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Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Traditional 510(k) PREMARKET NOTIFICATION Sonendo Endotherapy System
APPLICANT
Sonendo, Inc. 26061 Merit Circle, Suite 101
Laguna Hills, CA 92653
OFFICIAL CORRESPONDENT
Dan W. Miller Phone: 949.766.3636 x 544
FAX: 949.348.1866 (b)(4)
Records processed under FOIA Request 2013-5334; Released 2/6/14
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Sonendo, Inc. Sonendo Endotherapy System
Page 2 of 85 Premarket Notification
SONENDO ENDOTHERAPY SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
TABLE OF CONTENTS
SECTION PAGE TABLE OF CONTENTS ..........................................................................................................2 1. MEDICAL DEVICE USER FEE COVER SHEET (FORM FDA 3601) ............................ 4
2. CERTIFICATION OF COMPLIANCE WITH CLINICALTRIALS.GOV FDA FORM 3674 5
3. STANDARDS DATA REPORT FDA FORM 3654 ......................................................... 6
4. COVER LETTER ......................................................................................................... 7
5. INDICATIONS FOR USE STATEMENT ....................................................................... 10
6. 510(K) SUMMARY .................................................................................................... 11
7. TRUTHFUL AND ACCURATE STATEMENT ............................................................... 13
8. CLASS III SUMMARY AND CERTIFICATION ............................................................ 14
9. FINANCIAL CERTIFICATION OR DISCLOSURE STATEMENT ................................... 15
10. DECLARATION OF CONFORMITY & SUMMARY REPORTS ..................................... 16
11. EXECUTIVE SUMMARY ........................................................................................... 17
Device Description .................................................................................................. 17
Indications for Use .................................................................................................. 18
Predicate Devices .................................................................................................... 18
Performance Testing ............................................................................................... 19
12. DEVICE DESCRIPTION ............................................................................................. 20
12.1 CONSOLE ........................................................................................................ 21
12.2 MOLAR PROCEDURE KIT ................................................................................ 31
12.3 DEVICE OPERATION ........................................................................................ 35
13. SUBSTANTIAL EQUIVALENCE DISCUSSION ............................................................ 38
14. PROPOSED LABELING ............................................................................................. 45
14.1 SONENDO ENDOTHERAPY MOLAR PROCEDURE KIT INSTRUCTIONS FOR USE . 45
14.2 SONENDO ENDOTHERAPY SYSTEM CONSOLE INSTRUCTIONS FOR USE ........... 46
14.3 PRIMARY LABELING ....................................................................................... 47
15. STERILIZATION AND SHELF LIFE ........................................................................... 52
15.1 STERILITY ....................................................................................................... 52
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Sonendo, Inc. Sonendo Endotherapy System
Page 3 of 85 Premarket Notification
15.2 SHELF LIFE ..................................................................................................... 53
16. BIOCOMPATIBILITY ................................................................................................ 55
17. SOFTWARE .............................................................................................................. 65
18. ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY ........................ 73
19. PERFORMANCE TESTING ........................................................................................ 74
20. PERFORMANCE TESTING- ANIMALS ...................................................................... 84
21. CLINICAL DATA ...................................................................................................... 85
APPENDICES
(b)(4)
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Section 1 Medical Device User Fee cover Sheet
Sonendo, Inc. Sonendo Endotherapy System
Page 4 of 85 Premarket Notification
1. Medical Device User Fee Cover Sheet (Form FDA 3601) (see attached)
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Form Approved: OMB No 0910-511 Expiration Date: February 28, 2013 See Instructions for OMB Statement
DEPARTMENT OF HEALTH AND HUMANSERVICES FOOD AND DRUG ADMINISTRATION MEDICAL DEVICE USER FEE COVERSHEETA completed cover sheet must accompany each original application or supplement subject tofees. If payment is sent by U.S. mail or courier, please include a copy of this completed formwith payment. Payment and mailing instructions can be found at:http://www.fda.gov/oc/mdufma/coversheet.html
1. COMPANY NAME AND ADDRESS(include name, street address, city state,country, and post office code)
SONENDO INCSonendo, Inc.26061 Merit CircleSuite 10126061 Merit CircleLaguna Hills CA 92653US
1.1 EMPLOYER IDENTIFICATION NUMBER(EIN)
*****1718
2. CONTACT NAME Dan Miller2.1 E-MAIL ADDRESS
2.2 TELEPHONE NUMBER (include Areacode)
949-766-3636
2.3 FACSIMILE (FAX) NUMBER (IncludeArea code)
949-305-5201
3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if youare unsure, please refer to the application descriptions at the following web site:http://www.fda.gov/oc/mdufmaSelect an application type: 3.1 Select a center [X] Premarket notification(510(k)); except for third party [X] CDRH [ ] 513(g) Request for Information [ ] CBER [ ] Biologics License Application (BLA) 3.2 Select one of the types below [ ] Premarket Approval Application (PMA) [X] Original Application [ ] Modular PMA Supplement Types: [ ] Product Development Protocol (PDP) [ ] Efficacy (BLA) [ ] Premarket Report (PMR) [ ] Panel Track (PMA, PMR, PDP) [ ] Annual Fee for Periodic Reporting (APR) [ ] Real-Time (PMA, PMR, PDP) [ ] 30-Day Notice [ ] 180-day (PMA, PMR, PDP)
4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determiningthis status) [ ] YES, I meet the small business criteria and havesubmitted the required qualifying documents to FDA
[X] NO, I am not a small business
4.1 If Yes, please enter your Small Business Decision Number:
(b)(4)
(b)(4)
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2/2https://userf ees.f da.gov /OA_HTML/mduf maCScdCf gItemsPopup.jsp?v cname=Dan Miller&v cmpname…
"Close Window" Print Cover sheet
5. FDA WILL NOT ACCEPT YOUR SUBMISSION IF YOUR COMPANY HAS NOT PAID ANESTABLISHMENT REGISTRATION FEE THAT IS DUE TO FDA. HAS YOUR COMPANYPAID ALL ESTABLISHMENT REGISTRATION FEES THAT ARE DUE TO FDA? [X] YES (All of our establishments have registered and paid the fee, or this is our first device,and we will register and pay the fee within 30 days of FDA's approval/clearance of this device.) [ ] NO (If "NO," FDA will not accept your submission until you have paid all fees due to FDA.This submission will not be processed; see http://www.fda.gov/cdrh/mdufma for additionalinformation)
6. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USERFEE EXCEPTIONS? IF SO, CHECK THE APPLICABLE EXCEPTION.
[ ] This application is the first PMA submitted by aqualified small business, including any affiliates
[ ] The sole purpose of the application isto support conditions of use for a pediatricpopulation
[ ] This biologics application is submitted undersection 351 of the Public Health Service Act for aproduct licensed for further manufacturing use only
[ ] The application is submitted by a stateor federal government entity for a devicethat is not to be distributed commercially
7. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WEREWAIVED DUE TO SOLE USE IN A PEDIATRIC POPULATION THAT NOW PROPOSESCONDITION OF USE FOR ANY ADULT POPULATION? (If so, the application is subject to thefee that applies for an original premarket approval application (PMA). [ ] YES [X] NO
PAPERWORK REDUCTION ACT STATEMENT Public reporting burden for this collection of information is estimated to average 18 minutesper response, including the time for reviewing instructions, searching existing data sources,gathering and maintaining the data needed, and completing and reviewing the collection ofinformation. Send comments regarding this burden estimate or any other aspect of thiscollection of information, including suggestions for reducing this burden, to the address below.
Department of Health and Human Services, Food and Drug Administration, Office of ChiefInformation Officer, 1350 Piccard Drive, 4th Floor Rockville, MD 20850 [Please do NOT return this form to the above address, except as it pertains to comments onthe burden estimate.]
8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKETAPPLICATION
27-Dec-2012
Form FDA 3601 (01/2007)
(b)(4)
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Section 2 Certification of Compliance- ClinicalTrials.gov
Sonendo, Inc. Sonendo Endotherapy System
Page 5 of 85 Premarket Notification
2. Certification of Compliance with ClinicalTrials.gov FDA Form 3674 (see attached)
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Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
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Section 3 Standards Data Report Form(s)
Sonendo, Inc. Sonendo Endotherapy System
Page 6 of 85 Premarket Notification
3. Standards Data Report FDA Form 3654 (see attached)
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118
Records processed under FOIA Request 2013-5334; Released 2/6/14
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Records processed under FOIA Request 2013-5334; Released 2/6/14
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Section 5 Indications for Use Statement
5. Indications for Use Statement
INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ___________ Device Name: Sonendo Endotherapy System Indications for Use: The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___
Prescription Use __X___
AND/OR Over-The-Counter Use_____
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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Section 6 510(k) Summary
Sonendo, Inc. Sonendo Endotherapy System
Page 11 of 85 Premarket Notification
6. 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
APPLICANT: Sonendo, Inc.
DATE PREPARED: December 29, 2012
CONTACT PERSON: Dan W. Miller Sonendo, Inc. 26061 Merit Circle, Suite 101 Laguna Hills, CA 92653 Phone: (949) 766.3636 x 544
TRADE NAME: Sonendo Endotherapy System
CLASSIFICATION NAME:
Ultrasonic Scaler
DEVICE CLASSIFICATION:
Class 2, per 21 CFR 872.4850
PRODUCT CODE ELC
PREDICATE DEVICES: EMS Piezon Master 700 (K093000) Sonic Air MM 1500+ (MID) (K081268)
Substantially Equivalent To: The Sonendo Endotherapy System is substantially equivalent in intended use, principal of operation and technological characteristics to the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268). Description of the Device Subject to Premarket Notification: The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece. Indication for Use: The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy. Technical Characteristics: The Sonendo Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:
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Section 6 510(k) Summary
Sonendo, Inc. Sonendo Endotherapy System
Page 12 of 85 Premarket Notification
Performance Data:
(b)(4)
(b)(4)
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Section 7 Truthful & Accurate Statement
Sonendo, Inc. Sonendo Endotherapy System
Page 13 of 85 Premarket Notification
7. Truthful and Accurate Statement Pursuant to 21 CFR 807.87(j) I certify that in my capacity as Vice President, Quality/Regulatory/Clinical Affairs for Sonendo, Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
_________________________________________ ________________ Dan W. Miller Date Sonendo, Inc.
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Section 8 Class III Summary and Certification
Sonendo, Inc. Sonendo Endotherapy System
Page 14 of 85 Premarket Notification
8. Class III Summary and Certification The Sonendo Endotherapy System is a Class II medical device under 21 CFR 872.4850. The Class III Summary and Certification requirement as described in 21 CFR §807.87(j) and §807.94 do not apply to this device and submission.
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Section 9 Financial Certification or Disclosure Statement
Sonendo, Inc. Sonendo Endotherapy System
Page 15 of 85 Premarket Notification
9. Financial Certification or Disclosure Statement The requirement for financial certification or disclosure requirement as described in 21 CFR §807.87(i) does not apply to this submission.
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Section 10 Declaration of Conformity & Summary Reports
Sonendo, Inc. Sonendo Endotherapy System
Page 16 of 85 Premarket Notification
10. Declaration of Conformity & Summary Reports This submission is a traditional 510(k) submission. The requirement for a declaration of conformity and a summary report of testing does not apply.
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Section 11 Executive Summary
Sonendo, Inc. Sonendo Endotherapy System
Page 17 of 85 Premarket Notification
11. Executive Summary (b)(4)
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Section 11 Executive Summary
Sonendo, Inc. Sonendo Endotherapy System
Page 18 of 85 Premarket Notification
(b)(4)
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Sonendo Endotherapy System
Molar Procedure Kit DRAFT
Instructions for Use
Federal law restricts this device to sale by or on the order of licensed dental professional
26061 Merit Circle, Suite 101 Laguna Hills, CA 92653 PH: 949-766-3636 FAX:949-348-1866
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Section 15 Sterilization & Shelf Life
Sonendo, Inc. Sonendo Endotherapy System
Page 52 of 85 Premarket Notification
15. Sterilization and Shelf Life
Sterilization Validation
(b)(4)
(b)(4)
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Section 15 Sterilization & Shelf Life
Sonendo, Inc. Sonendo Endotherapy System
Page 53 of 85 Premarket Notification
(b)(4)
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Section 15 Sterilization & Shelf Life
Sonendo, Inc. Sonendo Endotherapy System
Page 54 of 85 Premarket Notification
.
(b)(4)
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Section 16 Biocompatibility
Sonendo, Inc. Sonendo Endotherapy System
Page 55 of 85 Premarket Notification
16. Biocompatibility (b)(4)
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Section 17 Software
Sonendo, Inc. Sonendo Endotherapy System
Page 65 of 85 Premarket Notification
17. Software (b)(4)
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Section 19 Performance Testing- Bench
Sonendo, Inc. Sonendo Endotherapy System
Page 74 of 85 Premarket Notification
19. Performance Testing (b)(4)
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Appendices
Sonendo, Inc.
Sonendo Endotherapy System Page 1
Premarket Notification
Appendix 2 Sonendo Endotherapy System Technical Drawings
(see attached)
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Appendices
Sonendo, Inc.
Sonendo Endotherapy System Page 1
Premarket Notification
Appendix 3 Sonendo Endotherapy System Biocompatibility Reports
(see attached)
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CONFIDENTIAL Sonendo ®
Title Software Risk/Hazard Analysis
Sonendo ® | Page 1 of 19
Software Risk/Hazard Analysis
(b)(4)
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Appendices
Sonendo, Inc.
Sonendo Endotherapy System Page 1
Premarket Notification
Appendix 11 Sonendo Endotherapy System Electromagnetic Compatibility Test
Report
(see attached)
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Appendices
Sonendo, Inc.
Sonendo Endotherapy System Page 1
Premarket Notification
Appendix 13 , Thermal Safety Experiment Report
(see attached)
(b)(4)
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SONENDO Inc –Confidential (b)(4)
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Appendices
Sonendo, Inc.
Sonendo Endotherapy System Page 1
Premarket Notification
Appendix 17 Imaging of Cavitation Clouds
(see attached)
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CONFIDENTIAL Sonendo™
(b)(4)
(b)(4)
(b)(4)
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Appendix I
Optical Analysis via Stereo Microscope (8x)
Thirteen specimens imaged at 8x magnification
Sonendo Endotherapy System
(b)(4)
(b)(4)
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SONENDO Inc.–Confidential
Appendix II
Optical Analysis via Stereo Microscope (8x)
Five specimens imaged at 8x magnification
EMS Piezon Master 700
(b)(4)
(b)(4)
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Appendix III
Optical Analysis via Scanning Electron Microscope
Four canals imaged at 50x and 200x magnification
Sonendo Endotherapy System
(b)(4)
(b)(4)
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SONENDO Inc.–Confidential
Appendix IV
Optical Analysis via Scanning Electron Microscope
Four canals imaged at 50x and 200x magnification
EMS Piezon Master 700
(b)(4)
(b)(4) (b)(4)
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Page 1 of 6 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
December 29, 2012 MD6066279-956733 K130025
Sonendo, Inc
NA 949-766-3636
26061 Merit Circle, Suit 101 949-305-5201
Laguna HIlls CA 92653 USA
Dan Miller
Vice President of Regulatory/Clinical Affairs, and Quality Assurance dmiller@sonendo.com
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):
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Page 2 of 6 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)
Other Reason (specify):
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
Other Reason (specify):
Additional or Expanded Indications
March 12, 2013: First Round Deficiencies Notification, Dr. Belani
SECTION D1
SECTION D3
SECTION D2
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Page 3 of 6 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
ELC
K093000 EMS Piezon Master 700 EMS Electro Medical Systems SA
K081268 Sonic Air MM 1500+ (MID) Micro-Mega S.A.
Ultrasonic Scaler
Sonendo Endotherapy System
Sonendo Endotherpay Molar Handpiece Kit
109-0008-001
109-0006-001
K130025
ELC 21 CFR 872.4850
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
SECTION F
SECTION G
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Note: Submission of the information entered in Section H does not affect the need to submit device establishment registration.
FDA Document Number (if known)
MANUFACTURING / PACKAGING / STERILIZATION SITES RELATING TO A SUBMISSION
K130025
SECTION H(b)(4)
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Page 6 of 6 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
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
DateStandards No. Standards Title Version
ISO 10993-1 International Organization for Standardization
Biological Evaluation of Medical Device- Part 1 Evaluation and Testing
4
01/01/2009
ISO 10993-5 International Organization for Standardization
Biological Evaluation of Medical Device- Part 5 Tests for In Vitro Cytotoxicity
3
01/01/2009
ISO 10993-10International Organization for Standardization
Biological Evaluation of Medical Device- Part 10 Tests for Irritation and Delayed Hypersensitivity
3
01/01/2010
ISO 10993-11International Organization for Standardization
Biological Evaluation of Medical Device- Part 11 Tests for Systemic Toxicity
2
01/01/2006
ISO 11137-1International Organization for Standardization
Sterilization of Health Care Products- Radiation- Part 1 Requirements for Development of Validation
1
01/01/2006
ISO 11137-2International Organization for Standardization
Sterilization of Health Care Products- Radiation- Part 2 Establishing Sterilization Dose
2
01/01/2006
IEC 60601-1-1-2 International Electrotechnical Commission
Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests 3
01/01/2007
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FDA FORM 3514 K130025: Section I Utilization of Standards (continued)
# Standards No.
Standards Organization
Standards Title Version Date
8 IEC 60601-1 International Electrotechnical Commission
Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
3 01/01/2006
9 ISO 11607-1 International Organization for Standardization
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
1 01/01/2006
Page 1 of 1
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Section 19 Performance Testing- Bench
19. Performance Testing
(b)(4)
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