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 Description

The Cryo V6.0 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cryo V6.0 device, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical safety tested against UL2601/UL60601-1 standard	Cryo V6.0's mechanical safety tested against UL2601/UL60601-1 and found equal to Cryo5
Electrical safety tested against UL2601/UL60601-1 and IEC60601-1-2 standards	Cryo V6.0's electrical safety tested against UL2601/UL60601-1 and IEC60601-1-2 and found equal to Cryo5
Effectiveness measured by air flow, specifically maximum output air flow, to be equivalent to the predicate device Cryo5.	The measurement shows that the maximum output air flow of Cryo V6.0 is equal to Cryo5.

Summary of Device Performance: The Cryo V6.0 device met all specified acceptance criteria by demonstrating equivalent mechanical safety, electrical safety, and maximum output air flow to its predicate device, Cryo5.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the traditional sense of human or device performance data. The "effectiveness" was tested by an air flow measurement, suggesting a physical test on the device itself.

Sample Size for Test Set: Not applicable or not specified for a clinical or comparative effectiveness study. The test involved measurements on the Cryo V6.0 and comparison to Cryo5.
Data Provenance: The air flow measurement was conducted at "Zimmer Medizinsysteme" (the manufacturer). This indicates a retrospective comparison against the predicate device's established performance, or possibly a direct comparison of a Cryo V6.0 unit against a Cryo5 unit. The country of origin is Germany (where Zimmer Medizinsysteme GmbH is located).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided and is likely not applicable to the type of testing described. The "ground truth" for the declared acceptance criteria (mechanical safety, electrical safety, air flow) would be established by validated testing methodologies and compliance with international standards, not expert consensus in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the technical testing (safety standards, air flow measurement) performed. Adjudication methods are typically used in clinical studies involving interpretation of results by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission is for a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving improved effectiveness or conducting a comparative effectiveness study involving human readers.

Effect size of human readers improvement: Not applicable, as no such study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a manner of speaking, a "standalone" evaluation was done in the sense that the device's technical performance (safety and air flow) was assessed directly without human interaction performing its intended clinical function for an outcome evaluation. The assessment was of the device's compliance with safety standards and its physical air flow output, independent of a human operator's performance or clinical outcomes.

7. The Type of Ground Truth Used

The "ground truth" for this submission relies on:

Technical Standards Compliance: For mechanical and electrical safety, the ground truth is adherence to established international and national safety standards (UL2601/UL60601-1 and IEC60601-1-2).
Predicate Device Performance: For effectiveness (maximum output air flow), the ground truth is the established performance of the legally marketed predicate device, Cryo5. The new device must match or exceed this performance.

It does not involve expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Cryo V6.0 is a physical medical device (a refrigeration unit), not an algorithm or AI system that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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K060345
p.1/-

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 GmbHJunkersstrasse 9D - 89231 Neu-UlmGermanyContact Person: Mr. Armin PetraschkaPhone: +49-731-9761-140Fax: +49-731-9761-4475E-mail: a.petraschka@zimmer.de
Device Trade Name:	Cryo V6.0
Common Name:	Skin Refrigerant
Classification:	Class II (21CFR 878.4810)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 isblown onto the skin using an air hose. The details of Cryo V6.0 are described insection 7 "Device Description and Comparison.doc".
Intended use of the Device:	The Cryo V6.0 Cold Air Device is intended to minimize pain and thermalinjury during laser and dermatological treatments and for temporary topicalanesthetic 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.