SureAx-Guide™

The SureAx-Guide Guidewire is a peripheral vascular guidewire indicated for facilitating delivery of percutaneous catheters into peripheral blood vessels. It is not intended for coronary or neurovascular use. The device consists of a stainless-steel wire with PTFE coating on the proximal portion and a PVP-based hydrophilic coating on the distal portion, available in 135 cm and 190 cm lengths, supplied sterile for single use.

The SureAx-Guide shares the same materials, coatings, critical dimensions, and design as the predicate COOK Approach Hydro ST Guidewire, including identical nominal outer diameter (0.014 inches), tip length (13.5 cm), and packaging. The primary technological difference is sterilization method: the subject device uses gamma radiation while the predicate uses ethylene oxide, both achieving equivalent sterility assurance level (SAL 10⁻⁶).

Testing conducted per ISO 10993 series (biocompatibility), ANSI/AAMI/ISO 11137-1 (sterilization validation), ASTM F640 (radiopacity), ASTM D4332 and D4169 (packaging), ASTM F1980 (shelf life), and FDA guidance documents on intravascular catheters and guidewires including lubricious coating labeling and performance tests.

Substantial equivalence is established through identical product code (DQX), regulatory classification (Class II catheter guidewire), intended use, design, materials, dimensions, and performance characteristics. Comprehensive preclinical and bench testing demonstrates the device meets all design requirements and performs equivalently to the predicate despite the sterilization method difference, which does not raise new safety or efficacy concerns.