NuVasive NVM5 System

K143641 · Nu Vasive, Incorporated · PDQ · Mar 27, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K143641
• Device Name: NuVasive NVM5 System
• Applicant: Nu Vasive, Incorporated
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Mar 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

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.

Device Story

NVM5 System provides intraoperative neurophysiologic monitoring during spinal surgery. Inputs include electrical signals from electrodes on surgical accessories (EMG, MEP, SSEP) and anatomical data (CT, MRI, or radiographic images) for guidance. System processes these inputs to provide real-time feedback to surgeons via a touch-screen interface. Functions include nerve avoidance, screw proximity testing, neuromuscular block assessment, and pedicle cannulation guidance. Bendini software uses optical (IR) tracking to locate spinal instrumentation and generate rod-bending instructions. Used in OR by surgeons; remote monitoring allows secondary physician access. Output assists surgeons in assessing neurophysiologic status, monitoring spinal cord/motor pathway integrity, and placing spinal hardware, potentially reducing risk of surgically induced injury.

Clinical Evidence

Bench testing only. Verification and validation testing performed per software requirements. Laboratory benchtop and cadaveric testing validated pulse parameters, response detection, GUI boundary conditions, point acquisition, and rod-bending instruction accuracy. Results demonstrate performance meets or exceeds predicate device.

Technological Characteristics

System includes Patient Module (PM), computer, and disposable conductive probes/electrodes. Features optical (IR) tracking technology, IR tracking instruments, and rod bender. Connectivity includes remote monitoring application. Compliant with IEC 60601-1. Software includes EMG, MEP, SSEP, Guidance, and Bendini modules. Stimulation modes include manual and automatic.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery in adult patients. Functions include nerve avoidance (XLIF), proximity assessment for bone screw placement (Screw Test), spontaneous EMG monitoring (Free Run EMG), neuromuscular block assessment (Twitch Test), motor pathway integrity monitoring (MEP), sensory spinal cord function assessment (SSEP), remote monitoring, and pedicle cannulation guidance (L1-S1).

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 (K141968)

Submission Summary (Full Text)

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Re:

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

March 27, 2015

Nuvasive, Incorporated Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

> K143641 Trade /Device Name: NuVasive® NVM5® System Common or Usual Name: Neurological surgical monitor; Stereotaxic Instrument Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator; Evoked response electrical stimulator; Neurological stereotaxic instrument; Electromyography (EMG) monitor/stimulator Device Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: February 23, 2015 Received: February 24, 2015

Dear Mr. Markovich,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel - S

Carlos L. Peña, PhD, MS for Carlos Esfor 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)

## K143641

Device Name NuVasive® NVM5 System

# Indications for Use (Describe)

The NVM5® System is a medical device that is 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 LI-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 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 (LI-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.

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)

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Image /page/3/Picture/0 description: The image is a 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.

# 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:

Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Date Prepared: December 19, 2014

### B. Device Name

| Trade or Proprietary Name: NuVasive® 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 NVM5 System is substantially equivalent to the predicate NuVasive NVM5 System - 510(k) - K141968.

### D. 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:

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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. 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, with the word "Speed" fading into the word "of".

- 1. Electromyography (EMG)
- 2. Motor Evoked Potential (MEP)
- 3. Somatosensory Evoked Potential (SSEP)
- 4. Remote Reader
- 5. Guidance
- 6. 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.

### 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.
- 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

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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 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:

- Modified angular assessment tool
- o Additional mobile application for angular assessment option

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Image /page/6/Picture/6 description: The image shows the logo for NUVASIVE. The logo is oriented vertically, with the company name stacked on top of the slogan "Speed of Innovation". Below the text is a stylized graphic element in purple and gray.

| Specification/<br>Property | Predicate Device<br>NuVasive NVM5 System (K141968) | Subject Device<br>NuVasive NVM5 System |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The NVM5® System is a medical device that is intended for intraoperative<br>neurophysiologic monitoring during spinal surgery. The device provides information<br>directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5<br>provides this information by electrically stimulating nerves via electrodes located on<br>surgical accessories and monitoring electromyography (EMG), transcranial or lumbar<br>motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of<br>nerves. The 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 surgeon to locate<br>and evaluate spinal nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to<br>locate and evaluate spinal nerves by providing proximity information before,<br>during or after bone preparation and placement of bone screws. Free Run EMG – The Free Run EMG function identifies spontaneous EMG<br>activity of spinal nerves by continually displaying a live stream waveform of any<br>mechanically induced myotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to<br>assess moderate degrees of neuromuscular block in effect by evaluating muscle<br>contraction following a train of four stimulation pulses. 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 dysfunction in<br>axonal conduction of the corticospinal tract and peripheral nerves. The MEP<br>function provides an adjunctive method to allow the surgeon to monitor spinal<br>cord and motor pathway integrity during procedures with a risk of surgically<br>induced motor injury. SSEP – The SSEP function allows the surgeon to assess sensory spinal cord<br>function in surgical procedures during which the spinal cord is at risk. Remote Reader - The Remote reader function provides real time remote access to<br>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<br>percutaneous pedicle cannulation procedures in the lumbar and sacral spine<br>(L1-S1) of adult patients, and when used in conjunction with radiographic<br>imaging and EMG, allows the surgeon to assess the angulation of system<br>accessories relative to patient spinal anatomy for the creation of a cannulation<br>trajectory for bone screw placement. Bendini – The Bendini Spinal Rod Bending function is used to locate spinal<br>implant system instrumentation (screws, hooks) to determine their relative<br>location to one another to generate bend instructions to shape a spinal rod. A<br>surgeon is able to use those instructions and bend a rod using the Bendini Bender,<br>a mechanical rod bender. | The NVM5® System is a medical device that is intended for intraoperative<br>neurophysiologic monitoring during spinal surgery. The device provides information<br>directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5<br>provides this information by electrically stimulating nerves via electrodes located on<br>surgical accessories and monitoring electromyography (EMG), transcranial or lumbar<br>motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of<br>nerves. The 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 surgeon to<br>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<br>locate and evaluate spinal nerves by providing proximity information before,<br>during or after bone preparation and placement of bone screws. Free Run EMG – The Free Run EMG function identifies spontaneous EMG<br>activity of spinal nerves by continually displaying a live stream waveform of any<br>mechanically induced myotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to<br>assess moderate degrees of neuromuscular block in effect by evaluating<br>muscle contraction following a train of four stimulation pulses. 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 dysfunction<br>in axonal conduction of the corticospinal tract and peripheral nerves. The<br>MEP function provides an adjunctive method to allow the surgeon to monitor<br>spinal cord and motor pathway integrity during procedures with a risk of<br>surgically induced motor injury. SSEP - The SSEP function allows the surgeon to assess sensory spinal cord<br>function in surgical procedures during which the spinal cord is at risk. 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 Guidance - The Guidance function is intended as an aid for use in either open<br>or percutaneous pedicle cannulation procedures in the lumbar and sacral spine<br>(L1-S1) of adult patients, and when used in conjunction with radiographic<br>imaging and EMG, allows the surgeon to assess the angulation of system<br>accessories relative to patient spinal anatomy for the creation of a cannulation<br>trajectory for bone screw placement. Bendini The Bendini Spinal Rod Bending function is an intraoperative<br>assessment tool used to locate spinal implant system instrumentation (screws,<br>hooks) to determine their relative location to one another to generate bend<br>instructions to shape a spinal rod. A surgeon is able to use those instructions<br>1 |
| Specification/<br>Property | Predicate Device<br>NuVasive NVM5 System (K141968) | Subject Device<br>NuVasive NVM5 System |
| Software<br>Modalities /<br>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 | XLIF Detection – Identical algorithm as predicate Basic & Dynamic Screw Test – Identical algorithm as predicate Free Run EMG - Identical algorithm as predicate Twitch Test (Train of Four) - Identical algorithm as predicate MEP - Modified stimulation parameters SSEP - Addition of baseline algorithm and optional view Guidance - Identical algorithm as predicate Bendini - Identical rod-bending algorithm as predicate |
| Total Available<br>Channels | 32 | 32 |
| Headbox/<br>Patient Module | Yes | Yes |
| IEC 60601-1<br>Compliant | Yes | Yes |
| Full Scale View<br>Range | $\pm$ 0.5µV to $\pm$ 8mV | $\pm$ 0.5µV to $\pm$ 8mV |
| Frequency<br>Response | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz…