COOL-TIP RF SYSTEM

K984552 · Radionics, Inc. · GEI · Mar 5, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984552
• Device Name: COOL-TIP RF SYSTEM
• Applicant: Radionics, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Device Story

Cool-Tip RF System uses radiofrequency (RF) energy to coagulate tissue. System consists of RF generator, electrodes, and associated accessories. Used in percutaneous, laparoscopic, or intraoperative surgical settings by physicians. Device delivers RF energy to target tissue via electrodes; thermal energy causes coagulation. Provides controlled tissue ablation/coagulation; benefits include localized treatment of target tissue during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

RF energy-based tissue coagulation system. Includes RF generator and electrodes. Designed for percutaneous, laparoscopic, and intraoperative use. No specific materials or software algorithms described.

Indications for Use

Indicated for tissue coagulation during percutaneous, laparoscopic, and intraoperative surgical procedures. No specific patient population, age, or contraindications provided.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Mr. Jeffrey R. Mannion Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

Re: K984552 Trade Name: Cool-Tip RF System Regulatory Class: II Product Code: GEI Dated: December 21, 1998 Received: December 22, 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 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. 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 vours.

Stupt Rlvedys

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): | K984552 |
|---------------------------|--------------------|
| DEVICE NAME: | Cool-Tip RF System |

INDICATIONS FOR USE:

:

The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number | K984552 |
|---------------|---------|
|---------------|---------|

| | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|--|------------------------------------------|----|--------------------------------------------------|
|--|------------------------------------------|----|--------------------------------------------------|