Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

The Millipede70 Aspiration Catheter with Perfuze Aspiration Tube Set is a neurovascular device designed to remove blood clots from the brain in acute ischemic stroke patients. It uses direct aspiration to revascularize patients with large vessel blockages in the intracranial arteries within 8 hours of symptom onset and is intended for patients who cannot receive or have failed thrombolytic drug therapy.

The subject device is a single-lumen, reinforced catheter with variable stiffness, hydrophilic coating, and a radiopaque distal marker. The only design change from the predicate is a minimal increase in maximum outer diameter at the distal end from 0.0835 inches to 0.0837 inches. All materials, sterilization method (ethylene oxide), working length (136 cm), and the Perfuze Aspiration Tube Set design remain identical to the predicate device.

Not stated in this summary. The document references bench testing methods (dimensional verification, simulated use, visual inspection, hydrophilic coating integrity, kink resistance, tip stiffness, and torque strength) but does not cite specific consensus standards such as ISO, IEC, or ASTM numbers.

Substantial equivalence is supported because the subject and predicate devices share identical indications for use, fundamental design, operating principle, materials, and sterilization. The 0.0002-inch increase in distal outer diameter does not raise different safety or effectiveness questions; successful completion of bench testing (dimensional verification, simulated use, coating integrity, kink resistance, tip stiffness, and torque strength) demonstrates the subject device meets specifications and performs as intended under simulated conditions equivalent to the predicate.