DCwire Micro-guidewire

The DCwire Micro-guidewire is a single-use, sterile device with a shapeable tip used to gain intravascular access and position interventional devices in small-diameter, tortuous blood vessels for peripheral and neuro diagnostic and interventional procedures. It comes in three stiffness profiles (Soft, Standard, and Support) and is supplied with an introducer and torque device as accessories.

The device has a 304 stainless steel core with PTFE coating, a nickel-titanium micro-machined nitinol tip, and a platinum-tungsten alloy radiopaque coil. It is available in two diameter series: 10 Series (distal 0.010", proximal 0.012") and 14 Series (distal 0.014", proximal 0.014"). The device uses epoxy glue and UV curable adhesive, polyvinylpyrrolidone hydrophilic top coating, and polyurethane base coating, and is sterilized with ethylene oxide gas.

Testing followed FDA guidance on "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Biocompatibility testing used ISO 10993 series standards (ISO 10993-4, -5, -10, -11, -23), ASTM standards (F756, F2382, F2888), and USP General Chapter <151>. Sterilization validation used ISO 11135:2014.

Substantial equivalence is established based on identical intended use, same fundamental materials (stainless steel core, nitinol tip, platinum-based radiopaque markers), identical operating principles (shapeable, torqueable guidewire for vascular navigation), and similar sterilization methods compared to predicate devices Synchro SELECT Guidewire (K202522) and PVS 1600 Synchro 0.010" Guidewire (K032146). Non-clinical performance testing demonstrates the device meets all acceptance criteria with results comparable to predicates.