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The Volta AF-Xplorer assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms (EGMs) exhibiting spatio-temporal dispersion, i.e., dispersed EGMs. The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems: - Two compatible EP recording systems: the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626), - a 3D mapping system: EnSite X 3D mapping system (Abbott) (K221213). A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer system, depending on the type of communication used: - Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer software. - Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20, 10, 5 or 2m) which transmits the digital signals directly to the computer. The computer and its attached display are located outside the sterile operating room area. The Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The Volta AF-Xplorer assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the Volta AF-Xplorer software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms. The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems: - two compatible EP recording systems (identical to VX1 and VX1+ (Volta Medical (K201298, । K223516)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626), - a 3D mapping system (new compared to VX1 and identical to VX1+): EnSite X 3D mapping system -(Abbott) (K221213). A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer system, depending on the type of communication used: - -Unidirectional analog communication with the EP recording systems via a custom-made cable (two diferent variants: DSUB, Octopus) and an Advantech PCI-1713U analog-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer software. - -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20.10. 5 or 2m) which transmits the digital signals directly to the computer. The computer and its attached display are located outside the sterile operating room area. The Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs). The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems: - two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626), - a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213). A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used: - Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software. - -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer. The computer and its attached display are located outside the sterile operating room area. The VX1+ software analyzes the patient's electrograms to cue operators in real-time to intracardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.