Velacur One (LI-1100)

Velacur ONE is a portable ultrasound elastography system that non-invasively measures liver tissue stiffness, ultrasound attenuation, and Velacur Determined Fat Fraction (VDFF) by generating mechanical shear waves at 40-70 Hz and imaging them with ultrasound. The device is intended for use in clinical settings by trained medical professionals to aid in managing patients with liver diseases, including hepatic steatosis, and VDFF measurements are restricted to adults 18 and older.

Both the proposed device and predicate use pulse-echo ultrasound to measure elastography via external shear wave generation at 40-70 Hz, with identical attenuation measurement algorithms (Spectral Shift Reference Phantom method) and VDFF estimation combining attenuation and backscatter coefficients. The proposed device consolidates hardware from four components to three by integrating the computing unit into a single core unit, adds distributed voice coils to the activation unit, and updates the user interface to a modern platform while maintaining the same workflow, power output, and measurement performance.

IEC 60601-1-2:2020 (EMC), IEC 60601-1:2020 (general safety), IEC 60601-1-6:2020 (usability), IEC 62304:2015 (software lifecycle), IEC 60601-2-37:2015 (ultrasonic equipment), IEC 62359:2017 (ultrasonic field characterization), ISO 14971:2019 (risk management), ISO 10993-1:2018 (biocompatibility), and IEC 62133-2:2017 (battery safety).

The proposed device maintains identical intended use, indications for use, imaging method, and measurement algorithms (elasticity, attenuation, VDFF) as the predicate, measuring the same physical variables through the same technology platform. Bench testing demonstrated equivalent accuracy and precision: elasticity bias difference of 2.45%, attenuation bias of 9.1% (vs. predicate 8.0%, both under 10% acceptance criteria), and VDFF bias of 8% (vs. predicate 9%); all systems passed defined acceptance criteria when compared to each other. Hardware and software changes were validated using the same methods as the predicate, human factors testing revealed no new hazardous scenarios, and the device raised no new safety or effectiveness issues.