CollOvine™ Wound Dressing

CollOvine Wound Dressing is a sterile, single-use advanced wound care device made from medical-grade ovine (sheep) collagen. It is designed for adults to manage exuding wounds including pressure ulcers, venous ulcers, diabetic ulcers, burns, and surgical wounds by maintaining a moist wound environment. The device is available in three sizes (1×1, 2×2, and 4×4 inches) and is applied as a primary dressing under professional wound care supervision.

CollOvine is composed of pure ovine collagen, while the predicate Fibracol Plus contains bovine collagen blended with 10% calcium alginate. Both devices are single-use, biocompatible (ISO 10993-1), and classified as wound dressings with animal-derived materials under product code KGN. CollOvine uses gamma irradiation for sterilization; the predicate's sterilization method is not publicly available. Both have similar pH and absorbency profiles.

ISO 10993 Part 1 (Biological Evaluation of Medical Devices) was applied. Specific testing included acute systemic toxicity, primary skin irritation, dermal sensitization, pyrogenicity, subacute systemic toxicity, subcutaneous implant studies, in vitro cytotoxicity, and chemical characterization. The ovine collagen sourcing complies with ISO 22442 for animal tissue controls.

CollOvine is substantially equivalent because it shares the same indications for use, device classification, regulatory class, and product code as the predicate Fibracol Plus. Although the collagen source differs (ovine versus bovine), both materials demonstrate biocompatibility under ISO 10993-1, and CollOvine's pH and absorbency testing showed similarity to the predicate. The functional performance—maintaining a moist wound environment for exuding wound management—is identical, and both are single-use collagen-based wound dressings applied with secondary dressings and standard fixations.