EchoGuide (Version 1)

EchoGuide (Version 1) is a 3D automated ultrasound system designed to help healthcare providers identify cannulation sites on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients undergoing hemodialysis. It uses a motorized 2D linear array probe on a track to acquire live coronal plane images, allowing users to assess position, trajectory, and size of the access before marking and proceeding with cannulation.

EchoGuide uses a 2D linear array moved along a track to perform coronal plane imaging, whereas its predicate Sonic Window uses a matrix array in a fully integrated handheld device. Both use ultrasonic transducers to transmit sound waves and convert reflected signals to electrical signals for processing. The differences in form factor and array type do not raise new safety or effectiveness questions, as both devices produce the same final coronal plane output.

ISO 10993-1:2009 (Biological evaluation), ISO 10993-5:2009 (In vitro cytotoxicity), ISO 10993-10:2010 (Irritation and skin sensitization), IEC 60601-2:2014 and IEC 60601-1:2005 (Medical electrical equipment safety and performance), IEC 62127-1:2012 (Ultrasonic field measurement), IEC 62359:2017 (Thermal and mechanical indices), and IEC 60601-2-37:2015 (Ultrasonic diagnostic equipment requirements).

EchoGuide meets substantial equivalence because it performs the same intended function as Sonic Window—vascular ultrasound imaging to support cannulation of arteriovenous fistulas/grafts—and uses the same imaging modality (coronal plane ultrasound via transducer). Although EchoGuide's indication is more specific (identification of cannulation sites on mature AVFs/AVGs), this is a subset of Sonic Window's broader indication for vascular imaging and access guidance. Bench and clinical testing confirm EchoGuide meets design requirements, imaging adequacy, and all applicable safety and performance standards; the differences in array type and form factor do not raise new safety or effectiveness concerns.