Intended Use

The VMS+ 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 device is a software-based analysis tool that works adjunctively with ultrasound systems, employing a knowledge-based reconstruction database for 3D image processing and volume measurement of cardiac chambers. It uses real-time video capture, external ECG triggering, and pulsed DC 6DOF magnetic tracking for accurate ultrasound image acquisition and reconstruction.

Performance

The device underwent comprehensive electrical, electromagnetic, mechanical safety testing, and standards compliance. Bench testing verified the accuracy of left ventricle, left atrium, and right atrium volume reconstructions via automated and manual methods. Clinical studies were not required for FDA clearance due to substantial equivalence to predicate device.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/15/2017

    5 months
  • 2

    FDA Approval

    5/14/2018

Other devices from Ventripoint Diagnostics, Ltd.

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