(460 days)
The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.
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The provided document is an FDA 510(k) clearance letter for the Ventlab End-Tidal CO2 Nasal Cannula. This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed technical study report with performance metrics, acceptance criteria, or ground truth establishment.
Therefore, the information requested in your prompt regarding acceptance criteria, specific performance data, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text.
This document focuses on regulatory approval based on equivalence to a predicate, not on a detailed clinical or technical performance study as would be found in a research paper or a more extensive submission report.
§ 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).