NEUROMAP by RADIONICS, INC. | FDA 510(k) Summary

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 Description

The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin.

AI/ML Overview

This FDA clearance letter (K981820) for the Radionics, Inc. NeuroMap™ device does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a standard 510(k) clearance document, indicating that the device has been found substantially equivalent to a predicate device and can therefore be legally marketed. It focuses on regulatory aspects such as:

Substantial Equivalence: The primary basis for clearance is that the NeuroMap™ is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness.
Intended Use: The letter explicitly states the intended use of the device: "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."
Regulatory Class: The device is classified as Class II.
General Controls: The letter reminds the manufacturer of general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because this information is not present in the provided document.

Such details would typically be found in the 510(k) summary or in the premarket notification submission itself, which is a much more extensive document than the clearance letter. The clearance letter only announces the agency's decision based on its review of that submission.

Summary

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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510(k) NUMBER (IF KNOWN):	K 981820
DEVICE NAME:	Radionics Inc. NeuroMan™

INDICATIONS FOR USE:

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

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

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).