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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.

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Long-term ventilator for intensive care. For patients requiring tidal volume starting at 50 ml.

Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more. Savina is used in intensive care units, recovery rooms, inter and intra hospital transport and subacute care facilities. LPO means Low-Pressure-Oxygen and allows the supply of oxygen from a low pressure source (such as an oxygen concentrator), independently of high pressure O2 sources. The external low pressure oxygen source is to be provided by the user. The LPO option does not affect the ventilation performance. The only difference between HPO and LPO mode is the supply and monitoring of the O2 concentration. The LPO Option is available for Savina with SW 3.n.

I am sorry but this document does not contain the information requested. This is a 510(k) premarket notification for a ventilator, and it describes the device's intended use and substantial equivalence to previously cleared devices. It does not include information about acceptance criteria or a study that proves the device meets those criteria, as such studies are typically required for more complex or novel devices that pose higher risks.

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