(205 days)
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).
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.
The CRYOTRON 2 ® Cryotherapy Device consists of four components that are housed in a mobile cart:
A pistol-grip hand-piece that delivers the carbon dioxide spray.
An electronic console/control panel that provides operational information to the user.
A rechargeable battery.
A cylinder of compressed medical-grade carbon dioxide gas (sold separately).
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.
The provided text is a 510(k) summary for the CRYOTRON 2 Cryotherapy Device. It describes the device, its intended use, and its predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
This document is from 2003, well before the widespread adoption of AI/ML in medical devices, and the device described is a physical cryotherapy device, not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information elements related to AI/ML device testing are not applicable and not present in the provided text.
Based on the provided text, I cannot complete the table or answer the questions as they pertain to AI/ML device performance and testing.
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K030281 1 of 1
AUG 2 0 2003
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| SPONSOR: | Cryonic Medical North America1350 Danielson Rd.Montecito, CA 93108805.886.8168 |
|---|---|
| Contact: | Sandra Williamson610.470.7693 |
| 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.The CRYOTRON 2 ® Cryotherapy Device consists of four components that are housed in a mobile cart: A pistol-grip hand-piece that delivers the carbon dioxide spray.An electronic console/control panel that provides operational information to the user.A rechargeable battery.A cylinder of compressed medical-grade carbon dioxide gas (sold separately). 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.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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
August 13, 2003
N/A