IC-Flow™ Imaging System 2.0

The IC-Flow™ Imaging System 2.0 is a real-time near-infrared (NIR) fluorescence imaging system used with Indocyanine Green (ICG) to visualize blood flow, tissue perfusion, and the lymphatic system in adult and pediatric patients one month and older. It is indicated for fluorescence imaging and angiography before and after vascular, plastic, micro-, and reconstructive procedures, as well as for lymphatic vessel visualization following subcutaneous ICG administration.

The device uses a high-power LED as the excitation light source (unlike some predicates using lasers), with a CMOS image sensor at 1920×1200 pixel resolution, working distance of 170–200 mm, and image section of 75×100 mm. It comprises a handheld camera, controller with LAN and HDMI connections, and operates in fluorescence mode only. The system is not intended for intraoperative use (restricted to hospitals/clinics), whereas the primary predicate SPY-PHI is designed for operating room use during surgery.

IEC 62304 (software lifecycle), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), EN 301 489-1 v2.2.1 and EN 301 893 V2.1.1 (EMC/radio equipment), IEC 62471 (photobiological safety), IEC 62366-1 (usability), and internal protocols for cleaning/disinfection, packaging, and performance testing.

Both the subject device and predicates (SPY-PHI K230727 and pde-neo K133719) share the same ICG-based NIR fluorescence imaging principle, identical regulatory classification (Class II, product code IZI), same intended users (physicians/healthcare professionals), and comparable optical imaging specifications. Although the IC-Flow 2.0 uses LED rather than laser excitation and is restricted to non-operative settings (versus intraoperative SPY-PHI), these differences do not raise new safety or effectiveness questions because the bench and performance testing demonstrate equivalent diagnostic capability, and risk management per ISO 14971 identifies no novel hazards introduced by the design variations.