Intri26 Introducer Sheath

The Intri26 Introducer Sheath is a catheter-based device designed to provide vascular access for insertion of endovascular devices while minimizing blood loss. It also enables injection, infusion, and aspiration of contrast media and other fluids into or from blood vessels. The device consists of a single-lumen catheter with hydrophilic coating, hemostasis valve, stopcock with flush port, and a radiopaque marker for fluoroscopic visualization.

The Intri26 is 26 French (8.9 mm inner diameter, 9.9 mm outer diameter) with a 33 cm effective length, compared to the predicate Intri24 which is 24 French (7.9 mm ID, 8.7 mm OD). Both use identical construction materials (stainless steel coil with Pebax and PTFE liner), hydrophilic coating, and user-actuated hemostasis valves. The key difference is the larger diameter to accommodate bigger vessels (≥11 mm versus ≥9 mm). Both are compatible with 0.035-inch guidewires and single-use devices with <24-hour placement duration.

ISO 10993-1 (biocompatibility), ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 (sterilization by ethylene oxide to SAL 10⁻⁶). Extensive verification and validation testing included pressure/flow testing, dimensional inspection, insertion force assessment, guidewire compatibility, and GLP animal safety and performance evaluation.

The Intri26 has the same intended use, principles of operation, and fundamental design as the predicate Intri24 Introducer Sheath. The only technological difference is the larger diameter (26 Fr vs 24 Fr) to access larger vessels. Non-clinical performance data demonstrate all acceptance criteria were met and show that dimensional differences do not raise new safety or effectiveness concerns compared to the predicate.