InZone IST Detachment System; IZDS Connecting Cable

The InZone IST Detachment System is a handheld, battery-powered device designed to electrolytically detach Stryker Neurovascular embolization coils from their delivery wires during minimally invasive endovascular procedures. It is used with the IZDS Connecting Cable (for monopolar devices) or standalone (for bipolar devices) to treat intracranial aneurysms and other vascular malformations in the neuro and peripheral vasculature.

The device operates via an electrolytic process using body fluids as a conductor; it generates a maximum of 12 VDC and 1.0 mA current for monopolar embolization devices, or 28 VDC and 2.4 mA for bipolar devices. It has the same design, materials, energy source, and principle of operation (electrolytic detachment) as the predicate device, with modifications limited to the indications for use statement and trade name.

Risk assessment was conducted in accordance with ISO 14971:2021 (design failure modes and effects analysis). The device is subject to FDA's Class II Special Controls Guidance Document for Vascular and Neurovascular Embolization Devices issued 29 December 2004.

The modifications do not alter the fundamental intended use or scientific technology of the predicate device (K212455). Design verification testing and risk assessment demonstrated that the generalized indications for use do not affect safety and effectiveness, and no new questions of safety or effectiveness were raised. The device treats the same diseases in the same patient population using identical technological characteristics as the predicate.