NEURODRIVE SYSTEM

K051830 · Alpha Omega , Ltd. · GZL · Sep 16, 2005 · Neurology

Device Facts

• Record ID: K051830
• Device Name: NEURODRIVE SYSTEM
• Applicant: Alpha Omega , Ltd.
• Product Code: GZL · Neurology
• Decision Date: Sep 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

Alpha Omega NeuroDrive 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

NeuroDrive system assists neurosurgeons in operating room during functional neurosurgery; aids in precise placement of depth electrodes. Device functions as surgical navigation/positioning aid. System provides mechanical or electronic guidance to surgeon for electrode trajectory and depth. Output used by surgeon to verify electrode location relative to anatomical targets. Benefits include increased accuracy in electrode placement, potentially reducing surgical time and improving clinical outcomes in functional neurosurgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and intended use.

Technological Characteristics

Class II device (21 CFR 882.1330, Product Code GZL). Functions as a depth electrode placement aid for functional neurosurgery. Technical specifications and materials not detailed in provided documentation.

Indications for Use

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

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2005

Shlomo Pundak, Ph.D QA Manager Alpha Omega Ltd. Ha'avoda Street, P.O.B 810 Nazareth Illit 17105, Israel

Re: K051830 Trade/Device Name: NeuroDrive system Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: August 12, 2005 Received: August 23, 2005

Dear Dr. Pundak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfall in the Medical Device 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). and Cobinette For (110) has the device, subject to the general controls provisions of the Act. The r ou may career a 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 11 your de rooms 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 or any I 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- Shlomo Pundak, Ph.D

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whil anow you to begin manceang your and equivalence of your device to a legally premaired predicated on: "The Privating of cassification 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 If you desire specific advice for your as no novel 115. Also, please note the regulation entitled, Colliact the Office of Compullion and (21 (21CFR Part 807.97). You may obtain Misolalling of Icroronee to presidentibilities under the Act from the Division of Small other general information on your respensed its toll-free number [phone] or Manufacturers, Internet and Statess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buchud
for

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

Enclosure

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K051830

## INDICATIONS FOR USE

KOS1830 510(k) Number (if known): NeuroDrive system Device Name: Alpha Omega NeuroDrive 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. Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

OR

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

05 1830 Barbara Bonehutsfr MKM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Numbe