CollOvine™ Wound Powder

CollOvine™ Wound Powder is a sterile, single-use wound dressing composed of medical-grade ovine (sheep) collagen in powder form. It is designed for adults to manage exuding wounds including pressure ulcers, diabetic ulcers, venous ulcers, burns, donor sites, abrasions, and traumatic wounds by maintaining a moist wound environment. The powder is applied directly to the wound bed and used with a non-occlusive secondary dressing.

CollOvine uses ovine collagen (from sheep hide) while the predicate Stimulen uses bovine collagen (from cow hide). Both are collagen-based wound dressings, biocompatible per ISO 10993-1, single-use devices sterilized by gamma irradiation. CollOvine collagen is described as soluble collagen, whereas Stimulen uses modified soluble collagen. Both share the same product code (KGN), regulatory class (Unclassified), and nearly identical indications for use.

ISO 10993-1 for biocompatibility; ISO 22442 for sourcing, collection, storage, and viral inactivation of animal tissue collagen; USP 85 Limulus Amoebocyte Lysate (LAL) method for endotoxin testing. Safety testing included acute systemic toxicity, skin irritation, dermal sensitization, pyrogenicity, subacute systemic toxicity, subcutaneous implant studies, and in vitro cytotoxicity.

CollOvine is substantially equivalent because it is a collagen-based wound dressing with identical indications for use, same regulatory classification (Unclassified), same product code (KGN), comparable biocompatibility, similar pH and absorbency to the predicate, and the same sterilization method. The only material difference is the collagen source (ovine versus bovine), which does not create a new or different intended use or safety concern given successful biocompatibility and safety testing.