RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR

K981672 · Radiotherapeutics Corp. · GEI · Jul 17, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981672
• Device Name: RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
• Applicant: Radiotherapeutics Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

RadioTherapeutics RF-2000 is a medium-power electrosurgical generator; provides radiofrequency (RF) energy to separately approved electrodes; used for thermal coagulation of soft tissues. Operated by clinicians in a medical setting. Device transforms electrical power into RF output delivered through electrodes to target tissue; thermal effect achieves coagulation. Clinical benefit includes controlled tissue destruction/coagulation during surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Medium-power electrosurgical generator; RF energy output; designed for use with external electrodes for soft tissue coagulation. Class II device (Product Code: GEI).

Indications for Use

Indicated for thermal coagulation of soft tissues using separately approved electrodes. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

Mr. Colin J. Nichols RadioTherapeutics, Corporation 2685 Marine Way, Suite 1408 Mountain View, California 94043-1115

Re: K981672 Trade Name: RadioTherapeutics RF-2000 Radiofrequency Generator Regulatory Class: II Product Code: GEI Dated: May 8, 1998 Received: May 12, 1998

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 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.

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.

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Page 2 - Mr. Colin J. Nichols

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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## RadioTherapeutics RF Generator Model RF 2000

## Indications for Use Statement

510(k) Number: Unknown K981677

Device Name: RadioTherapeutics™ Corp. RF Generator Model #RF-2000

Indications For Use:

ー 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 | K981672 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

510(k) Submission APPENDIX X

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