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NAW Alution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, postsurgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.

NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

The subject device of this submission is NAWAlution Skin and Wound Cleanser for prescription and OTC use. NAWAlution is a clear, colorless liquid intended for the management of wounds. The solution is applied by spraying it directly onto the affected area and/or the dressing. As a result of mechanical action of the solution moving across the wound bed foreign objects, foreign debris and exudate, including, dirt, debris, and microorganisms, are removed from the wound. Moistening and cleansing a wound, such as by using NAWAlution, allows for the natural healing process to take place. NAWAlution for prescription use is supplied in an 8 fluid oz. (237 mL) or 16 fluid oz. (473 mL) spray bottle with a plunger-activated pump applicator. NAWAlution for over-the-counter is supplied in a 50 mL (1.8 fluid oz.) spray bottle with a plunger-activated pump applicator. The solution contains cocamidopropylbetaine, hydrochloric acid, PHMB, zinc/iron, and purified water.

The provided document is a 510(k) premarket notification for the NAWAlution Skin and Wound Cleanser, which has been determined to be substantially equivalent to legally marketed predicate devices. It describes the device's intended use and compares its features to several predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states that "The safety and effectiveness of NAWAlution is supported by biocompatibility testing, functional performance testing, and shelf-life testing conducted with the proposed device." However, no details about the acceptance criteria for these tests, the specific results that met them, or the methodologies are provided.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The document focuses on demonstrating substantial equivalence to predicate devices based on identical intended use and similar technological characteristics, rather than presenting a performance study against predefined acceptance criteria.

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