(58 days)
EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision™ Cardiac Mapping System v2.6:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information.
When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite™ Derexi™ Module:
When used with EnSite™ Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.
AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™ Cardiac Mapping System v2.6 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.
The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System is designed for use in the EP laboratory in conjunction with other equipment.
The EnSite™ Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite™ Velocity™ / EnSite Precision™ System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing.
The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier.
The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSiteTM VelocityTM Cardiac Mapping System base software only collects impedance data. Adding EnSite PrecisionTM software to the base software allows the system to receive both magnetic data from the MediGuideTM Technology System or the EnSite PrecisionTM Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite PrecisionTM Module and EnSite PrecisionTM software (added to the base software) together make up the EnSite PrecisionTM Cardiac Mapping System.
The EnSite PrecisionTM software interfaces to the MediGuideTM Technology System or the EnSite PrecisionTM Module to collect magnetic position and orientation information. The EnSite PrecisionTM software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor EnabledTM (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase.
The EnSite PrecisionTM Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite PrecisionTM Link, EnSite PrecisionTM Field Frame, and EnSite PrecisionTM Patient Reference Sensors.
Expansion Module Device Description:
The EnSite PrecisionTM Cardiac Mapping System v2.6 includes the following optional expansion software modules:
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EnSiteTM VerismoTM Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSiteTM VelocityTM Cardiac Mapping System. The EnSiteTM VerismoTM Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
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EnSiteTM DerexiTM Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMateTM Recording System to support the exchange of mapping point data and patient setup information between the two systems.
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EnSiteTM CourierTM Module - The EnSiteTM CourierTM Module is an optional expansion module that allows the EnSiteTM VelocityTM Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
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EnSiteTM FusionTM Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSiteTM NavXTM Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
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EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
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EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user.
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AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.
The provided text is a 510(k) premarket notification for the EnSite Precision™ Cardiac Mapping System v2.6 and EnSite™ Velocity™ Cardiac Mapping System v5.2. This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines various non-clinical tests performed.
Crucially, this document does NOT contain information about acceptance criteria and a study that comprehensively proves the device meets those criteria, especially in the context of an AI/ML-driven diagnostic device as implied by the initial request's detailed points (e.g., MRMC studies, expert ground truth, sample size for test/training sets, etc.).
The document states:
- "The proposed EnSite Precision Cardiac Mapping System v2.6 software release is a minor level software release to enable implementation of a software feature, EnSite LiveView, which provides the users the ability to display real-time mapping data without the need to save mapping points, addresses open software anomalies, and improves the system's ability to limit personally identifiable information when archiving studies."
- "Design verification activities were performed with their respective acceptance criteria to ensure that the proposed modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications."
- "An acute system level animal study to ensure the modified system had acceptable performance."
- "Software verification testing to ensure the software continues to meet requirements following the proposed modifications."
- "Design validation studies to ensure the installation process for updating the software meets requirements."
These statements indicate that internal verification and validation occurred against established specifications, and an animal study was performed for system performance. However, there is no information about a study proving specific AI/ML performance against clinical acceptance criteria with human assessment, ground truth establishment, or multi-reader studies.
Therefore, I cannot provide the requested information based solely on the provided text, as it does not detail a study designed to prove AI/ML diagnostic performance against the specific criteria listed in the prompt. The device described is a cardiac mapping system, and the "EnSite LiveView" feature seems to be an enhancement to existing mapping capabilities, not a new AI-driven diagnostic interpretation tool requiring extensive clinical validation of AI accuracy.
If the request is for a general example of such a study, I can provide a hypothetical one, but it would not be based on the provided text.
Since the prompt specifically asks for information from the provided text, I must state that the relevant information is not present.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).