(90 days)
The use of the Microcap capnograph monitor is indicated whenever a professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
Not Found
This FDA letter from 1998 for the Microcap device (K981114) does not contain any information regarding acceptance criteria or a study proving the device meets such criteria.
The letter is a 510(k) clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This process focuses on comparing the new device's indications for use and technological characteristics to an existing device, rather than requiring the submission of new clinical or performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document primarily confirms regulatory clearance, not detailed performance study results.
§ 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).