(19 days)
The EGM gas monitor is indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal Law restricts this device to sale by or on the order of a physician.
The M1013A Essential Gas Module provides a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2). It is designed to work with the Philips IntelliVue MP20/30/40/50/60/70/90 Anesthesia option #H30 through a digital interface (RS232). It is intended for measuring the airway gases of #1100 through a dignal interrace (1020) maintenance of, and emergence from anesthesia. The module produces display waves for O2, CO2, N2O, and anesthetic agents, together with The module produces display waves for O2, CO2, N2O, anesthetic agents, and airway respiration rate. An anesthetic agent must be selected manually for measurement. An automatic zero calibration is performed by the Essential Gas Module as required to maintain measurement accuracy.
The provided text is a 510(k) summary for the Essential Gas Module (EGM) and a clearance letter from the FDA. It does not contain a detailed study description with specific acceptance criteria, reported performance, sample sizes, expert qualifications, or adjudication methods.
This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and validation data.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document states:
"Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development verification and validation of the device was carried out in accordance with applicable standards and company internal procedures. The results provide assurance that the device meets its specifications and is safe and effective for its intended use."
This indicates that internal verification and validation were performed to meet specifications, but the specifics of these studies (acceptance criteria, sample sizes, etc.) are not detailed in this public 510(k) summary.
§ 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).