DualView Catheter

The DualView Catheter is a diagnostic imaging catheter designed for intravascular imaging of coronary arteries in patients undergoing transluminal interventional procedures. It combines optical coherence tomography (OCT) at 1300 nm wavelength and 40 MHz ultrasound imaging to obtain 360° cross-sectional images and longitudinal views of vessel walls by rotating and pulling back an imaging core inside a catheter sheath.

The DualView Catheter is 2.6 Fr at the imaging window and 3.0 Fr at the proximal shaft, with 1370 mm effective length and uses a 0.014" guidewire. It operates manually with a hydrophilic coating and has a 36-month shelf life after ethylene oxide sterilization. The primary predicate (Dragonfly Optis) is slightly larger (2.7 Fr/3.2 Fr) with slightly shorter length (1350 mm) and 24-month shelf life, while the secondary predicate (Opticross) uses ultrasound only without OCT.

ISO 10993-1 (biocompatibility), ISO 11135:2014/Amd 1:2018 (ethylene oxide sterilization), IEC 62304 (software standards), IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60825, and IEC 60601-2-37 (electrical safety and EMC). Performance testing included radio-detectability, tensile strength, particle counts, imaging quality, and stent crossability.

The DualView Catheter is substantially equivalent because it shares the same intended use (coronary imaging for interventional candidates) and nearly identical technological characteristics—specifically dual OCT/ultrasound imaging modality, comparable dimensions and guidewire compatibility, and manual operation—with the primary predicate Dragonfly Optis. Performance testing, animal studies confirming safety with combined OCT/ultrasound energy, and biocompatibility validation across the shelf life demonstrate functional equivalence, supporting the determination that it poses no greater risk and provides equivalent performance despite minor dimensional and sterilization method differences.