NPseal

The NPseal is a single-use, non-powered negative pressure wound therapy device designed for closed surgical incisions up to 25 cm long. It uses an integrated mechanical pump to maintain negative pressure between -75 and -125 mmHg, promoting wound healing by removing small amounts of exudate. Each dressing can be worn up to 7 days, with total therapy limited to 14 days across multiple dressing changes.

The NPseal is substantially identical to its predicate device in all aspects except total therapy time. Both use a nonpowered integrated mechanical pump with a multilayer pad of hydrophilic polyurethane foam and polyurethane film. Materials, negative pressure range, single-use design, sterility method (gamma irradiation), biocompatibility (ISO 10993-1), and MR safety are all unchanged. The modification extends total therapy from 7 days to 14 days while maintaining 7-day single dressing wear time.

ISO 10993-1 is cited for biocompatibility compliance. No additional consensus standards or specific test methods are detailed in this submission.

The only modification is a labeling change extending total therapy time from 7 to 14 days; all other device characteristics, materials, technology, and performance specifications remain identical to the predicate K250708. The submission asserts that previously performed verification and validation data already support the safety and effectiveness of the device under the extended 14-day protocol, and no new functional, performance, or clinical testing was deemed necessary because the change is purely a labeling update not affecting device design or operation.