(268 days)
The EnSite™ Velocity™ Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with 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 system alone.
OR
When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart
Intended Use for the EnSite™ Velocity™ Cardiac Mapping System optional expansion software modules:
EnSite™ Verismo™ Segmentation Tool (K101697) - 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 (K110549) - 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 (K101419) - 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 (K082467) - EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers
EnSite™ Contact Force Module (K141050) - When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
VeriSense System Software Module (K130727) - When used with the VeriSense System Software Module, the EnSite System is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI)
• 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
The EnSite™ Velocity™ Cardiac Mapping System with software version 5.0.1 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, Model EE3000 consists of a display workstation subsystem (DWS) and an Amplifier subsystem. The EnSite Amplifier collects the data from the patient connections and sends them to the DWS Workstation. The Amplifier connects to the DWS through a fiber optic cable and a media converter to convert the optical signals to digital signals. The EnSite™ Velocity™ DWS software displays the cardiac signal data received from the Amplifier on the workstation monitors and stores it for later retrieval.
Display Work Station (DWS) Subsystem
DWS - The DWS houses the system software and connects all the components together.
Monitors - Two monitors display patient information. One monitor is positioned near the workstation and keyboard for system operation, and the physician places the second monitor near the patient table for use.
Isolation transformer - All system components on the DWS connect to line power through a medical-grade isolation transformer.
Printer - Allows for printing study data
Amplifier Subsystem
Amplifier - contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software application via fiber Ethernet. The Amplifier converts these signals to a digital format and sends them to the workstation for processing.
NavLink - Connects surface electrodes and the system reference surface electrode to the Amplifier.
ArrayLink - Connects the EnSite Array Multi-electrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode.
CathLink - Connects the diagnostic catheters to the Amplifier
GenConnect - Connects the ablation catheter and dispersive surface electrodes to the Amplifier.
RecordConnect - The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier.
ECG cable - The ECG cable connects standard ECG electrodes to the Amplifier.
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 v5.0.1 is designed for use in the EP laboratory in conjunction with other equipment.
Expansion Module Device Description:
The EnSite™ Velocity™ Cardiac Mapping System v5.0 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™ Velocity™ System VeriSense System Software Module - an optional expansion module that allows the EnSite Velocity System to interface with St. Jude Medical's VeriSense Kit to display the graphical representation of Electrical Coupling Index (ECI).
EnSite™ AutoMap Module - a new optional module that automatically collects mapping points based on criteria set by the user
Based on the provided text, the document is a 510(k) summary for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with EnSite™ AutoMap Module v1.0.1.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria and reported device performance for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 or its EnSite™ AutoMap Module v1.0.1.
Instead, it broadly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional testing acceptance criteria (to ensure software modifications do not affect safety or effectiveness, and meet established performance specifications). | "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." |
| Evaluation of software changes and operating system along with the addition of the optional software module (to show the application software is acceptable for use and meets requirements). | "The changes to the application software and operating system along with addition of the optional software module were evaluated through software verification and validation to show that the application software is acceptable for use and meets requirements." |
| Review of risk management (to ensure no new hazards have been introduced by the change, and mitigate identified hazards). | "The changes to the application software and operating system along with addition of the optional software module were evaluated through review of risk management to ensure no new hazards have been introduced by this change. The risk analysis was completed and risk controls were implemented to mitigate identified hazards." |
| Cybersecurity requirements (conformance to risk management process: risk assessment, risk control, and maintenance of cybersecurity activities). | "The Ensite™ Velocity™ Cardiac Mapping System conforms to the Cybersecurity requirements through the cybersecurity risk management process comprised of a risk assessment, risk control, and maintenance of cybersecurity activities." |
| Substantial Equivalence to predicate devices (based on technological characteristics and data provided, to be at least as safe and effective). This is the overarching "acceptance criteria" for 510(k) clearance, and the document serves as the manufacturer's claim that this criterion is met. | "The technological characteristics for the devices are the same as the predicate devices. Based on this and the data provided in this pre-market notification, the subject devices and predicate devices have been shown to be substantially equivalent." (This is the ultimate conclusion of the 510(k) submission, rather than a quantifiable performance metric for the device itself). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any specific performance tests. The testing described is primarily software verification and validation, and risk management, rather than performance evaluation against a clinical or representative dataset of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set. The validation described is focused on internal software testing and risk management, not a clinical study requiring expert ground truth.
4. Adjudication Method
No adjudication method is mentioned, as there is no indication of a study requiring expert review or consensus for ground truth.
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
The document does not describe an MRMC comparative effectiveness study, nor does it mention any assessment of how much human readers improve with or without AI assistance. The EnSite™ AutoMap Module is an "optional module that automatically collects mapping points based on criteria set by the user," suggesting an automated function rather than an AI-assisted human reading task.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone software testing (software verification and validation), but it does not present quantifiable "standalone performance" metrics in the context of, for example, diagnostic accuracy. The "AutoMap Module" suggests an automated function, which could be considered a standalone algorithm for collecting mapping points, but no specific performance data for this module is provided. The testing mentioned is at a functional level ("met established performance specifications").
7. The Type of Ground Truth Used
The document does not specify the "type of ground truth" (expert consensus, pathology, outcomes data, etc.). The testing described is primarily functional and software-level verification and validation against pre-defined specifications and requirements, rather than against external, medically derived ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The EnSite™ AutoMap Module is described as automatically collecting mapping points "based on criteria set by the user," which does not necessarily imply a machine learning model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, there is no information on how its ground truth would have been established.
§ 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).