NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

K993622 · Alpha Omega , Ltd. · GZL · Jan 24, 2000 · Neurology

Device Facts

• Record ID: K993622
• Device Name: NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
• Applicant: Alpha Omega , Ltd.
• Product Code: GZL · Neurology
• Decision Date: Jan 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.

Device Story

NeuroTrek is a physiological navigation system for functional neurosurgery; used in OR by neurosurgeons. System inputs include electrophysiological signals from microelectrodes advanced into brain tissue. Device performs on-line recording and stimulation to map motor/sensory neurons; enables target localization and boundary design for lesioning or electrode implantation. Output provides real-time electrophysiological activity assessment; allows surgeons to confirm target structure position and avoid irreversible damage to adjacent centers like vision or somatosensory areas. Benefits include precise target focusing and improved clinical outcomes for procedures like Pallidotomy and Thalamotomy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Physiological navigation system; utilizes microelectrodes for recording and stimulation. Complies with IEC 601-1, IEC 601-1-2, and IEC 601-1-4 standards. System facilitates on-line electrophysiological monitoring.

Indications for Use

Indicated for neurosurgeons in the operating room during functional neurosurgery (e.g., Pallidotomy, Thalamotomy) to record from and stimulate brain motor and sensory neurons to assist in depth electrode placement and target localization.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Guideline System 3000 (Axon Instruments, Inc) (K970943)
• NeuroMap (RADIONICS) (K981820)

Submission Summary (Full Text)

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## 510(k) Summary

### Alpha Omega Ltd.

## NeuroTrek

Physiological Navigation System for Neurosurgery 510(k) Number K 993622

#### Submitter's Name:

Alpha Omega Ltd. Ha'avoda Street, P.O.Box 810 Nazareth Illit 17105, Israel Tel: [phone] Fax: [phone]

## Contact Person:

Shoshana Friedman 117 Ahuzah St. Ra'ananna 43373, Israel Tel: [phone] Fax: [phone]

# Trade Name:

NeuroTrek

# Classification Name:

Depth Electrode

### Classification:

The FDA has classified these devices as class II device (product code 84 GZL) and are reviewed by the Neurology panel.

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#### Predicate Devices:

The NeuroTrek system is substantially equivalent to:

- · Guideline System 3000 (Axon Instruments, Inc), cleared under K970943.
- · NeuroMap (RADIONICS), cleared under K981820.

#### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food. Drug, and Cosmetic Act. However, the NeuroTrek Physiological Navigation System for Neurosurgery complies with the following voluntary standards: IEC 601-1, IEC 601-1-2,IEC 601-1-4.

### Indication for Use:

Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.

#### Device Description:

The NeuroTrek is a physiological navigation system designed for clinical use during Pallidotomy or Thalamotomy and other neurosurgical procedures to assist in optimal target localization.

During surgery, a microelectrode is advanced into the brain with on-line recording and stimulation performed for precise focusing on the target organ and for evaluating the symptoms before and after. The physiological navigation and localization during the procedure is done for achieving better clinical results (short and long term). "On line" assessment of the electrophysiological activity assures the doctors that they are not about to cause irreversible damage to adjacent centers (i.e. Vision, Somatosensory), and allows confirmation of the target structure position.

The NeuroTrek system also enables design boundaries of target and localization of part position of the target for lesioning and electrode implantation.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 24 2000

Ms. Shoshana Friedman, RAC. General Manager Alpha Omega Ltd. C/O Push-Med Ltd 117, Ahuza Street Ra'ananna 43373 Israel

Re: K993622

> Trade Name: NeuroTrek System Regulatory Class: II Product Code: GZL Dated: October 20, 1999 Received: October 26, 1999

Dear Ms. Friedman:

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 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. 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 (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 requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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

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#### Page 2 - Ms. Shoshana Friedman, RAC.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

K 993622 510(k) Number (if known):

NeuroTrek system Device Name:

Indications for Use: Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K993622

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Rgg36222 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use_