AuST CSP Introducer

The AuST CSP Introducer is a single-use catheter designed to provide a pathway for introducing diagnostic and therapeutic devices into the human vasculature for intracardiac placements. It features a braid-reinforced shaft, deflectable segment, radiopaque distal tip, handle with 3-way stopcock, and hemostasis valve to prevent air and fluid leakage. The device is not intended for neural placements.

The proposed device has a 25F inner diameter (30F outer diameter) with 39cm active length, compared to the predicate's four available sizes ranging 8.5F-13.2F with lengths of 44-84cm. Both feature deflectable sheaths, soft atraumatic tips with ventilation holes, deflection control handles, hemostasis valves, side ports for irrigation/aspiration, and dilators. Both use ethylene oxide sterilization, hydrophilic coating, and identical materials (PEBAX, PTFE, stainless steel, Vestamid, polyvinylpyrrolidone).

Testing was conducted per AAMI TIR28 for sterilization validation. Biocompatibility testing met ISO 10993-1 requirements. Performance testing included visual inspection, simulated use testing, deflection verification, valve leak testing, tensile testing, dimensional verification, flush testing, torque testing, and particulate characterization.

The proposed device is substantially equivalent to the predicate AuST Steerable Sheath because both share the same intended use (introduction of diagnostic/therapeutic devices for intracardiac placement), same regulatory classification (Class II), same product code (DYB), identical principles of operation, and equivalent technological characteristics including materials, sterilization method, and core features. Minor differences in outer diameter and length represent design variants that raise no new safety or effectiveness questions.