(29 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 EnSite™ Array Catheter, the EnSite™ Velocity™ 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 system alone.
Or
When used with the 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 v2.2:
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™ 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 with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 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 v5.2 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 Multi-electrode 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 position 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.
Expansion Module Device Description
The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:
- EnSite™ Verismo™ 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 EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
- EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
- EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ 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.
- EnSite™ Fusion™ 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 EnSite™ NavX™ 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.
- 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.
- EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
- 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.
Based on the provided FDA 510(k) submission summary for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K183128), here's an analysis regarding acceptance criteria and the study proving the device meets them:
Crucial Observation: This 510(k) summary is for a Special 510(k) submission. A Special 510(k) is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or lead to a new intended use. As stated in the document:
"The proposed labeling modifications to the subject device pertain to warnings only. The labeling modifications include removal of the black box warning from the cover of the Instructions for Use as well as the addition of a warning in the warnings section of the Instructions for Use. There are no new or increased risks that result from the proposed modifications presented within the submission, and the changes do not raise any new questions of safety and effectiveness in regards to the subject device."
"No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."
This means that the submission does not contain new performance data or a new study proving the device meets specific acceptance criteria for functionality or clinical impact. Instead, it relies on the predicate device's existing performance, as the changes are limited to labeling and deemed not to affect safety or effectiveness.
Therefore, many of the details typically associated with studies proving device performance against acceptance criteria (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment for new data) are not applicable to this specific Special 510(k) submission.
Addressing your points based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for labeling changes only, there are no explicit new "acceptance criteria" for device performance in this document, nor new "reported device performance" data from new studies. The device's performance is implicitly accepted as equivalent to the predicate device.
If we were to infer "acceptance criteria" from the premise of a Special 510(k), it would be that the modified device must perform no worse than the predicate and introduce no new risks.
| Acceptance Criteria (Inferred for Special 510(k)) | Reported Device Performance (from this submission) |
|---|---|
| No new or increased risks introduced | "No new or increased risks that result from the proposed modifications" |
| No new questions of safety and effectiveness | "The changes do not raise any new questions of safety and effectiveness" |
| Same fundamental scientific technology as predicate | "The technological characteristics for the devices are the same as the predicate devices." |
| Same intended use and indications for use as predicate | "Both the subject and predicate devices have the same intended use, indications for use..." |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not applicable. No new test set data was used or generated for this Special 510(k) submission, as stated: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."
- Data Provenance: Not applicable for new performance data. The device relies on the established performance of its predicate, EnSite™ Velocity™ Cardiac Mapping System v5.2 (K182644) and EnSite™ Precision™ Cardiac Mapping System v2.2 (K182644). The provenance of data for the predicate would be detailed in its original 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new test set requiring adjudication was created for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device (EnSite Velocity/Precision Cardiac Mapping System) is a "Programmable Diagnostic Computer" primarily for displaying catheter position and cardiac electrical activity. It's not described as an AI-powered diagnostic device in the context of assisting human readers with interpretation (e.g., radiology AI). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the information provided for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable for this Special 510(k) for reasons similar to point 5. The device's function is to display mapping information, not to provide an automated diagnosis that would be evaluated in a standalone manner without human oversight.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for new data in this submission. The "ground truth" for catheter mapping systems typically relates to the accuracy of position sensing and electrical signal display, which would have been established during the development and clearance of the predicate devices. This might involve phantom studies, in-vitro testing, and potentially clinical correlation, but this specific document does not detail new ground truth establishment.
8. The sample size for the training set
- Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense for image or signal interpretation. The system is a diagnostic computer that processes and displays data, not an AI model that learns from large datasets.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an AI/ML model.
§ 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).