TUBULAR ELECTRODE DEVICE

K992542 · Conway Stuart Medical, Inc. · GEI · Oct 27, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992542
• Device Name: TUBULAR ELECTRODE DEVICE
• Applicant: Conway Stuart Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Tubular electrodes (Models A4000, A4400, A8000) designed for electrosurgical tissue coagulation. Devices feature varying needle configurations (4 or 8 needles) and optional irrigation/aspiration capabilities. Operated by trained medical personnel in clinical settings. Device delivers electrosurgical energy to target tissue to achieve coagulation. Benefit includes controlled tissue treatment during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tubular electrode design with 4 or 8 needle configurations. Optional integrated irrigation and aspiration channels. Energy source: Electrosurgical generator (not specified).

Indications for Use

Indicated for coagulation of tissue in patients requiring electrosurgical procedures. Intended for use by qualified medical personnel trained in electrosurgery.

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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

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

K992542 Re:

Trade Name: Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration Regulatory Class: II Product Code: GEI Dated: July 27, 1999 Received: July 30, 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 endednent and 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, eond manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see ahove) into cither class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Fenance . Ipple day) . The Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially cquivalent 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)

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inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure mispections, the Food and Drag Hanmay result in regulatory action. In addition, FDA may to comply with the GMT Tegulation may result in regarity of the Federal Register. Please note:
publish further announcements concerning your device in the Federal Register. publish further anilouncements concerning , when ission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic might have under books on other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF Imaling or volusion for your device and thus, permits your device to proceed to the market.

If you desire spccific 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 and additionally 6071594-4595. Additionally, for questions on the promotion and Compliance at [phone]. Pradition of Compliance at [phone]. advertising of your dovies, prome entitled, "Misbranding by reference to prematicet Also, prease note the regulation email.org.neral information on your responsibilities under the montheation (21 CF (21 CF (007.97). Outler got 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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Indications for Use 9.3

## Indications for Use

MA

510(k) Number (if known):

992542

Device Name:

Indications for Use:

Conway Stuart Medical Tubular Electrode Conway Bidal A4000, A4400, A8000

Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use OR Prescription Use (Optional format 1-2-06) (per 21 CFR 801.109)

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