(254 days)
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™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias 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.
The EnSite™ Velocity™ 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 EnSite™ Velocity™ Surface Electrode Kit contains single use surface electrodes and patches for use in conjunction with St. Jude Medical's EnSite System. The kit contains the following devices:
• The electrode patches
• The Electrocardiogram (ECG) electrodes
• The system reference patch electrode
The surface electrodes transmit information from the patient to the EnSite™ System for signal conditioning and data inference.
This document is a 510(k) Pre-Market Notification for the St. Jude Medical EnSite™ Velocity™ Cardiac Mapping System v4.0.2 with EnSite™ Velocity™ Surface Electrode Kit. The submission focuses on changes to the surface electrode kit and asserts substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics for the entire EnSite™ Velocity™ Cardiac Mapping System. Instead, it describes performance testing specifically for the changes made to the EnSite™ Velocity™ Surface Electrode Kit. Since the core mapping system remains the same as the predicate, the focus is on demonstrating that the revised electrode kit functions equivalently and safely.
Below is a table summarizing the tests performed on the Surface Electrode Kit and the outcome, as stated in the document:
| Test Performed on Surface Electrode Kit | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Gel Adhesion | N/A (implied to meet requirements) | Met established performance specifications |
| Electrode Impedance | N/A (implied to meet requirements) | Met established performance specifications |
| Electrode Capacitance | N/A (implied to meet requirements) | Met established performance specifications |
| Impedance Stability | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Wire Resistance | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Flex Life | N/A (implied to meet requirements) | Met established performance specifications |
| Current Dispersion | N/A (implied to meet requirements) | Met established performance specifications |
| Maximum Temperature | N/A (implied to meet requirements) | Met established performance specifications |
| Dielectric Strength | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Pullout Force | N/A (implied to meet requirements) | Met established performance specifications |
| Biocompatibility Test | N/A (conforms to standards) | Conforms to EN ISO 10993-1, -5, -10 |
| Shelf Life Test | N/A (implied to meet requirements) | Met established performance specifications |
| Packaging Test | N/A (implied to meet requirements) | Met established performance specifications |
| Usability Test | N/A (implied to be acceptable) | Acceptable for use and meets requirements |
| Non-GLP Animal Test | N/A (implied to be acceptable) | Performed to verify device met pre-determined acceptance criteria |
Note: The document states, "All testing performed met the established performance specifications." However, the specific quantitative acceptance criteria are not provided in the publicly available summary for each test.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a quantitative sample size (e.g., number of patients, number of electrodes) for the various tests conducted on the surface electrode kit. It refers generally to "design verification activities" and "bench and animal testing."
- Data Provenance: The document does not specify the country of origin of the data. It indicates the studies were internal design verification and validation activities conducted by St. Jude Medical. The studies appear to be prospective in nature, as they were conducted to verify the changes to the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not describe any studies that involved human experts establishing ground truth for the performance of the device, particularly for the algorithmic aspects of cardiac mapping. The testing described focuses on the physical and electrical characteristics of the surface electrode kit (gel adhesion, impedance, cable integrity, etc.) and its in-vivo compatibility in an animal model. These tests typically rely on defined engineering specifications and measurements rather than expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective engineering and biological evaluations, not requiring an adjudication method by human readers/experts for result interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This submission is for substantial equivalence of an updated component (surface electrode kit) of an existing cardiac mapping system. The studies focus on confirming the safety and performance of the modified electrodes compared to the predicate's electrodes, not on comparing human reader performance with and without AI assistance for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The testing performed on the surface electrode kit (gel adhesion, impedance, material properties, etc.) and the non-GLP animal test can be considered "standalone" as they assess the physical and electrical performance of the device components independent of direct human diagnostic interpretation. The cardial mapping system itself is a diagnostic tool, but the focus of this submission's testing is on the interface with the patient via the electrodes, ensuring its technical performance.
7. The Type of Ground Truth Used
The ground truth used for the tests on the surface electrode kit are based on:
- Engineering specifications and measurements: For tests like impedance, cable resistance, flex life, temperature, dielectric strength, and pullout force, the ground truth would be predetermined acceptable ranges or thresholds based on electrical and mechanical engineering principles.
- Biocompatibility standards: For biocompatibility, the ground truth is adherence to internationally recognized standards (EN ISO 10993 series).
- Pre-determined acceptance criteria: For the animal testing, the ground truth would be that the device "met the pre-determined acceptance criteria" which would likely involve normal physiological responses and proper functioning of the mapping system with the new electrodes.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware system (cardiac mapping system) with associated physical components (surface electrode kit). If there are internal firmware or software algorithms in the mapping system itself, their development or "training" is not detailed in this 510(k) summary, as the submission focuses on changes to the surface electrode kit.
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 algorithm in this submission.
§ 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).