(78 days)
The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.
The Cardima EP SELECT Switchbox is a passive switching unit used in conventional electrophysiology (EP) diagnostic procedures. It is designed to provide a convenient means by which the user can record or pace from multiple unipolar or bipolar intracardiac electrodes. The device is designed to be placed on a horizontal surface or at the patient's side. It is designed to accept up to eight electrodes using standard pin connectors typically found in the EP lab. Switching between record or pace modes is accomplished by a simple switch for each electrode.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety. | The results show that the switchbox meets conformance with the standard. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical or performance data using a sample of devices. The safety and effectiveness study was based on conformance to an engineering standard. Therefore, traditional sample size and data provenance for a test set (e.g., country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study involving patient data. The study primarily involved testing the device itself against engineering specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The ground truth was established by conformance to an industrial safety standard (IEC-60601-1), which involves engineering testing and evaluation, not expert consensus on clinical interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable as the "test set" refers to the device being evaluated against an engineering standard, not a clinical dataset requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a passive switching unit, not an AI or diagnostic tool that would typically involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) performance study was not conducted for an AI component. The device is a hardware component with a specific electrical function, not an algorithm. The study was focused on the device's electrical safety and functionality.
7. Type of Ground Truth Used:
The ground truth used was conformance to established engineering and safety standards, specifically International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.
8. Sample Size for the Training Set:
This information is not applicable. The device is a hardware product, not a machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a machine learning model. The safety and effectiveness were established through
"Declaration of Conformity" with a recognized consensus standard.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).