(13 days)
Use during mask ventilation to assist in the determination of a patent airway.
Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a medical device called "Pedi CO2 Easy". It primarily focuses on the regulatory approval process and includes the indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based solely on this document. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, which is the basis for its approval, but it does not detail the technical studies that would typically include acceptance criteria and performance data.
To answer your request, I would need access to the actual 510(k) submission document (not just the FDA's decision letter), which would contain the performance testing results and study design.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).