Bovine Dermis Collagen Dermal Matrix

Bovine Dermis Collagen Dermal Matrix is an absorbent, porous collagen wound dressing made from purified bovine dermal tissue. It is indicated for managing various wounds including full and partial thickness wounds, chronic wounds (pressure ulcers, venous ulcers, diabetic ulcers), surgical wounds, trauma wounds, draining wounds, and partial thickness burns.

The subject device is made of Type I bovine dermis collagen with formaldehyde crosslinking and uses gamma irradiation sterilization at 10^-6 SAL. It has an absorption capacity of 31.0 mL/g, is 3 mm thick, available in sizes up to 700 cm², and has a 36-month shelf life. The primary difference from predicate K040211 is the addition of formaldehyde crosslinking and lower sterilization dose; however, the manufacturing process is identical to secondary predicate K152600.

Not stated in this summary.

Both the subject device and primary predicate K040211 share identical starting materials (bovine dermis collagen), identical sterilization method (gamma irradiation), same tissue source, similar technical characteristics, and the same intended use for wound management. The formaldehyde crosslinking step and lower sterilization dose used in the subject device are not novel but rather match the secondary predicate K152600, a cleared 510(k) for collagen dental wound dressings. In vitro characterization and biocompatibility testing confirm the subject device performs equivalently to predicates. Risk analysis demonstrates that formaldehyde residuals in the largest dressing size do not raise new safety concerns.