Ventripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics Ltd.The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.
Intended Use
The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
Technology
The VMS+ 4.0 uses a Knowledge-Based Reconstruction (KBR) algorithm to generate 3D heart chamber models from 2D ultrasound images captured at specific angles, referenced against a database of MRI heart shape catalogs. It requires user placement and manual adjustment of anatomical landmark control points, refined by an edge detection algorithm. The system includes a hardware stand with computer, position sensors for 3D orientation tracking of the ultrasound transducer and patient movement, and software handling image capture, landmark placement, and reconstruction. It can also import 3D datasets and MRI studies.
Performance
Bench and software verification testing demonstrated the VMS+ 4.0 performs as intended, meeting acceptance criteria. An internal user validation showed that user performance for anatomical point placement with VMS+ 4.0 is at least as good as the predicate device. Electrical safety and electromagnetic compatibility tests were performed and passed. Cybersecurity testing was conducted including penetration testing to ensure device security. Modifications do not introduce new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/1/2024
10 months - 2
FDA Approval
2/26/2025
Other devices from Ventripoint Diagnostics Ltd.
- Ventripoint Medical System Plus (VMS+) 3.02019 • 510K
- Ventripoint Medical System Plus (VMS+)2018 • 510K
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