EmeryGlide™ (EG18008901)

EmeryGlide is a sterile, disposable guidewire with a 0.035-inch diameter and 180 cm length, constructed from a glass fiber and polymer core wrapped in an aramid fiber mantle and PTFE coating. It is designed to direct catheters to desired anatomical locations in the vasculatory system during diagnostic or interventional procedures, with discrete ring markers for MRI and X-ray visibility in an angled configuration.

EmeryGlide has identical intended use, principle of operation (manual), diameter (0.035 inches), and effective length (180 cm) as the predicate MRWire Guide Wire. Key differences include an extended shelf life of 1 year versus 6 months, alternative PTFE colorant formulation, a change in packaging material from flat PET-O/PP paper to coated Tyvek pouch, transfer to a new contract sterilizer and manufacturer, and MR Conditional designation with specific field gradient and SAR limits.

Testing per ISO 11070:2014 (flexing/bending), ISO 14125:2011 (bending modulus), ASTM F88/F88M-23 (seal strength), ASTM F1929-23 (dye penetration), ASTM F1886/F1886M-16 (visual inspection), ASTM F2096-11 (bubble leak), ISTA 3A:2018 (transportation), ISO 11737-1:2018 (bioburden), ISO 10993 series (biocompatibility), USP <85>/AAMI ST72:2019 (LAL/endotoxin), ISO 11135:2014 (sterilization), and USP <788>/AAMI TIR42:2021 (particulate evaluation).

Substantial equivalence is based on identical intended use, technology, principle of operation, dimensions, materials, sterilization method, and performance characteristics. All performance tests on both fresh and accelerated-aged samples met acceptance criteria consistent with the predicate. The modifications (alternative PTFE colorant, packaging material change, new sterilizer/manufacturer, and extended shelf life) do not alter the device's fundamental scientific technology or performance, and verification/validation activities confirmed equivalence.