EdgeFlow UW20

The EdgeFlow UW20 is a wearable ultrasound patch device that non-invasively measures bladder volume in adult patients with BMI up to 30. It attaches to the lower abdomen and periodically acquires ultrasound images transmitted to a mobile app, where AI-based software automatically segments the bladder and estimates volume. It is intended for use by qualified healthcare professionals in hospitals and clinics for periodic monitoring.

The EdgeFlow UW20 is a wearable patch (versus handheld predicate), uses a phased-array transducer with electronic sector scanning at 120 degrees with a single scan plane (versus two planes in predicate), incorporates locked AI-enabled deep learning for volume estimation, measures 0–999 mL with accuracy of ±20 mL (0–100 mL) and ±15% (101–999 mL), and includes BLE and Wi-Fi connectivity. It operates in B-mode and harmonic imaging modes, similar to the predicate.

Acoustic output per IEC 60601-2-37:2007+AMD1:2015 (Track 3), electrical safety per IEC 60601-1:2005+AMD1:2012+AMD2:2020 and AAMI ES60601-1, EMC per IEC 60601-1-2:2014+AMD1:2020 and EN 60601-1-2:2015/A1:2021, wireless per ANSI C63.27-2017 and ETSI EN 300 328 V2.2.2, radio per FCC Part 15, and biocompatibility per ISO 10993-1:2018 (cytotoxicity ISO 10993-5:2009, sensitization ISO 10993-10:2021, irritation ISO 10993-23:2021).

Both devices share the same intended use (non-invasive bladder volume measurement by qualified healthcare professionals), use ultrasound and automated AI-based analysis, and operate at the same measurement range and accuracy levels. Differences in wearable form factor, number of scan planes, and specific accuracy specifications were addressed through comprehensive bench, acoustic, biocompatibility, electrical safety, EMC, wireless, in-vivo wearable performance testing (97.24% acoustic coupling retention), and AI software validation (F1 score 0.975, Dice 0.936, MAE 14.43 mL for 0–100 mL). These differences do not raise new questions of safety or effectiveness.