Amulet™ Steerable Delivery Sheath

The Amulet™ Steerable Delivery Sheath is a 14F catheter delivery device designed to provide a pathway for delivering the Amplatzer™ Amulet™ Left Atrial Appendage Occluder. It features a deflectable distal tip that can bend 120° clockwise and includes a dilator, radiopaque body for fluoroscopic visibility, and a marker band for positioning guidance during cardiac procedures.

The device incorporates a deflectable sheath with dual curve geometry in two dimensions creating three-dimensional positioning, includes a dilator for tissue penetration, and features a 14F flush adapter. The key difference from the predicate is the in-process solvent used to prepare the distal tip PEBAX extrusions surface, along with newly implemented tip bond tensile specifications and in-process tensile test methods that align with existing product requirements.

ISO 10993-1 (biocompatibility evaluation), ISO 14971 (risk management), ASTM F2475 (biocompatibility testing), ISO 11135 (sterilization via ethylene oxide gas), and FDA Guidance on International Standard ISO 10993-1 for biological evaluation of medical devices.

The subject device shares substantially equivalent design, function, packaging, sterilization process, materials, fundamental technology, and operating principles with the predicate Amulet Steerable Delivery Sheath (K232690). Although the surface preparation solvent for PEBAX extrusions differs, biocompatibility evaluation determined this change presents negligible risk to the established safety profile. Performance qualification testing confirmed the device met specifications for occluder retrieval, sheath integrity, and tensile bonds; sterilization and microbiology assessment found no increased risk, and no new materials were introduced, maintaining identical patient contact types and durations.