(96 days)
The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
The Reprocessed Polaris X Steerable Diagnostic EP Catheters are designed for use in intracardiac pacing and recording only. The catheters have been designed to carry electrical signals for the purpose of endocardial stimulation (pacing) or recording. The catheter is a uni-directional steerable catheter. The curve is actuated by means of a patented thumb-slide.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Electrophysiology (EP) Catheter. It does not contain information about an AI/ML device or a study comparing AI performance against acceptance criteria. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, expert qualifications, or MRMC studies.
The document focuses on demonstrating substantial equivalence of the reprocessed catheter to existing predicate devices based on design, materials, function, intended use, and various functional and safety tests relevant to a reprocessed medical 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).