NEUROMAP

K981820 · Radionics, Inc. · GZL · Nov 20, 1998 · Neurology

Device Facts

• Record ID: K981820
• Device Name: NEUROMAP
• Applicant: Radionics, Inc.
• Product Code: GZL · Neurology
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.

Device Story

NeuroMap™ is an intraoperative electrophysiological monitoring system used by neurosurgeons during functional neurosurgery. The device receives electrical signals from electrodes placed within the brain or on the skin surface. It processes, displays, and stores these CNS signals to assist the surgeon in identifying specific brain structures. By analyzing these electrical patterns, the surgeon can confirm anatomical locations before performing lesioning procedures. The system is intended for use in the operating room environment to aid in surgical decision-making and improve the accuracy of target localization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrophysiological monitoring system; inputs signals from intracranial and surface electrodes; displays and stores CNS electrical activity; intended for intraoperative use; software-based signal analysis for anatomical localization.

Indications for Use

Indicated for use by neurosurgeons in the operating room during functional neurosurgery to assist in the localization of brain structures prior to lesioning by displaying and storing CNS electrophysiological activity from brain and skin 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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NOV 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey R. Mannion Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

Re: K981820 Trade Name: NeuroMap™ Regulatory Class: II Product Code: GZL Dated: August 24, 1998 Received: August 25, 1998

Dear Mr. Mannion:

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. 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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Page 2 - Mr. Jeffrey R. Mannion

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 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/dsma/dsmamain.html".

Sincerely yours,

Acelly

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

Enclosure

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| Page | 1 of 1 |
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| 510(k) NUMBER (IF KNOWN): | K 981820 |
|---------------------------|--------------------------|
| DEVICE NAME: | Radionics Inc. NeuroMan™ |

INDICATIONS FOR USE:

The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.

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Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981820