Prelude Small O.D. Introducer Guide Wire

The Prelude Small O.D. Introducer Guide Wire is a stainless-steel device composed of a core wire inside a stainless-steel coil, designed to facilitate placement of introducer sheaths during diagnostic and interventional procedures in the peripheral vasculature. It is available in outer diameters of 0.018", 0.021", and 0.025", with lengths from 45 to 80 cm, in straight and J-tipped configurations with Standard or Firm stiffness profiles.

The subject device has identical design and materials to the predicate: both feature a stainless-steel core wire with a grind profile ending in a flexible distal tip, both have stainless-steel coils attached at proximal and distal ends, and both possess equivalent wire lengths, outer diameters, and tip configurations. Neither device includes a safety wire or coating, and both operate on the same fundamental technology and principles.

Not stated in this summary. The document references FDA Guidances and industry standards generally but does not cite specific ISO, IEC, or ASTM standards by name.

Substantial equivalence is supported by the identical materials of construction (stainless-steel core and coil), identical design architecture, and identical intended use (facilitating introducer sheath placement in peripheral vascular procedures). The subject device met all predetermined acceptance criteria in non-clinical performance and biocompatibility testing with results comparable to the predicate device, demonstrating equivalent functionality and safety in the same clinical context.