The Next Generation NVM5® System is a medical device that is intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surger and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMC), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM software used to locate spinal implant instrumentation for the placement of spinal rods. · XLIF (Detection) — The XLIF (Detection) function allows the surgeon to locate and evaltiate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate 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 EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying alive stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) — The Twitch Test function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The ME? function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor 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 in surgical procedures during which the spinal cord is at risk.

• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.

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

Device Description

The NG-NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NG-NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover. a Twitch Test function is utilized to test the ability of the nerve to respond, or contract. following four stimulation pulses to determine the presence of neuromuscular block.

The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.

In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:

1. Electromyography (EMG)
Motor Evoked Potential (MEP) 2.
1. Somatosensory Evoked Potential (SSEP)
1. Remote Access
1. Bendini

The NG-NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

AI/ML Overview

This document describes the NuVasive Next Generation NVM5 System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities.

The relevant information regarding acceptance criteria and study to prove device meets the acceptance criteria is detailed below:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in distinct quantitative values. Instead, it states that "The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as the performance of the predicate device". The comparison table provided (Table 1 – Comparison of Technical Characteristics on page 6) focuses on technological characteristics and functionalities of the subject device against predicate devices, indicating equivalence rather than specific performance metrics against pre-defined thresholds.

Criterion Category	Acceptance Criteria (Implied / Compared to Predicate)	Reported Device Performance
Overall Performance	Substantially equivalent to predicate devices, meeting design specifications and performance characteristics.	Demonstrated substantial equivalence and met design specifications and performance characteristics. The system performs equivalently to the predicate devices.
Accuracy of Angle and Offset Measurement (Bendini software)	Accurate measurement of angle and offset.	Laboratory bench top testing verified accuracy of angle and offset measurement.
Graphical User Interface (GUI) and System Components Functionality	GUI and system components function as intended.	Laboratory bench top testing validated that the GUI and system components function as intended.
Current and Power Densities (Cutaneous Electrodes)	Current and power densities are acceptable and comparable to predicate.	Current and power densities were calculated and supported substantial equivalence of cutaneous electrodes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Laboratory bench top testing" and "Verification and Validation Testing" but does not specify sample sizes for these tests, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of data). This suggests that the studies were non-clinical in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies described are non-clinical benchtop and verification/validation tests, not studies requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document, as the studies are non-clinical benchtop and verification/validation tests, not clinical studies requiring adjudication methods for ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies. The device is for intraoperative neurophysiologic monitoring and spinal rod bending assistance, and the studies described are non-clinical verification and validation activities. There is no indication of AI assistance being evaluated in comparison with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The studies described are non-clinical benchtop and verification/validation tests focusing on the device's technical performance, including the accuracy of angle and offset measurement and the functionality of the GUI and system components. This implicitly evaluates some aspects of the device's standalone performance (e.g., the Bendini software's ability to locate instrumentation and generate bend instructions). However, the device is intended for intraoperative use, with direct information provided to the surgeon, indicating a human-in-the-loop context. The document does not explicitly delineate studies demonstrating "algorithm only without human-in-the-loop performance" as a separate category of evaluation beyond the aforementioned technical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical benchtop tests, the "ground truth" would have been established by engineering specifications, calibrated measurement tools, and predefined functional requirements (e.g., ensuring a certain angle is measured correctly by the device against a known standard). This is implicit in "Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended."

8. The sample size for the training set

The document describes non-clinical testing for verification and validation and does not mention training sets, as it is not an AI/machine learning device in the context of data-driven model training.

9. How the ground truth for the training set was established

As no training set is mentioned for an AI/machine learning model, this information is not applicable. The device's validation is based on engineering specifications and direct performance measurements.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2017

NuVasive Incorporated Mary Adams Regulatory Affairs Consultant 7475 Lusk Blvd. San Diego, California 92121

Re: K162313

Trade/Device Name: NuVasive Next Generation NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: February 15, 2017 Received: February 16, 2017

Dear Ms. Adams:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162313

Device Name

NuVasive® Next Generation NVM5 System

Indications for Use (Describe)

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying alive stream waveform of any mechanically induced myotome contractions.

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

• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.

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)

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510(k) Summary

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

A. Submitted by:

Mary Adams Regulatory Affairs Consultant NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (909) 991-5235 Date Prepared: March 13, 2017

B. Device Name

	Trade or Proprietary Name:	NuVasive® Next Generation NVM5® System
Common or Usual Name:	Neurological surgical monitor;Stereotaxic Instrument
Classification Name:	Surgical Nerve Stimulator/Locator;Evoked response electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG) monitor/stimulator
Device Class:	Class II
Classification:	§874.1820, §882.1870, §882.4560, §890.1375
Product Code:	PDQ, ETN, GWF, HAW, IKN, OLO

C. Predicate Devices

The subject NuVasive Next Generation (NG) NVM5 System is substantially equivalent to the following predicate devices:

NuVasive NVM5 System K152942 (Primary Predicate) Medtronic NIM 3.0 Nerve Integrity Monitor K083124 (Additional Predicate) NuVasive NVM5 System K132694 (Reference Predicate for current density of the cutaneous electrodes)

D. Device Description

The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle

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screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.

In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:

1. Electromyography (EMG)
Motor Evoked Potential (MEP) 2.
1. Somatosensory Evoked Potential (SSEP)
1. Remote Access
1. Bendini

Intended Use E.

The Next Generation NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods.

XLIF (Detection) The XLIF (Detection) function allows the surgeon to locate and ● evaluate spinal nerves, and is used as a nerve avoidance tool.
Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate 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 EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor 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 in ● surgical procedures during which the spinal cord is at risk.

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Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

F. Technological Characteristics

As was established in this submission, the subject NG-NVM5 System is substantially equivalent to other 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 technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and functions. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates include additional angular and offset spinal parameter assessment.

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Table 1 – Comparison of Technical Characteristics
Specification/Property	Predicate DeviceMedtronic NIM 3.0 NerveMonitoring System (K083124)	Predicate DeviceNuVasive NVM5 System (K152942 and K132694)	Subject DeviceNuVasive NG-NVM5 System
Intended Use /Indications forUse	Intended Use: The NIM 3.0 is intended forlocating and identifying cranial andperipheral motor and mixed motor-sensorynerves during surgery, including spinal cordand spinal cord nerve roots. The APSelectrode is an accessory intended forproviding automatic periodic stimulation tonerves when used with the Medtronic NerveMonitoring Systems.Indications for NIM 3.0 EMG MonitoringProcedures include:Intracranial, Extracranial, Intratemporal,Extratemporal, Neck Dissections, ThoracicSurgeries, and Upper and LowerExtremitiesIndications for Spinal procedures whichmay use NIM 3.0 EMG monitoring include:Degenerative Treatments, Pedicle ScrewProcedures, Fusion Cages, Rhizotomy,Orthopedic Surgery, Open andPercutaneous Lumbar and Cervical SurgicalProcedures, and Thoracic SurgicalProcedures.	The NVM5® System is a medical device that is intended for intraoperativeneurophysiologic monitoring during spinal surgery. The device providesinformation directly to the surgeon, to help assess a patient'sneurophysiologic status. NVM5 provides this information by electricallystimulating nerves via electrodes located on surgical accessories andmonitoring electromyography (EMG), transcranial or lumbar motor evokedpotential (MEP), or somatosensory evoked potential (SSEP) responses ofnerves. The System also integrates Bendini® software used to locate spinalimplant instrumentation for the placement of spinal rods.• XLIF (Detection) – The XLIF (Detection) function allows the surgeon tolocate and evaluate spinal nerves, and is used as a nerve avoidance tool.• Basic & Dynamic Screw Test - The Screw Test functions allow thesurgeon to locate and evaluate spinal nerves by providing proximityinformation before, during or after bone preparation and placement ofbone screws.• Free Run EMG - The Free Run EMG function identifies spontaneousEMG activity of spinal nerves by continually displaying a live streamwaveform of any mechanically induced myotome contractions.• Twitch Test (Train of Four) - The Twitch Test Function allows thesurgeon to assess moderate degrees of neuromuscular block in effect byevaluating muscle contraction following a train of four stimulation pulses.• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulationtechniques for motor evoked potentials are used to assess for acutedysfunction in axonal conduction of the corticospinal tract and peripheralnerves. The MEP function provides an adjunctive method to allow thesurgeon to monitor spinal cord and motor pathway integrity duringprocedures with a risk of surgically induced motor injury.• SSEP - The SSEP function allows the surgeon to assess sensory spinalcord function in surgical procedures during which the spinal cord is atrisk.• Remote Reader - The Remote reader function provides real time remoteaccess to the NVM5 System for a monitoring physician outside of theoperating room• Guidance - The Guidance function is intended as an aid for use in eitheropen or percutaneous pedicle cannulation procedures in the lumbar andsacral spine (L1-S1) of adult patients, and when used in conjunction withradiographic imaging and EMG, allows the surgeon to assess theangulation of system accessories relative to patient spinal anatomy for thecreation of a cannulation trajectory for bone screw placement.• Bendini - The Bendini Spinal Rod Bending function is used to locatespinal implant system instrumentation (screws, hooks) to determine theirrelative location to one another to generate bend instructions to shape aspinal rod. A surgeon is able to use those instructions and bend a rodusing the Bendini Bender, a mechanical rod bender.	The Next Generation NVM5® System is a medical device that isintended for intraoperative neurophysiologic monitoring during spinalsurgery, neck dissections, thoracic surgeries, and upper and lowerextremities. The device provides information directly to the surgeon,to help assess a patient's neurophysiologic status. NG-NVM5 providesthis information by electrically stimulating nerves via electrodeslocated on surgical accessories and monitoring electromyography(EMG), transcranial or lumbar motor evoked potential (MEP) orsomatosensory evoked potential (SSEP) responses of nerves. TheSystem also integrates Bendini™ software used to locate spinal implantinstrumentation for the placement of spinal rods.• XLIF (Detection) - The XLIF (Detection) function allows thesurgeon to locate and evaluate spinal nerves, and is used as a nerveavoidance tool.• Basic & Dynamic Screw Test - The Screw Test functions allow thesurgeon to locate and evaluate spinal nerves by providing proximityinformation before, during or after bone preparation and placementof bone screws.• Free Run EMG - The Free Run EMG function identifiesspontaneous EMG activity of spinal nerves by continuallydisplaying a live stream waveform of any mechanically inducedmyotome contractions.• Twitch Test (Train of Four) – The Twitch Test Function allows thesurgeon to assess moderate degrees of neuromuscular block ineffect by evaluating muscle contraction following a train of fourstimulation pulses.• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2)stimulation techniques for motor evoked potentials are used toassess for acute dysfunction in axonal conduction of thecorticospinal tract and peripheral nerves. The MEP functionprovides an adjunctive method to allow the surgeon to monitorspinal cord and motor pathway integrity during procedures with arisk of surgically induced motor injury.• SSEP - The SSEP function allows the surgeon to assess sensoryspinal cord function in surgical procedures during which the spinalcord is at risk.• Remote Access - The remote monitoring and local wireless controlprovides real-time capabilities to the NG-NVM5 System foradditional physicians.• Bendini - The Bendini Spinal Rod Bending function is used tolocate spinal implant system instrumentation (screws, hooks) todetermine their relative location to one another to generate bendinstructions to shape a spinal rod. A surgeon is able to use thoseinstructions and bend a rod using the Bendini Bender, a mechanicalrod bender.
Specification/Property	Predicate DeviceMedtronic NIM 3.0 NerveMonitoring System (K083124)	Predicate DeviceNuVasive NVM5 System (K152942 and K132694)	Subject DeviceNuVasive NG-NVM5 System
SoftwareModalities /Functionalities	• Stimulating EMG (manualand APS)• Free run EMG	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Remote Reader• Guidance• Bendinio NuvaMap O.R.• NuvaLine spinal parameter assessment tools (optional)	• XLIF (Detection)• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test• MEP• SSEP• Remote Access (Remote Monitoring and LocalWireless Control)• Bendinio NuvaMap O.R.
Algorithms	• APS	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Guidance• Bendini - Rod bending and spinal parameter assessment	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Remote Access• Bendini – Rod bending and spinal parameterassessment
Total AvailableChannels	Up to 8	32	32
Headbox/Patient Module	Unknown	Yes	Yes
IEC 60601-1Compliant	Yes	Yes	Yes
Full Scale ViewRange	$\pm$ 2.5 μV to $\pm$ 50 mV	$\pm$ 0.5μV to $\pm$ 8mV	$\pm$ 0.5μV to $\pm$ 5mV
FrequencyResponse	15 Hz to 1.85 kHz	3 Hz to 4.8 kHz	3 Hz to 1.5 kHz
User Interface	Medtronic supplied computer withkeyboard and mouse	NuVasive-supplied computer withoptional touch screen and/or keyboard/mouseMobile device (for NuvaLine only)	NuVasive-supplied computerwith separate touch screen and/or keyboard/mouseMobile device
Remote Access	No	Yes	Yes
Train of FourTesting	N/A	Yes	Yes

Specification/Property	Predicate DeviceMedtronic NIM 3.0 NerveMonitoring System (K083124)	Predicate DeviceNuVasive NVM5 System (K152942 and K132694)	Subject DeviceNuVasive NG-NVM5 System
NeedleElectrodes	Various	Various	Various
SurfaceElectrodes	Various	Various	Various, including new cutaneous electrodes for lumbarMEP
ElectrodeLeads	Various	Various	Various
StimulatingProbes	Various	Various	Various
RecordingChannels	EMG	EMG, MEP, and SSEP	EMG, MEP, and SSEP
EMG
EMGModalities	• Free Run EMG	• XLIF (Detection)• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test	• XLIF (Detection)• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test
XLIF (Detection)
Types ofModes	Triggered Stimulation	Automatic Stimulation	Automatic Stimulation
ThresholdValues forColor Alerts	No	Yes	Yes (Identical to predicate)
Audio feedback	No	Yes	Yes
Basic & Dynamic Screw Test
Types ofModes	N/A	Automatic Stimulation	Automatic Stimulation
ThresholdValues forColor Alerts	N/A	Yes	Yes (Identical to predicate)
Audio feedback	N/A	Yes	Yes
Free Run EMG
Types ofModes	Manual Stimulation	Manual Stimulation	Manual Stimulation
ThresholdValues forColor Alert	Yes	Yes	Yes (Identical to K152942)
Audio feedback	Yes	Yes	Yes
	Predicate Device	Predicate Device	Subject Device
Specification/Property	Medtronic NIM 3.0 NerveMonitoring System (K083124)	NuVasive NVM5 System (K152942 and K132694)	NuVasive NG-NVM5 System
		Twitch Test
Types ofModes	N/A	Manual and Automatic Stimulation	Manual and Automatic Stimulation
ThresholdValues forColor Alerts	N/A	Yes	Yes
Audio feedback	N/A	Yes	Yes
		MEP
Types ofModes	N/A	Manual and Automatic Stimulation	Manual and Automatic Stimulation
ThresholdValues forColor Alerts	N/A	Yes	Yes (Identical to predicate)
Audio feedback	N/A	Yes	Yes
		SSEP
Types ofModes	N/A	Manual Stimulation	Manual Stimulation
ThresholdValues forColor Alerts	N/A	Yes	Yes (Identical to predicate)
Audio feedback	N/A	Yes	Yes
		Remote Access
Screen-sharingaccessibility	Remote Monitoring	Remote Monitoring	Remote Monitoring and Local Wireless Control
Guidance
Clinical Use	N/A	Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation	Not applicable
PerformanceRequirements	N/A	Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle	Not applicable
IEC 60601Compliant	N/A	YES	YES
User Interface	N/A	Touch screen, graphical user interface and audio	Not applicable

Specification/Property	Predicate Device	Predicate Device	Subject Device
	Medtronic NIM 3.0 NerveMonitoring System (K083124)	NuVasive NVM5 System (K152942 and K132694)	NuVasive NG-NVM5 System
Bendini
Components	N/A	Optical (IR) tracking technology system, IR trackinginstruments, computer.	Optical (IR) tracking technology system, IR trackinginstruments, computer.
User Interface	N/A	Touch screen, graphical user interface and audio.	Touch screen, graphical user interface and audio.
IEC 60601Compliant	N/A	YES	YES
Instrumentation	N/A	• IR Digitizer (with integrated passive spheres)• Rod Bender• Optional Mobile application	• IR Digitizer (with integrated passive spheres)• Rod Bender• Optional Mobile application

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G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NG-NVM5 System is substantially equivalent to other predicate devices and to verify that the NG-NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NG-NVM5 System was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device. Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended. Additionally, the current and power densities were calculated to support substantial equivalence of cutaneous electrodes.

The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NG-NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.