CRYOTRON 2 CRYOTHERAPY DEVICE

K030281 · Cryonic Medical North America · MLY · Aug 20, 2003 · PM

Device Facts

• Record ID: K030281
• Device Name: CRYOTRON 2 CRYOTHERAPY DEVICE
• Applicant: Cryonic Medical North America
• Product Code: MLY · PM
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CRYOTRON 2 ® Cryotherapy Device is for use by, or on the order of a Physician, or by a trained, credentialed clinician. The CRYOTRON 2 ® Cryotherapy Device is 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

Device delivers topical spray of compressed medical-grade CO2 via pistol-grip hand-piece; utilizes natural expansion of liquid CO2 to create cold micro-crystal spray. Operated by physician or trained clinician in clinical setting. System includes mobile cart, electronic console, rechargeable battery, and CO2 cylinder. Infrared sensor monitors skin surface temperature; console displays temperature; hand-piece LED flashes when skin reaches 4°C; optional laser pointer indicates measurement zone. User applies spray in sweeping motion for 30-60 seconds at 3-5 inch distance. Rapid cooling (thermal shock) occurs via sublimation. Real-time temperature feedback assists clinician in monitoring treatment, potentially preventing over-cooling while providing therapeutic pain and inflammation relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises mobile cart, pistol-grip hand-piece, electronic console, rechargeable battery, and medical-grade CO2 cylinder. Features infrared temperature sensor for skin monitoring, LED visual indicator, and laser pointer for targeting. Operates via CO2 expansion and sublimation. No specific material standards or software architecture details provided.

Indications for Use

Indicated for temporary reduction of pain, swelling, inflammation, and hematoma resulting from minor surgical procedures, minor sprains, or minor sports injuries; also indicated as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

Predicate Devices

• Gebauer's Instant Ice (K021726)

Submission Summary (Full Text)

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K030281 1 of 1

## AUG 2 0 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| SPONSOR: | Cryonic Medical North America<br>1350 Danielson Rd.<br>Montecito, CA 93108<br>805.886.8168 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sandra Williamson<br>610.470.7693 |
| DEVICE NAME: | CRYOTRON 2 ^® Cryotherapy Device |
| COMMON OR USUAL NAME: | Cryotherapy Device |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Gebauer's Instant Ice, K021726, Product Code MLY |
| DEVICE DESCRIPTION: | The CRYOTRON 2 ^® Cryotherapy Device delivers a topical spray of compressed medical-grade carbon dioxide. The patented technology of the CRYOTRON 2 ^® Cryotherapy Device uses the natural expansion of liquid CO₂ to create a cold spray of micro- crystals delivered under pressure. Using a gradual sweeping motion, the user applies the spray to the treatment site for 30-60 seconds at a distance of 3-5 inches. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin.<br>The CRYOTRON 2 ^® Cryotherapy Device consists of four components that are housed in a mobile cart: <ul><li>A pistol-grip hand-piece that delivers the carbon dioxide spray.</li><li>An electronic console/control panel that provides operational information to the user.</li><li>A rechargeable battery.</li><li>A cylinder of compressed medical-grade carbon dioxide gas (sold separately).</li></ul> An infrared temperature measurement system continuously monitors the temperature of the skin surface. The skin surface temperature is displayed on the electronic console, and a red LED on the pistol-grip hand-piece flashes when the skin surface temperature falls to 4°C. An optional laser pointer within the pistol-grip hand-piece provides a visual indication of the zone where the skin temperature is measured. |
| INTENDED USE: | The CRYOTRON 2 ^® Cryotherapy Device is for use by, or on the order of a Physician, or by a trained, credentialed clinician.<br>The CRYOTRON 2 ^® Cryotherapy Device is 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). |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra Williamson Regulatory Consultant Cryonic Medicl North America 1350 Danielson Road Montecito, California 93108

Re: K030281

Trade/Device Name: CRYOTRON 2® Cryotherapy Device Regulatory Class: Unclassified Product Code: MLY Dated: May 22, 2003 Received: May 27, 2003

Dear Ms. Williamson:

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 - Ms. Sandra Williamson

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark N. Millman

Celia M. Witten, Ph.D., M.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

CRYOTRON 2® Cryotherapy Device

INDICATIONS/CONTRAINDICATIONS:

The CRYOTRON 2® Cryotherapy Device is 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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*for*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

| 510(k) Number | K030281 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

August 13, 2003