Ventripoint Medical System Plus (VMS+) 4.0

The Ventripoint Medical System Plus (VMS+) 4.0 is a software-based medical imaging device that records, analyzes, stores, and retrieves 2D ultrasound images for 3D reconstruction of the heart's four chambers. It calculates volumes and ejection fractions of the left ventricle, right ventricle, left atrium, and right atrium using a Knowledge-Based Reconstruction algorithm that references an MRI heart shape database.

VMS+ 4.0 maintains the same core technology as predicate VMS+ 3.0: Knowledge-Based Reconstruction algorithm, 3D visualization, same measurements (EDV, ESV, ejection fractions, stroke volumes, cardiac outputs), and identical acquisition workflow. Two hardware/software modifications: (1) automated control point first-guess placement via button press—users still manually adjust final positions as required—and (2) removal of magnet from the tracking system transmitter/sensor, changing from magnetic-based to magnet-free 3D positioning while preserving free-hand scanning operation.

IEC 60601-1 (electrical safety and essential performance) and IEC 60601-1-2 (electromagnetic compatibility). Software verification and validation followed FDA Guidance for Industry on Device Software Functions. Cybersecurity testing followed FDA Guidance on Cybersecurity in Medical Devices.

VMS+ 4.0 is substantially equivalent because it shares identical indications for use, intended use, KBR algorithm, measurements, and clinical workflow with predicate VMS+ 3.0 (K191493). The automated point placement is only an optional workflow optimization; users must still manually verify and adjust control points exactly as with the predicate, so final clinical output remains unchanged. The magnet-free tracking system maintains the same free-hand scanning operation and performance specifications. Bench testing, user validation, and safety/EMC testing all confirmed performance parity with the predicate, introducing no new safety or effectiveness questions.