(140 days)
Prescription Use: Neuwater (Hydrocyn aqua) is intended for moistening acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritation of the skin.
Over-the-Counter: Neuwater (Hydrocyn aqua) is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
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The provided document is a 510(k) clearance letter from the FDA for the NEUWATERTM (HydrocynTM aqua) Wound Cleanser. This type of document declares substantial equivalence to a predicate device, which means it asserts that the new device is as safe and effective as a legally marketed device.
However, the provided text does not contain any information about the acceptance criteria, device performance study, sample sizes, expert qualifications, or ground truth details that would typically be found in a performance study report for an AI/ML powered medical device.
This document is for a "Wound Cleanser," which is a relatively simple medical device (likely a liquid solution) and not an AI/ML diagnostic or prognostic tool. Therefore, the detailed performance metrics, ground truth establishment, and expert adjudication methods commonly associated with AI/ML device approval are not applicable here and are not present in this regulatory filing.
To answer your request, if this were an AI/ML device, the relevant information would typically be found in sections discussing performance data, clinical trials, or validation studies, which are absent in this specific 510(k) clearance letter for a wound cleanser.
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