Sonosite LX and Sonosite PX Ultrasound Systems

The Sonosite LX and Sonosite PX Ultrasound Systems are general-purpose diagnostic ultrasound devices intended for use by qualified physicians and healthcare professionals to acquire and display real-time ultrasound images for evaluation of the human body across multiple clinical applications including abdominal, cardiac, fetal, musculoskeletal, and peripheral vessel imaging. The systems operate in multiple modes including B-mode, M-mode, Pulsed Wave and Continuous Wave Doppler, and Color Doppler, and are powered by either battery or AC electrical power.

The systems employ the same fundamental scientific and technological characteristics as the predicate devices, including identical transducer types (linear array, curved linear array, phased array, intracavitary, trans-esophageal), frequency range (1.0–19.0 MHz), 128 digital transmit and receive channels, identical acoustic output specifications, and all existing imaging modes. The primary modification is the addition of a PIV Assist feature that automates localization and measurement of veins and arteries, building on pre-existing manual compression and color Doppler techniques already present in the predicates.

IEC 62304 (ANSI AAMI IEC 62304:2006/A1:2016) for medical device software life cycle processes and ISO 14971 (ANSI AAMI ISO 14971:2019) for risk management. Testing included design phase reviews, risk assessment, requirements development and review, system and software verification, and performance validation of the PIV Assist algorithm.

The PIV Assist feature is an automated enhancement of existing vein and artery localization and measurement functionality already cleared on both predicate devices—it automates the previously manual Catheter-to-Vein Ratio (CVR) feature and existing diameter/depth measurement capabilities. No hardware changes were made to either device; the feature operates within the same acoustic output parameters and uses existing 2D imaging and color Doppler modalities. Performance validation demonstrated high precision (95.58–97.32%), recall (94.49–97.07%), and measurement accuracy across diverse patient demographics, with the ability for users to revert to manual measurements if desired, thus raising no new safety or effectiveness questions.