RFG-3C PLUS

K982489 · Radionics, Inc. · GXD · Oct 5, 1998 · Neurology

Device Facts

• Record ID: K982489
• Device Name: RFG-3C PLUS
• Applicant: Radionics, Inc.
• Product Code: GXD · Neurology
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is intended to create lesions in nervous tissue.

Device Story

The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is a medical device designed to create lesions in nervous tissue. It operates by delivering radiofrequency energy to target tissue via specialized electrodes. The device is intended for use by clinicians in a professional healthcare setting. By generating controlled thermal lesions, the device facilitates therapeutic interventions involving nervous tissue. The system provides the necessary energy output and control mechanisms for the physician to perform these procedures, aiding in clinical decision-making related to pain management or other neurological conditions requiring lesioning.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) notification.

Technological Characteristics

Radiofrequency lesion generator; Class II device (Product Code: GXD). Operates by delivering radiofrequency energy to create thermal lesions in nervous tissue. Technical specifications and materials are consistent with established radiofrequency ablation technology.

Indications for Use

Indicated for the creation of lesions in nervous tissue for patients requiring radiofrequency ablation procedures.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1098

Mr. Jeffrev R. Mannion Sr. Requlatory Enqineer Radionics, Inc. 22 Terry Ave. Burlington, Massachusetts 01803

K982489 Re: RFG-3C Plus Radiofrequency Lesion Generator Trade Name: Requlatory Class: II Product Code: GXD Dated: July 16, 1998 Received: July 17, 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 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. प्रे substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 requlation 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 requlations.

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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/dsmamain.html".

Sincerely yours,

Colia M. Witton, Ph.D.

Cella 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):

*982489

Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator DEVICE NAME:

INDICATIONS FOR USE:

The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is intended to create lesions in nervous tissue.

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982489

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1098

Mr. Jeffrey R. Mannion Sr. Requlatory Engineer Radionics, Inc. 22 Terry Ave. Burlington, Massachusetts 01803

K982489 Re: Trade Name: RFG-3C Plus Radiofrequency Lesion Generator Regulatory Class: II Product Code: GXD Dated: July 16, 1998 Received: July 17, 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 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will yerify 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.