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The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.

The Globe Pulsed Field System (Globe PF System) comprises the following components and accessories to support anatomical and electrophysiological mapping, and pacing stimulation of cardiac tissue: • **Globe Controller:** Used for the acquisition and processing of signals for cardiac anatomical and electrophysiological mapping, generation of mapping energy and stimulation pulses. • **Globe Workstation:** A PC workstation configured with the Globe Software, which the clinician uses to assess contact between the mapping catheter electrodes and the atrial wall, map the atrial electrical activity, and apply stimulation pulses for diagnostic purposes. • **Globe Positioning System (GPS™) Electrodes and GPS Cable:** Surface electrodes and cables for localization of the mapping catheter.

The PhysCade System is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician. The clinical significance of utilizing the PhysCade System to help identify areas with intra-cardiac atrial electrograms exhibiting local early activated potentials and other features of interest during atrial arrhythmias has not been established by clinical investigations.

The PhysCade™ System (PhysCade) is an artificial intelligence (AI) enabled device intended to assist clinicians in their management of patients with heart rhythm disorders (arrhythmias). PhysCade is a medical decision support system which post-processes electrograms (EGMs) collected inside the heart during electrophysiology (EP) mapping procedures using compatible diagnostic EP catheters. The PhysCade software has advanced algorithms that analyze the collected EGMs to provide information on regions of interest in the heart that may be useful to the clinician to support clinical decisions together with other available patient-related information. PhysCade provides specialized analyses of data from a compatible multipolar catheter. The primary output (coPILOT) indicates the predominant earliest site of activation relative to the catheter electrode array. Supporting outputs include determining activation times of successive beats in the EGM signal on each electrode (coMAP), voltage at each electrode, signal quality, and sequences of propagation over multiple beats of the arrhythmia on the catheter. The PhysCade System consists of a computer workstation, display, and custom software and is not connected to other devices or medical equipment.

The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias. The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor. The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias. The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

The DeepRhythmAI is a cloud-based software utilizing CNN and transformer models for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.

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.

VitalRhythm is a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias. VitalRhythm is compatible with the "Vista Solution" platform, which includes the VitalPatch biosensor and VistaCenter web application. VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making. VitalRhythm provides analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch in patients who are 18 years of age or older. Results of the VitalRhythm are displayed within the VistaCenter web application to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians. VitalRhythm is not intended for use in life-supporting or sustaining systems or for critical care monitoring. The arrhythmia analysis results are not intended to be the sole means of diagnosis and are offered on an advisory basis only, in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

VitalRhythm is a cloud-based, arrhythmia detection software application that is compatible and intended to be used with the VitalConnect "Vista Solution" platform. The Vista Solution Platform consists of the VitalPatch biosensor, a phone (VistaPhone) or tablet (VistaTablet) relay device preloaded with the VistaPoint software application, VC Cloud and the cloud-based VistaCenter user interface. VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making. VitalRhythm analyzes ECG data and RR-interval from the VitalPatch biosensor for reporting of cardiac arrhythmias to be reviewed and adjudicated by qualified healthcare professionals and/or cardiac technicians. The cloud-based VitalRhythm software application supports the analysis of ECG data and RR-interval using a proprietary algorithm developed using deep learning techniques. The application works in the following way: 1. VitalRhythm accepts ECG and RR-interval data transmitted from the VitalPatch via a secure, cloud-based API (Application Programming Interface). 2. ECG and RR-interval data are analyzed by VitalRhythm using a proprietary algorithm, which detects the following cardiac rhythms: - Atrial fibrillation/atrial flutter - AV Block (2nd degree, Type I and II) - Pause - Paroxysmal supraventricular tachycardia (PSVT) - Ventricular tachycardia/run - Sinus bradycardia - Sinus tachycardia - Normal sinus rhythm - Others (inconclusive) 3. For use with Mobile Cardiac Telemetry (MCT), i.e., outpatient cardiac telemetry: any of the above listed arrhythmias that are detected by the software algorithm are displayed in VistaCenter to be reviewed and analyzed by a qualified cardiac technician in the 24/7 attended Cardiac Monitoring Center, prior to transmitting a notifiable event consistent with the prescribed notification criteria to the prescribing physician during the monitoring period. An event report is generated by VistaCenter as a result of the analysis. For use with patient monitoring in non-critical healthcare settings: any of the above listed arrhythmias that are detected by the software algorithm are displayed and notified in VistaCenter, in accordance with the notification criteria, during the monitoring period to be reviewed by the prescribing healthcare professional for non-urgent clinical decision-making. The features, operating procedures, and mitigations in place for the compatible devices ensure continuous data collection and transmission to support the VitalRhythm application for the intended use. Further information is provided in the VitalRhythm Instructions for Use document.

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

The Intra-Operative Positioning System (IOPS) consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact reusable multi-patient use device. The associated accessories are single use devices provided sterile (EtO). The IOPS displays the position and orientation of sensor equipped catheters, guidewires, and tracking pad utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time, superimposing navigation of the catheters and guidewires to the patient's vascular map displayed on a monitor. The system is for use as an adjunct to fluoroscopy and does not make a diagnosis. The associated accessories include: - Guidewire - Catheters - Fiducial Tracking Pad - Guidewire Handle

CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool. CER-S analysis provides indications for evaluation of: - Patients with rhythm disturbances (cardiac arrhythmias), - Patients with transient myocardial ischemia, - Patients with pacemaker (only if pacing detection is available from the input recording), - Patients needing HRV evaluation. - Newborn patients limited to QRS detection.

CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER). Different modules provide: - ECG Beat detection and classification, - analysis of ECG rhythm, arrhythmia detection, - interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows, - interactive Continuous ECG Viewer, - interactive display/management of ECG Templates, - holter-like report for analyzed Continuous ECG records, - record exportation, in ISHNE format, - generation of aECG FDA HL7 XML (v. 2). Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary. Moreover, CER-S allows the automatic analysis for the following patch location: - two-electrode patches positioned in the left upper chest area at a roughly inclined angle - three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle - three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.

The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through third-party intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.