The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVMS 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 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 Reader - The Remote Reader function provides real time remote access to the NVMS System for a monitoring physician outside of the operating room.

· Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-SI) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.

· 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 NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. 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), 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.

Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

1. Electromyography (EMG)
1. Motor Evoked Potential (MEP)
1. Somatosensory Evoked Potential (SSEP)
1. Remote Reader
1. Guidance
1. Bendini

The 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

Here's a summary of the acceptance criteria and the study that proves the NuVasive NVM5 System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K123307, also a NuVasive NVM5 System) rather than defining explicit quantitative acceptance criteria as might be seen for a novel device. The "acceptance criteria" are implied by the claim of substantial equivalence and meeting design specifications.

Acceptance Criteria (Implied by Substantial Equivalence and Design Specs)	Reported Device Performance (Subject Device)
Intended Use / Indications for Use:	Identical to predicate device, including:
- Intraoperative neurophysiologic monitoring during spinal surgery	- Intraoperative neurophysiologic monitoring during spinal surgery
- Assess patient's neurophysiologic status	- Assess patient's neurophysiologic status
- Electrical stimulation of nerves via electrodes	- Electrical stimulation of nerves via electrodes
- Monitoring EMG, MEP (transcranial or lumbar), SSEP responses	- Monitoring EMG, MEP (transcranial or lumbar), SSEP responses
- Integration of Bendini software for spinal rod placement	- Integration of Bendini software for spinal rod placement
- XLIF (Detection) function for nerve localization/avoidance	- XLIF (Detection) function for nerve localization/avoidance
- Basic & Dynamic Screw Test for nerve proximity information	- Basic & Dynamic Screw Test for nerve proximity information
- Free Run EMG for spontaneous EMG activity	- Free Run EMG for spontaneous EMG activity
- Twitch Test (Train of Four) for neuromuscular block assessment	- Twitch Test (Train of Four) for neuromuscular block assessment
- MEP for assessing axonal conduction/motor pathway integrity	- MEP for assessing acute dysfunction in axonal conduction of corticospinal tract and peripheral nerves, and monitoring spinal cord and motor pathway integrity (Expanded "Transcranial or lumbar" for MEP)
- SSEP for assessing sensory spinal cord function	- SSEP for assessing sensory spinal cord function
- Remote Reader function for remote access to system	- Remote Reader function for remote access to system
- Guidance function for pedicle cannulation in lumbar/sacral spine	- Guidance function (expanded from lumbar/sacral to thoracolumbar and sacral spine (L1-S1)) for pedicle cannulation, assessing angulation of accessories relative to patient spinal anatomy for cannulation trajectory with radiographic imaging and EMG.
- Bendini function for spinal rod bending instructions	- Bendini function for locating spinal implant instrumentation and generating bend instructions for spinal rods.
Technological Characteristics:	Identical to predicate device, with minor modifications shown to be substantially equivalent:
- Software Modalities/Functionalities	- XLIF (Detection), Basic & Dynamic Screw Test, Free Run EMG, Twitch Test, MEP, SSEP, Remote Monitoring, Guidance, Bendini (Identical, with MEP indicating both transcranial and lumbar)
- Algorithms	- Identical algorithms as predicate.
- Total Available Channels	- 32
- Headbox/Patient Module	- Yes
- IEC 60601-1 Compliant	- Yes
- Full Scale View Range	- $\pm 0.5 \mu V$ to $\pm 8mV$
- Frequency Response	- 3 Hz to 4.8 kHz
- User Interface	- NuVasive-supplied computer or NuVasive provided touch screen and [optional] keyboard/mouse
- Remote Monitoring	- Yes
- Train of Four Testing	- Yes
- Needle Electrodes	- Various
- Surface Electrodes	- Various
- Electrode Leads/Stimulating Probes/Recording Channels	- Various
- EMG Modalities	- XLIF (Detection), Basic & Dynamic Screw Test, Free Run EMG, Twitch Test
- Stimulation Modes (Automatic/Manual)	- Automatic (XLIF, Basic & Dynamic Screw Test), Manual (Free Run EMG, SSEP), Manual & Automatic (Twitch Test, MEP)
- Threshold Values for Color Alerts	- Yes (Identical to predicate where applicable)
- Audio feedback	- Yes
- Screen-sharing accessibility	- Remote Monitoring
- Guidance Clinical Use & Performance Requirements	- Requires input from CT, MRI, or radiographic images; assists surgeon in pedicle cannulation based on user-predefined trajectory; integrated with EMG stimulation. Angular tolerance of $\pm 2^\circ$, confirmation of alignment to pre-planned trajectory, seamlessly integrated with insulated Jamshidi Needle. (Identical to predicate)
- Bendini Components & User Interface	- Optical (IR) tracking technology system, IR tracking instruments, computer. Touch screen, graphical user interface, and audio. Instrumentation: IR Digitizer (with integrated passive spheres), Rod Bender. (Identical to predicate)
Safety and Performance (general):	Met or exceeded the performance of the predicate device. "The results of these studies showed that the subject NVM5® System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent."
- Biocompatibility (for Dual Surface Electrodes)	- Passed ISO 10993 testing for cytotoxicity, sensitization, and irritation/intracutaneous.
- Software Validation	- Verification and Validation Testing according to Software Requirements Specifications, including modifications. Regression Testing.
- System Integration (Bendini)	- Bendini System Integration Testing.
- Functional Testing (Dual Surface Electrodes)	- Dual Surface Electrode Functional Testing.

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes "Nonclinical testing" including "NVM5 System Verification and Validation Testing," "NVM5 System software Regression Testing," "Bendini System Integration Testing," "Dual Surface Electrode Functional Testing," and "ISO 10993 Biocompatibility Testing."

Sample Size for Test Set: The exact sample sizes for each of these nonclinical tests are not specified in the provided text. The testing focuses on system-level verification and validation.
Data Provenance: The studies are described as "Nonclinical testing" and internal "verification and validation testing." There is no mention of data provenance in terms of country of origin or whether it was retrospective or prospective clinical data, as this was primarily a technical and software update submission, not a new clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical accuracy or interpretation during these nonclinical tests. The tests performed are engineering-focused:

Software verification against specifications.
Regression testing to ensure changes didn't break existing functionality.
Integration testing.
Functional testing of a component (Dual Surface Electrode).
Biocompatibility testing against ISO standards.

For such tests, "ground truth" would typically refer to the expected outputs or behavior defined by the design specifications or established by standard test methods.

4. Adjudication Method for the Test Set

Since the testing described is nonclinical performance, software, and biocompatibility testing, an adjudication method in the sense of reconciling expert opinions on clinical cases (e.g., 2+1, 3+1) is not applicable and not mentioned in the document. The tests would likely have pass/fail criteria based on predefined engineering or regulatory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or mentioned. The submission is focused on demonstrating substantial equivalence through nonclinical performance and software testing for a modified device, not a comparative clinical study with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The studies described are primarily standalone testing of the device's functions and components, rather than human-in-the-loop performance. The "human-in-the-loop" aspect is implicit in the intended use where the device provides information to the surgeon for assessment. The software and hardware functionalities were tested independently to ensure they meet specifications and perform as expected.

7. Type of Ground Truth Used

The ground truth used for the nonclinical tests would be:

Design Specifications: For the NVM5 System Verification and Validation and Software Regression Testing, the "ground truth" would be the predefined Software Requirements Specifications.
Predicate Device Performance: For demonstrating substantial equivalence, the "ground truth" is the established performance and characteristics of the predicate NuVasive NVM5 System (K123307).
Standard Test Methods: For Biocompatibility Testing, the "ground truth" is defined by the ISO 10993 standards and their acceptance criteria.
Expected Functional Output: For Bendini System Integration Testing and Dual Surface Electrode Functional Testing, the "ground truth" would be the expected functional outputs and interactions defined by the system design.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its sample size. This type of information is typically relevant for submissions involving machine learning algorithms that are trained on data. While the NVM5 System contains "algorithms," they are described as "identical algorithms as predicate," implying established, deterministic algorithms rather than newly trained AI models. The testing described is verification and validation of these established algorithms and the system as a whole.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" for machine learning is mentioned, the method for establishing its ground truth is not applicable and not described in this document.

Summary

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11.132694

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:

Sheila Bruschi Manager. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: May 13, 2014

Device Name B.

Trade or Proprietary Name:	NuVasive ® NVM5 ® System
Common or Usual Name:	Neurological surgical monitor;Stereotaxic Instrument.
Classification Name:	Neuro 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 NVM5 System is substantially equivalent to the predicates:

. 510(k) K123307, NuVasive NVM5 System
510(k) K991054, Nicolet Biomedical, Inc. Bravo Multi-Modality System .
510(k) K092744, R&D Medical Products, Inc. Neonatal ECG Electrodes .

Device Description D.

Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also

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integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

1. Electromyography (EMG)
1. Motor Evoked Potential (MEP)
1. Somatosensory Evoked Potential (SSEP)
1. Remote Reader
1. Guidance
1. Bendini

E. Intended Use

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. 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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Image /page/2/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter "N" on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.

Remote Reader The Remote Reader function provides real time remote access to the . NVM5 System for a monitoring physician outside of the operating room.
. Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
. 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 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 devices 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 Dual Surface Electrodes
· . Modified MEP Indications for Use
Modified SSEP specifications .

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NUVASIVE		VuVasive® NVM5® System
Specification/	Table 1 - Comparison of Technical CharacteristicsPredicate Device --------ು ಅವರು ಮಾಡು ಮಾಡಿ ಮಾರ್ಗ್ ಪ್ರದಾಖೆಗಳು ಒ	.
Property	- 1Nu Vasive NVM5 System (K123307): "	Subject Device " ( 1 1 1 1 1 1 1 1 1 1 1 1 1 1Nu Vasive NVM5 System NVM5 Systemम् एक्स्कृतिक्तिः:
	neurophysiologic monitoring during spinal surgery. The device provides informationprovides this information by electrically stimulating nerves via electrodes located onevoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses nerves. The System also integrates Bendini" software used to locate spinal implasurgical accessories and monitoring electromyography (EMG), transcranial motordirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM2he NVM5 System is a medical device that is intended for intraoperativeinstrumentation for the placement of spinal rods.	lirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 providesked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves.europhysiologic monitoring during spinal surgery. The device provides informationis information by electrically stimulating nerves via electrodes located on surgicalssories and monitoring electromyography (EMG), transcranial or lumbar motoThe System also integrates Bendini® software used to locate spinal implan instrumentation for the placement of spinal rods.The NVM5* System is a medical device that is intended for intraoperative
	XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate andevaluate spinal nerves, and is used as a nerve avoidance tool.	XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate andvaluate spinal nerves, and is used as a nerve avoidance tool
	and evaluate spinal nerves by providing proximity information before, during or afterBasic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locatebone preparation and placement of bone screws.	sic & Dynamic Screw Test - The Screw Test functions allow the surgeon to located evaluate spinal nerves by providing proximity information before, during or afterone preparation and placement of bone screws.●
	Free Run EMG - The Free Run EMG function identifies spontancous EMG activityof spinal nerves by continually displaying a live stream waveform of anymechanically induced myotome contractions.	spinal nerves by continually displaying a live stream waveform of anyFree Run EMG – The Free Run EMG function identifies spontancous EMG activitymechanically induced myotome contractions.
Intended Use /	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.	witch Test (Train of Four) - The Twitch Test Function allows the surgeon to assessoderate degrees of neuromuscular block in effect by evaluating muscle contractionllowing a train of four stimulation pulses
Indications forUse	TceMEP - Transcranial stimulation techniques for motor evoked potentials are usedTceMEP function provides an adjunctive method to allow the surgeon to monitorduring procedures with a risk of surgicallconduction of the corticospinal tractto assess for acute dysfunction in axonalspinal cord and motor pathway integrityinduced motor injury.	MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniquesfor motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP functionpathway integrity during procedures with a risk of surgically induced motor injury.●
	SSEP - The SSEP function allows the surgeon to assess sensory spinal cord functionn surgical procedures during which the spinal cord is at risk	SSEP – The SSEP function allows the surgeon to assess sensory spinal cord functionsurgical procedures during which the spinal cord is at risk
	Remote Reader - The Remote Reader function provides real time remote access tothe NVM5 System for a monitoring physician outside of the operating room	cmote Reader - The Remote Reader function provides real time remote access tothe NVM5 System for a monitoring physician outside of the operating room
	spinal anatomy for the creation of a cannulation trajectory for bone screw placementpercutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-S1)allows the surgeon to assess the angulation of system accessories relative to patieof adult patients, and when used in conjunction with radiographic imaging and EGuidance ~ The Guidance function is intended as an aid for use in either open on	and EMG, allows the surgeon to assess the angulation of system accessories relativeto patient spinal anatomy for the creation of a cannulation trajectory for bone screwrcutaneous pedicle cannulation procedures in the thoracolumbar and sacral spincS I) of adult patients, and when used in conjunction with radiographic imaginguidance - The Guidance function is intended as an aid for use in either open
	those instructions and bend a rod using the Bendini Bender, a mechanical rod benderBendini ~ The Bendini Spinal Rod Bending function is used to locate spinal implarsystem instrumentation (screws, hooks) to determine their relative location to ormother to generate bend instructions to shape a spinal rod. A surgeon is able to	hose instructions and bend a rod using the Bendini Bender, a mechanical rod benderndini – The Bendini Spinal Rod Bending function is used to locate spinal implannother to generate bend instructions to shape a spinal rod. A surgeon is able to usestem instrumentation (screws, hooks) to determine their relative location to onplacement.
Specification/Property	Predicate DeviceNuVasive NVM5 System (K123307)	Subject DeviceNuVasive NVM5 System
SoftwareModalities /Functionalities	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Remote Monitoring Guidance Bendini	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test MEP SSEP Remote Monitoring Guidance Bendini
Algorithms	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Guidance Bendini	Identical algorithms as predicate.
Total AvailableChannels	32	32
Headbox/Patient Module	Yes	Yes
IEC 60601-1Compliant	Yes	Yes
Full Scale ViewRange	$\pm 0.5\mu V$ to $\pm 8mV$	$\pm 0.5\mu V$ to $\pm 8mV$
FrequencyResponse	3 Hz to 4.8 kHz	3 Hz to 4.8 kHz
User Interface	NuVasive-supplied computer orNuVasive provided touch screen and [optional] keyboard/mouse	NuVasive-supplied computer orNuVasive provided touch screen and [optional] keyboard/mouse
RemoteMonitoring	Yes	Yes
Train of FourTesting	Yes	Yes
Needle Electrodes	Various	Various
SurfaceElectrodes	Various	Various
Specification/Property	Predicate DeviceNuVasive NVM5 System (K123307)	510(k) Premarket NotificationNuVasive® NVM5® System
Electrode LeadsStimulatingProbes	Various	Subject DeviceNuVasive NVM5 System
RecordingChannels	Various	Various
	EMG, MEP, and SSEP	EMG, MEP, and SSEP
EMG Modalities	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Automatic Stimulation	Automatic Stimulation
	Yes	Yes (Identical to predicate)
	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Basic & Dynamic Screw Test	Automatic Stimulation
	Yes	Yes (Identical to predicate)
	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Free Run EMG	Manual Stimulation
	Yes	Yes (Identical to predicate)
	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Twitch Test	Manual and Automatic Stimulation
	Yes	Yes (Identical to predicate)
	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	MEP	Manual and Automatic Stimulation
	Yes	Yes (Identical to predicate)
	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	SSEP	Manual Stimulation
	Yes	Yes
	Yes	Yes


		510(k) Premarket NotificationNuVasive® NVM5® System

Specification/Property	Predicate DeviceNuVasive NVM5 System (K123307)	Subject DeviceNuVasive NVM5 System
Threshold Valuesfor Color Alerts	Yes	Yes
Audio feedback	Yes	Yes
Screen-sharingaccessibility	Remote Monitoring	Remote Monitoring
	Guidance
Clinical Use	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	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
PerformanceRequirements	Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle	Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle
IEC 60601Compliant	YES	YES
User Interface	Touch screen, graphical user interface and audio	Touch screen, graphical user interface and audio
Components	BendiniOptical (IR) tracking technology system, IR tracking instruments, computer.	Optical (IR) tracking technology system, IR tracking instruments, computer.
User Interface	Touch screen, graphical user interface and audio.	Touch screen, graphical user interface and audio.
IEC 60601Compliant	YES	YES
Instrumentation	IR Digitizer (with integrated passive spheres) Rod Bender	IR Digitizer (with integrated passive spheres) Rod Bender

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NUVASIVE

510(k) Premarket Notification

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ে Performance Data

Nonclinical testing was performed to demonstrate that the subject NVM5 System is substantially equivalent to other predicate devices and to verify that the NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NVM5 System was subjected to verification and validation testing, as follows:

. NVM5 System 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
NVM5 System software Regression Testing .
Bendini System Integration Testing .
Dual Surface Electrode Functional Testing ●
ISO 10993 Biocompatibility Testing cytotoxicity, sensitization, and ● irritation/intracutaneous

The results of these studies showed that the subject NVM5® System meets or exceeds 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 NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices.

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

May 16, 2014

NuVasive, Inc. Ms. Sheila Bruschi Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, CA 92121

Re: K132694

Trade/Device Name: NuVasive NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical nerve locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: April 17, 2014 Received: April 18, 2014

Dear Ms. Bruschi:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS 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) K132694

Device Name NuVasive® NVM5 System

Indications for Use (Describe)

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

· 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.

· 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 Reader - The Remote Reader function provides real time remote access to the NVMS System for a monitoring physician outside of the operating room.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Peña -S

FORM FDA 3881 (1/14)

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

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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.