(247 days)
The ZOLL E Series with Intubation Assist Option is intended to provide the user with a simple way of counting breaths as detected by a capnometer once the Endotracheal Tube (ET) has been placed and the rescuer is delivering the first initial ventilations. Ventilations can be counted based on EtCO2 and/or tranthoracic impedance.
The ZOLL E Series products (K042007) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry, End Tidal Carbon Dioxide (EtCO2), 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement (2:002), 12-2002 Pressure and Temperature and data printing and recording in a single instrument. The EtCO2 feature in the E Series supports both mainstream and sidestream options and allows for capnographic display of the CO2 waveform as well as capnometric and respiration rate readings. The mainstream and sidestream options use the same connector on the E Series unit and may be used interchangeably. Both sensor types determine CO2 concentration in the breathing inses by measuring the amount of light absorbed by gases flowing through the airway or sampling cell.
The Intubation Assist Option for those units equipped with EtCO2 provides a simple means of counting breaths after the endotracheal (ET) tube has been placed and the means or ocanting the first initial ventilations to confirm tube placement. Counting breaths as detected by a capnometer is a standard initial step in determining tube placement. Both EtCO2 and transthoracic impedance are standard features in the currently cleared E Series.
The provided text does not contain detailed acceptance criteria or a study proving the device meets acceptance criteria for the "ZOLL E Series with Intubation Assist Option." The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria.
The key information regarding performance is:
- Performance Testing: "Extensive performance testing ensures that the ZOLL E Series with Intubation Assist Option performs as well as the indicated predicate device 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."
- Conclusion: "Performance and safety testing of the ZOLL E Series with Intubation Assist 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 some performance testing was done, but the specific acceptance criteria, reported performance, and details of the study (sample size, experts, ground truth, etc.) are not included in this summary.
Therefore, I cannot populate the requested table or provide the detailed study information as it is not present in the provided text. The document confirms that the device was deemed substantially equivalent based on unspecified "extensive performance testing" and safety testing to industry standards.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.