NuVasive Next Generation NVM5 System

K162313 · Nu Vasive, Incorporated · PDQ · Mar 16, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K162313
• Device Name: NuVasive Next Generation NVM5 System
• Applicant: Nu Vasive, Incorporated
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Mar 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

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. 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 Story

NG-NVM5 System provides intraoperative neurophysiologic monitoring; inputs include electrical nerve stimulation via surgical accessory electrodes and EMG, MEP, or SSEP signal monitoring. System processes signals to assess nerve proximity, neuromuscular block, and spinal cord/motor pathway integrity. Outputs include live EMG waveforms, proximity alerts, and rod-bending instructions. Used in OR by surgeons; supports remote monitoring and local wireless control by additional physicians. Bendini software uses IR tracking to locate spinal instrumentation and generate rod-bending instructions. Device aids surgeons in nerve avoidance and monitoring during procedures with risk of surgically induced injury; benefits include real-time assessment of neurophysiologic status and improved spinal rod shaping.

Clinical Evidence

Bench testing only. Verification and validation testing performed per software requirements. Laboratory bench testing verified accuracy of angle and offset measurements and validated GUI and system component functionality. Current and power densities calculated for cutaneous electrodes.

Technological Characteristics

Class II surgical nerve stimulator/locator. Hardware includes Patient Module (PM), computer, and disposable conductive probes/electrodes. Sensing/actuation via electrical stimulation and EMG/MEP/SSEP monitoring. Bendini function uses optical (IR) tracking technology. Connectivity includes local wireless control and remote access. Compliant with IEC 60601-1. Software includes EMG, MEP, SSEP, Remote Access, and Bendini modalities.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities in patients requiring assessment of neurophysiologic status.

Regulatory Classification

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.

Predicate Devices

• NuVasive NVM5 System (K152942)
• Medtronic NIM 3.0 Nerve Integrity Monitor (K083124)
• NuVasive NVM5 System (K132694)

Submission Summary (Full Text)

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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 [phone] or [phone] 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

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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)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.

## 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: [phone] Date Prepared: March 13, 2017

### B. Device Name

| | Trade or Proprietary Name: | NuVasive® Next Generation NVM5® System |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Common or Usual Name: | Neurological surgical monitor;<br>Stereotaxic Instrument | |
| Classification Name: | Surgical Nerve Stimulator/Locator;<br>Evoked response electrical stimulator;<br>Neurological stereotaxic instrument;<br>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 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

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Image /page/4/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a purple and gray abstract leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size and a gradient of gray to purple.

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.
- 3. Somatosensory Evoked Potential (SSEP)
- 4. Remote Access
- 5. 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.

#### 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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Image /page/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.

- 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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Image /page/6/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font and purple color.

| Table 1 – Comparison of Technical Characteristics | | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification/<br>Property | Predicate Device<br>Medtronic NIM 3.0 Nerve<br>Monitoring System (K083124) | Predicate Device<br>NuVasive NVM5 System (K152942 and K132694) | Subject Device<br>NuVasive NG-NVM5 System |
| Intended Use /<br>Indications for<br>Use | Intended Use: The NIM 3.0 is intended for<br>locating and identifying cranial and<br>peripheral motor and mixed motor-sensory<br>nerves during surgery, including spinal cord<br>and spinal cord nerve roots. The APS<br>electrode is an accessory intended for<br>providing automatic periodic stimulation to<br>nerves when used with the Medtronic Nerve<br>Monitoring Systems.<br><br>Indications for NIM 3.0 EMG Monitoring<br>Procedures include:<br><br>Intracranial, Extracranial, Intratemporal,<br>Extratemporal, Neck Dissections, Thoracic<br>Surgeries, and Upper and Lower<br>Extremities<br><br>Indications for Spinal procedures which<br>may use NIM 3.0 EMG monitoring include:<br><br>Degenerative Treatments, Pedicle Screw<br>Procedures, Fusion Cages, Rhizotomy,<br>Orthopedic Surgery, Open and<br>Percutaneous Lumbar and Cervical Surgical<br>Procedures, and Thoracic Surgical<br>Procedures. | The NVM5® System is a medical device that is intended for intraoperative<br>neurophysiologic monitoring during spinal surgery. The device provides<br>information directly to the surgeon, to help assess a patient's<br>neurophysiologic status. NVM5 provides this information by electrically<br>stimulating nerves via electrodes located on surgical accessories and<br>monitoring electromyography (EMG), transcranial or lumbar motor evoked<br>potential (MEP), or somatosensory evoked potential (SSEP) responses of<br>nerves. The System also integrates Bendini® software used to locate spinal<br>implant instrumentation for the placement of spinal rods.<br>• XLIF (Detection) – The XLIF (Detection) function allows the surgeon to<br>locate and evaluate spinal nerves, and is used as a nerve avoidance tool.<br>• Basic & Dynamic Screw Test - The Screw Test functions allow the<br>surgeon to locate and evaluate spinal nerves by providing proximity<br>information before, during or after bone preparation and placement of<br>bone screws.<br>• Free Run EMG - The Free Run EMG function identifies spontaneous<br>EMG activity of spinal nerves by continually displaying a live stream<br>waveform of any mechanically induced myotome contractions.<br>• Twitch Test (Train of Four) - The Twitch Test Function allows the<br>surgeon to assess moderate degrees of neuromuscular block in effect by<br>evaluating muscle contraction following a train of four stimulation pulses.<br>• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation<br>techniques for motor evoked potentials are used to assess for acute<br>dysfunction in axonal conduction of the corticospinal tract and peripheral<br>nerves. The MEP function provides an adjunctive method to allow the<br>surgeon to monitor spinal cord and motor pathway integrity during<br>procedures with a risk of surgically induced motor injury.<br>• SSEP - The SSEP function allows the surgeon to assess sensory spinal<br>cord function in surgical procedures during which the spinal cord is at<br>risk.<br>• Remote Reader - The Remote reader function provides real time remote<br>access to the NVM5 System for a monitoring physician outside of the<br>operating room<br>• Guidance - The Guidance function is intended as an aid for use in either<br>open or percutaneous pedicle cannulation procedures in the lumbar and<br>sacral spine (L1-S1) of adult patients, and when used in conjunction with<br>radiographic imaging and EMG, allows the surgeon to assess the<br>angulation of system accessories relative to patient spinal anatomy for the<br>creation of a cannulation trajectory for bone screw placement.<br>• Bendini - The Bendini Spinal Rod Bending function is used to locate<br>spinal implant system instrumentation (screws, hooks) to determine their<br>relative location to one another to generate bend instructions to shape a<br>spinal rod. A surgeon is able to use those instructions and bend a rod<br>using the Bendini Bender, a mechanical rod bender. | The Next Generation NVM5® System is a medical device that is<br>intended for intraoperative neurophysiologic monitoring during spinal<br>surgery, neck dissections, thoracic surgeries, and upper and lower<br>extremities. The device provides information directly to the surgeon,<br>to help assess a patient's neurophysiologic status. NG-NVM5 provides<br>this information by electrically stimulating nerves via electrodes<br>located on surgical accessories and monitoring electromyography<br>(EMG), transcranial or lumbar motor evoked potential (MEP) or<br>somatosensory evoked potential (SSEP) responses of nerves. The<br>System also integrates Bendini™ software used to locate spinal implant<br>instrumentation for the placement of spinal rods.<br>• XLIF (Detection) - The XLIF (Detection) function allows the<br>surgeon to locate and evaluate spinal nerves, and is used as a nerve<br>avoidance tool.<br>• Basic & Dynamic Screw Test - The Screw Test functions allow the<br>surgeon to locate and evaluate spinal nerves by providing proximity<br>information before, during or after bone preparation and placement<br>of bone screws.<br>• Free Run EMG - The Free Run EMG function identifies<br>spontaneous EMG activity of spinal nerves by continually<br>displaying a live stream waveform of any mechanically induced<br>myotome contractions.<br>• Twitch Test (Train of Four) – The Twitch Test Function allows the<br>surgeon to assess moderate degrees of neuromuscular block in<br>effect by evaluating muscle contraction following a train of four<br>stimulation pulses.<br>• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2)<br>stimulation techniques for motor evoked potentials are used to<br>assess for acute dysfunction in axonal conduction of the<br>corticospinal tract and peripheral nerves. The MEP function<br>provides an adjunctive method to allow the surgeon to monitor<br>spinal cord and motor pathway integrity during procedures with a<br>risk of surgically induced motor injury.<br>• SSEP - The SSEP function allows the surgeon to assess sensory<br>spinal cord function in surgical procedures during which the spinal<br>cord is at risk.<br>• Remote Access - The remote monitoring and local wireless control<br>provides real-time capabilities to the NG-NVM5 System for<br>additional physicians.<br>• Bendini - The Bendini Spinal Rod Bending function is used to<br>locate spinal implant system instrumentation (screws, hooks) to<br>determine their relative location to one another to generate bend<br>instructions to shape a spinal rod. A surgeon is able to use those<br>instructions and bend a rod using the Bendini Bender, a mechanical<br>rod bender. |
| Specification/<br>Property | Predicate Device<br>Medtronic NIM 3.0 Nerve<br>Monitoring System (K083124) | Predicate Device<br>NuVasive NVM5 System (K152942 and K132694) | Subject Device<br>NuVasive NG-NVM5 System |
| Software<br>Modalities /<br>Functionalities | • Stimulating EMG (manual<br>and APS)<br>• Free run EMG | • XLIF Detection<br>• Basic & Dynamic Screw Test<br>• Free Run EMG<br>• Twitch Test (Train of Four)<br>• MEP<br>• SSEP<br>• Remote Reader<br>• Guidance<br>• Bendini<br>o NuvaMap O.R.<br>• NuvaLine spinal parameter assessment tools (optional) | • XLIF (Detection)<br>• Basic & Dynamic Screw Test<br>• Free Run EMG<br>• Twitch Test<br>• MEP<br>• SSEP<br>• Remote Access (Remote Monitoring and Local<br>Wireless Control)<br>• Bendini<br>o NuvaMap O.R. |
| Algorithms | • APS | • XLIF Detection<br>• Basic & Dynamic Screw Test<br>• Free Run EMG<br>• Twitch Test (Train of Four)<br>• MEP<br>• SSEP<br>• Guidance<br>• Bendini - Rod bending and spinal parameter assessment | • XLIF Detection<br>• Basic & Dynamic Screw Test<br>• Free Run EMG<br>• Twitch Test (Train of Four)<br>• MEP<br>• SSEP<br>• Remote Access<br>• Bendini – Rod bending and spinal parameter<br>assessment |
| Total Available<br>Channels | Up to 8 | 32 | 32 |
| Headbox/<br>Patient Module | Unknown | Yes | Yes |
| IEC 60601-1<br>Compliant | Yes | Yes…