OptoMonitor 3

The OptoMonitor 3 is a catheter tip pressure transducer system that measures cardiovascular blood pressure in heart chambers, coronary vessels, and peripheral vessels during interventional procedures. It provides hemodynamic information including fractional flow reserve (FFR) for diagnosis and treatment of blood vessels, and valve gradients during transcatheter aortic valve (TAVI) procedures.

The device uses a fiberoptic sensor embedded in a guidewire to sense pressure, with a reusable signal processor and LCD monitor display. Operating specifications include a pressure range of -30 to 300 mmHg, accuracy of ±1 mmHg plus ±1-3% of reading, operating temperature 15-30°C, and electrical isolation Class 2 (double isolation). The primary change from the predicate is the addition of ARi and TIARi adjunctive hemodynamic indicators to the real-time numerical values and recording outputs.

Not stated in this summary.

The device is substantially equivalent because it uses identical hardware components, system capabilities, pressure sensing technology, and operational specifications as the predicate OptoMonitor 3 (K213854). The only change is software-related: the addition of ARi/TIARi hemodynamic indicator display. Retrospective analysis of 30 pressure recordings from 10 patients demonstrated the calculated indices match literature formulas with Pearson correlations >0.99. A clinical annotation study of 420 waveforms showed high agreement (Bland-Altman analysis) between OptoMonitor 3 outputs and expert clinician annotations. Risk management identified no new safety or effectiveness concerns, with one pre-existing risk (suboptimal measurement conditions) deemed tolerable as benefits outweigh risks.