GYRUS PLASMA SKIN RESURFACING SYSTEM

K023111 · Gyrus Medical, Inc. · GEI · Mar 13, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023111
• Device Name: GYRUS PLASMA SKIN RESURFACING SYSTEM
• Applicant: Gyrus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 13, 2003
• 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 dermatological conditions. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Gyrus Plasma Skin Resurfacing (PSR) System is an electrosurgical generator used for dermatological procedures. Device delivers energy to treat superficial skin lesions, actinic keratosis, viral papillomata, and seborrhoeic keratosis. System includes generator, cable assembly/instrument, power cable, and footswitch. Operated by qualified medical personnel trained in electrosurgery in clinical settings. Device functions as an electrosurgical tool to ablate or coagulate tissue. Clinical benefit includes removal or treatment of specified skin conditions through controlled electrosurgical application.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical generator system. Includes generator, cable assembly/instrument, power cable, and footswitch. Classified as an electrosurgical cutting and coagulation device (21 CFR 878.4400).

Indications for Use

Indicated for treatment of superficial skin lesions, actinic keratosis, viral papillomata, and seborrhoeic keratosis in patients requiring dermatological electrosurgical intervention. 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

• Arthrocare Visage (K992180)
• Thermage Thermacool TC System (K013639)
• Lumenis (Coherent) UltraPulse CO2 Laser (K974789)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Gyrus PSR System<br>K 02311 | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 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<br>Telephone: [phone]<br>Facsimile: 763-416-3070 |
| Date Summary Prepared: | September 11, 2002 |
| 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 Devices: | Arthrocare Visage (K992180)<br>Thermage Thermacool TC System (K013639)<br>Lumenis (Coherent) UltraPulse CO2 Laser (K974789) |

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

- Superficial skin lesions .
- Actinic Keratosis
- Viral papillomata ●
- Sceborrhoeic Keratosis .

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

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| Statement of Intended Use: | The Gyrus PSR System is intended for treatment of dermatological conditions. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | This device is intended for use by qualified medical personnel trained in the use of electrosurgery. |
| Comparison to Predicate Devices: | The Gyrus PSR System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2003

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

Re: K023111

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: December 31, 2002 Received: December 31, 2002

Dear Mr. Jensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 either class II (Special Controls) or class III (PMA), 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 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 that FDA has 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 comply with all 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 product 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) 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C Provost

Celia 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

510(k) Number (if known):

Not Yet Assigned

KO23111

Device Name:

Gyrus PSR System ELECTROSURGICAL GENERATOR

## Indications For Use:

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

- Superficial skin lesions .
- . Actinic Keratosis
- Viral papillomata ●
- . Sceborrhoeic Keratosis

The-system-is-intended-for-use-by-qualified-medical-personnel-trained in-the-use-ofelectrosurgical equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

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

OR

510(k) Number K(23)11