Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

The Splashwire Hydrophilic Guide Wire is a catheter guide wire intended for use in the peripheral vascular system to facilitate placement of devices during diagnostic and interventional procedures. It is not intended for coronary angioplasty or neurovasculature use.

The device consists of a nitinol core wire with ground tapered distal section, a polyurethane jacket containing tungsten for radiopacity, and a hydrophilic coating. The subject device modification introduces guide wires with a 3.0 mm J-shaped distal tip, compared to the predicate which did not have this specific J-tip variant.

FDA Guidance on Coronary, Peripheral, and Neurovascular Guidewires Performance Tests (October 2019); FDA Guidance on Intravascular Catheters with Lubricious Coatings (October 2019); ISO 10993-1:2018 and ISO 10993-18:2020 for biological evaluation; TIR28:2016 for ethylene oxide sterilization; and performance bench testing including dimensional verification, torqueability, lateral stiffness, catheter compatibility, and kink resistance.

The subject and predicate devices share identical fundamental technology, materials, and operating principles with the same indications for use. The J-tip modification represents a minor design variant that does not alter the core function. All performance testing results were comparable to the predicate and met predetermined acceptance criteria, demonstrating substantial equivalence.