SION blue PLUS

SION blue PLUS is a steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) available in 190cm and 300cm lengths. It is intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), and is not for use in the neurovasculature.

The device is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils, featuring an inner coil, outer coil, and safety wire soldered together. Key differences from the predicate include: exclusion of the 180cm length model, modified outer coil length and hydrophilic coating length, altered PTFE coating length, and a change of all outer coil solder to Au-Sn (versus Ag-Sn/Au-Sn in the predicate). A 3cm radiopaque tip and silicone/hydrophilic distal coatings with PTFE proximal coatings are applied.

Testing was conducted in accordance with FDA Guidance on ISO-10993 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process' (dated 08SEP2023) and International Standard ISO 10993-1.

SION blue PLUS is substantially equivalent because it has identical intended use and same or similar technological characteristics (components, design, materials, sterilization method, and operating principles) as the predicate SION blue devices. In vitro bench testing demonstrated the device met all acceptance criteria and performed similarly to predicate/reference devices, with biocompatibility testing conducted on the predicate device showing acceptable safety profiles. The technological differences (coating lengths, solder composition, length exclusion) are minor modifications that do not affect the fundamental function or safety profile of the guide wire.