NEUROPROBES

K052527 · Alpha Omega Engineering , Ltd. · GZL · Apr 12, 2006 · Neurology

Device Facts

• Record ID: K052527
• Device Name: NEUROPROBES
• Applicant: Alpha Omega Engineering , Ltd.
• Product Code: GZL · Neurology
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Alpha Omega NeuroProbes are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.

Device Story

NeuroProbe is a neurosurgical device designed for temporary stimulation or recording of electrical signals within small, localized areas of the brain. Used by neurosurgeons during neurosurgical procedures; device facilitates intraoperative monitoring or stimulation. Input consists of electrical signals from brain tissue (recording) or delivery of electrical current (stimulation). Output is either recorded electrical data for clinical review or localized neural stimulation. Device aids in mapping or modulating neural activity during surgery, potentially assisting in surgical planning or therapeutic intervention.

Clinical Evidence

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

Technological Characteristics

Depth electrode for neurosurgical use. Designed for temporary electrical stimulation or signal recording. Class II device under 21 CFR 882.1330. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for use in neurosurgical procedures requiring temporary electrical stimulation or recording of electrical signals from localized brain tissue.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2006

Alpha Omega Engineering, Ltd. c/o Mr. Shlomo Pundak QA Manager P.O. Box 810 Nazzerth Illit 17105 Israel

Re: K052527

Trade/Device Name: NeuroProbe Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: March 10, 2006 Received: March 20, 2006

Dear Mr. 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

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Page 2 - Mr. Shlomo Pundak

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Melkerson

Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOS2527

Device Name: NeuroProbe

Indications for Use:

Alpha Omega NeuroProbes are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.

Prescription Use X (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)

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

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