CRYOFOS

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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 {1}------------------------------------------------ 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. Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The name is stacked vertically, with "Jennifer R." on the top line and "Stevenson -S3" on the bottom line. The background of the image is a light blue color, and the letters are black. 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 {2}------------------------------------------------ # 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 | {4}------------------------------------------------ # 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "CRYOFOS" in a stylized font. The letters "CRYO" are in a light green color, while the letters "FOS" are in a blue color. The letters are stacked closely together, creating a compact and modern design. 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).