EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems are diagnostic ultrasound imaging devices used to visualize and assess human body structures and blood flow. They support multiple modes of operation including B-mode, Doppler, color flow, and harmonic imaging for use in clinics, hospitals, and point-of-care settings by trained healthcare professionals.

This submission modifies the Segmental Wall Motion (SWM) algorithm to version 2 and introduces Auto EF with contrast software—both previously cleared features being integrated into a single software release (version 13). SWM v2 uses machine learning to automatically evaluate left ventricular segmental function from three apical views with user manual editing capability. Auto EF with contrast is AI-based and assesses ejection fraction from contrast-enhanced transthoracic echo using two apical views. No hardware changes were made; existing cleared transducers are used.

IEC 62304 (Medical device software life cycle), IEC 62366-1 (Usability engineering), ISO 14971 (Risk management), and the FDA's February 2023 guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

The SWM v2 and Auto EF with contrast features are substantially equivalent because they replicate previously cleared algorithms (K243862 for SWM v2 and K243235 for Auto EF with contrast) without modification, merely integrating them into the EPIQ and Affiniti platforms. Retrospective performance studies demonstrated that SWM v2 sensitivity and specificity align with prior validation, and Auto EF with contrast achieved a Pearson correlation of 0.952 (95% CI 0.919–0.972) versus manual gold standard, meeting the predefined acceptance criterion of >0.75. Since only software was modified with no new hardware, acoustic, thermal, or biocompatibility risks, the devices maintain their predicate indications and safety profile.