processed 1295 BI results are not valid

until the positive control reads fluorescent positive. The positive control should read

positive at or before 4 hours. If the positive control reads negative (- symbol on the LCD

display) at 4 hours, check the 490H Auto-reader Operator’s Manual Troubleshooting

Guide. Retest the 490H Auto-reader with a new positive control.

With processed 1295 BIs, a final negative reading (- symbol on the LCD display) after 4

hours of incubation indicates an acceptable sterilization process. A positive (+ symbol

on the LCD display) result for a processed 1295 BI indicates a sterilization process

failure. Act immediately on any positive results for processed BIs. Determine the cause

of the positive BI following facility policies and procedures. Always retest the sterilizer

and do not use sterilizer for processing loads until it has been re-qualified according to

the manufacturer’s instructions.

Optional Visual pH Color Change Result

The 1295 BI is normally discarded after the fluorescent result has been recorded. If,

however, special studies are desired, 1295 BIs may be further incubated for a visual pH

color change result. In the case of the positive control BI, a yellow color change of the

growth media will appear within 24 hours. Any observation of a yellow color within the

vial indicates a positive result.

In the case of a processed 1295 BI, a media color change from purple to yellow

indicates a sterilization process failure. A negative pH color change result, i.e., media

remains purple, can be assessed at 7 days. To avoid media dry-out, it is recommended

that the 1295 BI be transferred to a humidified incubator operating at 60ºC after the

fluorescent result has been recorded.

Storage/ Shelf Life

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Store 1295 BIs in the original resealable foil pouch under normal room conditions: 59-86ºF (15-

30ºC).

Do not store 1295 BIs near sterilants or other chemicals.

The product’s expiration date is indicated on the BI and packaging by an hourglass symbol

followed by the year and month of expiration (e.g., 2017-11).

All of the information to the right of the lot‑in‑a‑box symbol indicates the lot number (e.g.,

2017‑11AD).

Disposal

Dispose of used 1295 BIs according to your health care facility policy. Steam sterilize

any positive biological indicators at 132°C (270°F) for 4 minutes or at 275°F (135°C) for

3 minutes in a dynamic-air-removal steam sterilizer prior to disposal. For processed BIs

observed to have a broken media ampoule after the sterilization process, leave the BI in

the peel-open pouch and place the pouch in packaging compatible with steam

sterilization before steam processing.

Explanation of Symbols

Do not use if package is damaged or open

Caution, see instructions for use

Single Use Only

Use by date

Batch code

Manufacturer

Catalog number

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Product is designed for use with vaporized hydrogen peroxide sterilization

processes.

Made in the U.S.A. of globally sourced materials by 3M Health Care 2510 Conway Ave. St. Paul, MN 55144 1-800-228-3957 www.3M.com 3M and Attest are trademarks of 3M. Used under license in Canada. STERRAD® is a trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company.

13.2. Primary Label

13.3. Certificate of analysis

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13.4 Predicate Labeling

The predicate and submission device labeling are identical with the following exceptions:

1) the Indications for Use now match Form 3881 included in this submission, and 2) the

CoA country of origin statement has been changed to state “Made in USA of globally

sourced materials”. The predicate labeling is provided in Appendix H.

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Shelf Life

14 Shelf Life 14.1 Stability Plan

1.0 Purpose of Study:

New product design verification

To determine if the resistance characteristics of 3M™ Attest™ Rapid

Readout Biological Indicator 1295 for hydrogen peroxide are sufficiently

stable for the claimed period, when the product is transported and stored in

accordance with label directions.

2.0 Reference Documents:

2.1 Association for the Advancement of Medical Instrumentation;

Sterilization of health care products – Biological indicators – Part 1:

General Requirements (ANSI/AAMI/ISO 11138-1:2006)

2.2 The United States Pharmacopeia 34, General Notices; 10

Preservation, Packaging, Storage, and Labeling; 1150 Pharmaceutical

Stability, 2011 (USP 34)

2.3 The Center for Devices and Radiological Health, Guidance for

industry and staff: Biological Indicator (BI) Pre-market notification

510(k) Submission, 2007 (FDA guidance document for BIs)

3.0 Product to be Evaluated:

Table 1

Test Lot or

Control Lot Product Name Product ID#/ Lot/Batch#

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14.2 Stability Report

9.0 Deviations from Plan:

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Biocompatibility

15. Biocompatibility

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Software

16. Software Statement

The submission device does not include software. This page is included for

ease of submission packet review.

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Electrical Safety and EMC

17. Electrical Safety and EMC Statement

The submission device is not electromechanical in nature. This page is

included for ease of submission packet review.

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Bench Testing

18. Bench Testing

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ANSI/AAMI/ISO 11138-1:2006(R) 2010 (Annex B) for carrier and primary

packaging materials.

Reference Documents:

STERRAD® 100S® Sterilizer Operators Manual.

Test System:

STERRAD® 100S® Sterilizer, ASP, Irvine, CA, USA.

Test Samples:

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Reference Standards:

FDA Guidance Document: Guidance for Industry and Staff – Biological

Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.

A Growth Recovery method was developed similar to the protocol outlined in

ANSI/AAMI/ISO 11138-1:2006(R) 2010 (Annex B) for carrier and primary

packaging materials.

Reference Documents:

STERRAD® 100S® Sterilizer Operators Manual.

Test System:

STERRAD® 100S® Sterilizer, ASP, Irvine, CA, USA.

Test Samples:

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Appendix A

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Page 1 of 5

Technical Report

TECH-REPORT-

Version

Status: Release

Release Date: 7/6/2014 10:55:16 AM

NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red

Location Name Description

3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020

3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US

SIGNERS:

Attachment J J-1Attachment J J-1

K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H

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Appendix B

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SIGNERS:

Attachment K K-1Attachment K K-1


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SIGNERS:

Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H

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Appendix H

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13.1.1 Instructions for Use for Attest™ Rapid Readout Biological Indicator 1295

3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization

Product Description The 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization (pink cap, referred to hereinafter as the 1295 BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use device.

A schematic illustrating the design of the 1295 BI is provided in Figure 1. The self-contained design includes a carrier with spores of Geobacillus stearothermophilus and a media ampoule containing bacteriological growth medium which meets the requirements for growth promoting ability specified in ANSI/AAMI/ISO 11138-1:2006/(R)2010. The spore carrier and media ampoule are contained in a plastic vial topped with a pink cap. A chemical process indicator printed with stripes which change from blue to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap.

The 1295 BI utilizes the α-glucosidase enzyme system, which is

generated naturally within growing cells of Geobacillus

stearothermophilus. The α-glucosidase in its active state is

detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-

fluorescent substrate, 4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent

by-product, 4-methylumbelliferone (MU), is detected in the 490H Auto-reader. The presence of fluorescence within 4 hours of incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization process failure. The 1295 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by-products that cause the media to change color from purple to yellow

Figure 1: Design of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization

Page 100



which also indicates a sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Readout Time The 4-hour rapid readout has been correlated with a 7-day visual pH color change result following the FDA’s Reduced Incubation Time protocol.

4-hour Fluorescent Result 1295 BIs have a 4 hour reduced incubation time result that correlates to the 7 day (168 hours) visual readout result ≥ 97% of the time.

Due to the high reliability of the 4-hour fluorescent result there is no advantage to incubating 1295 BIs beyond 4 hours. 1295 BIs meet ANSI/AAMI/ISO 11138-1:2006/(R)2010 and EN/ISO 11138-1:2006.

Indications for Use Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization in conjunction with the 3M™ Attest™ Auto‑reader 490H to conduct routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization models, NX and 100NX. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization provides a final result in 4 hours.

Contraindications

None. Warnings There is a glass ampoule inside the plastic vial of the biological indicator (BI). To avoid the risk of serious injury from peroxide burns:

Wear safety glasses and gloves when removing the BI from the sterilizer. Wear safety glasses and gloves when activating the BI. Handle the BI by the cap when crushing or flicking.

Residual hydrogen peroxide may be trapped within the 1295 BI if the media ampoule is damaged during the sterilization process. If a broken ampoule is observed after processing, avoid direct contact with the 1295 BI as it may result in hydrogen peroxide burns. Follow the disposal instructions provided at the end of this document.

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Precautions 1. Do not use the 1295 BI to monitor sterilization cycles which it is not designed to challenge:

a. Steam sterilization cycles; b. Dry heat sterilization cycles; or c. Ethylene oxide sterilization processes.

2. To reduce the risk associated with incorrect results:

Before sterilization, inspect 1295 BI to verify media ampoule is intact and process indicator stripes are blue. Do not use any 1295 BIs which have a broken media ampoule or process indicator stripes which are not blue.

Do not place tape or labels on 1295 BI prior to sterilization or incubation in the 490H Auto-reader.

Activate and incubate the 1295 BI within 1 hour after the completion of the sterilization cycle.

Do not incubate a 1295 BI if, after processing and before BI activation, it is observed to have a broken media ampoule. Retest the sterilizer with a new biological indicator.

After 1295 BI activation, ensure media has flowed to the spore growth chamber.

3. To ensure the product functions as intended throughout the labeled shelf life, store 1295 BIs in the resealable foil pouch until use.

Monitoring Frequency:

Follow facility Policies and Procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As a best practice and to provide optimal patient safety, 3M recommends that every sterilization load be monitored with a biological indicator.

Directions for Use 1. Remove 1295 BI from sealed foil pouch, then reseal pouch if other 1295 BIs remain in

pouch. Do not place any labels or indicator tape on the vial or on the cap. 2. Place the 1295 BI in a peel-open pouch indicated for use in vaporized hydrogen peroxide

sterilization processes. Do not place the 1295 BI in direct contact with a chemical indicator as residue could transfer to the biological indicator and affect the result.

3. Place the pouched BI in the most challenging area of the sterilizer. The sterilizer manufacturer should be consulted to identify the area of the chamber least favorable to sterilization.

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4. Process the load according to recommended practices. 5. After completion of the cycle, don gloves and remove the pouched BI from the sterilizer.

Inspect the 1295 BI to verify the media ampoule is intact. If it is, remove the BI from the peel-open pouch and proceed to Step 6. If the media ampoule is broken, leave the 1295 BI in the peel-open pouch and follow disposal instructions. Retest the sterilizer using a new 1295 BI.

6. Check the process indicator on the top of the cap of the 1295 BI. A color change of the stripes from blue to pink confirms that the 1295 BI has been exposed to the vaporized hydrogen peroxide sterilization process. This color change does not indicate that the process was sufficient to achieve sterility. If the process indicator is unchanged, check the sterilizer physical monitors.

7. Identify the 1295 BI by writing the load number, sterilizer, and processing date on the indicator label.

8. To activate the biological indicator, while wearing gloves, place the 1295 BI in a 490H Auto-reader incubation well which is color-coded pink. Press the cap of the BI down firmly to close the cap and crush the glass ampoule. Immediately remove the BI and flick it (see picture at right). Visually verify that media has flowed into the growth chamber at the bottom of the vial. If the media hasn’t filled the growth chamber, hold the BI by the cap and flick it until media fills the growth chamber. Return the activated 1295 BI to the incubation well and wait for the result. See the 490H Auto-reader Operator’s Manual for further information related to its use. NOTE: Activate and incubate the 1295 BI within 1 hour of the completion of the sterilization cycle.

9. Each day that a processed 1295 BI is incubated, activate and incubate at least one non-processed 1295 BI to use as a positive control. Follow the activation instructions provided in Step 8 above. Write a "C" (for "control") and the date on the BI label. The positive control should be from the same lot code as the processed biological indicator. The positive control BI helps confirm:

correct incubation temperatures are met, viability of spores has not been altered due to improper storage temperature,

humidity or proximity to chemicals, capability of media to promote rapid growth, and proper functioning of the 490H Auto-reader.

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10. Incubation and Reading: Incubate the positive control and processed 1295 BIs at 60 ± 2°C in a 490H Auto-reader. See the 490H Auto-reader Operator’s Manual for the proper use of this equipment. Positive results are available within 4 hours. The 490H Auto-reader will indicate a positive result as soon as it is obtained. The final negative 1295 BI reading is made at 4 hours. After the results are displayed and recorded, the 1295 BIs may be discarded.

Interpretation of Results: Fluorescent Result The positive control (unprocessed) 1295 BI must provide a positive fluorescent result (+ symbol on the 490H Auto-reader LCD display). Processed 1295 BI results are not valid until the positive control reads fluorescent positive. The positive control should read positive at or before 4 hours. If the positive control reads negative (- symbol on the LCD display) at 4 hours, check the 490H Auto-reader Operator’s Manual Troubleshooting Guide. Retest the 490H Auto-reader with a new positive control. With processed 1295 BIs, a final negative reading (- symbol on the LCD display) after 4 hours of incubation indicates an acceptable sterilization process. A positive (+ symbol on the LCD display) result for a processed 1295 BI indicates a sterilization process failure. Act immediately on any positive results for processed BIs. Determine the cause of the positive BI following facility policies and procedures. Always retest the sterilizer and do not use sterilizer for processing loads until it has been re-qualified according to the manufacturer’s instructions. Optional Visual pH Color Change Result The 1295 BI is normally discarded after the fluorescent result has been recorded. If, however, special studies are desired, 1295 BIs may be further incubated for a visual pH color change result. In the case of the positive control BI, a yellow color change of the growth media will appear within 24 hours. Any observation of a yellow color within the vial indicates a positive result. In the case of a processed 1295 BI, a media color change from purple to yellow indicates a sterilization process failure. A negative pH color change result, i.e., media remains purple, can be assessed at 7 days. To avoid media dry-out, it is recommended that the 1295 BI be transferred to a humidified incubator operating at 60ºC after the fluorescent result has been recorded.

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Storage/ Shelf Life Store 1295 BIs in the original resealable foil pouch under normal room conditions: 59-86ºF

(15-30ºC). Do not store 1295 BIs near sterilants or other chemicals. The product’s expiration date is indicated on the BI and packaging by an hourglass symbol

followed by the year and month of expiration (e.g., 2015-05). All of the information to the right of the lot‑in‑a‑box symbol indicates the lot number

(e.g., 2015‑05AD). Disposal Dispose of used 1295 BIs according to your health care facility policy. Steam sterilize any positive biological indicators at 132°C (270°F) for 4 minutes or at 135°C (275°F) for 3 minutes in a dynamic-air-removal steam sterilizer prior to disposal. For processed BIs observed to have a broken media ampoule after the sterilization process, leave the BI in the peel-open pouch and place the pouch in packaging compatible with steam sterilization before steam processing.

Explanation of Symbols

Batch code

Use by date

Catalog number

Do not use if package is damaged or open.

Do not reuse.

Caution, see instructions for use.

Manufacturer

Mark of conformity to European Directives. For France and other countries that recognize the mark for this device.

Authorized representative for the European Community.

Product is designed for use with vaporized hydrogen peroxide sterilization processes.

Made in the U.S.A. of globally sourced materials by

3M Health Care

Page 105



2510 Conway Ave. St. Paul, MN 55144 1-800-228-3957 www.3M.com 3M and Attest are trademarks of 3M. Used under license in Canada. STERRAD® is a trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company. © 2013, 3M. All rights reserved. Issue Date: 2013-12

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13.1.2 Label on Attest™ Rapid Readout Biological Indicator 1295 The label on the 1295 BI is shown below. Its dimensions are 1.9 inches wide by 0.7 inch tall. The label will identify the product, method of sterilization (hydrogen peroxide), the indicator organism, the lot number and the expiry date. For record keeping, the user can fill in the information regarding the load, sterilizer and date for the cycle the BI is run in.

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October 20, 2015

Dr. Riley Myers

Scientific Reviewer

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation [510(K)]

Document Mail Center - WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Re: K152060/S001 for the 3MTM AttestTM Rapid Readout Biological Indicator 1295

Dear Dr. Myers,

As requested in your letter dated September 17, 2015, please find enclosed 3M’s written

responses to your questions related to the 510(k) Premarket Notification for 3MTM AttestTM

Rapid Readout Biological Indicator 1295. This document is submitted as one paper copy

and an electronic copy that is an exact duplicate of the paper copy.

Please contact me at the number below if you should have any questions concerning this

submission.

Sincerely,

Matt S. Mortensen, PhD, RAC 3M Health Care Regulatory Affairs


Phone (651) 737-2670

Fax: (651) 736-0897

St. Paul, MN 55144-1000

[email protected]



K152060/S001 Summary of Responses

K152060

3M Health Care


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K152060/S001

Attachment 1 – Revised 510(k) Summary



Premarket Notification (510(k)) Summary

Sponsor Information:

3M Health Care


St. Paul, MN 55144-1000

Contact Person: Matt S. Mortensen, Ph.D., RAC

Regulatory Affairs

Phone Number: (651) 737-2670

FAX Number: (651) 737-5320

Date of Summary: October 19, 2015

Device Name and Classification:

Common or Usual Name: Biological Indicator

Proprietary Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295



Product Code: FRC

Predicate Devices:

K140392 - 3M™ Attest™ Rapid Readout Biological Indicator 1295

Description of Device:

The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological

indicator specifically designed for rapid and reliable routine monitoring of STERRAD®

vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M

Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate

sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A

chemical process indicator printed with stripes which change from blue to pink upon exposure to

vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same

fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid



Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-

reader indicates a sterilization failure.

Nonclinical Comparison to the Predicate Device

This submission is addressing clearance for use in an additional sterilizer. The 3M™ Attest™

Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of

the same model number. There device has the same materials, performance specifications, and

fundamental scientific technology.

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M

Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized hydrogen

peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and

Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

Comparison to Predicate Device

Feature Submission Device: 3MTM

AttestTM 1295 Biological Indicator

Predicate Device (K140392):

3MTM AttestTM 1295 Biological

Indicator

Indications for use

Use the 3M™ Attest™ Rapid Readout

Biological Indicator 1295 in

conjunction with the 3M Attest™

Auto‑reader 490H as a standard method

of routine monitoring of vaporized


processes in STERRAD® 100S,

STERRAD® NX (Standard and

Advanced cycles) and 100NX

(Standard, Flex, Express and Duo

cycles) systems.



1295 in conjunction with the 3M

Attest™ Auto‑reader 490H as a


monitoring of vaporized hydrogen

peroxide sterilization processes in

STERRAD® NX and 100NX

systems.



Viable spore


Resistance

characteristics

D-value

(Tested at 10 mg/L vaporized hydrogen

peroxide)



Same



Survival/Kill

Window


Carrier material Polyethylene terephthalate Same

Incubation

temperature 60 +/- 2 oC Same

Readout time 4 hour fluorescence result read on 3M

490H Auto-reader Same

Chemical

indicator

H2O2 sensitive ink; appears blue until

processed, then appears pink Same

Shelf-life 18 months Same

Conclusion

The 3MTM AttestTM 1295 Biological Indicator is substantially equivalent to the predicate device

in terms of their intended use, physical properties and technological characteristics. The non-

clinical testing demonstrates that the 3MTM AttestTM 1295 Biological Indicator is as safe, as

effective, and performs as well as the predicate device.



K152060/S001

Attachment 2 – Testing (b)(4)



Confidential Page 1 of 4

Technical Report

TECH-REPORT-

Version: ersion>>

Status: Release<<Status>>

Release Date: 10/21/2015 9:42:17 AM



3M MAPLEWOOD-3MUS-MN 3M

HEADQUARTERS - 01J9C020

3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020:

3M CENTER, MAPLEWOOD, MN, US

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K152060/S001

Attachment 3 – Cap and Sleeve Toxicology Assessment



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3MTM AttestTM Biological Indicator 1295 Cap and Sleeve Toxicology Assessment Page 5 of 17

3M Confidential Page 5 of 17

4. Ikarashi, Y., T. Tsuchiya, and A. Nakamura, Cytotoxicity of medical materials sterilized

with vapour-phase hydrogen peroxide. Biomaterials, 1995. 16(3): p. 177-183.

5. IARC. IARC Monographs on the Evaluation of the Carcinogenic Risks to Humans -

Overall Evaluation of Carcinogenicity: An Updating of the IARC Monographs Volumes

1 to 42. 1987. (Supplement 7): pp. 47-55. Lyon, France:

http://monographs.iarc.fr/ENG/Monographs/suppl7/Suppl7.pdf. Date accessed 11-10-

2014.

6. USFDA. Inactive Ingredients Database for Approved Drug Products. 2008 May 29,

2009; Available from: http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.

7. HPDB. Household Products Database. Polypropylene CASRN 9003-07-0. 2010 June,

2010 [cited 2008 October 7]; Available from: http://hpd.nlm.nih.gov/.

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1. Eurocolor. Colourants for Food Contact Plastics: Aspects of Product Safety. 2002 [cited

2006 August 25]; Available from: www.cefic.be/files/Publications/FDL_en.pdf.

2. Eurocolour, Safe Handling of Color Pigments (European Edition),

ETAD/BCMA/VdMI/EPSOM, Editor. 1995.

3. ChemIDplus. ChemID. Linear Quinacridone RN: 1047-16-1. 2006 [cited 2006

November 27]; Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CHEM.

4. HSDB. Hazardous Substances Data Bank. Cinquasia Red. 2003 November 27, 2006];

Available from: http://toxnet.nlm.nih.gov.

5. CPMA Quinacridone Committee. High Production Volume (HPV) Challenge Program

Test Plan for C.I. Pigment Violet 19 (CAS NO.: 1047-16-l) AND C.I. Pigment Red 122

(CAS NO. 980-26-7) and Dihydro Quinacridone (CAS NO. 5862-38-4). Document No.

201-16303A. 2006 June 2006 [cited 2006 December 10]; Available from:

http://www.epa.gov/HPV/pubs/summaries/ci19122d/c16303tp.pdf.

6. ECHA. European Chemicals Agency. 5,12-dihydroquino[2,3-b]acridine-7,14-dione.

2012 [cited 2012 December 28];

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb276f2-5d9b-3f37-e044-

00144f67d031/DISS-9eb276f2-5d9b-3f37-e044-00144f67d031 DISS-9eb276f2-5d9b-

3f37-e044-00144f67d031.html.

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4. CIR, Final Report on the Safety Assessment of Polyethylene. International Journal of

Toxicology, 2007. 26(Suppl. 1):115-127. Available from:

http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr299.pdf

5. US FDA. Cumulative Estimated Daily Intake/Acceptable Daily Intake Database. . 2012

January 27, 2012 [cited 2013 January 5]; Available from:

http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=&sd=e

disrev&page=1.

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K152060/S001

Attachment 4 – Comparison of 1295 and CycleSure BI



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(b)(4) Third Party Manufacturing Information



K152060/S001

Attachment 5 Testing

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