ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems are multi-purpose devices designed for a wide array of clinical imaging applications, incorporating advanced features like AI and ultrasonically-derived fat fraction measurement. Regulatory approval was granted based on substantial equivalence to predicate devices, supported by nonclinical data confirming safety and performance, with new AI features and transducers deemed consistent with existing technology.

Siemens Medical Solutions USA, Inc. received U.S. regulatory approval on November 19, 2024, for its ACUSON Sequoia, ACUSON Sequoia Select, ACUSON Origin, and ACUSON Origin ICE Diagnostic Ultrasound Systems. The regulatory body determined these multi-purpose medical devices are substantially equivalent to existing legally marketed predicate devices for their specified indications for use. This decision permits Siemens to market these systems, contingent on adherence to general regulatory controls, including annual registration, device listing, and good manufacturing practices. These ultrasound systems are designed for a broad spectrum of clinical applications, such as fetal, abdominal, pediatric, cardiac, and vascular imaging, and feature advanced capabilities including an ultrasonically-derived fat fraction measurement tool and intracardiac visualization. The substantial equivalence determination was based on comprehensive nonclinical data, which confirmed the devices' acoustic output, biocompatibility, and compliance with thermal, electrical, electromagnetic, and mechanical safety standards. Notably, new modifications like additional transducers and enhanced Artificial Intelligence (AI) features for imaging and measurement were assessed and found consistent with current technology, thus not necessitating new clinical studies.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific improvements or new clinical insights do the enhanced AI features offer compared to previous generations of ultrasound systems?; How does the ultrasonically-derived fat fraction measurement tool compare in accuracy and utility to established methods for body composition analysis?; What are the specific safety and performance data points from the nonclinical studies that supported the substantial equivalence determination for the new modifications?; Are there any specific patient populations or clinical scenarios where the ACUSON Origin ICE's intracardiac visualization capabilities provide a significant advantage over other imaging modalities?; What is the long-term post-market surveillance plan for these devices, especially regarding the performance and safety of the newly introduced AI features?