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The VMS 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. The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired.

The VentriPoint Medical System was cleared under 510(k) K140153 for use in adult patients with Pulmonary Arterial Hypertension. This current submission is intended to expand system use to right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH. Right ventricle evaluation is accomplished by the addition of a KBR heart catalog containing a variety of heart models that are not specific to PAH. All other system operational characteristics remain unchanged from the cleared device.

The VMS 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. The VMS system is used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.

The VentriPoint Diagnostic System is a client/server platform consisting of the VentriPoint Medical System (client) and VentriPoint Services (server). The VentriPoint Medical System (VMS) is a cart based system consisting of CE Marked off-the-shelf subassemblies which accepts the digital video output from any 2-D ultrasound machine. A 3-D tracking system is connected to the ultrasound transducer using a custom sleeve. This system provides 3-D spatial coordinates for the 2-D images. After recording the 2-D images and associated 3-D spatial coordinates. a trained medical professional uses the VMS graphical user interface to place a series of points on the 2-D images corresponding to selected anatomical structures. Those points. along with their 3-D spatial coordinates, are sent bv secure internet connection to the VentriPoint Services. The VentriPoint Services use a Knowledge Based Reconstruction expert system to convert those 3-D points into a dense 3-D model of the right ventricle and sends the model back to the VMS svstem where the results are displayed on the screen. This initial rendering is reviewed for accuracy by the product user. The border contours generated from the previously placed points are displayed and may be adjusted by the user to achieve a precise fit. Improvements are made by adding. deleting or moving points on the image slices where needed. after which the information is sent by secure internet connection to the VentriPoint Services to be reconstructed. The review and reconstruction process may be repeated until the user is satisfied that the best contour fit has been made. Once the 3-D model has been approved by credentialed site personnel, quantitative right ventricle measurements are reported. The data produced by VMS is intended to support qualified licensed medical professionals in clinical decision making when used in conjunction with other patient test information.