Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

The Makoto Intravascular Imaging System is a dual-modality device that combines near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) to visualize coronary and peripheral arteries. It detects lipid-core-containing plaques, assesses lipid burden, and identifies patients at increased risk of adverse cardiac events. The system includes a catheter, console with laser and processing hardware, and controller.

The proposed device adds two software features to the predicate: Automatic Border Contouring (ABC) for automated identification of lumen and external elastic membrane borders, and Guide Catheter Detection (GCD) for automatic detection of guide catheter edges. All hardware specifications (catheter dimensions, transducer frequency at 50 MHz, console components, imaging modes) remain identical to the predicate device K213303. Minor hardware changes were made to accommodate these features without significant impact on electromagnetic interference performance.

ISO 10993 and ASTM standards were cited for biocompatibility testing, including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility. IVUS Tracing Guidelines were referenced for establishing ground truth annotations in algorithm validation. No other consensus standards are explicitly cited in this summary.

The device is substantially equivalent because it maintains identical intended use, scientific principles, and safety profile as the predicate. The two new software features (ABC and GCD) perform assistive functions within the existing imaging workflow without changing the fundamental diagnostic capability. Bench testing of both features met predefined acceptance criteria aligned with inter-reader variability from manual contouring, demonstrating performance within clinically acceptable limits. Biocompatibility, sterilization, shelf-life, and EMI testing all matched predicate specifications. The device represents only minor design changes to a legally marketed predicate with no new intended use or clinical risk profile.