EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems are diagnostic imaging devices used to visualize the human body and analyze fluid flow across multiple clinical applications including abdominal, cardiac, fetal, musculoskeletal, and vascular imaging. The new Auto ElastQ software feature assists users in making liver stiffness measurements using 2D shear wave elastography by automatically recommending optimal frames and regions of interest (ROI) positions.

The Auto ElastQ feature is a workflow enhancement that automatically analyzes the cineloop buffer and recommends up to three stable frames and automatically places the measurement ROI in homogeneous, temporally stable locations. This contrasts with the predicate device's manual workflow where users must review elastography image loops, manually cine through frames, and position the ROI themselves. No new hardware, transducers, or measurement types are introduced; only the existing C5-1 transducer is used.

IEC 62304 Medical Device Software – Software life cycle processes (2006 + A2015), ISO 14971 Medical devices - Application of risk management to medical devices, and the FDA Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (February 2023).

The proposed devices are substantially equivalent because they maintain identical classification, product codes, intended users, use environments, and clinical indications as the predicate. The Auto ElastQ software performs the same stiffness measurement function as the manual ElastQ workflow but through automated frame and ROI selection rather than user navigation. Non-clinical verification testing and a retrospective data analysis study comparing Auto ElastQ algorithm-generated measurements to expert manual measurements demonstrated high agreement, showing the automated feature achieves equivalent measurement accuracy. Since the differences are limited to user interface workflow optimization with no new hardware or measurement types, and performance testing confirms equivalent results, safety and effectiveness are maintained.