GYRUS PLASMA SKIN RESURFACING SYSTEM

K041999 · Gyrus Medical, Inc. · GEI · Mar 2, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041999
• Device Name: GYRUS PLASMA SKIN RESURFACING SYSTEM
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus PSR System is intended for treatment of the following dermatological conditions: - Rhytides of the face . - Superficial skin lesions . - . Actinic Keratosis - . Viral papillomata - Seborrhoeic Keratosis . This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Gyrus PSR System is an electrosurgical generator used for dermatological resurfacing. Device delivers plasma energy to skin tissue to treat rhytides and various skin lesions. System includes generator, cable assembly/instrument, power cable, and footswitch. Operated by qualified medical personnel in clinical settings. Energy application facilitates tissue resurfacing/ablation. Clinical benefit includes improvement of dermatological conditions through controlled electrosurgical intervention.

Clinical Evidence

Clinical studies were conducted to validate the performance of the device. Data presented in the 510(k) notification demonstrate the device is safe and effective for its intended use.

Technological Characteristics

Electrosurgical generator and accessories (cable assembly, footswitch). Operates as an electrosurgical device (21 CFR 878.4400).

Indications for Use

Indicated for treatment of facial rhytides, superficial skin lesions, actinic keratosis, viral papillomata, and seborrhoeic keratosis in patients requiring dermatological resurfacing. 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.

Predicate Devices

• Gyrus Plasma Skin Resurfacing (PSR) System (K023111)

Submission Summary (Full Text)

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MAR 2 - 2005

| Gyrus PSR System | K041999 |
|------------------------|-----------------------------------------------------------------------------------|
| Submitted by: | Gyrus Medical Inc.<br>6655 Wedgwood Road, Suite 105<br>Maple Grove, MN 55311-3602 |
| Contact Person: | Mark Jensen<br>Vice President RA/QA |
| | Telephone: [phone]<br>Facsimile: 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<br>(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