NEUROVISION JJB SYSTEM

K072343 · Nuvasive, Inc. · GWF · Oct 29, 2007 · Neurology

Device Facts

• Record ID: K072343
• Device Name: NEUROVISION JJB SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: GWF · Neurology
• Decision Date: Oct 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.

Device Story

NeuroVision JJB System provides intraoperative neurological monitoring and nerve localization. System inputs include electrical signals captured via disposable/reusable conductive probes, electrodes, and leads. Control unit, featuring embedded computer and touchscreen, processes these signals to provide real-time status assessment. Used in operating rooms and non-critical care clinical settings by medical professionals. Output allows clinicians to monitor nerve status and assist in controlled spinal access. Device benefits include enhanced surgical navigation and nerve protection during procedures.

Clinical Evidence

No clinical data provided; non-clinical testing not applicable.

Technological Characteristics

System comprises a patient module, control unit with embedded computer, touchscreen interface, and various conductive probes/electrodes. Operates as an electromyography (EMG) monitor/stimulator. Connectivity is via wired leads. Sterilization method not specified.

Indications for Use

Indicated for neurological monitoring and status assessment in operating room and non-critical care clinical environments; assists in gaining controlled access to the spine. No specific patient age or gender restrictions provided.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• NuVasive NeuroVision JJB System (K062765)
• K051357

Reference Devices

• Epoch XP (K032741)

Submission Summary (Full Text)

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K072343

### 5. 510(K) SUMMARY

NUVASI

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

### A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### B. Device Name

Trade or Proprietary Name: NuVasive NeuroVision JJB System Electromyography (EMG) monitor/stimulator Common or Usual Name: Surgical nerve stimulator/locator Classification Name: Class II Device Class: \$874.1820, §882.1870 Classification: 77ETN, 84GWF Product Code:

### C. Predicate Devices

510(k) Number:

The subject device is substantially equivalent to the following previously cleared devices.

| Trade or Proprietary Name: | NuVasive NeuroVision JJB System |
|----------------------------|-----------------------------------|
| Manufacturer: | NuVasive, Inc. |
| Classification Name: | Surgical nerve stimulator/locator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870 |
| Product Code: | 77ETN, 84GWF |
| 510(k) Number: | K062765 |

K051357

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| Trade or Proprietary Name: | Epoch XP |
|----------------------------|-----------------------|
| Manufacturer: | Axon Systems |
| Classification Name: | Electroencephalograph |
| Device Class: | Class II |
| Classification: | §882.1400 |
| Product Code: | GWQ, GWE, GWF, GW- |
| 510(k) Number: | K032741 |

## D. Device Description

The NeuroVision JJB System consists of a Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads.

## E. Intended Use

The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.

### F. Substantial Equivalence

Data was provided which demonstrated the NuVasive NeuroVision JJB to be substantially The substantial equivalence is based upon equivalent to previously cleared devices. equivalence in indications for use, design, material, and function.

## G. Summary of Non-Clinical Tests (Not Applicable).

- H. Summary of Clinical Tests (Not Applicable).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2007

Nuvasive, Inc. % Ms. Laetitia Cousin 4545 Towne Centre Court San Diego, California 92121

> K072343 Trade/Device Name: Neurovision JJB System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: August 20, 2007 Received: August 21, 2007

Dear Ms. Cousin:

Re:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Laetitia Cousin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vou

Mark N. Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K072343

Device Name: NeuroVision® JJB System

Indications For Use:

The NeuroVision System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.

Prescription Use XI (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)

Page 1 of 1

Dion

Division of General, Restora and Neurological Devices

510(k) Number.