Ultrasound Workspace (UWS 6.0)

Ultrasound Workspace (UWS 6.0) is a software-only clinical package designed for review, quantification, and reporting of cardiovascular, fetal, and abdominal structures based on multi-dimensional ultrasound data. It supports physician diagnosis in patients with suspected disease. The submission introduces three new features: Segmental Wall Motion (SWM) for automated left ventricle assessment, 3D Auto TV for tricuspid valve quantification, and 3D Auto CFQ for mitral regurgitation volume and flow rate analysis, plus compatibility with VeriSight ICE/Pro ICE probe data.

SWM performs semi-automated border detection and tracking of 17 left ventricle segments using machine learning, generating segmental wall motion scores and overall wall motion score index (WMSI). 3D Auto TV uses semi-automated model-based segmentation of the tricuspid valve annulus to derive measurements. 3D Auto CFQ employs a novel fluid dynamics algorithm applied to 3D color flow images to quantify mitral regurgitation volume and peak flow rate, addressing spatial complexities over the entire systolic cycle rather than assuming a single constant orifice. All three features allow user review and editing of algorithm-generated results.

IEC 62304 (Medical device software – Software life cycle processes, 2006 + A2015) and ISO 14971 (Medical devices – Application of risk management to medical devices, 2019). The submission also aligns with FDA guidance on cybersecurity, device software content, technical performance assessment of quantitative imaging, and general software validation principles.

The predicate TOMTEC-ARENA (K213544) is substantially equivalent because it performs the same general function—quantification and reporting of cardiac, fetal, and abdominal structures—with identical indications for use, intended users, and user environments. Although the predicate lacks dedicated SWM and 3D Auto CFQ functionality, the reference device EPIQ (K240850) includes identical SWM and the predicate includes PISA methodology for mitral regurgitation quantification. The subject device's new features employ established techniques (semi-automated segmentation for SWM and 3D Auto TV analogous to 3D Auto MV; dynamic flow modeling for 3D Auto CFQ achieving the same measurement outputs as PISA). Performance validation demonstrates high correlation with ground truth methods (SWM Pearson r=0.957, 3D Auto TV limits of agreement within ±46-52%, 3D Auto CFQ LoA within acceptance criteria of ±61.6 mL), and all predefined acceptance criteria were met. No new safety or effectiveness questions are raised.