Ruby XL System

The Ruby XL System is a vascular embolization device comprised of a platinum coil attached to a composite delivery pusher and detachment handle. It is indicated for arterial and venous embolizations in the peripheral vasculature to block blood flow and treat vascular abnormalities.

The device uses identical materials (platinum/tungsten, adhesive, titanium, polymer), the same mechanical detachment mechanism, equivalent dimensional specifications appropriately sized for target vasculature, and identical sterilization (ethylene oxide, SAL >10-6). The coil has a complex secondary shape with finish matching the predicate.

ISO 10993-1 for biocompatibility evaluation. The submission references FDA Guidance for Use of International Standard ISO 10993-1 for biological evaluation of medical devices.

The Ruby XL System is substantially equivalent because it shares the same intended use (peripheral vascular embolization), operating principle (mechanical coil detachment), design concept (platinum coil with composite pusher), and fundamental technology as the predicate device K173614. All materials, construction methods, dimensions, detachment mechanisms, sterilization, and packaging are identical. Comprehensive bench-top testing (dimensional, radiopacity, friction, fatigue, torsional resistance, stiffness, corrosion, tensile, MRI compatibility) and biocompatibility testing confirmed equivalent performance without requiring animal or clinical studies.