(66 days)
The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
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I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study that proves the device meets them.
The document is a 510(k) clearance letter from the FDA for the RadioTherapeutics RF Generator Model #RF-2000. It states that the device has been reviewed and determined to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This letter primarily focuses on the regulatory clearance and indications for use, rather than detailed performance study results or acceptance criteria.
The text does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test or training sets.
- Data provenance, number of experts, qualifications, or adjudication methods.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established.
This document is a regulatory approval, not a scientific study report describing the device's performance in detail against specific criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 1997
Mr. Colin J. Nichols Official Correspondent RadioTherapeutics Corporation 2680 Bayshore Parkway, Suite 106 Mountain View, California 94043
Re: K972441
Trade Name: RadioTherapeutics™ RF Generator Model #RF-2000 Regulatory Class: II Product Code: GEI Dated: June 27, 1997 Received: June 30, 1997
Dear Mr. Nichols:
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 requirements , 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 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. Colin J. Nichols
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/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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RadioTherapeutics RF Generator Model RF 2000
Indications for Use Statement
510(k) Number: Unknown K972441
Device Name: RadioTherapeutics™ Corp. RF Generator Model #RF-2000
Indications For Use:
The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972441 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ✓ |
510(k) Submission APPENDIX X
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.