AXS Lift Intracranial Base Catheter

The AXS Lift Intracranial Base Catheter is a single-lumen, variable stiffness catheter with a hydrophilic coating designed to introduce interventional devices into the peripheral and neurovasculature. It features a radiopaque marker for visualization, a luer hub, and is supplied sterile and single-use with a peel-away introducer sheath and rotating hemostasis valve.

The subject device is a 7Fr catheter (0.097" outer diameter) available in lengths of 95, 105, 110, and 115 cm, compared to the predicate's 6Fr (0.081–0.083" outer diameter) in lengths of 95, 105, and 115 cm. Both have hydrophilic coatings, radiopaque markers, luer hubs, and straight tip designs. The subject device has a 6-month shelf life versus the predicate's 36 months, and contains bovine-derived tallow at the distal end, which the predicate does not mention.

EN ISO 10555-1 (catheter dimensions, tensile strength, burst pressure, leak testing, tip flexibility); EN ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, hemolysis, complement activation, thrombogenicity); ISO 80369-7 (air leak testing); ASTM F756 and F2382 (hemolysis and partial thromboplastin time); USP <151> (pyrogen testing); EN ISO 14971 (risk management).

The device is substantially equivalent because it shares the same intended use (introduction of interventional devices into peripheral and neurovasculature), the same regulatory classification (Class II, 21 CFR 870.1250), and substantially similar design principles and materials as the predicate. Although the subject device is larger (7Fr vs. 6Fr), has a shorter shelf life (6 vs. 36 months), and adds one effective length option (110 cm), all verification and validation testing demonstrates equivalent performance, biocompatibility, and safety profiles, with no new questions of safety or effectiveness raised by these differences.