(105 days)
The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetrey, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The design facilitates table top use while still providing a light weight and easy to carry device for transport.
The ZOLL R Series with WiFi Option is intended to be used by qualified medical professionals for the wireless transmission of data files, such as Summary Reports, Full Disclosure Waveforms and Device Logs between the R Series to a network server or handheld device.
Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
The R Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involing CPR, transportation, and definitive care are incorporated into a medically approved patient care protocol. Use of the R Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.
The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetrey, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The design facilitates table top use while still providing a light weight and easy to carry device for transport. The ZOLL R Series with WiFi Option is intended to be used by qualified medical professionals for the wireless transmission of data files, such as Summary Reports, Full Disclosure Waveforms and Device Logs between the R Series to a network server or handheld device.
The provided text is for a 510(k) summary for the ZOLL R Series® WiFi Option. Upon review of the submission, there is no specific performance study data or acceptance criteria for the WiFi option itself.
The submission states:
"Extensive performance testing ensures that the ZOLL R Series with WiFi Option performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards."
It then concludes that "Performance and safety testing of the ZOLL R Series with WiFi Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."
This indicates that the WiFi option was evaluated against existing standards and the performance of the predicate device (ZOLL R Series K060559) to show substantial equivalence. This type of submission relies on the existing clearance of the base device and demonstrates that the added WiFi functionality does not negatively impact safety or effectiveness, and performs its specific function (wireless data transmission) as expected.
Therefore, I cannot provide the requested table or information regarding specific acceptance criteria, sample sizes, ground truth establishment, or clinical study details as they are not present in the provided 510(k) summary for the WiFi option. The submission focuses on substantial equivalence to a predicate device rather than a de novo performance study for the WiFi functionality itself.
§ 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.