Bonvadis®

Bonvadis® is a non-sterile, water-based, semi-viscous topical wound dressing supplied in a 15g aluminum tube for prescription use. It contains humectant and emollient ingredients including Centella Asiatica and Mexican Mint extracts, designed to maintain a moist wound environment conducive to healing. It is indicated for management of partial and full thickness wounds, post-surgical wounds, burns (1st and superficial 2nd degree), diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Bonvadis® is substantially identical to predicate devices in being a non-sterile, water-based, preserved, semi-viscous formulation with neutral pH, topical delivery, and a mechanism of action providing moist wound environment. Key characteristics include: non-sterile status, humectant and emollient components for moisture donation, methyl and propyl paraben preservatives, and identical indications for use compared to predicate K232655.

Testing was performed per USP standards including USP<61> (microbial limits), USP<62> (microbial limits), and USP<51> (preservative effectiveness). Non-clinical tests included shelf-life stability, in-use stability, transepidermal water loss (TEWL), water retention capacity, biocompatibility, toxicological risk assessment, usability, and transportation testing.

Bonvadis® demonstrates substantial equivalence through identical intended use, indications, delivery system, mechanism of action, and sterility claim as the primary predicate K232655. Comprehensive non-clinical testing (stability, biocompatibility, preservative efficacy per USP standards, TEWL, water retention) confirmed the device performs comparably to predicates. The formulation's humectant and emollient components mirror predicate technology, and all quality parameters meet established criteria, establishing functional and performance equivalence without requiring clinical data.