NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

K002677 · Nuvasive, Inc. · BXM · Nov 13, 2000 · Anesthesiology

Device Facts

• Record ID: K002677
• Device Name: NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: BXM · Anesthesiology
• Decision Date: Nov 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.

Device Story

INS-1 Intraoperative Nerve Surveillance System; electronic monitor/stimulator for spinal surgery. Inputs: electrical energy delivered to tissues via cannula/probe; EMG signals from muscle groups via electrodes. Operation: device delivers low-amperage current to stimulate nerves; monitors EMG response in associated muscles; alerts surgeon when cannula tip nears nerve. Components: control unit, PreAmp module, conductive probe cables, electrodes. Used in OR by surgeons during percutaneous spinal procedures. Output: visual/auditory alerts regarding nerve proximity. Benefit: assists in nerve location/evaluation; helps avoid nerve injury during instrumentation; aids in verifying pedicle wall integrity.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing and animal studies (porcine model) demonstrating effective nerve location/monitoring and correlation with predicate device data.

Technological Characteristics

Electronic nerve stimulator/EMG monitor. Components: reusable control unit, PreAmp module, disposable/reusable conductive probes/electrodes. Principle: electrical nerve stimulation and EMG signal acquisition. System is standalone.

Indications for Use

Indicated for intraoperative EMG surveillance to assist in the location and evaluation of spinal nerves during percutaneous spinal surgery, including access to nerve roots, foramina, and intervertebral discs via posterior or posterolateral approaches.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

Predicate Devices

• Brackmann II EMG Monitoring System (WR Medical Electronics Co.)
• Neurovision SE Nerve Locator/Monitor (RLN Systems, Inc.)
• Viking IV Electromyography System (Nicolet Biomedical)
• Epoch 2000 Neurological Workstation (Axon Systems, Inc.)
• Neurosign 400 Motor Nerve Monitor (Magstim Company, Ltd.)

Submission Summary (Full Text)

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NOV 1 3 2000

K002677

# Section VII

# 510(k) Summary

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KO02677

## VII. 510(k) Summary

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

#### A. Submitted by:

R. Stephen Reitzler, RAC Vice President, Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road, Suite A San Diego, California 92131 Telephone: [phone] Telefacsimile: [phone]

### B. Device Name

Trade or Proprietary Name: INS-1 Introperative Nerve Surveillance System

Common or Usual Name: Electromyography (EMG) monitor/stimulator

Classification Name: Surgical nerve stimulator/locator

## C. Predicate Devices

The subject device is substantially equivalent, in whole or in part, to one or more of the following predicate devices, among others:

Brackmann IITM EMG Monitoring System (WR Medical Electronics Co.) Neurovision SE Nerve Locator/Monitor (RLN Systems, Inc.) Viking IV™ Electromyography System (Nicolet Biomedical) Epoch 2000 Neurological Workstation (Axon Systems, Inc.) Neurosign 400 Motor Nerve Monitor (Magstim Company, Ltd.)

### D. Device Description

The subject INS-1 System is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate spinal nerves with electrical energy, and through the use of electromyography (EMG) electrodes. monitors the sensitivity, and assists in determining the location, of spinal nerves during percutaneous surgery of the spine.

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The device employs a "Status" routine to determine the baseline functional status of exiting spinal nerves in the area of the operative target, and directs low amperage current through the distal tip of the NuVasive Expanding Cannula as it penetrates tissue to the operative target.

Through a series of EMG electrodes placed on the muscle groups associated with the spinal nerves at the operative level of the spine, the INS-1 System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and create an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.

An additional feature of the INS-1 System is a hand-held electrical probe which can assist the surgeon in determining if a nerve lies directly in the path of the instrumentation, and may also be used to ascertain whether a transpedicular screw has violated the pedicle wall.

The INS-1 System consists of a reusable Control Unit and PreAmp module, and an assortment of disposable and reusable conductive probe cables, electrodes, and electrode leads.

## E. Intended Use

The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.

### F. Comparison to Predicate Devices

The subject device has indications for use which are substantially equivalent to those of one or more of the predicate devices, is composed of the same or equivalent materials as one or more commercially marketed devices, has the same design features as one or more of the predicate devices, and has functional characteristics which are the same or equivalent to those of one or more of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues.

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## Summary of Non-Clinical Tests G.

Animal studies conducted in the porcine model have established that 1) the principle functions of the INS-1 System are effectively performed, such that spinal nerve status and location may be ascertained and monitored, and 2) that the data acquired by the subject device during simulated surgical use in the animal model correlate well with those acquired simultaneously by a predicate device.

## H. Summary of Clinical Tests

(Not applicable.)

## Conclusions of Non-Clinical and Clinical Tests I.

The subject device is substantially equivalent in function to that of at least one predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2000

Mr. R. Stephen Reitzler, RAC Vice President, Regulatory Affairs and Quality Assurance Nuvasive, Inc. 10065 Old Grove Road, Suite A San Diego, California 92131

Re: K002677

Trade Name: NuVasive INS-1 Intraoperative Nerve Surveillance System Regulatory Class: II Product Code: BXM Dated: August 24, 2000 Received: August 28, 2000

Dear Mr. Reitzler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may

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## Page 2 - Mr. R. Stephen Reitzler, RAC

result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish fesuit in regulatory action. In adamon, and the Federal Register. Please note: this further alliouncements concerning your submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notherion. The FDA intellig of succeantar equir device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation proceed to the marker. If you active op 10 for in vitro diagnostic devices), please contact the (21 CFR Fall and additionally, 8579. Additionally, for questions on the promotion and Office of Comphance at (301) >> contact the Office of Compliance at [phone]. Also, advertising of your device, prease contact and by reference to premarket notification' (21 CFR ( please note the regulation chance, "Misonations of the Act may be obtained from 1000 for and 607.97). Other general miormation on Joan Its toll free number [phone] or (301) the Division of Unian Frien address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Maik n muller

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## V. Draft Labeling

### A. Indications for Use

510(k) Number (if known): 11 00 2677

Device Name: NuVasive INS-1 Intraoperative Nerve Surveillance System

## Indications for Use:

The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K00267-