CHIKAI Nexus 014

The CHIKAI Nexus 014 is a neurovascular guide wire with a 0.36 mm outer diameter designed to facilitate placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy in the neurovasculature. It consists of a tapered stainless-steel core wire with inner and outer coils made of radiopaque platinum-nickel alloy, surrounded by various hydrophilic, polyurethane, PTFE, and silicone coatings for reduced friction.

The CHIKAI Nexus 014 differs from its predicate (CHIKAI black) in three areas: different inner coil structure, different lineup of usable lengths (215 cm and 300 cm versus 200 cm and 300 cm), and different coating length. Both devices share the same outer diameter (0.36 mm), core materials (austenitic stainless steel, Pt-Ni alloy), basic design, sterilization method (ethylene oxide), solder composition (Ag-Sn), and operating principle.

ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, thrombogenicity); ISO 11135:2014 (EO sterilization validation); AAMI TIR28:2016 (EO sterilization); AAMI/ANSI/ISO 10993-7:2008 (residuals); ASTM F1980 (shelf-life aging); ISO 11607-1 (package integrity); FDA guidance 'Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling' (October 2019).

The device shares identical intended use, operating principle, basic design, and materials with the predicate device. Bench testing demonstrates all performance criteria (tensile strength, torque strength, torqueability, coating integrity, lubricity, kink resistance, flexibility, and radiopacity) met acceptance standards comparable to the predicate. Biocompatibility testing across all ISO 10993 parameters showed non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, and non-hemolytic results. The three technological differences (inner coil structure, usable lengths, and coating length) do not raise different or new safety or effectiveness questions, as the device functions identically to the predicate in simulated clinical use.