(366 days)
PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy defibrillation, cardioversion, pacing and monitoring.
PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes
This document is an FDA 510(k) clearance letter for the "PadTac Pediatric Defib/Cardiovert/Pace/Monitoring Electrodes." It does not contain information about acceptance criteria or a study proving device performance in the manner requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than the results of a specific performance study against defined acceptance criteria.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study with performance metrics and ground truth establishment.
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”