InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

The InQwire Super Stiff Guide Wire is a medical device consisting of a stainless-steel core wire with a PTFE-coated stainless-steel coil, available in 0.032" and 0.035" outer diameters with lengths of 80cm to 260cm. It is used to facilitate placement of devices during diagnostic and interventional procedures in the peripheral vasculature and heart chambers, excluding coronary arteries and cerebral vasculature.

Both the subject InQwire Super Stiff Guide Wire and predicate PTFE Guide Wire consist of a stainless-steel coil wire and core wire with polytetrafluoroethylene (PTFE) coating. The subject device has different dimensional specifications compared to the predicate, but the fundamental technology and operating principles are identical.

Testing was based on FDA guidance documents for coronary, peripheral, and neurovascular guidewires (October 2019), intravascular catheters with lubricious coatings (October 2019), sterility information (January 2016), and biological evaluation (ISO 10993-1:2018 and September 2020 guidance). Sterilization process equivalence followed TIR28:2016 for ethylene oxide.

The InQwire Super Stiff Guide Wire is substantially equivalent to the predicate PTFE Guide Wire (K242824) because both devices share identical fundamental technology and operating principles with the same material composition, and the subject device met predetermined acceptance criteria across all non-clinical testing categories including dimensional verification, flexibility, tensile strength, coating integrity, and biocompatibility.