RADIONICS MICROELECTRODE KIT

K991399 · Radionics, Inc. · GXI · Sep 21, 1999 · Neurology

Device Facts

• Record ID: K991399
• Device Name: RADIONICS MICROELECTRODE KIT
• Applicant: Radionics, Inc.
• Product Code: GXI · Neurology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.

Device Story

Radionics Microelectrode Kit (MEK) comprises recording electrode, sheath, adaptor bushing, spacer, and passing cannula. Used in conjunction with Neuromap System, CRW Stereotactic frame, and lesion generator. Operates by recording electrical signals from nervous tissue to guide precise placement of lesions; provides stimulation and lesioning capabilities. Used in clinical neurosurgical settings by physicians. Output consists of electrical signal data used by the surgeon to determine target tissue location for functional neurosurgical procedures. Benefits include improved accuracy in targeting nervous tissue for therapeutic lesioning.

Clinical Evidence

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

Technological Characteristics

Kit includes recording electrode, sheath, adaptor bushing, spacer, and passing cannula. Designed for use with external stereotactic frames and lesion generators. Mechanical device for neurosurgical signal recording and tissue lesioning.

Indications for Use

Indicated for patients undergoing functional neurosurgical procedures requiring recording, stimulation, or lesioning of nervous tissue, including cordotomies, tractotomies, myelotomies, thalamotomies, and pallidotomies.

Regulatory Classification

Identification

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

Predicate Devices

• TM electrodes (pre-1976)
• TCM electrodes (pre-1976)

Submission Summary (Full Text)

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## SEP 2 1 1999 1991399 7.0 510(k) Summary:

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc, 22 Terry Avenue Burlington, MA 01803 Tel .: [phone] Fax: [phone]

This summary was prepared on April 19, 1999.

- 2.0 The name of the device is the Radionics Microelectrode Kit (MEK). The common name is recording and lesioning electrode kit, and its classification names are Depth electrode and Radiofrequency lesion probe
- 3.0 The above device is substantial equivalent to the TM and TCM electrodes which where commercially available prior to May 28, 1976.
- 4.0 The above device consists of a recording electrode, sheath, adaptor bushing, spacer and passing cannula. It is used with the Nueromap System, CRW Stereotaxtic frame and lesion generator to record signals in determining the placement of lesions.
- 5.0 The device like its predicates is intended for recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three overlapping profiles, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1999

Mr. Kevin J. O'Connell Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516

Re: K991399 Trade Name: Radionics Microelectrode Kit Regulatory Class: II Product Code: GXI Dated: July 20, 1999 Received: July 22, 1999

Dear Mr. O'Connell:

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 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 requirement, 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. Kevin J. O'Connell

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/dsmamain.html".

Sincerely yours,

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): K991139

Device Name: Radionics Microelectrode Kit

Indications for use: For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.

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(Division Sign-Off)
Division of General Restorative Devices K99/399
510(k) Number

PRESCRIPTION USE

(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)