(236 days)
The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.
Not Found
This is a 510(k) clearance letter for a device called "Arrhythmia Mapping System (8100/8300)" from 1997. It declares the device to be substantially equivalent to a predicate device.
Crucially, 510(k) clearance letters typically do not contain detailed acceptance criteria, study methodologies, or performance statistics like those requested in your prompt. Their primary purpose is to confirm substantial equivalence to a legally marketed predicate device, often based on comparisons of technological characteristics, intended use, and sometimes non-clinical (e.g., bench) testing, rather than complex clinical performance studies with acceptance criteria and defined statistical metrics.
Therefore, I cannot extract the requested information from the provided text. The document states the intended use of the device but provides no data on its performance, studies conducted, or the criteria for its acceptance.
§ 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).