0.014” Willow Guidewire

The 0.014" Willow Guidewire is a single-use medical device intended for general intravascular use in neurovascular and peripheral procedures. It facilitates the positioning and exchange of interventional devices within small diameter, tortuous blood vessels and can be shaped and torqued to aid navigation. The device is available in three stiffness profiles: Soft, Standard, and Support.

The subject device uses a cobalt chromium alloy core with PTFE coating (versus the predicate's 304 stainless steel core), laser-cut nitinol tip (versus micro-machined nitinol), and a platinum-tungsten radiopaque coil (versus pure platinum). The exchange length is 315 cm (versus 300 cm for predicate). It includes a shaping mandrel accessory not present in the predicate. Sterilization, adhesive, primer, and hydrophilic coating technologies remain equivalent.

ISO 14971:2019 (risk management), ISO 11135:2014 (ethylene oxide sterilization), ISO 10993-1, 10993-4, 10993-5, 10993-10, and 10993-11 (biocompatibility testing). FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019) was cited for bench testing protocols.

Substantial equivalence is established because the subject device shares identical indications for use, fundamental design and operating principles, and materials/manufacturing processes with the predicate Synchro SELECT Guidewire. Material changes (cobalt chromium versus stainless steel, platinum-tungsten versus platinum) and manufacturing differences (laser-cut versus micro-machined nitinol) are minor and do not raise new safety or effectiveness questions. Comprehensive bench testing demonstrates equivalent or superior performance across lubricity, durability, coating integrity, radiopacity, tensile strength, torqueability, and simulated use. Biocompatibility testing confirms non-cytotoxic, non-thrombogenic, and non-pyrogenic properties, and sterilization achieves the same SAL of 10⁻⁶.