uWS-Angio

uWS-Angio is post-processing software for viewing, processing, evaluating and analyzing XA (x-ray angiography) images compliant with DICOM 3.0 standard. It provides four applications: 2D Vessel Analysis for quantifying coronary and peripheral vessel dimensions, Left Ventricular Analysis for assessing cardiac function and wall motion, 2D Blood Flow Analysis for analyzing blood flow parameters in peripheral vessels, and Stitching for combining overlapping lower extremity images into a single visualization.

uWS-Angio is a software-only device with the same classification, product code (LLZ), and regulatory framework (21 CFR 892.2050, Class II) as the predicate. While the proposed device includes fewer total applications than the predicate device (syngo Application Software), the individual functions present—vessel contour extraction, contour editing, left ventricular volume and wall motion calculations, and ROI-based blood flow parameters—are substantially equivalent. The device adds some parameters (Arrival Time, Wash-in Rate, Rise Time) calculated from time-density curves, but these differences do not impact safety or effectiveness.

NEMA PS 3.1-3.20 (DICOM 2023e), ISO 14971 (risk management), IEC 62304 (software life cycle), and FDA guidance on cybersecurity in medical devices and device software functions. Testing included software verification and validation, hazard analysis, and performance verification across phantom studies, clinical case comparisons, and simulated datasets.

The device is substantially equivalent because it shares the same intended use (post-processing and analysis of angiographic images in healthcare settings), same regulatory classification and product code, and operates on the same fundamental scientific principles as the predicate. Performance verification demonstrated that vessel diameter measurements achieve 1.1–2.1% mean relative error, left ventricular volume calculations align with ground truth within acceptable limits of agreement, blood flow parameters achieve ICC >0.998 in simulation studies, and image stitching achieves sub-pixel registration accuracy. These safety and efficacy profiles are comparable to the predicate device despite minor functional differences that do not raise new safety concerns.