ALPHA DRIVE SYSTEM

K013396 · Alpha Omega , Ltd. · HAW · Aug 7, 2002 · Neurology

Device Facts

• Record ID: K013396
• Device Name: ALPHA DRIVE SYSTEM
• Applicant: Alpha Omega , Ltd.
• Product Code: HAW · Neurology
• Decision Date: Aug 7, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Alpha Omega Alpha Drive system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

Device Story

Alpha Drive System is a stereotaxic instrument used in functional neurosurgery. It assists neurosurgeons in the operating room by facilitating the precise placement of depth electrodes. The device functions as a mechanical positioning aid to support surgical navigation and electrode insertion. It is operated by neurosurgeons during clinical procedures to improve accuracy in targeting specific brain regions. The system provides mechanical stability and guidance, directly supporting the surgeon's ability to place electrodes for diagnostic or therapeutic purposes, thereby potentially improving surgical outcomes in functional neurosurgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotaxic instrument; mechanical positioning system for neurosurgical applications. Class II device under 21 CFR 882.4560. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use by neurosurgeons in the operating room to assist in functional neurosurgery and the placement of depth electrodes.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 0 7 2002

Alpha Omega, LTD. Shlomo Pundak, Ph.D. Quality Affairs Manager Ha'Avoda Street, P. O. Box 810 Nazareth Illit 17105 Israel

Re: K013396

Trade/Device Name: Alpha Drive System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: June 28, 2002 Received: July 15, 2002

Dear Dr. Pundak:

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 - Dr. Shlomo Pundak

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 and additionally 21 CFR Part 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milhem

Celia M. Witten, Ph.D., M.D.

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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## INDICATIONS FOR USE

| 510(k) Number (if known): | K013316 |
|---------------------------|---------|
|---------------------------|---------|

Alpha Drive system Device Name:

Alpha Omega Alpha Drive system is intended to be used to Indications for Use: assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

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510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use ____________

Mark N. Mcllveen

(Division Sign-Off) Division of General, Restorative and Neurological Devices 3396 510(k) Number_