LacertaMatrix

LacertaMatrix is a single-use, sterile wound dressing made of porcine gelatin and alligator-derived hyaluronic acid provided in various sizes up to 100 cm². It is indicated for managing multiple wound types including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, and trauma wounds. The dressing provides a moist healing environment and scaffold for tissue formation, gradually breaking down and resorbing over approximately 2 weeks as new tissue forms.

The subject device uses identical materials (porcine gelatin and alligator-derived hyaluronic acid) to the predicate, maintains the same matrix sheet form, and has identical sterilization (E-beam, SAL 10⁻⁶) and endotoxin specifications (<20 EU/device). Key differences include expanded lower size range (1–100 cm² versus 6.25–100 cm²) and an additional packaging configuration (dual sterile barrier in shelf-carton or mailer versus shelf-carton only), but all new sizes remain within the cleared reference device range (K213607).

Not stated in this summary. The document references Human Repeat Insult Patch Testing (HRIPT) and Skin Prick Testing, along with sterilization and distribution validation adoption rationales, but does not cite specific ISO, IEC, or ASTM consensus standards.

Substantial equivalence is established based on identical intended use (wound management), identical materials and design properties, same sterilization and endotoxin specifications, and performance testing showing no visible skin reactions in HRIPT testing. All technological differences (expanded sizes and packaging) do not raise new safety or effectiveness concerns and fall within previously cleared ranges.