Toro 88 Superbore Catheter

The Toro 88 Superbore Catheter is a single-lumen catheter with variable stiffness designed to introduce interventional devices into peripheral, coronary, and neuro vasculature. It features a reinforced shaft with stainless steel and nitinol wires, polymers of varying durometers, an internal lubricious liner, hydrophilic coating on the distal exterior, and a radiopaque tip marker for fluoroscopic visualization.

The Toro 88 has a straight distal edge compared to the predicate's beveled distal edge. The proximal outer diameter is 0.108 inches versus the predicate's 0.110 inches. It has an effective length of 118 cm, longer than the predicate models (80–105 cm for TracStar, 110 cm for Zoom 88). Shelf life is 12 months versus the predicate's 36 months. All other dimensional and material specifications match the predicate devices.

ISO 10993 series (biocompatibility); ASTM F756-17, F2382-18, F2888-19, F1886, F2096-11, F88/F88M-23 (packaging and material testing); ISO 10555-1:2023, ISO 80369-7:2021, ISO 80369-20:2024 (catheter performance and connectors); IEC 62366-1:2015/Amd 1:2020 (usability engineering); USP <85>, <151> (sterilization and pyrogen testing).

The Toro 88 is substantially equivalent based on identical indications for use and similar technological characteristics to the TracStar LDP, Zoom 88 LDP, and Zoom 88 LDP Support predicates. Minor design differences (straight vs. beveled tip, slightly smaller outer diameter, longer length) do not raise new safety or effectiveness concerns. Comprehensive bench testing including biocompatibility, performance, packaging, and sterilization all passed, demonstrating the device meets design specifications and performs as intended.