Search Results

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.

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.

The provided 510(k) summary for ARI Cold Spray (K033720) is for a topical skin refrigerant, which falls under a medical device, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K021726 Gebauer's Instant Ice™) based on:

• Intended Use: Both are topical skin refrigerants for temporary relief of minor pain and swelling.
• Technical Summary: Both achieve cooling through rapid evaporation of a chemical mixture on the skin, dispensed via aerosol technology.
• Basic Design, Technology, and Risk Factors: The document states these are equivalent.
• Temperature Characteristics: While chemical compositions differ, the cooling effects on the skin are stated to be similar.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria or a performance study as the provided text does not contain that information. The regulatory pathway for this device appears to be based on demonstrating equivalence to an already marketed device, rather than providing new performance data against pre-defined acceptance criteria.

Ask a specific question about this device