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The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first- and second-degree burns and scalds to cool, soothe and moisturize the burn area.

BURN-AID Hydrogel is a water-based gel containing extract of Melaleuca alternifolia (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel.

This document is a 510(k) summary for a medical device called BURN-AID Hydrogel. It describes the device, its intended use, and its comparison to predicate devices. However, it explicitly states "No additional testing necessary" under the "Testing" section.

Therefore, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

It's likely that because this device is being submitted as substantially equivalent to already approved predicate devices (BurnFree Hydrogel and Burnshield Hydrogel), the FDA did not require new performance studies. The 510(k) process often relies on demonstrating substantial equivalence rather than requiring novel clinical trials if the device is similar enough to existing ones.

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