(562 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is purely mechanical/chemical.
Yes
The device is intended for temporary relief and reduction of minor pain and swelling, which is a therapeutic purpose.
No
The device is described as a topical skin refrigerant for temporary relief of pain and swelling, not for diagnosing conditions.
No
The device description clearly states it is a spray containing chemical propellants delivered from a container, indicating a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the ARI Cold Spray is for topical application to the skin for temporary relief of pain and swelling. This is a physical effect on the body's surface.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Mechanism of Action: The ARI Cold Spray works by rapid evaporation of propellants on the skin, causing a cooling effect. This is a physical process, not a diagnostic test performed on a biological sample.
The description clearly indicates a topical refrigerant for physical relief, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Cold Spray is intended to be used as a topical skin refrigerant to be used like ice for the temporary relief and reduction of minor pain and swelling from sprains, bruising, contusions and minor sports injuries.
Product codes (comma separated list FDA assigned to the subject device)
MLY
Device Description
ARI Cold Spray is designed to deliver propane, isobutane, n-butane in a sprav. The mixture is self-propelled from the container due to the high vapor pressure of the contents.
The form of delivery is appropriate when the consumer follows the labeled directions for use. The cooling action is provided through rapid evaporation of the non-medicated propellants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
topical skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
1/2
510(k) Summary
Pursuant to the requirements of 21 CFR 807.92, this 510(k) summary of safety and effectiveness is provided.
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- Sponsor Information:
ARI 2523 South McDonough Road Orchard Hill, Georgia 30266
- Sponsor Information:
Contact: Gordon Dixon President Phone: 770-227-8222 Fax: 770-227-9190
Establishment Registration Number: 1037559
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- Device Identification
Device Trade Name Common Name: Device Classification Name: Classification: Device Product Code: Special Controls:
- Device Identification
ARI Cold Spray Cold Spray, Vapocoolant Vapocoolant Unclassified MLY None
-
- Predicate Device
K021726 Gebauer's Instant Ice™ (Mist Spray and Stream Spray Sold as a non-prescription over-the-counter product.
- Predicate Device
4. Description
ARI Cold Spray is designed to deliver propane, isobutane, n-butane in a sprav. The mixture is self-propelled from the container due to the high vapor pressure of the contents.
The form of delivery is appropriate when the consumer follows the labeled directions for use. The cooling action is provided through rapid evaporation of the non-medicated propellants.
1
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- Intended Use of Device
Cold Spray is intended to be used as a topical skin refrigerant to be used like ice for the temporary relief and reduction of minor pain and swelling from sprains, bruising, contusions and minor sports injuries.
- Intended Use of Device
-
- Technical Summary
Cooling effects of both devices (predicate and ARI Cold Spray), act in the same manner. The cooling effect experienced by the patient is caused by the evaporation of the chemical mixture on the skin. A chemical mixture is contained within a can, filled under pressure and dispensed using standard aerosol nozzle technology. The consumer applies the contents by pressing on a nozzle to dispense the product, onto the skin.
- Technical Summary
-
- Determination of Substantial Equivalence
There is demonstrated equivalency in basic product design, technology, and indications for use, risk factors and target populations.
- Determination of Substantial Equivalence
While the chemical compositions are different, the temperature characteristics are similar in that both have measurable cooling effects on the skin.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are composed of thick, curved lines. The logo also includes a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2005
ARI. Inc. C/o Ms. Cathryn N. Cambria 5536 Trowbridge Drive Dunwoody, Georgia 30338
Re: K033720 Trade Name: ARI Cold Spray Regulatory Class: Unclassified Product Code: MLY Dated: March 29, 2005 Received: April 1, 2005
Dear Mr. Borsai:
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.
3
Page 2 - Ms. Cathryn N. Cambria
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
Hipt Rlurdia
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
OTC Indications for Use
510(k) Number (if known): K033720
Device Name: ARI Cold Spray
Indications for Use:
The ARI Cold Spray is intended to be used as a topical skin refrigerant to be used like ice for the temporary relief and reduction of minor pain and swelling from sprains, bruising, contusions and minor sports injuries.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hypt Rurdu
(Division Division of General, Restorative. and Neurological Devices
510(k) Number_KO33720