Flexi-Seal AIR (with ENFit Connector)

The Flexi-Seal AIR is an indwelling fecal management catheter designed to manage fecal incontinence in adult patients by collecting liquid to semi-liquid stool and providing access for medication administration. It consists of a silicone catheter with a foam-filled retention balloon, an auto-inflate valve, an ENFit connector for irrigation and medications, and a collection bag with odor control sachets.

Key design changes versus the predicate (K190114) include: a new air-filled foam retention balloon with auto-valve for automatic inflation and pressure regulation (keeping pressure below 22 mm Hg) instead of manual water/saline inflation; an odor barrier outer polyurethane tube in a tube-in-tube configuration; a revised blue silicone cover with fingertip grips and taller key to prevent upside-down bag connection; and visual indicators (blue arrow and red no-entry symbol) to guide correct orientation.

Biocompatibility was evaluated per FDA guidance on ISO 10993-1:2018 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process). The device includes an ENFit connector compliant with ISO 80369-3.

The subject device performs the same intended function as the predicate—fecal management through stool collection and medication access. Non-clinical performance testing demonstrated functional and structural equivalence in balloon function, auto-inflate valve operation, joint strength, mechanical properties, and odor barrier performance. The design modifications (air inflation, auto-valve pressure relief, polyurethane outer layer, and ergonomic coupling features) enhance safety by preventing over-inflation and reducing user errors, without altering the fundamental technological principle or performance characteristics that establish substantial equivalence.