Cardiac Guidance

Cardiac Guidance is an AI-powered software-only device that provides real-time guidance during echocardiography to help medical professionals acquire standard 2D cardiac ultrasound images. It functions as an accessory to compatible general-purpose diagnostic ultrasound systems and assists in capturing ten specific cardiac views for adult patients, including parasternal, apical, and subcostal orientations.

The updated PCCP expands the list of supported cardiac views beyond the previous K201992 clearance, adds UI/UX improvements for compatibility with various screen sizes including mobile platforms, introduces a non-expert validation test protocol, and incorporates human factors testing. Core features include Quality Meter, Prescriptive Guidance, Auto-Capture, and Save Best Clip functionality that emulate expert sonographer behavior.

Not stated in this summary.

The device is substantially equivalent because it maintains the same intended use, design principles, and operational methodology as the Caption Guidance predicate device without introducing new or different safety and effectiveness questions. The modifications—expanded views, UI enhancements, and additional validation testing—do not alter the fundamental function of providing real-time guidance for cardiac image acquisition, and the defined PCCP establishes that future modifications will maintain safety and effectiveness through specified verification and validation testing with predefined acceptance criteria.