CRYOFOS

K170810 · Cryofos Medical GmbH · GEH · Sep 27, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170810
• Device Name: CRYOFOS
• Applicant: Cryofos Medical GmbH
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Sep 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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).

Device Story

Topical refrigerant system; delivers compressed medical-grade CO2 gas via pistol-grip handpiece; creates micro-crystalline dry-ice mist through natural gas expansion. Used in clinical settings by healthcare providers. Operator applies spray in circular/panning motion to treatment site (approx. 7cm distance) for 30-60 seconds. Device features infrared skin temperature monitoring; automatic CO2 beam shutdown if skin temperature drops below -1°C for 1 second to prevent necrosis. Provides rapid cooling (thermal shock) to 2-4°C. Benefits include reduced pain, swelling, and inflammation; potential reduction in medication use; accelerated post-operative mobility; shortened hospital stays.

Clinical Evidence

No clinical data generated for this device. Efficacy supported by literature review of hyperbaric CO2 cryotherapy across various conditions (tendinopathies, sports injuries, post-surgical recovery). Studies indicate reduced edema, hematoma, and inflammation, leading to decreased medication reliance and improved patient mobility.

Technological Characteristics

Topical CO2 cryosurgical unit. Components: pistol grip handpiece, console, rechargeable battery, CO2 cylinder. Principle: expansion cooling of liquid CO2 to form micro-crystalline dry-ice mist. Features: infrared skin temperature sensor, automatic shutdown logic. Electrical safety: IEC 60601-1; EMC: IEC 60601-1-2.

Indications for Use

Indicated for patients requiring temporary reduction of pain, swelling, inflammation, and hematoma resulting from minor surgical procedures, minor sprains, or minor sports injuries, and as an adjunct to rehabilitative treatment.

Regulatory Classification

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.

Predicate Devices

• CRYOTRON 2 Cryotherapy Device (K030281)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <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> |

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# 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: [phone] Fax: [phone]

### 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).