(18 days)
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.
The CryoMini consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
This document is a 510(k) summary for the CryoMini device, which is a skin refrigerant. The provided information focuses on demonstrating substantial equivalence to a predicate device (Cryo V6.0), rather than outlining explicit acceptance criteria and a dedicated study to prove unique performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (CryoMini) | Outcome |
|---|---|---|---|
| Mechanical Dimensions | Equivalent or "well tested and proofed" | Changed (smaller device size) | Met (Claimed as "well tested and proofed by reasonable people") |
| Electronic Board Placement | Equivalent or "well tested and proofed" | Changed | Met (Claimed as "well tested and proofed by reasonable people") |
| Electronic Safety | Meet UL60601-1 and IEC60601-1-2 standards | Tested and verified | Met |
| Electronic Functionality | Tested and verified | Tested and verified | Met |
| Air Flow Output (Maximum) | Equivalent to Cryo V6.0 or acceptable improvement | Higher than Cryo V6.0 | Met (Considered an improvement) |
| Air Temperature (Minimum) | Equivalent to Cryo V6.0 or acceptable | Higher than Cryo V6.0 | Met (Implied as acceptable, alongside other efficacy tests) |
| Therapy Skin Temperature | Reach necessary therapy skin temperature | Reached necessary therapy skin temperature | Met (Similar to Cryo V6.0) |
| Operating Principles | Similar to predicate (Cryo V6.0) | Similar | Met |
| Intended Use | Similar to predicate (Cryo V6.0) | Similar | Met |
| Functional Performance | Similar to predicate (Cryo V6.0) | Similar | Met |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is not a single, comprehensive clinical trial with defined endpoints but rather a series of internal tests and comparative analysis against the predicate device (Cryo V6.0) to demonstrate "substantial equivalence."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document describes "an air flow measurement" and "Some more tests," implying laboratory testing on the device itself, not human subjects.
- Data Provenance: The data originates from Zimmer Medizinsysteme GmbH (the manufacturer). It is retrospective in the sense that it relies on comparisons to an already cleared device, and the testing was conducted internally by the manufacturer. The country of origin is Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for the performance claims (e.g., air flow, temperature, therapy skin temperature) was established through direct physical measurements of the device's output, not through expert opinion on clinical outcomes or diagnostics. The statement "well tested and proofed by reasonable people" is vague and does not refer to qualified experts in a clinical context.
- Qualifications of Experts: Not applicable, as no external experts were used for ground truth establishment.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no clinical endpoint or diagnostic assessment requiring adjudication. The tests were direct physical measurements of the device's performance characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a physical medical device (skin refrigerant), not an AI diagnostic or assistance system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical instrument, not an algorithm, and does not operate in a standalone algorithmic fashion. Its performance is inherent to its mechanical and electrical function. The "study" mentioned (air flow measurement, temperature checks) would be considered standalone in the sense that it only measured the device's output without human intervention as a variable in the outcome.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the performance claims was based on physical measurements (air flow, air temperature) and the established performance characteristics of the predicate device (Cryo V6.0) regarding reaching "necessary therapy skin temperature." It's a technical demonstration of equivalence rather than clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
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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 info@zimmer.de Junkersstraße 9 Fax
510(k) SUMMARY
ー 4 2008 APR
| Date Prepared: | January/09/2008 |
|---|---|
| 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: | CryoMini |
| 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 CryoMini consists of a refrigeration unit that creates cold air. The cold air isblown onto the skin using an air hose. The details of CryoMini are described insection 7 "Device Description and Companson.doc ". |
| Intended use of the Device: | The CryoMini Cold Air Device is intended to minimize pain and thermal injury duringlaser and dermatological treatments and for temporary topical anesthetic relief forinjections. |
| Substantial Equivalence Claim to the following legally marketed devices: |
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- Cryo V6.0 (Zimmer) K060395
..
- 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 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_________________________________________________________________________________________________________________________________________________________________
§ 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.