Crossloop

The CROSSLOOP is a steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm), available in lengths of 200 cm, 235 cm, and 300 cm. It is intended to direct a catheter to desired anatomical locations in the peripheral vasculature, excluding coronary and cerebral vessels. The device consists of a stainless-steel core wire with a platinum-nickel alloy coil soldered with gold-tin solder, featuring a loop-structured distal tip and silicone/hydrophilic distal coating with hydrophobic proximal coating for lubricity.

The CROSSLOOP has technological differences from the predicate device (Astato 30) in its coil structure, core shaft, and distal tip structure. However, it shares the same basic construction with a stainless-steel core wire, Pt-Ni alloy coil, Au-Sn solder, similar coatings (hydrophilic PTFE and silicone), the same nominal outer diameter (0.46 mm/0.018 inch), similar length options, and identical sterilization method (ethylene oxide, SAL 10-6).

Not stated in this summary. The document references in vitro bench testing (tensile strength, torque strength, torqueability, tip flexibility, coating integrity, catheter compatibility, corrosion resistance, kink resistance, radio-detectability) and biocompatibility testing (cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, hemolysis, thromboplastin time, thrombogenicity, complement activation) but does not cite specific standards such as ISO, IEC, or ASTM numbers.

The CROSSLOOP is substantially equivalent because it shares the same intended use (peripheral vascular catheter guidance) and substantially similar technological characteristics as the predicate Astato 30, including identical materials (Pt-Ni coil, stainless-steel core, Au-Sn solder), coatings, sterilization method, and operating principle. All in vitro bench tests demonstrated that the CROSSLOOP met acceptance criteria and performed similarly to predicate and reference devices, and biocompatibility testing confirmed a similar safety profile. The identified design differences (coil structure, core shaft, distal tip structure) do not create new questions of safety or effectiveness, as they are within the scope of variations seen across reference devices in the same device category.