(194 days)
The CRYOFOS and Accessories indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
The CRYOFOS and Accessories is a topical refrigerant that acts as a vapocoolant. The CRYOFOS system consists of a pistol grip handpiece, console for controlling operations, a rechargeable battery (Panasonic R127R2PG), and a cvlinder of compressed medical grade Carbon Dioxide (CO2) gas (sold separately). The CRYOFOS has a user interface that displays treatment activation. The CRYOFOS system delivers a topical spray of compressed medical grade (CO2) that is pure, dry bacteriostatic and non-explosive via the pistol grip handpiece. The device uses the natural expansion of liquid CO2 in the atmosphere to create a cold spray of microcrystals delivered under pressure. The expansion cooling of the treatment gas forms a micro-crystalline dry-ice mist with which the cooling effect required for treatment is achieved. The end-user uses a gradual circular or panning motion with the handpiece to apply the CO2 to the treatment site for 30-60 seconds at a distance of approximately 7cm. Rapid cooling (thermal shock) of the skin occurs at temperatures of 2-4°C in 30 sec when the spray sublimates (pass directly from solid / ice phase to gas phase) as it contacts the skin.
The provided text describes the 510(k) premarket notification for the CRYOFOS and Accessories device, claiming substantial equivalence to a predicate device (CRYOTRON 2 Cryotherapy Device). However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML-based medical device.
The document pertains to a cryosurgical unit that delivers a topical spray of CO2 for cold therapy. The "testing" section primarily focuses on:
- Bench testing: Electrical safety (IEC 60601-1), EMC testing (IEC 60601-1-2), software verification, and performance/benchmark testing against the predicate device to confirm physical parameters like temperature reached and treatment time.
- Literature review: An "extensive literature review of studies" was used to establish clinical efficacy for cryotherapy in general, not a specific clinical study of the CRYOFOS device itself.
Therefore, I cannot fulfill your request for details on (all points below cannot be found from the provided text):
- A table of acceptance criteria and the reported device performance: The document mentions that the CRYOFOS reached a temperature of 2-4°C in 30 seconds, and the lowest temperature is -78.5°C, but these are performance characteristics, not formal acceptance criteria presented in a table format with corresponding results for a specific clinical study designed to prove the device meets these criteria.
- Sample size used for the test set and the data provenance: No clinical test set is described. The clinical efficacy was based on a literature review.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth was used.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/ML device and no MRMC study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Clinical efficacy was derived from an "extensive literature review" of existing cryotherapy studies, not new ground truth data collected for this specific device.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the provided document is a 510(k) submission for a physical medical device (cryosurgical unit) and relies on substantial equivalence to a predicate device, bench testing, and a literature review for general cryotherapy efficacy rather than a specific clinical study with ground truth and expert involvement for the CRYOFOS device itself as would be typical for an AI/ML product.
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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
September 27, 2017
CRYOFOS Medical Gmbh % Nick Stocks Vice President TensSource LLC 724 Bald Cypress Place Tampa, Florida 33614
Re: K170810
Trade/Device Name: CRYOFOS and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: July 12, 2017 Received: August 1, 2017
Dear Nick Stocks:
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 Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170810
Device Name CRYOFOS and Accessories
Indications for Use (Describe)
The CRYOFOS and Accessories indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "CRYOFOS" in a stylized font. The letters "CRYO" are in green, and the letters "FOS" are in blue. The letters are stacked vertically, with "CRYO" on top of "FOS". The font is sans-serif and appears to be bold.
510(k) SUMMARY
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CRYOFOS Medical is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K170810
Date Prepared: February 1, 2017
A. Submitter
TensSource 724 Bald Cypress Place Tampa, FL 33614 Establishment Registration Number: TBD
B. Company Contact
Nick Stocks Vice President Tel: (813) 889-0000 Fax: (813) 527-9949
C. Device Name
| Trade Name: | CRYOFOS and Accessories |
|---|---|
| Classification Names: | Unit, Cryosurgical, Accessories |
| Proposed Class/Device: | Class II |
| Product Codes: | GEH, MLY |
| Regulation : | 878.4350 |
D. Intended Use / Indications
The CRYOFOS and Accessories indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
E. Predicate/Legally Marketed Devices
| Device Name: | CRYOTRON 2 Cryotherapy Device |
|---|---|
| Company Name: | Cryonic Medical North America |
| 510(k) #: | K030281 |
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F. Device Description
The CRYOFOS and Accessories is a topical refrigerant that acts as a vapocoolant. The CRYOFOS system consists of a pistol grip handpiece, console for controlling operations, a rechargeable battery (Panasonic R127R2PG), and a cvlinder of compressed medical grade Carbon Dioxide (CO2) gas (sold separately). The CRYOFOS has a user interface that displays treatment activation. The CRYOFOS system delivers a topical spray of compressed medical grade (CO2) that is pure, dry bacteriostatic and non-explosive via the pistol grip handpiece. The device uses the natural expansion of liquid CO2 in the atmosphere to create a cold spray of microcrystals delivered under pressure. The expansion cooling of the treatment gas forms a micro-crystalline dry-ice mist with which the cooling effect required for treatment is achieved. The end-user uses a gradual circular or panning motion with the handpiece to apply the CO2 to the treatment site for 30-60 seconds at a distance of approximately 7cm. Rapid cooling (thermal shock) of the skin occurs at temperatures of 2-4°C in 30 sec when the spray sublimates (pass directly from solid / ice phase to gas phase) as it contacts the skin.
G. Testing
Verification and validation testing was completed to confirm that the CRYOFOS and Accessories provides equivalent results in comparison to the predicate device, CRYOTRON 2 Cryotherapy Device (K030281). Verification and validation testing included IEC 60601-1 electrical safety testing and IEC 60601-1-2 EMC testing to confirm device safety, software verification and validations to confirm software interaction and performance, as well as performance / benchmark testing using the CRYOFOS and Accessories as compared with the CRYOTRON 2 Cryotherapy device. The performance / benchmark testing confirmed the temperature of 2-4℃ in 30 sec is reached by both devices, the treatment time to reach thermal shock is 30 sec to 1 minute in both devices, the lowest temperature is -78.5℃ in both devices (due to physical law of CO2 gas), the pistol grip design is more stable with the subject device, and temperature detection is improved with the subject device such that the CO2 beam shuts down if the temperature of the skin is less than -1℃ for 1 second.
Clinical efficacy was determined through an extensive literature review of studies. The publications were presented here to show that it is possible to demonstrate very good to good results with cryotherapy using hyperbaric CO2 gas. The individual and partly randomized studies prove that the patient, which is always in the foreground, can benefit enormously from the treatment. The examinations refer to different ailment and treatment areas and it is therefore possible to give a comprehensive statement that the therapy is proven to be effective. Studies were carried out on tendinopathies, shoulder and elbow ailments, facial injuries, hemorrhage in hemophilia, Sudeck's atrophy, hand surgery, foot surgery, lumbago, rheumatic myopathies and much more. This covers the entire range of therapies required. Overall results for this form of therapy were excellent, confirmed by rapid healing of edemas, hematomas, and inflammation and therefore also pain. In this way, it was possible to reduce or even completely avoid the administration of
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accompanying medications against pain and antibiotic therapies. This ultimately also leads to the goal, i.e. of achieving faster post-operative mobility of individual joints and much earlier overall mobility of the patient. Hospital stays can thus be shortened and the patients can be discharged earlier in order to carry out follow-up rehabilitation. The CRYOFOS met all manufacturing and software specifications. No additional performance or clinical testing was conducted.
H. Substantial Equivalence
The CRYOFOS and Accessories are substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CRYOTRON 2 Cryotherapy Device (K030281) and raises no new issues of safety or effectiveness. The key differences are the CRYOFOS and Accessories include visible warnings as safety features, a more robust pistol handerip design with press kev, focused infrared measurement of skin temperature during treatment, and improved necrosis protection where that the CO2 beam shuts down if the temperature of the skin is detected to be less than -1°C for 1 second to limit burning of the skin. Treatment can be resumed again after a break of 2 seconds.
I. Conclusion
The CRYOFOS System uses the same identical Indications for Use as the predicate (K030281) device. The CRYOFOS System is very similar to the predicate device in terms of technological characteristics, mode of operation and design features. Based on the verification and validating testing regarding bench performance and the clinical literature provided in the submission: it has been determined that the CRYOFOS System performed as well as the predicate (K030281) device in terms of safety, effectiveness and performance. The bench performance testing also demonstrated that the technological differences between the CRYOFOS System and the predicate device raise no new concerns of safety or effectiveness and is substantially equivalent to predicate (K030281).
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.