revyve® Antimicrobial Skin and Wound Cleanser

revyve® Antimicrobial Skin and Wound Cleanser is a clear, colorless liquid wound cleanser containing poloxamer 407, EDTA, sodium citrate/citric acid, polyhexanide (PHMB), and glycerol in a 4 fl oz polyethylene squeeze bottle. It is intended for mechanical cleansing, moistening, debriding, and removal of foreign material and microorganisms from acute and chronic wounds (pressure ulcers, venous ulcers, diabetic foot ulcers, burns, post-surgical wounds) under professional supervision for Rx use, and for minor cuts, abrasions, and burns for OTC use.

revyve® is an aqueous formulation with identical technological properties to the predicate devices Atteris™ (BIAKOS) and NAWAlution. All three are non-sterile, single-use wound cleansers with the same preservative (PHMB), same biocompatibility profile, and same mechanism of action (mechanical cleansing). The devices share identical ingredients and formulation components.

ISO 10993-5 (cytotoxicity elution), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (pyrogen and acute systemic toxicity), and USP <51> (preservative effectiveness testing against seven challenge organisms including Aspergillus brasiliensis, Candida albicans, E. coli, Pseudomonas aeruginosa, and Staphylococcus species).

revyve® is substantially equivalent because it has nearly identical intended use, indications, technology, and preservative system as the predicate devices. Both Rx and OTC formulations match the predicates' clinical indications for mechanical wound cleansing. Performance testing demonstrates the preservative is effective, and biocompatibility data from the manufacturer's previously cleared revyve® Antimicrobial Wound Gel (K241809) with identical ingredients supports safety. No new questions of safety or effectiveness are raised.