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STAR Apollo™ Mapping System assists users in the interpretation and manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo Mapping System (v1.8) is a software driven system designed to assist operators in identifying Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use with FDA cleared electroanatomic mapping systems specifically:

• CARTO™ 3 EP Navigation System (V8.1) (K252302) (Biosense Webster) and
  • OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) (Biosense Webster)

for exporting geometry data, electrograms and electrode locations over ethernet connection during the electrophysiology procedure with CARTO 3 API (K231207) to provide input data for the STAR Apollo Mapping System.

• Ensite Precision Model EE 3000 Cardiac Mapping System (V2.6) (K201148) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• EnSite X EP System (V 1.1.1, V 2.0, V 3.0) (K213364) (K221213) (K231415) (Abbott Medical) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• Ensite X EP System (V 3.1) (K242016) (Abbott Medical) and either:
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
  • Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K242016) (Abbott Medical)

for exporting geometry data, electrograms and electrode locations via a portable external storage device or over ethernet data connection (Ensite X EP System (V 3.0, V 3.1) with LiveSync module) (K231415) (K242016) during the electrophysiology procedure to provide input data for the STAR Apollo Mapping System.

The principle of STAR Apollo Mapping System analysis is to use data on multiple individual wavefront trajectories to identify Repetitive Patterns of Activation (RPA) or regions of the atrium that represent Early Sites of Activation (ESA) which most often precede activation of neighboring areas, with the aim of helping clinicians to identify regions of the atria that may be the origins for AF activation. The system consists of proprietary STAR Apollo Mapping System software and a hardware component. STAR Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 11 Operating System. STAR Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the compatible Mapping System that has been collected with the compatible Mapping Catheter during the electrophysiology procedure. The Mapping Catheter is used to collect anatomy and electrogram data in the atria. Recordings are made for at least 30 seconds with the Mapping Catheter in a stable position and in contact with the atrial wall. These ≥30 second acquisitions are made in multiple, non-overlapping locations, to generate recordings over the entire atrial chamber. The data is exported via an external portable storage device or by streaming via an ethernet data cable connected to the data ethernet port of the EnSite X or CARTO 3 workstation. It is transferred to the laptop computer running the STAR Apollo Mapping System. The export data accepted from the Mapping Systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data is imported utilizing the portable external data storage device or via ethernet into the STAR Apollo Mapping System and then processed by the STAR Apollo Engine to generate a STAR Apollo Map visualized by the GUI. The STAR Apollo Map will highlight sites deemed to be Early Sites of Activation (ESA), as a red sphere at the endocardial locations corresponding to the recording electrode position. These sites are areas where the myocardium has initiated activation earlier than its neighboring sites on multiple occasions and therefore may be a potential site of AF initiation or maintenance. The more repetitive these sites are, the larger the red sphere appears on the STAR Apollo Map. The system will rank the ESA according to their repetition frequency and cycle length and identify the most relevant 3 sites. The system is designed to show the physician Repetitive Patterns of Activation (RPA). These are shown as colored arrows, which start from the leading electrode position, following the summarized activation sequence. The more repetitive or consistent that activation pattern is, the wider the white arrow. Based on this information the physicians may then use this as an additional guide for further mapping of the AF, using FDA cleared mapping system catheters.

The STAR Apollo Mapping System operates outside the sterile field and is only connected to the EnSite Precision, EnSite X EP or CARTO 3 workstation and not to the amplifier, patient, or any other devices used in the procedure. No data is transferred from the STAR Apollo Mapping System back to the EnSite Precision, EnSite X EP mapping system, or CARTO 3 i.e., data transfer is only in one direction. No modifications to the EnSite Precision, EnSite X EP mapping systems or CARTO 3 are made to accommodate the STAR Apollo Mapping System. The STAR Apollo Maps may be used to give physicians additional information about the AF activations. The physician may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the mapping system, and the compatible Mapping Catheter. The STAR Apollo System is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician in an electrophysiology procedure.

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HemoSphere Alta™ Advanced Monitoring Platform with Swan-Ganz™ Technology

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere Alta Swan-Ganz™ Patient Cable and Swan-Ganz™ Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Swan-Ganz™ Catheter and Swan-Ganz Jr™ Catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz™ Catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz™ Catheter connected to a pressure cable and pressure transducer, the Smart Wedge™ Algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge™ Algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge™ Algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge™ Algorithm parameters.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Oximetry Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Oximetry Cable and oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor - Pressure Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the FloTrac™ Sensor, FloTrac Jr™ Sensor, Acumen IQ™ Sensor, and TruWave™ Disposable Pressure Transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical or non-surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac Output provides a continuous cardiac output and derived parameters.

The Cerebral Autoregulation Index (CAI) algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere™ Pressure Cable and StO2 is acquired by the ForeSight™ Oximeter Cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) algorithm.

HemoSphere Alta Advanced Monitoring Platform with ForeSight™ Oximeter Cable

The non-invasive ForeSight™ Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight™ Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight™ Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta™ Advanced Monitoring Platform.

• When used with large sensors, the ForeSight™ Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
• When used with medium sensors, the ForeSight™ Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
• When used with small sensors, the ForeSight™ Oximeter Cable is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

The algorithm for measurement of blood hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight™ Oximeter Cable and noninvasive ForeSight IQ™ Sensors in cerebral locations.

HemoSphere Alta™ Advanced Monitoring Platform with Non-invasive technology

The HemoSphere Alta™ Monitor when used with the pressure controller and a compatible finger cuff are indicated for adult and pediatric patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere Alta™ Advanced Monitor and compatible finger cuffs non-invasively measures blood pressure and associated hemodynamic parameters. Refer to the non-invasive finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

HemoSphere Alta Advanced Monitoring Platform with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor

The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

The HemoSphere Alta Advanced Monitoring Platform is the next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates existing hemodynamic monitoring technologies into a unified platform.

The HemoSphere Alta Advanced Monitoring Platform's FDA 510(k) clearance letter and associated 510(k) summary (K252533) primarily focus on software modifications and the integration of previously cleared hardware components to an existing platform (K242451). The document states that no new clinical testing was performed in support of the subject 510(k). Therefore, the information provided mainly pertains to performance verification studies rather than standalone clinical performance studies involving ground truth establishment by experts for a novel algorithm.

However, based on the provided text, we can infer the acceptance criteria and study information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several verification activities without providing specific numerical acceptance criteria for each, except implicitly stating "All tests passed" or "All acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance

• For Usability Study: The document mentions "the intended users." It does not specify the numerical sample size of users or the provenance of the data (e.g., retrospective or prospective, country of origin).
• For Non-Clinical Performance (Bench Simulation): "Measured and derived parameters were tested using a bench simulation." No sample size in terms of patient data or data provenance is applicable here, as it's a bench test.
• For Software Verification: "Extensive software verification testing was conducted." No specific sample size of test cases or data provenance is provided.
• For Clinical Performance: "No new clinical testing was performed in support of the subject 510(k)." This indicates no patient-level test set data was used for this specific submission. The algorithms within the device (e.g., GHI, Smart Wedge, HPI, CAI, RVP, RVCO, AFM) likely had clinical performance studies for their initial clearances, but those details are not provided in this 510(k) for the HemoSphere Alta platform updates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• As "no new clinical testing was performed" for this 510(k) submission, there is no mention of experts establishing ground truth for a new clinical test set.
• For the Usability Study, "intended users" participated, implying clinical professionals, but their specific qualifications or their role in establishing "ground truth" (beyond identifying usability issues) are not detailed.

4. Adjudication Method for the Test Set

• Since no new clinical test set data with expert adjudication is described in this submission, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document does not mention any MRMC comparative effectiveness study comparing human readers with and without AI assistance for this 510(k) submission.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

• While the device contains various algorithms (e.g., GHI, HPI, Smart Wedge, CAI, RVP, RVCO, AFM), this 510(k) primarily addresses software updates and hardware integration to an existing platform. It doesn't detail standalone performance studies for these specific algorithms within this document. The description of these algorithms (e.g., "additional information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions") implies a non-standalone, assistive role, but explicit standalone performance studies are not part of this submission's provided information.

7. Type of Ground Truth Used

• "No new clinical testing was performed." Therefore, for this specific 510(k) submission, no new patient-level ground truth (expert consensus, pathology, outcomes data, etc.) was established for performance evaluation of new algorithms or features. The verification activities relied on bench simulations and usability testing, not clinical ground truth.

8. Sample Size for the Training Set

• The document pertains to the clearance of a device (HemoSphere Alta Advanced Monitoring Platform) with software modifications and hardware integration, not the development or training of new AI algorithms. Therefore, no information on the sample size of a training set is provided. The algorithms included in the HemoSphere Alta system (e.g., GHI, HPI, CAI) would have been developed and trained using data sets prior to their initial clearance. This current 510(k) does not detail those previous training sets.

9. How the Ground Truth for the Training Set Was Established

• Similar to the training set sample size, this information is not provided in this 510(k) document, as it focuses on software updates and hardware integration to an already cleared platform, not the initial development and training of novel algorithms.

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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.

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 professionals 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 ECG visualization and analysis reporting.

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.

DRAI consists of:

1. An API which allows the client to upload single- or two-lead ECG data and allows to download the results of the ECG analysis.
2. The automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.

DRAI works in the following sequence:

1. Accept uploading digital ECG files via secure API;

2. Analyze the uploaded ECG data using a proprietary algorithm, which detects cardiac beats/arrhythmias and intervals including:

   • QRS
   • Heart rate determination
   • RR Interval measurements
   • Non-paced supraventricular rhythm and arrhythmia calls as specified by product's Instruction for Use
   • Non-paced ventricular rhythm and arrhythmia calls: as specified by product's Instruction for Use
   • Atrioventricular blocks (second or third degree)

3. Analyze detected individual Ventricular ectopic beats also known as Premature Ventricular Contractions (PVCs) to form groups and subgroups of similar beat morphology if product is configured to do so.

4. The results of the ECG analysis can be downloaded via secure API by the external visualization software used by healthcare professionals for the ECG visualization and analysis reporting.

This document describes the acceptance criteria and the study proving the device meets these criteria for DeepRhythmAI, a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it states that the device's performance was evaluated against recognized consensus standards and a proprietary database, and that the PVC grouping algorithm meets "predefined requirements for accuracy." Without specific numerical targets, the table below will summarize the types of performance evaluations conducted and the reported outcomes as described.

2. Sample Size for the Test Set and Data Provenance

The 510(k) summary states that "the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population."

• Test Set Sample Size: The exact numerical sample size for the test set is not specified beyond "a large number of recordings."
• Data Provenance:
  • Country of Origin: Not explicitly stated. It refers to a "proprietary database (MDG validation db)."
  • Retrospective or Prospective: Not explicitly stated. Given it's a "validation db," it's likely retrospective data collected over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given 510(k) clearance letter. The document mentions "qualified healthcare professionals review and confirm the analytic result" in the context of the device's intended use and that the AI provides "supportive information for review." However, it does not detail how ground truth was established for the validation dataset, nor the number or qualifications of experts involved in that process.

4. Adjudication Method for the Test Set

The adjudication method used for establishing the ground truth for the test set is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, is not explicitly mentioned or described in the provided 510(k) summary. The device's indication for use states that "Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only," suggesting it functions as an assistive tool, but a formal MRMC study demonstrating improvement is not detailed.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The document states, "the algorithm was tested against the proprietary database (MDG validation db)" and that DeepRhythmAI "measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review." The performance assessment of the "automated proprietary deep-learning algorithm" and the "hierarchical Premature Ventricular Contraction (PVC) clustering algorithm" implies a standalone evaluation of the algorithm's capabilities.

7. Type of Ground Truth Used for the Test Set

The type of ground truth used is not explicitly stated. However, given the nature of ECG analysis for arrhythmias, it is highly probable that the ground truth was established through expert consensus or manual expert annotation of the ECG recordings in the "proprietary database (MDG validation db)."

8. Sample Size for the Training Set

The sample size for the training set is not provided in the document. The document mentions the use of "CNN and transformer models for automated analysis of ECG data," which implies a machine learning approach requiring a training set, but its size is not disclosed.

9. How the Ground Truth for the Training Set Was Established

The method for establishing ground truth for the training set is not provided in the document. As with the test set, it is likely that expert consensus or manual expert annotation was used to label the data for training the deep learning algorithms.

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The Vektor Computational ECG Mapping System (vMap®) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.

vMap is a standalone Software as a Medical Device (SaMD) application. vMap receives electrocardiogram (ECG) data (from other FDA-authorized medical devices) acquired non-invasively from the patient's body surface and processes these signals using proprietary algorithms to transform body surface measurements into cardiac electrical data. vMap utilizes this data to generate 2D cardiac information and 3D color maps that illustrate cardiac electrical features for physician analysis. vMap is intended for use in clinical environments, including electrophysiology (EP) laboratories and hospital settings.

vMap includes a main user application that provides an intuitive user interface to guide clinicians through the mapping workflow. vMap enables users to:

a. Create and manage mapping cases through an organized case management system.
b. Upload ECG data acquired from compatible recording systems.
c. Identify arrhythmias to be mapped, including marking arrhythmic beats on ECG plots.
d. Generate two-dimensional (2D) and three-dimensional (3D) heatmaps representing likely arrhythmia source locations.
e. View and interact with mapping results within the software interface.
f. Export results for integration with external electroanatomic mapping systems (e.g., Carto™, Ensite™)
g. Produce detailed case reports summarizing the mapping session and findings.

vMap SaMD operates on compatible general-purpose computing hardware that includes an off-the-shelf processing unit, monitor, keyboard and mouse. The vMap software is compatible with equivalent hardware components.

Principles of Operation:

vMap receives electrocardiographic signals acquired non-invasively from the body surface. The ECG signals are used in proprietary algorithms to transform the measured body surface signals into cardiac signals. These algorithms leverage simulated focal or rotor activity from simulated source locations across the entire heart. vMap analyzes focal-based mechanisms for focal-type and anatomical reentry-type arrhythmias (Focal Atrial Tachycardia, Premature Atrial Complex, Atrial Pacing, Ventricular Tachycardia, Premature Ventricular Complex, Ventricular Pacing, and Atrioventricular Reentrant Tachycardia, Typical Atrial Flutter and Atypical Atrial Flutter), and rotor-based mechanisms for fibrillation-type arrhythmias (Atrial Fibrillation and Ventricular Fibrillation). vMap software utilizes this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features, for analysis by a physician.

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The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

The LumiGuide system consists of the following primary devices:

The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.

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CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.

CoroFlow Cardiovascular system is used to calculate, display and store physiological parameters based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box.

Calculated parameters include physiological indices to assess coronary lesion severity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation (IMR, CFR).

The system also provides indices based on the same raw pressure and temperature measurements (IMR_Corr, RRR, Absolute Flow/ Resistance, dP/dt, Tau).

CoroFlow is installed on a personal computer and receives measurement data wirelessly via the CoroHub Receiver. Information is displayed on the computer screen which can optionally be slaved to a monitor inside the coronary cathlab. Data can be stored on a local storage unit or transferred to a network location.

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The HemoSphere Stream™ Module when used with a Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor. The device is designed for use in clinical environments requiring continuous assessment of blood pressure waveform morphology, without the need for an invasive catheter.

The HemoSphere Stream™ Module when used with the Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor.

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EnSite™ X EP System

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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