Echo Intracranial Base Catheter

The Echo Intracranial Base Catheter is a flexible, single-lumen catheter with a 0.100-inch inner diameter designed to facilitate insertion and guidance of interventional devices into the neurovasculature. It features a radiopaque marker band, luer hub, 14 cm lubricious coating on the distal shaft, and is supplied sterile and non-pyrogenic for single use only, packaged with a dilator and two hemostatic valves.

The subject device uses a stainless steel hypotube reinforcement (versus stainless steel coil in predicate), has a larger outer diameter of 0.118 inches (predicate 0.109 inches) and inner diameter of 0.100 inches (predicate 0.091 inches), and is offered in longer effective lengths of 100-105 cm (predicate 70-90 cm). Both devices share hydrophilic coating, EO sterilization, single-use supply, and common medical-grade materials, with the subject device including two hemostasis valves versus one in the predicate.

ISO 10555-1 (catheter mechanical testing), ISO 10993-1, 4, 5, 10, 11, 23 (biocompatibility), EN ISO 14971 (risk management), EN ISO 10993-7 (sterilization residuals), USP <151> (pyrogenicity). The device also underwent simulated use testing in a bench anatomical model and a GLP-compliant subacute animal study in swine vessels.

The subject device is substantially equivalent because it shares the same intended use (introduction of interventional devices into neurovasculature), uses identical materials and coating technology, employs the same fundamental operating principles, and demonstrates comparable performance in bench testing (particulate, coating integrity, tip stiffness, frictional force) and animal safety (vessel injury and tissue response comparable to controls). The narrower indication (neurovasculature only versus peripheral, coronary, and neurovasculature in predicate) and design differences (hypotube versus coil, larger dimensions, longer lengths) represent predictable variations that do not alter the fundamental catheter design or safety profile.