NUVASIVE NVJJB SYSTEM

K112717 · Nuvasive, Inc. · ETN · Apr 13, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K112717
• Device Name: NUVASIVE NVJJB SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Apr 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Indications for Use

The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves. MaXcess Detection The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. Difference Screw Test (DST) The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria. 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. 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 and motor pathway integrity during procedures with a risk of surgically induced motor injury. Remote Reader The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room. Nerve Retractor The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

Device Story

The NVJJB System is an intraoperative neurophysiological monitoring device used during spinal surgery. It consists of a patient module and a control unit with a touchscreen. The system inputs electrical stimulation to nerves via disposable probes/electrodes and monitors EMG or TcMEP responses. It features specific functions: MaXcess Detection and Screw Tests for nerve avoidance/proximity; Free Run EMG for spontaneous activity; Twitch Test for neuromuscular block assessment; TcMEP for motor pathway integrity; and a Remote Reader for off-site physician viewing. Surgeons use the real-time output to assess nerve integrity, guide screw placement, and avoid injury. The device benefits patients by providing continuous monitoring of spinal cord and nerve function, allowing for immediate intervention if neurophysiological changes occur during surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety and compatibility per IEC 60601-1, IEC 60601-2-40, and IEC 60601-1-2. Accessory testing included impedance/continuity, current density, electrical durability, fluid interference, biocompatibility (ISO 10993-1), sterilization validation (ISO 11135-1), and needle electrode penetration/friction testing.

Technological Characteristics

Class II surgical nerve stimulator/locator. Hardware: Patient Module and Control Unit with touchscreen. 8 recording channels. Stimulation: Constant current/voltage, rectangular monophasic pulses (max 240V, 0.05A). Connectivity: Remote monitoring via screen sharing. Sterilization: Disposable accessories. Standards: IEC 60601-1, IEC 60601-2-40, IEC 60601-1-2, ISO 10993-1, ISO 11135-1.

Indications for Use

Indicated for intraoperative neurophysiological monitoring and status assessment during spinal surgery in patients undergoing procedures with risk of surgically induced motor injury or requiring nerve avoidance.

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

• NVM5® System (K112718)
• NIM Eclipse and probes (formerly Axon Systems OrthoMon System) (K061113)
• DS7A Constant Current High Voltage Stimulator (K051357)
• Disc Electrodes (K061148)
• Subdermal Needle Electrodes (K022914)
• Stimulation/Dissection Instruments (K112709)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date April 13, 2012. The month is abbreviated as APR. The day is 13 and the year is 2012. The text is in a simple, sans-serif font.

Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in all caps. Below the company name is the tagline "Speed of Innovation" in a smaller font.

510(k) Premarket Notification NuVasive® NVJJB System, K112717

## 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: March 22, 2012

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® NVJJB System |
|----------------------------|-----------------------------------|
| Common or Usual Name: | Neurological surgical monitor |
| Classification Name: | Surgical Nerve Stimulator/Locator |
| Device Class: | Class II |
| Regulation: | §874.1820 |
| Product Code: | ETN, GWF, IKN |

#### Predicate Devices C.

The subject NuVasive® NVJJB 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 |
|---------|-------------------------------------------------------------------|-------------------------------|
| K112718 | NVM5® System | NuVasive, Inc. |
| K061113 | NIM Eclipse and probes (formerly Axon<br>Systems OrthoMon System) | Medtronic Xomed, Inc. |
| K051357 | DS7A Constant Current High Voltage Stimulator | Digitimer LTD |
| K061148 | Disc Electrodes | Rhythmlink International, LLC |
| K022914 | Subdermal Needle Electrodes | Rhythmlink International, LLC |
| K112709 | Stimulation/Dissection Instruments | NuVasive, Inc. |

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE". Below the word "NUVASIVE" is the tagline "Speed of Innovation".

### D. Device Description

The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TceMEP) responses of the muscle groups innervated 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 NVJJB System also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVJJB user interface. In summary, the NVJJB System includes the following three (3) software functionalities / modalities:

- 1. Electromyography (EMG)
- 2. Transcranial Motor Evoked Potential (TceMEP), or simply MEP
- 3. Remote Monitoring

The NVJJB® 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 NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves.

- · MaXcess Detection The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
- · Difference Screw Test (DST) The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria.
- · 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.

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Image /page/2/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a circular graphic on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "Speed of Innovation".

- 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 and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- · Remote Reader The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room.
- · Nerve Retractor The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

# F. Technological Characteristics

As was established in this submission, the subject NV.JJB® 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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| Specification/<br>Property | Subject Device | Predicate Devices | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NuVasive NVJJB System (K112717) | NuVasive NVM5 System (K112718) | Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC.<br>Digitimer (K051357) |
| Intended Use/<br>Indications for<br>Use | The <span style="font-style:italic">NVJJB</span> ™ System is a medical device that is intended for<br>intraoperative neurophysiological monitoring and status assessment<br>during spinal surgery. The device provides information directly to the<br>surgeon, to help assess a patient's neurophysiological status. <span style="font-style:italic">NVJJB</span><br>provides this information by electrically stimulating nerves via<br>electrodes located on surgical accessories and monitoring<br>electromyography (EMG) or transcranial motor evoked potential<br>(TcMEP) responses of nerves.<br>MaXcess Detection - The MaXcess Detection function allows the<br>surgeon to locate and evaluate spinal nerves, and is used as a nerve<br>avoidance tool. Difference Screw Test (DST) - The DST function allows the surgeon<br>to locate and evaluate spinal nerves before, during, or after placement<br>of bone screws by verifying nerve integrity and factoring it into the<br>alarm criteria. Basic & Dynamic Screw Test - The Screw Test functions allow the<br>surgeon to locate and evaluate spinal nerves by providing proximity<br>information before, during or after bone preparation and placement of<br>bone screws. Free Run EMG - The Free Run EMG function identifies spontaneous<br>EMG activity of spinal nerves by continually displaying a live stream<br>waveform of any mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allows the<br>surgeon to assess moderate degrees of neuromuscular block in effect<br>by evaluating muscle contraction following a train of four stimulation<br>pulses. TcMEP - Transcranial stimulation techniques for motor evoked<br>potentials are used to assess for acute dysfunction in axonal<br>conduction of the corticospinal tract. The TCMEP function provides<br>an adjunctive method to allow the surgeon to monitor spinal cord and<br>motor pathway integrity during procedures with a risk of surgically<br>induced motor injury. Remote Reader - The Remote Reader function provides real time<br>remote access to the NVJJB System for a monitoring physician<br>outside of the operating room. Nerve Retractor - The Nerve Retractor function allows the surgeon<br>to locate and identify spinal nerves by directly stimulating exposed<br>nerves to assist in identifying neurophysiological changes during<br>retraction. | The <span style="font-style:italic">NVM5</span> System is a medical device that is intended for<br>intraoperative neurophysiologic monitoring during spinal surgery.<br>The device provides information directly to the surgeon, to help<br>assess a patient's neurophysiologic status. <span style="font-style:italic">NVM5</span> provides this<br>information by electrically stimulating nerves via electrodes<br>located on surgical accessories and monitoring electromyography<br>(EMG), transcranial motor evoked potential (TCMEP) or<br>somatosensory evoked potential (SSEP) responses of nerves.<br>XLIF (Detection) - The XLIF (Detection) function allows the<br>surgeon to locate and evaluate spinal nerves, and is used as a<br>nerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions<br>allow the surgeon to locate and evaluate spinal nerves by<br>providing proximity information before, during or after bone<br>preparation and placement of bone screws. Free Run EMG-The Free Run EMG function identifies<br>spontaneous EMG activity of spinal nerves by continually<br>displaying a live stream waveform of any mechanically<br>induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allows<br>the surgeon to assess moderate degrees of neuromuscular block<br>in effect by evaluating muscle contraction following a train of<br>four stimulation pulses. TeMEP - Transcranial stimulation techniques for motor evoked<br>potentials are used to assess for acute dysfunction in axonal<br>conduction of the corticospinal tract. The TeMEP function<br>provides an adjunctive method to allow the surgeon to monitor<br>spinal cord motor pathway integrity during procedures with a<br>risk of surgically induced motor injury. SSEP-The SSEP function allows the surgeon to assess<br>sensory spinal cord function in surgical procedures during<br>which the spinal cord is at risk. Remote Reader - The Remote Reader function provides real<br>time remote access to the NVM5 System for a monitoring<br>physician outside of the operating room. The Guidance function is intended as an aid for use in either<br>open or percutaneous pedicle cannulation procedures in the<br>lumbar spine of adult patients, and when used in conjunction<br>with radiographic imaging and EMG, allows the surgeon to<br>assess the angulation of system accessories relative to patient<br>spinal anatomy for the creation of a cannulation trajectory for<br>bone screw placement. | 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 of<br>placement of spinal<br>instrumentation to avoid<br>injury to at risk nerve<br>roots | The DS7A and<br>DS7AH are<br>stimulators intended<br>for use during<br>neurological<br>monitoring and<br>assessment in a<br>clinical environment.<br>They are intended for<br>use by trained<br>personnel either<br>competent to apply<br>appropriate stimuli or<br>under the supervision<br>and instruction of one<br>who is. |

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| Specification/<br>Property | Subject Device<br>NuVasive NVJJB System (K112717) | Predicate Devices<br>NuVasive NVM5 System (K112718) | Predicate Devices<br>Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC.<br>Digitimer (K051357)<br>2 Stimulation |
|--------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------|----------------------------------------------------|
| Total Available<br>Channels | 8 | 32 | 32 | None |
| Headbox/<br>Patient Module<br>IEC 60601-1<br>Compliant | Digital Preamplifier with A/D Converter | Yes | Yes | Yes |
| Full Scale<br>View Range | Yes | Yes | Yes | N/A-Stimulation<br>Only |
| Frequency<br>Response | 30 Hz to 4.8 kHz | 3 Hz to 4.8 kHz | 1Hz to 4 kHz | N/A-Stimulation<br>Only |
| User Interface | Touch screen and [optional] keyboard/mouse | Touch screen and [optional] keyboard/mouse | Touch screen and<br>keyboard/mouse | Push button, Dials,<br>Switches and LCD<br>numbers |
| Remote<br>Monitoring | Yes | Yes | Yes | N/A-MEP only |
| Train of Four<br>Testing | Various | Various | Various | N/A-MEP only |
| Needle<br>Electrodes | Various | Various | Various | N/A-MEP only |
| Surface<br>Electrodes | Various | Various | Various | N/A-MEP only |
| Electrode<br>Leads | Various | Various | Various | N/A-MEP only |
| Stimulating<br>Probes | Various | Various | Various | N/A-MEP only |
| Recording<br>Channels | 8 | EMG, MEP, and SSEP | EMG, MEP, and SSEP | No |
| Number of<br>Recording<br>Channels | 8 | 10 | 32 | N/A |
| Response<br>Threshold | 10-300µV user settable for free run and stimulated | 10-300 μV | 10 µV to 10 mV | N/A |
| High Filter | 1.5k Hz | 1.5 kHz | 10 kHz | N/A |
| Low Filter | 30 Hz | 0.030 kHz | 0.5 kHz | N/A |
| Notch Filter | None | None | 50 or 60 Hz | N/A |
| Audible EMG | Yes | Yes | Yes | N/A |

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510(k) Premarket Notification K112717
NuVasive® NVJJB System

| Specification/<br>Property | Subject Device<br>NuVasive NVJJB System (K112717) | Predicate Devices<br>NuVasive NVM5 System (K112718) | Medtronic NIM Eclipse<br>(K061113) | MEPS, LLC.<br>Digitimer (K051357) |
|---------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------|-----------------------------------|
| CMRR | > 100 dB | > 100 dB @ 60 Hz | > 100 dB @ 60 Hz | N/A |
| A/D Sampling<br>Rate | 9.6 kHz | 9.6 kHz | Unknown | N/A |
| Automatic<br>Muting During<br>Artifact | Yes | Yes | Yes | N/A |
| Stimulation<br>Waveform | Rectangular, Monophasic Pulse | Rectangular, Monophasic Pulse | Rectangular, Monophasic and<br>Biphasic Pulse | N/A |
| Constant<br>Current/<br>Voltage | Yes | Yes | Yes | N/A |
| Theoretical<br>Max Voltage | 240 V | 300 V | 400 V | N/A |
| Max Current | 0.05 A | 0.09 A | 0.1 A | N/A |
| Max Pulse<br>Width | 0.0002 sec | 0.0002 sec | 0.0005 sec | N/A |
| Max Number<br>of Pulses per<br>second | 5 | 5 | 100 | N/A |
| Min Probe<br>Surface Area | 0.169 cm² | 0.169 cm² | 0.002 cm² | N/A |
| Calculated Values per IEC 60601-2-40 | | | | |
| Voltage | 50 V | 90 V | 100 V | N/A |
| Max RMS<br>Current | 1.6 mARMS | 2.8 mARMS | 22.3 mARMS | N/A |
| Max RMS<br>Current<br>Density | 6.1 mARMS/cm² | 16.57 mARMS/cm² | 11,150 mARMS/cm² | N/A |
| Max Charge<br>Density | 59 µC/cm² | 107 µC/cm² | 25,000 µC/cm² | N/A |
| Max Power<br>Density | 15 W/cm² | 48 W/cm² | 5000 W/cm² | N/A |
| | 510(k) Premarket Notification K112717<br><i>NuVasive® NVJJB System</i> | | | |
| Subject Device<br>NuVasive NVJJB System (K112717) | Predicate Devices<br>NuVasive NVM5 System (K112718) | Predicate Devices<br>Medtronic NIM Eclipse<br>(K061113) | Predicate Devices<br>MEPS, LLC.<br>Digitimer (K051357) | |
| 1000 V | 1000 V | N/A | 1000 V | |
| 1.0 A | 1.0 A | N/A | 1.0 A | |
| 0.00005 sec | 0.00005 sec | N/A | 0.00005 sec | |
| 4 | 8 | N/A | 10 | |
| 0.492 cm² | 0.492 cm² | N/A | 0.492 cm² | |
| 50 mJ | 50 mJ | N/A | 50 mJ | |
| 1000 V | 1000 V | N/A | 1000 V | |
| 14 mARMS | 20 mARMS | N/A | 22 mARMS | |
| 28.4 mARMS/cm² | 40.65 mARMS/cm² | N/A | 44.7 mARMS/cm² | |
| 101 µC/cm² | 102 µC/cm² | N/A | 102 µC/cm² | |
| 2032 W/cm² | 2032 W/cm² | N/A | 2032 W/cm² | |

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510(k) Premarket Notification K112717
NVJJB System NVJJB System

NUVASIVE

| | Subject NVJJB Dual Surface (K112717) | Predicate Sticky pad™ Electrodes (K061148) | Subject NVJJB Dual Needle (K112718) | Predicate Subdermal Needle Electrodes (K050194) | Subject NVJJB Corkscrew (K112718) | Predicate Subdermal Needle Electrodes (K050194) | Subject NVJJB Cranial Array (K112718) | Predicate Subdermal Needle Electrodes (K061148) |
|--------------------------|--------------------------------------|--------------------------------------------------------------------|-------------------------------------|-------------------------------------------------|----------------------------------------------------|---------------------------------------------------|---------------------------------------|-------------------------------------------------|
| Manufacturer | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC |
| Length(s) | N/A | N/A | Needle length: 12mm | Needle length: 13mm | N/A | N/A | Needle length: 12mm | Needle length: 13mm |
| Size(s) | Pad size: 17.81cm² | Pad size: 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 |
| Stim/Record Surface Area | 1.78cm² | 3 - 15.75cm² | 0.262cm² | 0.326cm² | 0.492cm² | 0.584cm² | 0.655cm² | 0.163cm² |

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Image /page/8/Picture/1 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 company name is the tagline "iSpeed of Innovation" in a smaller font. The logo appears to be printed in black ink on a white background.

# G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NV.J.B® System is substantially equivalent to other predicate devices and to verify that the NVJJB® System meets design specifications and performance characteristics, based upon the intended use. The NVJJB® 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

Accessories to the NVJJB® 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 NVJJB® 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 NV.JB® 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three wavy lines representing the body and a head-like shape at the top.

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

APR 1 3 2012

NuVasive, Incorporated % Mr. Elias Ketchum Senior Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K112717

Trade/Device Name: NuVasive NVJJB System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN, GWF, IKN Dated: March 22, 2012 Received: March 26, 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 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 I lease be advised that I Dris beauting that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any I ederal 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

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# Page 2-Mr. Elias Ketchum

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,

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): K112717

## Device Name: NuVasive® NVJJB® System

Indications For Use:

The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves.

- MaXcess Detection The MaXcess Detection function allows the surgeon to locate and evaluate . ● spinal nerves, and is used as a nerve avoidance tool.
- Difference Screw Test (DST) -- The DST function allows the surgeon to locate and evaluate . spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria.
- 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.
- 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 and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- Remote Reader The Remote Reader function provides real time remote access to the NVJJB . System for a monitoring physician outside of the operating room.
- Nerve Retractor- The Nerve Retractor function allows the surgeon to locate and identify spinal . nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

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)

William Goins, Ph.D. Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

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510(k) Number K112717