Helios Dermal Scaffold

Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis, supplied sterile in single-use sheet form in various sizes (1.5–500 cm²) and configurations (solid, fenestrated, or meshed). It is intended for wound management including partial and full-thickness wounds, pressure/diabetic/venous ulcers, partial-thickness burns, surgical wounds, trauma wounds, tunneled/undermined wounds, and draining wounds.

The device is identical to its predicate (PriMatrix) in fundamental technology, material composition (collagen and extracellular matrix), animal source (fetal bovine dermis), form (sheet), design options (solid, fenestrated, meshed), size range, single-ply construction, sterilization method (ethylene oxide at SAL 10⁻⁶), and storage conditions (dry, room temperature 15–30°C). The only difference is shelf life: Helios has 3 years versus PriMatrix's 5 years from lyophilization.

Not stated in this summary.

Substantial equivalence is established because Helios Dermal Scaffold is identical to PriMatrix in all material, design, sterilization, and functional characteristics, with only a shorter shelf life (3 vs. 5 years), which is considered substantially equivalent rather than materially different. The device is also identical to reference devices (CardiaMend and SurgiMend) in manufacturing process and biocompatibility, allowing existing performance data from those devices to support the SE determination. The identical technological platform and identical indications for use across all wound types establish functional and clinical equivalence.