CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR

• K Number: K983986
• Device Name: CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
• Manufacturer: CONWAY STUART MEDICAL, INC.
• Date Cleared: 1999-03-23 ( 134 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Model C4 Radiofrequency Electrosurgical Generator

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a Model C4 Radiofrequency Electrosurgical Generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. The number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

Summary

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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.

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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

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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(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
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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.

Regulation Number and Section

§ 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.