Collagen Wound Dressing

The Collagen Wound Dressing is a sterile, absorbent, porous topical wound dressing composed of freeze-dried cross-linked bovine collagen. It is indicated for prescription use in managing exuding wounds including pressure ulcers, diabetic ulcers, burns, and surgical wounds, and for over-the-counter use in managing minor cuts, scrapes, bruises, abrasions, lacerations, and burns. The biodegradable dressing absorbs wound exudate to form a gel that maintains a moist wound environment supporting natural healing.

The proposed device is manufactured from 100% bovine collagen in a single-layer porous microstructure sheet form using identical core processes as the predicate: freeze-drying, cross-linking, and irradiation sterilization. It uses single-barrier Tyvek packaging and is a single-use sterile product. The main difference from the predicate is an expanded range of sizes (25 additional sizes offered) and the addition of over-the-counter indications for minor wounds.

ISO 10993-1 (biocompatibility evaluation), ISO 11137-1/-2:2013 and ISO 11137-3:2017 (radiation sterilization validation), ISO 11737-1:2018 and ISO 11737-2:2019 (sterility testing), ISO 22442 (animal-derived materials safety), and FDA guidance on shelf life and medical devices containing animal-derived materials.

The proposed device demonstrates substantial equivalence because it shares identical intended use, similar indications for use, and very similar technological characteristics as the predicate device K231152. Both devices are composed of bovine collagen with identical manufacturing processes, structure, sterilization method, and functional principle of absorbing exudate to maintain a moist wound environment. All new risks raised by additional sizes were addressed through verification and validation activities including package verification, sterilization validation, and performance testing. The addition of OTC indications does not raise different safety or effectiveness questions, as similar collagen-based OTC wound dressing products already exist on the market.