(369 days)
TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.
The provided text is a 510(k) premarket notification approval letter for the "PADTAK Adult Defib/Cardiovert/Pace/Monitoring Electrodes." This document primarily indicates the FDA's finding of substantial equivalence to a predicate device and permits the marketing of the device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information regarding performance, sample size, ground truth, or study details from the provided text.
§ 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.”