MatriDerm pluS+ Bi-Layer

MatriDerm pluS+ Bi-Layer is a sterile, prescription-use wound dressing made of a two-layer collagen-elastin matrix with a silicone grid backing. It is intended for management of various wound types including chronic wounds, surgical wounds, burns, and trauma wounds by providing a moist healing environment and serving as a scaffold for cellular invasion and tissue regeneration.

The subject device adds a medical-grade silicone grid layer to control moisture loss and provide mechanical strength compared to the single-layer predicate device. Both use identical collagen and elastin materials from bovine sources, are biocompatible, resorbable, absorbent, single-use, non-pyrogenic, and sterilized by gamma radiation to 10⁻⁶ SAL. Size ranges expanded slightly from the predicate.

ISO 10993-1 for biocompatibility evaluation including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, implantation (porcine wound healing study), and genotoxicity. Sterilization validation, fluid absorbency, packaging/matrix stability, and bacterial endotoxin testing also performed.

The subject device is substantially equivalent because it uses the same collagen-elastin materials and indications as the predicate, maintains identical primary functions, and non-clinical performance testing plus a porcine wound healing study demonstrate that the added silicone layer does not impede healing or raise new safety/effectiveness concerns compared to the predicate device.