CRYOMINI

K080735 · Zimmer Elektromedizin GmbH · GEX · Apr 4, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080735
• Device Name: CRYOMINI
• Applicant: Zimmer Elektromedizin GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The CryoMini 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

CryoMini is a skin refrigerant device consisting of a refrigeration unit that generates cold air; cold air is delivered to the skin surface via an air hose. Used in clinical settings during laser and dermatological procedures; operated by healthcare professionals. The device functions by cooling the skin to provide pain relief and thermal protection during treatments. It serves as a smaller, modified version of the predicate Cryo V6.0, featuring updated mechanical dimensions and electronic board placement. Clinical benefit includes pain reduction and prevention of thermal injury during procedures.

Clinical Evidence

Bench testing only. Effectiveness was verified via air flow measurements comparing the CryoMini to the Cryo V6.0. Testing demonstrated that the device achieves the necessary therapeutic skin temperature for the intended clinical applications.

Technological Characteristics

Refrigeration unit generating cold air; air hose delivery system. Electronic safety tested against UL60601-1 and IEC60601-1-2. Smaller form factor compared to predicate. No specific materials or software algorithms described.

Indications for Use

Indicated for patients undergoing laser or dermatological treatments to minimize pain and thermal injury, and for temporary topical anesthetic relief during 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 V6.0 (K060395)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is black and white and features the word "zimmer" in a bold, sans-serif font. Above the word "zimmer" is the number "k080735". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller font.

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Zimmer Medizinsysteme GmbH Tel. 0731 / 9761-0
0731 / 9761-118 [e-mail] Junkersstraße 9 Fax

## 510(k) SUMMARY

ー 4 2008 APR

| Date Prepared: | January/09/2008 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | CryoMini |
| 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 CryoMini 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 CryoMini are described in<br>section 7 "Device Description and Companson.doc ". |
| Intended use of the Device: | The CryoMini Cold Air Device is intended to minimize pain and thermal injury during<br>laser and dermatological treatments and for temporary topical anesthetic relief for<br>injections. |
| Substantial Equivalence Claim to the following legally marketed devices: | |

- 1. Cryo V6.0 (Zimmer) K060395
..

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80735

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## Summary of Substantial Equivalence:

Compared with already cleared device Cryo V6.0, at CryoMini mechanical dimensions and placement on the electronic board changed. The smaller device size is well tested and proofed by reasonable people. Also the electronic safety test and functionality is tested and verified.

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

The effectiveness is tested by an air flow measurement at Zimmer Medizinsysteme GmbH. The measurement shows that the maximum output air flow of CryoMini is higher than air flow of Cryo V6.0 but also the minimum air temperature is higher than in Cryo V6.0. Some more tests show that similar to Cryo V6.0 the necessary therapy skin temperature is reached with CryoMini also.

The Zimmer CryoMini 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 Cryo V6.0.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 4 2008

Zimmer Elektromedizin GmbH % TÜV SÜD Product Service GmbH Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112

Re: K080735

Trade/Device Name: CryoMini, 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: March 26, 2008 Received: March 28, 2008

Dear Stefan 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

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Page 2 - Stefan Preiss

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N. Millman

Mark N. Melkerson 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:

Indications for Use:

CryoMini, Skin Refrigerant

The CryoMini 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 প্রি (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)

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________