Next Generation Access Platform

The Next Generation Access Platform is a percutaneous catheter system consisting of an access sheath, dilator, introducer sheath, rotating hemostasis valve, and hemostasis valve adapter. It is indicated for introducing interventional devices into peripheral, coronary, and neuro vasculature. The sheath is single-lumen, braid-reinforced with variable stiffness, a hydrophilic coating on the distal 40 cm, and a radiopaque marker band.

The subject device offers two size variants (6F+ and 7F) with overall lengths of 80–110 cm and 80–90 cm respectively, compared to predicate dimensions of 80–105 cm and 90 cm. Both use hydrophilic coating and ethylene oxide sterilization. The subject device incorporates a hemostasis valve adapter accessory; materials and manufacturing processes mirror those of the predicates (K182918 and K191717).

ISO 10993-5 (cytotoxicity), ISO 10993-4 (hemocompatibility), ISO 10993-10 (sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-23 (irritation), ISO 10555-1 (catheter performance), ISO 80369-7 (hub validation), ISO 11135 (sterilization), ASTM F1980 (accelerated aging), and USP 151 (pyrogenicity).

The subject and predicate devices share identical intended use and indications for peripheral, coronary, and neuro vascular access. Dimensional and material differences are minor; both possess the same fundamental design (single-lumen, braid-reinforced, hydrophilic-coated sheaths with identical accessory components). Comprehensive bench testing—including tensile strength, kink resistance, burst pressure, torque, and usability—demonstrated performance comparable to predicates. Biocompatibility testing met all acceptance criteria, and design validation confirmed equivalent clinical usability. No new safety or effectiveness questions arise from these minor technological variations.