PATH BGC

The PATH BGC is a balloon guide catheter designed to facilitate insertion and guidance of intravascular catheters into blood vessels in the neurovascular system. It features a dual coaxial lumen design with an inner coil-reinforced lumen and outer braid-reinforced lumen, along with a compliant balloon that provides temporary vascular occlusion during angiographic procedures.

The subject device differs from the predicate (Modified FlowGate K131492) in several material and dimensional aspects: outer/inner jackets use Neusoft UR862A/Pebax instead of Pebax alone; distal tip is polyurethane rather than Pebax; balloon material is polyurethane instead of silicone; catheter hub is polycarbonate versus polyurethane; and dimensions are slightly smaller (0.070in inner diameter versus 0.084in). The subject device also offers four effective lengths (90, 95, 100, 105cm) versus two for the predicate, and includes different accessory items.

Testing was conducted per ISO 10993-1:2018 (biocompatibility), ISO 10993-5, -10, -11, -23, -4 (cytotoxicity, sensitization, toxicity, irritation); ISO 10555-1 (catheter performance); ISO 80369-7 (luer hub compatibility); ISO 11135:2014 (EtO sterilization); ASTM F756, F2096-11, F88, F2382, F2888; and USP <151> standards.

Both devices share the same intended use (facilitating catheter insertion and providing temporary vascular occlusion in neurovascular procedures) and operating principle (balloon guide catheter). Material and dimensional differences do not raise new safety concerns because the subject device completed comprehensive bench testing (kink resistance, coating lubricity, balloon fatigue, delivery/retrieval forces) and biocompatibility testing (including thrombogenicity) that demonstrated performance equivalent to the predicate. The subject device's polyurethane balloon and smaller profile are supported by successful performance testing and do not fundamentally alter the device's safety or effectiveness profile.