CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR

K983986 · Conway Stuart Medical, Inc. · GEI · Mar 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983986
• Device Name: CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
• Applicant: Conway Stuart Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

Device Story

Model C4 Radiofrequency Electrosurgical Generator; used for tissue coagulation. Operated by qualified medical personnel trained in electrosurgery. Device functions by delivering radiofrequency energy to tissue via compatible Conway Stuart Medical electrodes. Output affects clinical decision-making by enabling controlled coagulation during surgical procedures. Benefits include effective hemostasis and tissue management.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Radiofrequency electrosurgical generator; intended for tissue coagulation. Operates via RF energy delivery through compatible electrodes. Technical specifications and material standards not detailed in provided text.

Indications for Use

Indicated for coagulation of tissue in patients requiring electrosurgical procedures. Contraindicated when, in the physician's judgment, electrosurgical procedures are contrary to the patient's best interest.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086

K983986 Re: Trade Name: Model C4 Radiofrequency Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: February 12, 1999 Received: February 23, 1999

Dear Dr. Wehman:

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.

{1}------------------------------------------------

Page 2 - Thomas C. Wehman, Ph.D.

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 vour 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,

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

{2}------------------------------------------------

510(k) Premarket Notification Model C4 Radiofrequency Electrosurgical Generator

## K983986

## Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Contraindications for Use:

Model C4 Radiofrequency Electrosurgical Generator

The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

The use of the CSM Model C4 RF generator is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | |
|------------------------------------------|--|
| OR Over-the-Counter Use | |
| (Optional format 1-2-06) | |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K983986 |
|---------------|---------|
|---------------|---------|

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.