Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

The Kerecis Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration, and Kerecis Parvus Autologous Hydration are lyophilized, terminally sterilized fish skin wound dressings made from biocompatible, resorbable Wild North Atlantic Cod skin. They are single-use devices applied to wound beds to maintain a moist wound environment and are indicated for management of various wound types including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, trauma wounds, surgical wounds, and draining wounds.

The subject devices share identical design, materials (Atlantic Cod fish skin with or without silicone film layer), manufacturing processes, sterilization method (ethylene oxide), and principle of operation as their predicate devices. The only modification is the inclusion of lactated Ringer's solution and autologous body fluids as optional rehydration agents in the instructions for use, in addition to sterile saline which was the sole rehydration fluid in the predicates.

Not stated in this summary.

Substantial equivalence is demonstrated because the subject devices are physically and functionally identical to their predicates in all aspects except labeling. They use the same materials, manufacturing processes, sterilization methods, and are intended for identical indications. The only modification—adding lactated Ringer's solution and autologous body fluids as rehydration options—does not alter the fundamental scientific technology or intended use. Performance testing confirmed that device function remains consistent with the predicates when rehydrated with these alternative fluids, establishing that the devices perform comparably to their legally marketed predicates.