CROSSLEAD 0.018inch

The CROSSLEAD 0.018inch is a steerable guide wire with a maximum diameter of 0.46mm, available in lengths of 100-300 cm. It is intended to direct a catheter to desired anatomical locations in the peripheral vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures. The device consists of a hybrid nitinol and stainless-steel core with coils, coated with hydrophilic, polyurethane, and PTFE materials for lubricity.

The subject device differs from the predicate (Gladius Mongo18 PV ES) in outer coil structure and core shaft structure. Both share the same nominal outer diameter (0.46mm/0.018 inch), similar material composition (Ni-Ti/stainless-steel core, stainless steel and Pt-Ni coils), identical coating types (hydrophilic polyurethane and PTFE), and the same ethylene oxide sterilization method (SAL 10⁻⁶). The subject device offers additional usable lengths including 100cm.

Not stated in this summary. The document references in vitro bench testing but does not cite specific ISO, IEC, ASTM, or other consensus standards by number or name.

Substantial equivalence is established because the subject device and predicate share identical intended use (peripheral vascular catheter guidance) and substantially similar technological characteristics including materials, coatings, sterilization, and operating principles. Non-clinical laboratory testing (tensile strength, torque, flexibility, coating integrity, corrosion resistance, dimensional verification, and biocompatibility) demonstrated the subject device met all acceptance criteria and performed similarly to predicate and reference devices. The technological differences in outer coil and core shaft structure do not raise different safety or effectiveness questions because bench testing showed comparable performance profiles.