(80 days)
The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is intended to create lesions in nervous tissue.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "RFG-3C Plus Radiofrequency Lesion Generator." This type of document does not contain information about acceptance criteria or a study proving that a device meets such criteria.
A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device already legally marketed. It typically relies on comparisons of technological characteristics, indications for use, and performance data (often bench testing or animal studies, if human clinical trials are not required for substantial equivalence). It does not usually involve a detailed report of a study designed to meet specific acceptance criteria in the way an AI/ML medical device submission would.
Therefore, for your request, I cannot provide the specific details about acceptance criteria or a study that proves the device meets those criteria from this document. The information you're asking for is more typical of a clinical validation study for a novel device or an AI/ML algorithm, not a 510(k) for a device like a radiofrequency lesion generator from 1998.
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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 (301) 594-4659. 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/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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11:3
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.
§ 882.4400 Radiofrequency lesion generator.
(a)
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.(b)
Classification. Class II (performance standards).