APR 2 32013

SNUVASIVEK 123307/S01 - NaVasive® NVMS® System

March 15, 2013

510(k) Summary

In accordance with Title 21.of the Code of Federal Regulations, Part 807, and in particular 21 CER§807.92, the following summary of information is provided:

A. Submitted by:

Sheila BruschiManager, Regulatory AffairsNuVasive, Incorporated7475 Lusk Blvd.San Diego, California 92121Telephone: (858) 909-1800

Date Prepared: March 13, 2013

B. Device Name

Trade or P .roprietary Name: NuVasive® NVM5' SystemCommon or Usual Name: Neurological surgical monitor;

Stereotaxic InstrumentClassification Name: Surgical Nerve Stimulator/Locator;

Evoked response electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMO) monitor/stimulator

Device Class: Class 11Classification: §874.1820, §882.1870, §882.4560, §890.1375Product Code: PDO. FUN, GWF, HAW, IKN, OLO

C. Predicate Devices

The subject NuVasive NVMS System is substantially equivalent to one or more of the followingpredicate devices listed in Table 1 below.

_____________Table 1 - Predicate Devices ________

510O(k) Trade -or proprietary or model name Manufacturer

K 112718 NVM5 Sy'stemn NuVasive, Inc.K122742 Bendini 'Spinal Rod Bending System NuVasive, Inc.K050438 -StealthStation MedtronicKO012448 VectorVision Trauma BrainLAB

D. Device Description

NVMS System is a medical device that is intended for intraoperative neurophysiologicmonitoring during spinal surgery. The device provides information directly to the surgeon, tohelp assess a patient's neurophysiologic status. NVMS provides this information by tlectricallystimulating nerves via electrodes located on surgical accessories and monitoringelectromyography (EMO), transcranial motor evoked potential (TcMEP) or somatosensoryevoked potential* (SSEP) responses of nerves. Moreover, a Twitch Test ("Train of Four")function is utilized to test the ability of the nerve to respond, or contract, following fourstimulation pulses to determine the presence of neuromuscular block.

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NUVASIVE7 K123307/SOI -NuVasive N VMS® System..... .March 15, 2013

Additionally, the NVMS System includes an integrated stereotactic guidance system (NVMSGuidance) to support the delivery of pedicle screws during EMO monitoring. Thle System alsointegrates BendinliM software used to locate spinal implant instrumentation for the placement ofspinal rods. Lastly, the system also offers an optional screen sharing application (RemoteMonitoring) to allow a secondary physician to remotely view the events represented on theNVMS user interface. In summary, the NVMS System includes the following six (6) softwarefunctionalities / modalities:

I1. Electromyography (EMG)2. Transcranial Motor Evoked Potential (TceMEP), or simply MEP

3. Somatosensory Evoked Potential (SSEP)

4. Guidance

5. Bendini6. Remote Monitoring

The NVMS System hardware consists of a Patient Module (PM) and computer, as well asaccompanying accessory components which consist of an assortment of disposable conductiveprobes, electrodes, and electrode leads.

E. Intended Use

The NVMS System is a medical device that is intended for intraoiperative neurophysio logicmonitoring during spinal surgery. The device provides information directly to the surgeon, tohelp assess a patient's neurophysiologic status. NVMS provides this information by electricallystimulating nerves via electrodes located on surgical accessories and monitoringelectromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensoryevoked potential (SSEP) responses of nerves. The System also integrates Bendini TM softwareused to locate spinal implant instrumentation for the placement oftspinal rods.

*XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate andevaluate spinal nerves, and is used as a nerve avoidance tool.

*Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate andevaluate spinal nerves by providing proximity information before, during or after bonepreparation and placement of bone screws.

*Free Run EMO - Thle Free Run 13MG function identifies spontaneous EMG activity ofspinal nerves by continually displaying a live stream waveform of any mechanicallyinduced myotome contractions.

.Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assessmoderate degrees of neuromuscular block in effect by evaluating muscle contractionfollowing a train of four stimulation pulses.

*TceMEP - Transcranial stimulation techniques for motor evoked potentials are used toassess for acute dysfunction in axonal conduction of the corticospinal tract. The TceMEPfunction provides an adjunctive method to allow the surgeon to monitor spinal cord andmotor pathway integrity during procedures with a risk of surgically induced motor injury.

*SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function insurgical procedures during which the spinal cord is at risk.

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!-NUJVASIVE K123307/SOI -Na Vasive N VMS® SystemMarch 15, 2013

* Remote Reader - The Remote Reader function provides real time remote access to theNVM5 System for a mionitoring physician outside of the operating room.

* Guidance - The Guidance function is intended as an aid for use in either open orpercutaneous pedicle cannulation procedures in the lumbar and sacral spine (L I-S I) of adultpatients, and when used in conjunction with radiographic imaging and EMO, allows thesurgeon to assess the angulation of system accessories relative to patient spinal anatomy forthe creation of a cannulation trajectory for bone screw placement.

SBendini - The Bendini Spinal Rod Bending function is used to locate spinal implant systeminstrumentation (screws, hooks) to determine their relative location to one another togenerate bend instructions to shape a spinal rod. A surgeon is able to use those instructionsand bend a rod using the Bendini Bender, a mechanical rod bender.

F. Technological Characteristics

As was established in this submission, the subject NVMS System is substantially equivalent toother predicate devices cleared by the FDA for commercial distribution in the United States.The subject device was shown to be substantially equivalent and have equivalent technologicalcharacteristics to its predicate devices through comparison in areas including design, intendeduse, material composition, and functions. The technological differences within this 5 10O(k) thatwvere shown to be substantially equivalent to the predicates include:

* Addition of Red/Yellow/Green background alerts to the SSEP Function* Addition of the Bendini function (equivalent to predicate Bendini System K 122742),

and* Use of the NVMS System with NuVasive-supplied compatible computer.

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G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NVMS System issubstantially equivalent to other predicate devices and to verify' that the NVMS Systemmeets design specifications and performance characteristics, based upon the intended use.The NVM5 System was subjected to verification and validation testing, as well as electricalsafety / compatibility testing, as follows:

" IEC 60601-1 (1988), Al1 (1991), A2 (1995): Medical Electrical Equipment Part 1:General Requirements for Safety

* IEC 60601-2-40 (1988): Medical Electrical Equipment Part 2-40:Particularrequirements for the safety of electromyographs and evoked response equipment

* IEC 60601-1-2 (2001), Al1 (2004): Medical Electrical Equipment Part 1-2: GeneralRequirements for Safety Collateral Standard Electromagnetic Compatibility

* NVMS System Verification and Validation Testing

* NVM5 System software Regression Testing

* Guidance performance data comparison from literature - data from clinicalliterature demonstrated substantial equivalence of the subject device to thepredicates BrainLAB VectorVision Trauma and Medtronic StealthStation forlumbosacral levels: (1) Accuracy of percutaneous lumbar pedicle screw placementusing the oblique or "owl 's-eye " view and novel guidance technology (I NeurosurgSpine, 20 10) and (2) Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort (J NeurosurgSpine, 2009)].

" Nonclinical testing performed for the Bendini function included evaluation ofsoftware performance per predetermined specifications outlined in the SRS, GUIfunctionality, error handling, system accuracy during data acquisition, verificationof instrument performance in combination with the software, and verification ofsoftware algorithms.

The results of these studies showed that the subject NVMS System meets or exceeds theperformance of the predicate device, and the device was therefore found to be substantiallyequivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, andcomparison to predicate devices, the subject NVMS System has been shown to besubstantially equivalent to legally marketed predicate devices, and safe and effective for itsintended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

~prii Food and Drug Administration

23 ,201310903 New Hampshire AvenueDocument Control Center - W066-G609Silver Spring, MD 20993-0002

NuVasive, Inc.Sheila BrusehiManager, Regulatory Affairs7475 Lusk Blvd.San Diego, CA 92121

Re: K123307Trade/Device Name: NuVasive NVM5 SystemRegulation Number: 21 CFR 874.1 820Regulation Name: Surgical nerve stimulator/locatorRegulatory Class: Class 11Product Code: PDQ, ETh, GWF, HAW, IKN, OLODated: March 15, 2013Received: March 20, 2013

Dear Ms. Bruschi:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH4 does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthfuil and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) orclass IIl (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Ms. Sheila Bruschi

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CER 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go to:http://www.fda.g~ov/MedicaDevices/Safetv/ReportaProblem/defaulIt.htm for the CDRH 's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet address:http://www. fda.2ov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yous

JoyceM 7W hang -Sfor Victor Krauthamer, Ph.D.

Acting DirectorDivision of Neurological

and Physical Medicine DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Indications for Use

510O(k) Number (if known): K1 23307

Device Name: NVMS1 System

Indications For Use:

The NVMV5® System is a medical device that is intended for intraoperativeneurophysiologic monitoring during spinal surgery. The device provides informationdirectly to the surgeon, to help assess a patient's neurophysiologic status. NVMV5provides this information by electrically stimulating nerves via electrodes located onsurgical accessories and monitoring electromyography (EMG), transcranial motorevoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses ofnerves. The System also integrates BendiniTM software used to locate spinal implantinstrumentation for the placement of spinal rods.

* XLIF® (Detection) - The XLIF (Detection) function allows the surgeon to locateand evaluate spinal nerves, and is used as a nerve avoidance tool.

" Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon tolocate and evaluate spinal nerves by providing proximity information before,during or after bone preparation and placement of bone screws.

* Free Run EMG - The Free Run EMVG function identifies spontaneous EMVGactivity of spinal nerves by continually displaying a live stream waveform of anymechanically induced myotome contractions.

* Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon toassess moderate degrees of neuromuscular block in effect by evaluating musclecontraction following a train of four stimulation pulses.

* TcMEP - Transcranial stimulation techniques for motor evoked potentials areused to assess for acute dysfunction in axonal conduction of the corticospinaltract. The TcMEP function provides an adjunctive method to allow the surgeon tomonitor spinal cord and motor pathway integrity during procedures with a risk ofsurgically induced motor injury.

" SSEP - The SSEP function allows the surgeon to assess sensory spinal cordfunction in surgical procedures during which the spinal cord is at risk.

* Remote Reader - The Remote Reader function providesreal time remote accessto the NVMV5 System for a monitoring physician outside of the operating room.

* Guidance - The Guidance function is intended as an aid for use in either open orpercutaneous pedlicle cannulation procedures in the lumbar and sacral spine (Li-Si) of adult patients, and when used in conjunction with radiographic imagingand EMG, allows the surgeon to assess the angulation of system accessoriesrelative to patient spinal anatomy for the creation of a cannulation trajectory forbone screw placement.

* Bendini - The Bendini Spinal Rod Bending function is used to locate spinalimplant system instrumentation (screws, hooks) to determine their relativelocation to one another to generate bend instructions to shape a spinal rod. Asurgeon is able to use those instructions and bend a rod using the BendiniBender, a mechanical rod bender.

Prescription Use X AND/OR Over-The-Counter Use ____

(Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce MtWhang -S(Division Sign Off)Division of Neurological and Physical MedicineDevices (NMD)

510(k) Number K123307

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