(72 days)
The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to defibrillate the heart during surgical procedures.
When used with a ZOLL defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allow the defibrillator to operate only as a manual device.
The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.
ZOLL Autoclavable Internal Handles with Integrated Electrodes
This document is a 510(k) premarket notification decision letter from the FDA for the ZOLL Autoclavable Internal Handles with Integrated Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory approval letter, not a technical study report.
Therefore, I cannot provide the requested information based on the input text.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.