(50 days)
Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
6Fwoven fixed curve construction113 – 128cm usable lengthCurve Configurations: Josephson, Cournand, & DamatoElectrode Spacing: 2mm / 5mm / 2mm, 5mm / 1cmNumber of Electrodes: 4Electrode Width: 1.5mm Proximal / 2mm DistalCable: EasyMate
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "Clipper Diagnostic Electrode Catheter."
This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a randomized clinical trial with specific performance acceptance criteria. The FDA clearance is based on the device having the same intended use and similar technological characteristics as previously cleared devices, and it does not detail specific performance metrics or studies as requested in the prompt.
Therefore, I cannot provide the requested information based on the provided text.
§ 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).