CHIKAI Nexus petit

The CHIKAI Nexus petit is a neurovascular guide wire intended for use in the neuro vasculature to facilitate placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. It is a hybrid tapered core wire with Ni-Ti alloy and stainless steel components, a Pt-Ni coil, polyurethane and hydrophilic coatings, available in 220 cm length with multiple tip shapes.

The CHIKAI Nexus petit differs from the predicate (HYBRID Guidewire 007D) in use of Pt-Ni coil and Au-Sn solder, Ni-Ti pipe for core wire connection, polyurethane coatings, and outer diameter (0.33 mm max vs. 0.30 mm max). Both share the same basic hybrid tapered core design, materials composition (Ni-Ti distal, stainless-steel proximal), hydrophilic coating, and intended neuro vasculature use.

Testing followed ISO 10993 series for biocompatibility, ISO 11135:2014 for sterilization validation (achieving SAL 10⁻⁶ via ethylene oxide), AAMI TIR28:2016 for sterilization processing, ASTM F1980 for shelf-life acceleration, ISO 11607-1 for packaging integrity, and ANSI/AAMI ST72:2011 for bacterial endotoxin testing.

The CHIKAI Nexus petit is substantially equivalent because it shares the same intended use, indications (neuro vasculature catheter placement), regulatory classification, operating principle, and basic design as the HYBRID Guidewire predicate. Technological differences do not raise new safety or effectiveness questions. Non-clinical bench testing demonstrates comparable performance in dimensional verification, simulated use, tensile and torque strength, coating integrity, lubricity, and biocompatibility.