AuST Steerable Sheath

The AuST Steerable Sheath is a single-use percutaneous catheter that provides a pathway for introducing diagnostic and therapeutic devices into the human vasculature, including intracardiac, renal, and peripheral placements. It features a braid-reinforced shaft, deflectable segment, radiopaque tip, handle with stopcock, and hemostasis valve. The device is not intended for neural placements.

The proposed device is identical to the predicate in dimensions (8.5F to 13.2F inner diameters, 44-84 cm lengths), deflection capability (180 degrees bi-directional), materials, and core features. Key differences are: addition of external silicone oil lubricant on some models, modified handle design with different color and ergonomic shape, and expanded valve designs (adding a three-part valve option to the existing two-part designs).

ISO 10993-1 for biocompatibility testing. Simulated use testing included device preparation, dilator shoulder extension, guidewire passage, deflection, valve leak tests, flush tests, and ancillary device navigation. Additional mechanical testing included tensile tests, torque tests, dilator tip cycling, and particulate evaluation.

The proposed device is substantially equivalent to predicate K251051 because both share identical indications for use, intended anatomical locations, principles of operation, and core technological characteristics. Minor design modifications (handle ergonomics, lubricant coating, valve variants) do not alter fundamental safety or effectiveness, and all performance testing confirms the device performs as intended.