NPseal

The NPseal is a single-use, non-powered negative pressure wound therapy device with an integrated mechanical pump that maintains negative pressure in the -75 to -125 mmHg range. It is indicated for patients with closed surgical incisions up to 25 cm in length, promoting wound healing by removing small amounts of exudate over up to 7 days of wear.

The NPseal uses a non-powered integrated mechanical pump to generate negative pressure. It features a multilayer pad composed of hydrophilic polyurethane foam with high fluid absorbency and a breathable polyurethane film designed to collect and move exudate away from the wound. The key modification is the addition of an alternative source for the hydrophilic polyurethane foam component, plus labeling updates including MR Safe designation and a latex-free statement.

ISO 10993-1 (biocompatibility); device is sterilized via gamma irradiation. Assessment of MR safety was performed via evaluation of known materials.

The device is substantially equivalent because it maintains identical indications for use, wound types, negative pressure range, wear time, and functional design as the predicate NPseal (K241522). The only material change—the alternative source for hydrophilic polyurethane foam—meets the same performance specifications as verified by biocompatibility, performance testing, and shelf-life testing. Labeling updates (MR Safe status, latex-free statement, and wear time removal) are administrative clarifications that do not affect the device's safety or effectiveness.