Derma-Gide

Derma-Gide is a sterile, single-use acellular wound dressing made primarily from porcine collagen with a bilayer structure—a dense compact upper layer for protection and a porous spongy lower layer as a scaffold. It is intended for managing various wounds including pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, and trauma skin wounds.

Derma-Gide has identical composition (Collagen Type 1 ~68%, Type 2 ~15%, Elastin ~14%), thickness (2.5–5 mm), shape (rectangle and round), and sterilization method (gamma) as the predicate devices. The only difference is the addition of a new 5 × 6 cm rectangular size variant packaged in a different sterile barrier pouch; all devices can be sutured and trimmed as needed.

Not stated in this summary.

Substantial equivalence is claimed because the subject device has identical indications for use, materials, composition, thickness, shapes, sterilization methods, and performance characteristics as the predicate devices (Geistlich Derma-Gide K171842 and K182838). The only change is the addition of a larger rectangular variant, supported by bench testing confirming it meets the same product specifications and acceptance criteria including DSC and porosity testing.