GeniPhys Collymer Self-Assembling Scaffold

Collymer Self-Assembling Scaffold is a wound management device composed of purified, self-assembling collagen derived from porcine dermis. It is supplied as a two-part system: a collagen solution and a self-assembly reagent that, when mixed, form a collagen scaffold suitable for wound healing. The device is intended for management of various wound types including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, and trauma wounds.

Both the subject device and predicate (Integra Flowable Wound Matrix) use animal-based collagen sources and form gel/scaffold materials that are applied topically to create a moist wound environment. The subject device uses purified, acid-soluble, self-assembling type I collagen from porcine dermis delivered via a dual syringe/luer connector system, while the predicate uses granulated cross-linked bovine tendon collagen and glycosaminoglycan. Both devices are biocompatible, sterile, single-use formulations with identical product code (KGN) and indications for use.

ISO 10993-1 (biocompatibility), ISO 22442-3 (viral inactivation for animal-derived materials), ASTM D4169 (shipping), and FDA guidance on sterile drug product manufacturing. Biocompatibility testing included chemical characterization, applicable endpoints, and toxicological risk assessment.

The subject device demonstrates substantial equivalence because it shares identical indications for use and product code as the predicate device. While composition differs (porcine collagen vs. bovine collagen), both are animal-based collagen sources that form gel/scaffold materials and are applied topically. Non-clinical testing showed the subject device exhibits biocompatibility, effective viral inactivation, consistent sterility, appropriate shipping stability, and at least 6 months stability at refrigerated conditions. These characteristics match the predicate's functional profile without raising new safety or effectiveness questions, and all minor compositional differences are addressed by appropriate biocompatibility and processing validation studies.