Promogran Prisma™ Collagen Matrix with ORC and Silver

Promogran Prisma™ Collagen Matrix with ORC and Silver is a sterile, freeze-dried wound dressing composed of 44% oxidized regenerated cellulose, 55% collagen, and 1% silver. It transforms into a soft gel in the presence of wound exudate and can be used alone with a secondary dressing or in combination with the ActiV.A.C. Negative Pressure Wound Therapy System for management of various wound types including diabetic ulcers, venous ulcers, pressure ulcers, burns, and traumatic wounds.

The subject device shares identical indications for use, operating principles, sterilization method (gamma irradiation at 10⁻⁶ SAL), packaging, shelf-life (2 years), wound sizes, care settings, and dressing material composition with the predicate device. The primary difference is the addition of compatibility with V.A.C.® Peel and Place Dressings in conjunction with ActiV.A.C. Negative Pressure Wound Therapy, whereas the predicate used V.A.C.® Granufoam and V.A.C.® Simplace Dressings.

ISO 11137 (gamma irradiation sterilization); ISO 13485 (quality management system requirements cited for design controls, nonconforming product handling, and corrective/preventative action).

The subject device is substantially equivalent to the predicate because it maintains identical composition, indications for use, operating principles, and technological characteristics. The extension to include V.A.C.® Peel and Place Dressing compatibility does not introduce new safety concerns, as simulated use testing confirmed the dressing does not inhibit negative pressure delivery, biocompatibility was previously established, and human factors testing confirmed the revised instructions for use are safe and effective.