NUVASIVE NVM5 SYSTEM

K132694 · Nu Vasive, Incorporated · PDQ · May 16, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K132694
• Device Name: NUVASIVE NVM5 SYSTEM
• Applicant: Nu Vasive, Incorporated
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: May 16, 2014
• 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. 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 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 Story

NVM5 System provides intraoperative neurophysiologic monitoring during spinal surgery; inputs include electrical nerve stimulation via surgical accessory electrodes and physiological signals (EMG, MEP, SSEP). System processes signals to monitor nerve/spinal cord integrity; provides real-time feedback to surgeons via touch screen interface. Includes integrated stereotactic guidance (NVM5 Guidance) for pedicle screw placement using radiographic imaging/EMG; Bendini software for spinal rod shaping; and remote screen sharing for monitoring physicians. Benefits include nerve avoidance, assessment of neuromuscular block, and monitoring of motor/sensory pathways to reduce risk of surgically induced injury. Used in OR; operated by surgeons and monitoring physicians.

Clinical Evidence

Bench testing only. Verification and validation testing performed per software requirements, including regression testing, Bendini system integration, dual surface electrode functional testing, and ISO 10993 biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous).

Technological Characteristics

System includes Patient Module (PM), computer, disposable conductive probes, electrodes, and leads. Sensing/actuation via electrical stimulation and EMG/MEP/SSEP monitoring. Connectivity includes remote monitoring/screen sharing. Guidance uses optical (IR) tracking. Software includes EMG, MEP, SSEP, Remote Reader, Guidance, and Bendini modules. Compliant with IEC 60601-1. Full scale view range ±0.5µV to ±8mV; frequency response 3 Hz to 4.8 kHz.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery in adult patients. Guidance function indicated for open or percutaneous pedicle cannulation in lumbar and sacral spine (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 (K123307)
• Nicolet Biomedical, Inc. Bravo Multi-Modality System (K991054)
• R&D Medical Products, Inc. Neonatal ECG Electrodes (K092744)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 tagline "The Power of Innovation" in a smaller font. The logo is black and white.

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: [phone] Date Prepared: May 13, 2014

#### Device Name B.

| Trade or Proprietary Name: | <i>NuVasive</i> ® <i>NVM5</i> ® <i>System</i> |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Neurological surgical monitor;<br>Stereotaxic Instrument. |
| Classification Name: | Neuro 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 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.

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

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Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized eye-like shape on the left and the word "NUVASIVE" in bold, sans-serif font on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

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)
- 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.

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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 Characteristics<br>Predicate Device --------<br>ು ಅವರು ಮಾಡು ಮಾಡಿ ಮಾರ್ಗ್ ಪ್ರದಾಖೆಗಳು ಒ | . |
| Property | - 1<br>Nu Vasive NVM5 System (K123307)<br>: " | Subject Device " ( 1 1 1 1 1 1 1 1 1 1 1 1 1 1<br>Nu Vasive NVM5 System NVM5 System<br>म् एक्स्कृतिक्तिः<br>: |
| | neurophysiologic monitoring during spinal surgery. The device provides information<br>provides this information by electrically stimulating nerves via electrodes located on<br>evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses nerves. The System also integrates Bendini" software used to locate spinal impla<br>surgical accessories and monitoring electromyography (EMG), transcranial motor<br>directly to the surgeon, to help assess a patient's neurophysiologic status. NVM2<br>he NVM5 System is a medical device that is intended for intraoperative<br>instrumentation for the placement of spinal rods. | lirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides<br>ked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves.<br>europhysiologic monitoring during spinal surgery. The device provides information<br>is information by electrically stimulating nerves via electrodes located on surgical<br>ssories and monitoring electromyography (EMG), transcranial or lumbar moto<br>The System also integrates Bendini® software used to locate spinal implan instrumentation for the placement of spinal rods.<br>The NVM5* System is a medical device that is intended for intraoperative |
| | XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and<br>evaluate spinal nerves, and is used as a nerve avoidance tool. | XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and<br>valuate spinal nerves, and is used as a nerve avoidance tool |
| | and evaluate spinal nerves by providing proximity information before, during or after<br>Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate<br>bone preparation and placement of bone screws. | sic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate<br>d evaluate spinal nerves by providing proximity information before, during or after<br>one preparation and placement of bone screws.<br>● |
| | Free Run EMG - The Free Run EMG function identifies spontancous EMG activity<br>of spinal nerves by continually displaying a live stream waveform of any<br>mechanically induced myotome contractions. | spinal nerves by continually displaying a live stream waveform of any<br>Free Run EMG – The Free Run EMG function identifies spontancous EMG activity<br>mechanically induced myotome contractions. |
| Intended Use / | Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess<br>moderate degrees of neuromuscular block in effect by evaluating muscle contraction<br>following a train of four stimulation pulses. | witch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess<br>oderate degrees of neuromuscular block in effect by evaluating muscle contraction<br>llowing a train of four stimulation pulses |
| Indications for<br>Use | TceMEP - Transcranial stimulation techniques for motor evoked potentials are used<br>TceMEP function provides an adjunctive method to allow the surgeon to monitor<br>during procedures with a risk of surgicall<br>conduction of the corticospinal tract<br>to assess for acute dysfunction in axonal<br>spinal cord and motor pathway integrity<br>induced motor injury. | MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques<br>for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function<br>pathway integrity during procedures with a risk of surgically induced motor injury.<br>● |
| | SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function<br>n surgical procedures during which the spinal cord is at risk | SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function<br>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 | cmote Reader - The Remote Reader function provides real time remote access to<br>the NVM5 System for a monitoring physician outside of the operating room |
| | spinal anatomy for the creation of a cannulation trajectory for bone screw placement<br>percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-S1)<br>allows the surgeon to assess the angulation of system accessories relative to patie<br>of adult patients, and when used in conjunction with radiographic imaging and E<br>Guidance ~ 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 relative<br>to patient spinal anatomy for the creation of a cannulation trajectory for bone screw<br>rcutaneous pedicle cannulation procedures in the thoracolumbar and sacral spinc<br>S I) of adult patients, and when used in conjunction with radiographic imaging<br>uidance - 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 bender<br>Bendini ~ The Bendini Spinal Rod Bending function is used to locate spinal implar<br>system instrumentation (screws, hooks) to determine their relative location to or<br>mother 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 bender<br>ndini – The Bendini Spinal Rod Bending function is used to locate spinal implan<br>nother to generate bend instructions to shape a spinal rod. A surgeon is able to use<br>stem instrumentation (screws, hooks) to determine their relative location to on<br>placement. |
| Specification/<br>Property | Predicate Device<br>NuVasive NVM5 System (K123307) | 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 | Identical algorithms 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 | $\pm 0.5\mu V$ to $\pm 8mV$ | $\pm 0.5\mu V$ to $\pm 8mV$ |
| Frequency<br>Response | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz |
| User Interface | NuVasive-supplied computer or<br>NuVasive provided touch screen and [optional] keyboard/mouse | NuVasive-supplied computer or<br>NuVasive provided touch screen and [optional] keyboard/mouse |
| Remote<br>Monitoring | Yes | Yes |
| Train of Four<br>Testing | Yes | Yes |
| Needle Electrodes | Various | Various |
| Surface<br>Electrodes | Various | Various |
| Specification/<br>Property | Predicate Device<br>NuVasive NVM5 System (K123307) | 510(k) Premarket Notification<br>NuVasive® NVM5® System |
| Electrode Leads<br>Stimulating<br>Probes | Various | Subject Device<br>NuVasive NVM5 System |
| Recording<br>Channels | 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 Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Automatic Stimulation | Automatic Stimulation |
| | Yes | Yes (Identical to predicate) |
| | Yes | Yes |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Basic & Dynamic Screw Test | Automatic Stimulation |
| | Yes | Yes (Identical to predicate) |
| | Yes | Yes |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Free Run EMG | Manual Stimulation |
| | Yes | Yes (Identical to predicate) |
| | Yes | Yes |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Twitch Test | Manual and Automatic Stimulation |
| | Yes | Yes (Identical to predicate) |
| | Yes | Yes |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | MEP | Manual and Automatic Stimulation |
| | Yes | Yes (Identical to predicate) |
| | Yes | Yes |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | SSEP | Manual Stimulation |
| | Yes | Yes |
| | Yes | Yes |
| | | |
| | | |
| | | 510(k) Premarket Notification<br><i>NuVasive® NVM5® System</i> |
| |…