(362 days)
Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted.
Harmac Quadpolar MappingPacing Catheter with Stylet
The provided document is limited to a 510(k) clearance letter for the Harmac Quadpolar Mapping Pacing Catheter with Stylet. This type of document primarily confirms that the device is substantially equivalent to a predicate device and is cleared for marketing. It does not contain the detailed information required to describe acceptance criteria, the specific study design, or device performance metrics as requested in your prompt.
Therefore, I cannot provide the information requested in your prompt based on the provided text. The document refers to "indications for use" but does not elaborate on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.
§ 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).