(129 days)
The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation 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 (i.e., linear mapping catheters).
EnSite 3000® System Components
EnSite® Multi-electrode Diagnostic Catheter
The EnSite® Multi-electrode Diagnostic Catheter (EnSite® catheter) is a single use, 9 French, percutaneous catheter. The EnSite® catheter is designed for use only with the EnSite 3000® System in an electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.
EnSite 3000® Electrophysiology Workstation
The EnSite 3000® Electrophysiology Workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multi-electrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac clectrograms. The EnSite 3000® may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.
The EnSite 3000® System is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.
Acceptance Criteria and Study Details for EnSite 3000® System
Based on the provided 510(k) summary, the EnSite 3000® System did not include specific quantitative acceptance criteria or a detailed clinical study demonstrating its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria were explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device and safety through non-clinical testing. | The EnSite 3000® System, including the EnSite® Multi-electrode Diagnostic Catheter and EnSite 3000® Electrophysiology Workstation, was found to be substantially equivalent to the currently marketed EnSite 3000® System (itself, indicating a modification or updated version) for the stated intended use. Non-clinical performance data included "a battery of bench and user tests" conducted in accordance with in-house procedures. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "a battery of bench and user tests," but does not provide details on the number of cases or subjects involved in these tests.
- Data Provenance: Not specified. The tests were "conducted in accordance with in-house procedures," suggesting an internal testing environment rather than a specific country or whether the data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of the device (electrophysiology cardiac mapping), "user tests" would likely involve electrophysiologists or cardiac technicians, but their number and specific qualifications are not detailed.
4. Adjudication Method:
- Adjudication Method: Not applicable or not specified. The document does not describe a process for establishing ground truth through expert adjudication. The focus was on demonstrating functionality and safety during bench and user testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. The device is a diagnostic tool for mapping cardiac arrhythmias, and the study as described focused on demonstrating its functionality and substantial equivalence, not comparing its effectiveness with and without AI assistance for human readers.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study with AI assistance was performed.
6. Standalone Performance Study (Algorithm Only):
- Standalone Performance Study: Yes, to some extent. The "Non-clinical performance data" section refers to "proprietary software algorithms to reconstruct and display right atrial endocardiograms." While not a formal "standalone performance study" as understood in modern AI/ML device evaluations, the bench and user tests inherently assessed the performance of the system's algorithms in reconstructing and displaying data, albeit within a simulated or controlled environment. However, specific metrics for the algorithm's standalone accuracy are not provided.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not explicitly stated or defined beyond the context of "bench and user tests." For a device that maps intracardiac electrograms, ground truth would typically involve comparing the device's output to known electrical activity (e.g., from a simulator or a highly accurate reference mapping system) or clinical outcomes. The document does not specify how "ground truth" was established for validating the accuracy of the reconstructed endocardiograms during these tests.
8. Sample Size for Training Set:
- Sample Size for Training Set: Not applicable. The document describes the EnSite 3000® System as utilizing "proprietary software algorithms." There is no indication that these algorithms were developed using machine learning or required a "training set" in the contemporary sense. The focus is on the functionality and accuracy of the pre-programmed algorithms rather than a learned model.
9. How Ground Truth for Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no indication of a training set being used for machine learning.
§ 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).