NUVASIVE NVM5 SYSTEM

K112718 · Nuvasive, Inc. · ETN · Mar 16, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K112718
• Device Name: NUVASIVE NVM5 SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Mar 16, 2012
• 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 motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves. 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 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. TcMEP Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord 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 spine 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.

Device Story

NVM5 System is an intraoperative neurophysiologic monitoring device for spinal surgery. Inputs include electrical signals from nerves via surgical accessory electrodes (EMG, TcMEP, SSEP) and angular data from accelerometers (Guidance). The system processes these signals to provide real-time feedback to the surgeon via a touch-screen interface. Modalities include nerve avoidance (XLIF), screw proximity testing, spontaneous EMG monitoring, neuromuscular block assessment (Twitch Test), and pedicle cannulation guidance. A remote monitoring feature allows secondary physicians to view data outside the OR. The device assists surgeons in assessing nerve proximity, spinal cord integrity, and screw trajectory, potentially reducing the risk of surgically induced nerve or motor injury. Used in clinical OR settings by surgeons and monitoring personnel.

Clinical Evidence

Bench testing only. Electrical safety and compatibility testing per IEC 60601-1, 60601-2-40, and 60601-1-2. Guidance function accuracy validated against infrared tracking systems. Accessories underwent impedance, current density, biocompatibility (ISO 10993-1), and sterilization (ISO 11135-1) testing. Published literature cited regarding accuracy of percutaneous lumbar pedicle screw placement.

Technological Characteristics

Hardware includes Patient Module and Control Unit with embedded computer/touch screen. Uses disposable conductive probes, needle/surface electrodes. Sensing: EMG, TcMEP, SSEP, and accelerometer-based angular sensing. Connectivity: Remote monitoring capability. Sterilization: Validated for accessories (SAL 10^-6). Electrical: Constant current/voltage stimulation, rectangular monophasic pulses.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery in adult patients. Used for nerve avoidance, assessment of neuromuscular block, monitoring of spinal cord motor/sensory pathway integrity, and as an aid for pedicle cannulation trajectory assessment.

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

• Cadwell Cascade (K962455)
• DS7A Constant Current High Voltage Stimulator (K051357)
• NIM Eclipse and probes (K061113)
• StealthStation® System (K050438)
• Disc Electrodes (K061148)
• Subdermal Needle Electrodes (K022914)

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, abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "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:

## Submitted by: A.

Elias Ketchum Sr. Associate, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

Date Prepared: February 1, 2012

## B. Device Name

| Trade or Proprietary Name: | NuVasive® NVM5 System |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Neurological surgical monitor |
| 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: | ETN, GWF, HAW, IKN |

## C. Predicate Devices

The subject NuVasive® NVMS System is substantially equivalent to one or more of the following predicate devices listed in Table 1 below.

| 510(k) | Trade or proprietary or model name | Manufacturer |
|---------|-------------------------------------------------------------------|-------------------------------|
| K962455 | Cadwell Cascade | Cadwell Laboratories, Inc. |
| K051357 | DS7A Constant Current High Voltage Stimulator | Digitimer LTD |
| K061113 | NIM Eclipse and probes (formerly Axon Systems<br>OrthoMon System) | Medtronic Xomed, Inc. |
| K050438 | StealthStation® System | Medtronic Inc. |
| K061148 | Disc Electrodes | Rhythmlink International, LLC |
| K022914 | Subdermal Needle Electrodes | Rhythmlink International, LLC |

## D. Device Description

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

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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete square shape on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline ":Speed of Innovation".

monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of the muscle groups imnervated by the nerves. Moreover, a Twitch Test ("Train of Four") 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. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVMS System includes the following five (5) software functionalities / modalities:

- 1. Electromyography (EMG)
- 2. Transcranial Motor Evoked Potential (TcMEP), or simply MEP
- 3. Somatosensory Evoked Potential (SSEP)
- 4. Remote Monitoring
- 5. Guidance

The NVM5® System hardware consists of a Patient Module (PM) and a Control Unit (CU) comprised of an embedded computer with touch screen controls and an interface card, 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 motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves.

- 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 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.

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Image /page/2/Picture/1 description: The image shows the logo for "NUVASIVE". The logo consists of a stylized, curved shape on the left, followed by the company name in capital letters. Below the company name, there is a tagline that reads "Speed of Innovation".

- TcMEP Transcranial stimulation techniques for motor evoked potentials are used to . assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord 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 spine 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.

## 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions.

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## 510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System

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| Specification/ Property | Subject Device<br>NuVasive NVM5 System (K112718) | Cadwell Cascade (K962458) | Predicate Devices<br>Medtronic NIM Eclipse (K061113) | MEPS, LLC. Digitimer (K051357) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The <i>NVM5®</i> 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 neurophysiologic<br>status. <i>NVM5®</i> provides this information by electrically stimulating nerves via<br>electrodes located on surgical accessories and monitoring electromyography<br>(EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked<br>potential (SSEP) responses of nerves.<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<br>any 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. TcMEP - Transcranial stimulation techniques for motor evoked potentials are<br>used to assess for acute dysfunction in axonal conduction of the corticospinal<br>tract. The TcMEP function provides an adjunctive method to allow the<br>surgeon to monitor spinal cord motor pathway integrity during procedures<br>with a risk of 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. The Guidance function is intended as an aid for use in either open or<br>percutaneous pedicle cannulation procedures in the lumbar spine of adult<br>patients, and when used in conjunction with radiographic imaging and EMG,<br>allows the surgeon to assess the angulation of system accessories relative to<br>patient spinal anatomy for the creation of a cannulation trajectory for bone<br>screw placement. | The Cadwell Cascade system<br>is intended to perform the<br>measurements needed for<br>Electromyography (EMG),<br>Nerve Conduction Velocity<br>(NCV, F wave, H wave),<br>Evoked Potentials (Brain<br>Stem, Visual,<br>Somatosensory) and<br>Repetitive Nerve Stimulation. | The OrthoMon system is<br>intended for use to<br>record, monitor and<br>stimulate/record<br>biopotential signals<br>including<br>electromyography<br>(EMG), evoked response<br>and nerve/muscle<br>potentials and for the<br>intraoperative diagnosis<br>of acute dysfunction in<br>corticospinal axonal<br>conduction. The system<br>provides feedback to the<br>surgeon and OR team to<br>assist in the localization<br>and assessment of spinal<br>nerves and verification<br>of placement of spinal<br>instrumentation to avoid<br>injury to at risk nerve<br>roots | The DS7A and DS7AH<br>are stimulators intended<br>for use during<br>neurological monitoring<br>and assessment in a<br>clinical environment.<br>They are intended for<br>use by trained personnel<br>either competent to<br>apply appropriate stimuli<br>or under the supervision<br>and instruction of one<br>who is. |

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| | | | 510(k) Premarket Notification K112718<br>NuVasive® NVM5 System | | | |
|------------------------------------|--------------------------------------------------|--|----------------------------------------------------------------|------------------------------------|----------------------------------------------|--|
| | | | Predicate Devices | | | |
| | | | Cadwell Cascade<br>(K962458) | Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC. Digitimer<br>(K051357) | |
| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System (K112718) | | | | | |
| Total Available Channels | 32 | | 32 | 32 | 2 Stimulation | |
| Headbox/<br>Patient Module | Yes | | Yes | Yes | None | |
| IEC 60601-1<br>Compliant | Yes | | Yes | Yes | Yes | |
| Full Scale View<br>Range | $\pm$ 0.5 $\mu$ V to $\pm$ 8mV | | 10 $\mu$ V to 10mV | $\pm$ 10 $\mu$ V to $\pm$ 25mV | N/A-Stimulation Only | |
| Frequency<br>Response | 3 Hz to 4.8 kHz | | 0.5 Hz to 10kHz | 1Hz to 4 kHz | N/A-Stimulation Only | |
| User Interface | Touch screen and [optional] keyboard/mouse | | Laptop with optional mouse | Touch screen and keyboard/mouse | Push button, Dials, Switches and LCD numbers | |
| Remote<br>Monitoring | Yes | | Yes | Yes | N/A-MEP only | |
| Train of Four<br>Testing | Yes | | Yes | Yes | N/A-MEP only | |
| Needle Electrodes | Various | | Various | Various | N/A-MEP only | |
| Surface<br>Electrodes | Various | | Various | Various | N/A-MEP only | |
| Electrode Leads | Various | | Various | Various | N/A-MEP only | |
| Stimulating<br>Probes | Various | | Various | Various | N/A-MEP only | |
| Recording<br>Channels | EMG, MEP, and SSEP | | EMG, MEP, and SSEP | EMG, MEP, and SSEP | No | |
| Number of<br>Recording<br>Channels | 10 | | N/A | 32 | N/A | |
| Response<br>Threshold | 10-300 $\mu$ V | | N/A | 10 $\mu$ V to 10 mV | N/A | |
| High Filter | 1.5 kHz | | N/A | 10 kHz | N/A | |
| Low Filter | 0.030 kHz | | N/A | 0.5 kHz | N/A | |
| Notch Filter | None | | N/A | 50 or 60 Hz | N/A | |

) Premarket Notification K112
N.V.L. Inc. ® NVL55

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## 510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System

| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System (K112718) | Cadwell Cascade<br>(K962458) | Predicate Devices<br>Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC. Digitimer<br>(K051357) |
|--------------------------------------|--------------------------------------------------|------------------------------|---------------------------------------------------------|-----------------------------------|
| Audible EMG | Yes | N/A | Yes | N/A |
| CMRR | > 100 dB @ 60 Hz | N/A | > 100 dB @ 60 Hz | N/A |
| A/D Sampling<br>Rate | 9.6 kHz | N/A | Unknown | N/A |
| Automatic Muting<br>During Artifact | Yes | N/A | Yes | N/A |
| Stimulation<br>Waveform | Rectangular, Monophasic Pulse | N/A | Rectangular, Monophasic and<br>Biphasic Pulse | N/A |
| Constant<br>Current/Voltage | Yes | N/A | Yes | N/A |
| Theoretical Max<br>Voltage | 300 V | N/A | 400 V | N/A |
| Max Current | 0.09 A | N/A | 0.1 A | N/A |
| Max Pulse Width | 0.0002 sec | N/A | 0.0005 sec | N/A |
| Max Number of<br>Pulses per second | 5 | N/A | 100 | N/A |
| Min Probe<br>Surface Area | 0.169 cm² | N/A | 0.002 cm² | N/A |
| Calculated Values per IEC 60601-2-40 | | | | |
| Voltage | 90 V | N/A | 100 V | N/A |
| Max RMS<br>Current | 2.8 mARMS | N/A | 22.3 mARMS | N/A |
| Max RMS<br>Current Density | 16.57 mARMS/cm² | N/A | 11,150 mARMS/cm² | N/A |
| Max Charge<br>Density | 107 µC/cm² | N/A | 25,000 µC/cm² | N/A |
| Max Power<br>Density | 48 W/cm² | N/A | 5000 W/cm² | N/A |

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# 510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System

| :<br>్ శిశ్ | MEPS, LLC. Digitimer | ្រី ជា ជួរ | 1000 V | 1.0 A | 0.00005 sed | 1 0 | 0.492 cm2 | | 50 mJ | 1000 V | 22 mArms | 4.7 mARMS/CI | 102 µC/cm² | 2032 W/cm² |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------|-----------------|------------------------------|------------------|-----------------------------------|------------|---------|------------------|------------------------|----------------------|-------------------|
| Predicate Devices | A Medtronic NIM Ecl | ﺍﻟﻤﺮﺍﺟﻊ | N/A | N/A | N/A | N/A | N/A | | N/A | N/A | N/A | N/A | N/A | N/A |
| | dwell Cascade (K962458) ------------------------------------------------------------------------------------------------------------------------------------------------------ | 일본 일본 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 19 | N/A | N/A | N/A | N/A | N/A | | N/A | N/A | N/A | N/A | N/A | N/A |
| : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | Subject Device System (K112718) Tasive NYM5 System (K112718) -----------------------------------------------------------------------------------------------------------------<br>ਿੱਚ ਹੈ। ਇਸ ਨੇ 2008 ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਸੀ। ਹਵਾਲੇ 2008 ਦੀ ਸੀ। | МЕР -<br>المواليد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال | 000 V | 1 .0 A | 0.00005 se | 8 | 0.492 cm² | | 50 m.J | 000 V | 20 mArm | 0.65 mArms/c | 02 μC/cm | 032 W/cm |
| | Specification/ Property T | 【 | neoretical Mar Voltage | Max Curren | lax Pulse Widtl | Max Number o ulses per secor | Min Surface Area | ilculated Values per IEC 60601-24 | Max Energy | Voltage | Max RMS Current | Max RMS Current Densit | Max Charg<br>Density | Max Powe Density |

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## 510(k) Premarket Notification K11277
NuVasive® NuVasive® NVM5 Syste

| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System (K112718) | SSEP | Cadwell Cascade<br>(K962458) | Predicate Devices | Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC. Digitimer<br>(K051357) |
|--------------------------------------|--------------------------------------------------|---------------------|------------------------------|-------------------|------------------------------------|-----------------------------------|
| Theoretical Max<br>Voltage | 300 V | 400 V | N/A | N/A | N/A | N/A |
| Max Current | 0.09 A | 0.1 A | N/A | N/A | N/A | N/A |
| Max Pulse Width | 0.0003 sec | 0.001 sec | N/A | N/A | N/A | N/A |
| Max Number of<br>Pulses per second | 9.7 | 90 | N/A | N/A | N/A | N/A |
| Min Surface Area<br>Electrode | 0.262 cm² | 0.262 cm² | N/A | N/A | N/A | N/A |
| Calculated Values per IEC 60601-2-40 | | | | | | |
| Voltage | 90 V | 100 V | N/A | N/A | N/A | N/A |
| Max RMS<br>Current | 4.8 mARMS | 30 mARMS | N/A | N/A | N/A | N/A |
| Max RMS<br>Current Density | 18.32 mARMS/cm² | 114.5 mARMS/cm² | N/A | N/A | N/A | N/A |
| Max Charge<br>Density | 10 $ µC/cm² $ | 381 $ µC/cm² $ | N/A | N/A | N/A | N/A |
| Max Power<br>Density | 36.8 W/cm² | 38 W/cm² | N/A | N/A | N/A | N/A |

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| Clinical Characteristics for Guidance Function | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device – NVM5 Guidance (K112718) | Predicate Device – StealthStation® (K050438) | Substantially Equivalent |
| This function is intended as an aid for use in percutaneous pedicle cannulation in the lumbar spine of adult patients, and in conjunction with radiographic imaging that allows the surgeon to assess the angulation of accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone cement. | The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.<br><br>(Note: For the purposes of this predicate comparison the scope of the indications to be compared are limited to cannulation of a pedicle for pedicle screw placement) | Yes – the Guidance function has limited indications compared to the predicate. |
| Requires input derived from CT, MRI, or radiographic images | Requires input derived from CT, MRI, or radiographic images | |
| Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory with EMG stimulation | Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation | Yes |
| References angular sensing technology coupled with associated tracking instruments | References angular and position sensing technology coupled with associated tracking instruments | Yes |
| Utilizes a C-Arm Reticle with radio dense markers | Utilizes a C-Arm Reticle with radio dense markers | Yes |

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| 510(k) Premarket Notification K112718<br><i>NuVasive® NVM5 System</i> | | Substantially Equivalent | | | |
|-----------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----|
| | | Yes - The reduced degree of data<br>collected by Guidance is still deemed<br>substantially equivalent since it is used<br>in conjunction with fluoroscopic<br>imaging, not indicated for used by the<br>predicate StealthStation. The amount of<br>data collected by Guidance is sufficient<br>to provide angular outputs to compare<br>against the angular inputs identified by<br>the user as the planned trajectory,<br>considering that intraoperative<br>radiographic imaging is used to confirm<br>the starting point and correct trajectory<br>of the cannulation needle. | Yes | Yes | Yes |
| | Specification/<br>Property | Subject Device – NVM5 Guidance (K112718) | Predicate Device – StealthStation® (K050438) | | |
| | Scientific<br>Principles<br>(continued) | • Uses accelerometers to sense angular measurements<br>based on gravity by collecting 2 degrees of freedom<br>(DOF) (rx, ry) data<br><br>• Displays instrument orientation only (rotational<br>information in the x and y planes only) with respect<br>to gravity | • Uses infrared technology to capture positional and<br>rotational information via 6 DOF (x, y, z, rx, ry, rz)<br>data<br><br>• Displays the location and orientation (positional and<br>rotational information in the x, y, and z planes) of<br>instruments in real time merged with pre-<br>operatively obtained images of patient anatomy | | |
| | Performance<br>Requirements | • Angular tolerance of ±2°<br>• Confirmation of alignment to pre-planned trajectory<br>• Seamlessly integrated with an insulated Jamshidi<br>Needle | • Angular tolerance of ±2°<br>• Confirmation of alignment to pre-planned trajectory<br>• Seamlessly integrated with an insulated Jamshidi<br>Needle | | |
| | Conformance<br>with Recognized<br>Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Yes | |
| | User Interface | Touch screen, graphical user interface and audio | Touch screen, graphical user interface and audio | Yes | |
| | System<br>Materials/<br>Biosafety | Tracking instruments composed of known and<br>accepted (biocompatible) materials. | Tracking instruments composed of known and<br>accepted (biocompatible) materials. | Yes | |
| | System<br>Sterilization | As selected for individual accessories, and validated to<br>assure an SAL of 10-6. | As selected for individual accessories, and validated to<br>assure an SAL of 10-6. | Yes | |

Page 10 of 12

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0(k) Premarket Notification K112718
NuVasive® NVM5 System

1979

| | Subject<br>NVM5<br>Dual Surface<br>(K112718) | Predicate<br>Sticky-pad™<br>Electrodes<br>(K061148) | Subject<br>NVM5<br>Dual Needle<br>(K112718) | Predicate<br>Subdermal<br>Needle<br>Electrodes<br>(K050194) | Subject<br>NVM5<br>Corkscrew<br>(K112718) | Predicate<br>Subdermal<br>Needle<br>Electrodes<br>(K050194) | Subject<br>NVM5<br>Cranial<br>Array<br>(K112718) | Predicate<br>Subdermal<br>Needle<br>Electrodes<br>(K061148) | Subject<br>NVM51-<br>PAS<br>Needle<br>(K112718) | Predicate<br>I-PAK<br>Needle<br>(K061113) |
|--------------------------|----------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Medtronic |
| Length(s) | N/A | N/A | Needle length: 12mm | Needle length: 13mm | N/A | N/A | Needle length: 12mm | Needle length: 13mm | Overall assembly length: 8.75" | Overall assembly length: 7.58" |
| Size(s) | Pad size: 17.81cm² | Pad size:<br>Min: 1.5 x 2.0cm (3.0cm²)<br>Max: 4.5 x 3.5cm (15.75cm²) | Needle diameter: 0.036cm | Needle diameter: 0.04cm | Needle Diameter: 0.058cm<br>Needle height: 0.302cm | Needle diameter: 0.06cm<br>Needle height: 0.380cm | Needle diameter: 0.036cm | Needle diameter: 0.04cm | • Outer sheath diameter: 0.250"<br>• Inner sheath diameter: 0.179"<br>• Cannula diameter: 0.118" | • Outer Cannula proximal diameter: 0.187"<br>• Outer Cannula distal diameter: 0.125"<br>• Stylette diameter: 0.093" |
| Stim/Record Surface Area | 1.78cm² | 3 - 15.75cm² | 0.262cm² | 0.326cm² | 0.492cm² | 0.584cm² | 0.655cm² | 0.163cm² | 0.645 – 2.987cm² | 0.3cm² |

Page 11 of 12

NUVASIVE

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Image /page/11/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter N on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.

## G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NVM5 Sustem is substantially equivalent to other predicate devices and to verify that the NVM5 Sustem meets design specifications and performance characteristics, based upon the intended use. The NVM5® System was subjected to electrical safety and compatibility testing and was certified to the following standards, including all applicable normative reference standards:

- . IEC 60601-1 (1988), A1 (1991), A2 (1995): Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC 60601-2-40 (1988): Medical Electrical Equipment Part 2-40:Particular . requirements for the safety of electromyographs and evoked response equipment
- IEC 60601-1-2 (2001), A1 (2004): Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility
- . Guidance performance testing - Accuracy testing for the creation of a cannulation trajectory for bone screw placement that demonstrated equivalent degrees of variance and that the accelerometer-based NVM5 Guidance function and the infrared tracking from the StealthStation are equivalent in their performance (supplemented with the following published clinical literature: Accuracy of percutaneous lumbar pedicle screw placement using the oblique or "owl's-eve" view and novel guidance technology (J Neurosurg Spine. 2010), and Improving accuracy and reducing radiation exposure in minimally invasive lumbar interbody fusion (J Neurosurg Spine, 2010))

Accessories to the NVM50 System also underwent the following performance testing. where applicable:

- Impedance and continuity testing .
- Current density testing .
- Electrical performance and durability .
- Fluid interference .
- Biocompatibility testing per ISO 10993-1 .
- Sterilization validation per ISO 11135-1 .
- Penetration and friction testing of needle electrodes .

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, and safe and effective for its intended use.

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Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

## Public Health Service

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

Elias Ketchum Sr. Associate, Regulatory Affairs NuVasive, Inc. 7475 Lusk Boulevard San Diego, CA 92121

MAR 1 6 2012

Re: K112718

Trade/Device Name: NuVasive® NVM5® System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, GWF, HAW, IKN Dated: February 6, 2012 Received: February 7, 2012

Dear Mr. Ketchum:

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 for association 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 Tou may, therefore, mans of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (boo acore). 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.

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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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Melvin R. Fields, M.D.

Malvina B. Eydelman/M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use .

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: NuVasive® NVM5 System

Indications For Use:

The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring spinal I he NYM - System is a medical Geneven, to the surgeon, to help assess a patient's neurophysiologic status. Surgery. The device provides maron and surves via electrodes located on surgical accessories IV WP > provides this intermation by clectrically secreted potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves.

- 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 . Dasic & Dyllanite Serve Test = The Deter Teachens and many and preparation and placement of bone screws.
- Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by . I to kun Live dive 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.
- TcMEP Transcranial stimulation techniques for motor evoked potentials are used to assess for acute . I coller = Transcranial stimataton techniquicospinal tract. The TcMEP function provides an adjunctive motor pathway integrity during procedures with a method to allow the surgeon to monitor spinal cord i 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.
- The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation . The Outdation is thenom is theneve as an the ntsed 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kristen Bowsher

Page 1 of 1 Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_ K 112718