DermiSphere Dermal Template

DermiSphere™ hDRT is a wound dressing made from crosslinked bovine collagen microspheres embedded in a bovine collagen hydrogel matrix. It is indicated for managing various wounds including partial and full-thickness wounds, pressure ulcers, venous and diabetic ulcers, surgical wounds, trauma wounds, and draining wounds as a single-use device.

The subject device uses Type I bovine collagen from dermis with crosslinked microspheres as a subcomponent, whereas the predicate (Avagen) uses collagen from bovine tendon with glycosaminoglycan (GAG) and is fully crosslinked. Both provide scaffolding for cellular invasion and capillary growth; the subject device has slightly lower drapability (7.88 mm vs 8.97 mm). The subject device is available in smaller sizes (4×5 cm and 10×12 cm) compared to the predicate's larger sizes.

Testing was performed in accordance with ISO 10993-1 for biocompatibility testing matrix and ISO 10993-18 for exhaustive extraction chemical characterization. Bench testing included dimensions, drapability, and pyrogenicity assessment.

Both devices are collagen-based biodegradable wound dressings with identical indications for use and the same mode of action (providing a scaffold for tissue invasion and vascularization). Although the subject device uses dermis-sourced collagen with crosslinked microspheres while the predicate uses tendon collagen with GAG, the material differences are not significant because both primarily comprise Type I bovine collagen and achieve equivalent collagen stability and biological function. Biocompatibility testing and bench characterization demonstrate the subject device raises no different safety or effectiveness questions.