GYRUS PLASMA SKIN RESURFACING SYSTEM by GYRUS MEDICAL, INC.

The provided document, K041999, is a 510(k) summary for the Gyrus Plasma Skin Resurfacing (PSR) System. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study summary that would typically prove a device meets acceptance criteria.

The document mainly focuses on:

Identifying the device and its manufacturer.
Stating its intended use and comparison to a predicate device.
Confirming its substantial equivalence by the FDA.
Listing the specific dermatological conditions it's intended to treat.

There are no tables of acceptance criteria nor detailed study results with sample sizes, expert qualifications, or ground truth methodologies. The statement mentions "clinical studies have been done to validate the performance of the device" and "The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent," but these details are not provided within the given text.

Therefore, based solely on the provided text, I cannot fill in the requested table and answer the specific questions about acceptance criteria and study details. The input document is a summary statement for regulatory clearance, not a detailed scientific study report.

Summary

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MAR 2 - 2005

Gyrus PSR System	K041999
Submitted by:	Gyrus Medical Inc.6655 Wedgwood Road, Suite 105Maple Grove, MN 55311-3602
Contact Person:	Mark JensenVice President RA/QA
	Telephone: 763-416-3005Facsimile: 763-416-3070
Date Summary Prepared:	May 5, 2004
Name of the Device:
Proprietary Name:	Gyrus Plasma Skin Resurfacing (PSR) System
Common/Usual Name:	Electrosurgical Generator and Accessories
Classification Name:	Electrosurgical Device (per 21 CFR 878.4400)
Predicate Device:	Gyrus Plasma Skin Resurfacing (PSR) System(K023111)

510(k) Summary of Safety and Effectiveness

Description: The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

Rhytides of the face .
Superficial skin lesions .
. Actinic Keratosis
. Viral papillomata
Seborrhoeic Keratosis .

Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

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Statement of Intended Use:

PSR System is intended for The Gyrus treatment of dermatological conditions.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Comparison to Predicate Device:

The Gyrus PSR System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. In addition, clinical studies have been done to validate the performance of the device. The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to legally marketed devices with respect to intended use and technological characteristics, and is safe and effective in its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 - 2005

Mr. Mark Jensen Vice President, RA/QA Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 105 Maple Grove, Minnesota 55311

Re: K041999

Trade/Device Name: Gyrus Plasma Skin Resurfacing (PSR) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 22, 2004 Received: November 23, 2004

Dear Mr. Jensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications forcrone stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreation of the enactment date of the Medical Device Amendments, or to commerce proc to may 20, 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 19, 10, 19, 1 de need that have act (Act) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reade of the made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I outhall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic read at radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Mark Jensen

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hancemis your antial equivalence of your device to a legally premarket notification. The PDA maing of substanted vice 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), please
s and the may on any and 11, 2011 and 11:50 am and 11, and 11, meet the reg If you desire specific advice for your ac not of the same note the regulation entitled, Contact the Office of Comphance at (210) = F & eart 807.97). You may obtain "Misoranuing by reference to premailer.com.com the Act from the Division of Small other general information on your responsible in toll-free number (800) 638-204) or and find and Manufacturers, International and Consults +4.6www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

uriam C. Provost

Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K041999

510(k) Number (if known): K041999

Device Name: Gyrus PSR System ELECTROSURGICAL GENERATOR

Indications For Use:

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

Rhytides of the face ●
Superficial skin lesions .
Actinic Keratosis .
Viral papillomata .
Seborrhoeic Keratosis .

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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(Division Sign - )ff) Division of General, Restorative. and Neurological Devices

510(k) Number K641799

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.