(57 days)
EnSite™ Velocity™ Cardiac Mapping System: 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: 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™M 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 realtime.
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 EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping System 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 EnSiteTM VelocityTM 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 EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in the EP laboratory in conjunction with other equipment. The EnSite VelocityTM 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 EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ Module to collect magnetic position and orientation information. The EnSite Precision™ 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 Enabled™ (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 Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.
The provided document does not contain information regarding the acceptance criteria or a study proving the device meets those criteria for an AI/ML-driven medical device.
The document is a 510(k) premarket notification for the Abbott EnSite Velocity Cardiac Mapping System and EnSite Precision Cardiac Mapping System. This device is described as a cardiac mapping and navigation system, used to display the 3D position of electrophysiology catheters and cardiac electrical activity.
The "Non-Clinical Testing Summary" section (pages 7-8) details various types of performance and safety tests conducted, such as:
- Packaging tests (Visual Inspection, Bubble Leak Test, Pouch Seal Strength)
- Shelf Life tests (Electrode Gel Adhesion, Electrode Impedance & Capacitance, Impedance Stability, Electrode Temperature & Current Dispersion)
- Cable Pullout
- Electrode Identification
- Design Validation (Nominal Design Verification, Impedance Tests, Electrical Safety, Adhesion Testing)
- Risk Management
However, these are standard engineering and product validation tests for medical devices, focusing on the physical and electrical performance of the system and its components. There is no mention of:
- Any AI/ML components within the device for which acceptance criteria would typically involve performance metrics like sensitivity, specificity, accuracy, or other clinically relevant measures derived from a test set.
- A "study that proves the device meets the acceptance criteria" in the context of an AI/ML product's clinical performance against ground truth.
- Specific quantitative acceptance criteria for algorithm-driven performance.
- Details about a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on training sets or how ground truth for a training set was established.
The "EnSite Verismo Segmentation Tool," "EnSite AutoMap Module," and "AutoMark Module" are mentioned as optional expansion modules, with "EnSite Verismo" generating 3D models from DICOM images and "AutoMap" automatically collecting mapping points based on user criteria, and "AutoMark" displaying lesion marks based on user parameters and other system data. While these modules involve some level of automation or processing, the document does not treat them as AI/ML systems requiring a specific clinical validation study against diagnostic ground truth. The testing mentioned appears to be functional and safety testing, not statistical performance validation of an AI model's output.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The device in this submission does not appear to be an AI/ML device in the context of the detailed AI/ML performance validation questions.
§ 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).