(164 days)
The Reprocessed Response Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Reprocessed Response Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The provided text describes the regulatory clearance for a reprocessed medical device, specifically Diagnostic Electrophysiology (EP) Catheters. It is not a study demonstrating the performance of a diagnostic AI device. Therefore, the requested information about acceptance criteria, study design, expert ground truth, MRMC studies, or training/test set details for an AI device cannot be extracted from this document.
This document focuses on demonstrating substantial equivalence of a reprocessed physical device to its predicate devices through functional and safety testing, not on the performance of a software/AI algorithm. The "Functional and Safety Testing" section lists various tests performed on the reprocessed catheters (e.g., biocompatibility, cleaning validation, electrical continuity), which are typical for physical medical devices.
In summary, this document does not contain the information required to answer the prompt as it pertains to an AI/software device.
§ 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).