AuST Steerable Sheath

The AuST Steerable Sheath is a single-use percutaneous catheter with a braid-reinforced shaft, bidirectional deflectable segment, and radiopaque distal tip. It is designed to provide a pathway for introducing diagnostic and therapeutic devices into the human vasculature, including intracardiac, renal, and peripheral placements, but is not intended for neural use.

The modified device adds two new features to the predicate: a composite valve configuration and shaft configurations with different extrusion lengths while maintaining overall working length. The proposed device also introduces two additional active lengths (44 cm and 65 cm) versus the predicate's 74 cm and 84 cm options. All other specifications—inner/outer diameters, deflection angles, materials, sterilization method, and design features—remain identical to the predicate.

Sterilization validation per ANSI/AAMI/ISO 11135; biocompatibility testing per ISO 10993-1; visual inspection; simulated use testing with ancillary devices; valve liquid leak test; tensile tests; dimensional verification; and dilator removal force testing.

The proposed device maintains identical intended use, anatomical location, principles of operation, materials, and most technological characteristics as the predicate (K242106). The minor modifications—composite valve configuration and different shaft extrusion lengths—do not create new safety or effectiveness concerns because they preserve the device's overall working length and functional performance. All performance testing demonstrates the device performs as intended and is substantially equivalent to the predicate under the same regulatory framework.