Novasight Hybrid System

The Novasight Hybrid System is an intravascular imaging device that combines ultrasound (IVUS) and optical coherence tomography (OCT) to create real-time cross-sectional images of coronary arteries. It is intended for patients undergoing coronary interventional procedures and consists of a mobile console, patient interface module, bedside controller, bedside panel, and a single-use catheter.

The v3.0 subject device differs from the v1.0 predicate by adding two new components (Bedside Controller and Bedside Panel), improving ultrasound frequency from 40 MHz to 50 MHz broadband, reducing crossing profile from 2.8 Fr to 2.6 Fr, expanding rotational speed range from 30–100 RPS to 30–140 RPS, and expanding pullback speed from 0.5–25 mm/s to 1–40 mm/s. It also adds four AI algorithms for automated feature detection (Sheath Detection, Lumen Detection for OCT, EEL and Lumen Detection for IVUS, and Stent Strut Detection).

ISO 10993-1 (biocompatibility), IEC 60601-1, IEC 60601-2-37, IEC 60601-2-18, and IEC 60601-1-2 (electrical safety and EMC), ASTM D4169 (shipping simulation), and FDA Guidance on device software functions and human factors validation.

Both devices share identical intended use, indications for use, mechanism of action, and principles of operation. The technological differences (enhanced performance specifications, added software algorithms, new components for improved usability) do not raise new or different safety and effectiveness questions. Performance testing demonstrates substantially equivalent performance to the predicate device.