CLEANCUT by MEDQUEST PRODUCTS, INC.

MedQuest Products Inc.'s Clean-Cut™ electrodes are intended for use in electrosurgery to perform cutting, coagulation, dessication, and fulguration. Each electrode is intended to be a disposable electrode, designed to fit standard electrosurgical pencils, and to be powered by standard electrosurgical generators.

Device Description

CleanCut Electrosurgery Electrode

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding the "CleanCut Electrosurgery Electrode." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

Acceptance criteria or reported device performance.
The study that proves the device meets acceptance criteria.
Sample sizes for test or training sets, nor data provenance.
Number/qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance studies.
Type of ground truth used.
How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 7 1999

Mr. Pratap S. Khanwilkar President MedQuest Products, Inc. N143, 825 North 300 West Salt Lake City, Utah 84103-1414

K972335 Trade Name: CleanCut Electrosurgery Electrode Regulatory Class: II Product Code: GEI Dated: November 25, 1998 Received: December 1, 1998

Dear Mr. Khanwilkar:

Re:

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. Pratap S. Khanwilkar

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

510(k) Number (if known):_KG2235

Device Name: Clean-Cut Electrosurgery Electrode

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	IC972335

MedQuest Products Inc., June 1997

CONFIDENTIAL AND PROPRIETARY

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.