Spectricept Skin and Wound Cleanser

Spectricept Skin and Wound Cleanser is a clear hypotonic aqueous solution containing water, hypochlorous acid, and stabilizing chloride salts in an 8 oz non-sterile PET bottle. It is intended for professional and OTC use to cleanse, irrigate, moisten, and remove debris and foreign material from wounds, dermal lesions, pressure ulcers, surgical wounds, burns, abrasions, and minor skin irritations through mechanical action as the fluid moves across the wound bed.

The subject device is identical to the predicate in formulation (99.94% water, 0.036% hypochlorous acid, 0.008% each of copper, zinc, and ferric chloride), container closure system (8 oz PET bottle), shelf life (12 months), mechanism of action (mechanical debris removal), sterility status (non-sterile), and antimicrobial effectiveness testing (USP<51>). The only change is labeling to reflect prolonged contact duration (>24 hours to <30 days) rather than limited contact (<24 hours).

ISO 10993-3 (genotoxicity/carcinogenicity), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-6 (local effects after implantation), ISO 10993-11 (systemic toxicity), ASTM F756 (hemolytic properties), USP<85> (bacterial endotoxins), and USP<51> (antimicrobial effectiveness).

The subject device has identical composition, indications for use, mechanism of action, and technological characteristics to the predicate device K213514. The only modification is the label duration classification, which is supported by additional biocompatibility testing (ISO 10993-6 and ISO 10993-11) demonstrating safety for prolonged contact. Since the device performs the same function with identical formulation and design, and additional testing confirms biocompatibility for the extended contact duration, substantial equivalence is established without raising new safety or effectiveness questions.