CRYO, MODEL V6.0

K060395 · Zimmer Elektromedizin GmbH · GEX · Feb 24, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060395
• Device Name: CRYO, MODEL V6.0
• Applicant: Zimmer Elektromedizin GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Cryo V6.0 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Story

Cryo V6.0 is a skin refrigerant device consisting of a refrigeration unit that generates cold air. The device delivers this cold air to the patient's skin surface via an air hose. It is intended for use in clinical settings during laser and dermatological procedures to minimize pain and thermal injury, as well as to provide temporary topical anesthetic relief for injections. The device is operated by healthcare professionals. The output is a stream of cold air, which the clinician directs at the treatment site to cool the skin, thereby mitigating thermal damage and patient discomfort during procedures.

Clinical Evidence

Bench testing only. Effectiveness was established through air flow measurements comparing the maximum output of the Cryo V6.0 to the predicate Cryo 5, showing equivalent performance. Safety was validated through electrical and mechanical testing against UL2601/UL60601-1 and IEC60601-1-2 standards.

Technological Characteristics

Refrigeration unit generating cold air delivered via hose. Electrical/mechanical safety tested per UL2601/UL60601-1 and IEC60601-1-2. Device includes electronic control boards for operation. No specific materials or software algorithm classes are detailed.

Indications for Use

Indicated for patients undergoing laser or dermatological treatments requiring pain and thermal injury minimization, and for patients requiring temporary topical anesthetic relief for injections.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Cryo 5 (K040727)

Submission Summary (Full Text)

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K060345
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Zinmer Medizinsystene GubH Junkersstraße 9

Tel . 0731 / 9761-0 0131 / 9761-118 into() zimmer . de мый дария тара

## 510(k) SUMMARY

ドボス

| Date Prepared: | January/23/2005 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer Medizinsysteme GmbH<br>Junkersstrasse 9<br>D - 89231 Neu-Ulm<br>Germany<br>Contact Person: Mr. Armin Petraschka<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Trade Name: | Cryo V6.0 |
| Common Name: | Skin Refrigerant |
| Classification: | Class II (21CFR 878.4810)<br>Laser surgery instrument for use in general and plastic surgery and dermatology. |
| Performance Standards: | None established (as a medical device) under section 514. |
| Description of Device: | The Cryo V6.0 consists of a refrigeration unit that creates cold air. The cold air is<br>blown onto the skin using an air hose. The details of Cryo V6.0 are described in<br>section 7 "Device Description and Comparison.doc". |
| Intended use of the Device: | The Cryo V6.0 Cold Air Device is intended to minimize pain and thermal<br>injury during laser and dermatological treatments and for temporary topical<br>anesthetic relief for injections. |

#### .ntial Equivalence Claim to the following legally marketed devices: SL

- 1. Cryo 5 (Zimmer) K040727
..

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## 060395

# p. 212

#### Summary of Substantial Equivalence:

Compared with already cleared device Cryo5, at Cryo V6.0 mechanical dimensions and electronic board, including control functions, has changed.

Equal to Cryo5 mechanical and electrical safety of Cryo V6.0 are tested against the standards UL2601/UL60601-1 and IEC60601-1-2.

The effectiveness is tested by an air flow measurement at Zimmer Medizinsysteme. The measurement shows that the maximum output air flow of Cryo V6.0 is equal to Cryo5.

The Zimmer Cryo V6.0 is substantially equivalent to the compared device on the basis of similarities in operating principles, intended use and functional performance.

### Summary of fundamental technology:

The modifications have not altered the fundamental technology of predicate device the Cryo5.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three lines representing the branches of government. The text "U.S. Department of Health and Human Services, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

Zimmer Elektromedizin GmBH c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K060395

Trade/Device Name: Cryo V6.0, Skin Refrigerant Regulation Number: 21 CFR 878.4810 regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 10, 2006 Received: February 15, 2006

Dear Mr. Preiss:

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. Preiss

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Molkerson, M.S.

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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d. Intended Use

Device Name:

Cryo V6.0, Skin Refrigerant

Indications for Use:

The Cryo V6.0 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

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

Over-The-Counter Use ロ (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)

gmde

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

510(k) Number_ Ko60395