IntraSight Plus

IntraSight Plus is a multi-function diagnostic imaging system for evaluating vascular morphology in coronary and peripheral arteries during endovascular procedures. It provides intravascular ultrasound (IVUS) imaging, pressure-derived functional measurements (FFR/iFR), quantitative vessel analysis, and co-registration of ultrasound with X-ray images to assist physicians during cardiac catheterization and coronary interventions.

IntraSight Plus consolidates two separate predicate device systems (IntraSight and SyncVision) into a single unified workstation with one tower, one display, and one keyboard/mouse setup instead of two separate systems. It supports the same IVUS catheters as the predicate IntraSight (with the addition of OmniWire pressure guide wires) and maintains identical software functionality including IVUS, FFR/iFR, QCA, and co-registration modules.

IntraSight Plus complies with FDA-recognized consensus standards addressing software, cybersecurity, interoperability, electromagnetic compatibility, electrical/mechanical/thermal safety, usability, and packaging validation. Specific standard names (ISO 13485, etc.) are referenced in the Quality Management System Regulation context but detailed standard citations are not fully enumerated in this summary.

IntraSight Plus is substantially equivalent because it has identical intended use, indications for use, and user population as the predicate devices (IntraSight System K190078 and SyncVision System K190626). The differences—primarily hardware consolidation reducing redundancy—do not introduce new uses or raise new safety/effectiveness questions, and non-clinical testing confirms compliance with applicable standards.