(99 days)
The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits.
The release of software version VA2 includes a re-labeling of the MicrO2+ and the recognition of Masimo LNOP sensors. The modifications implemented with the release of software version VA2 have not altered the basic fundamental technology of the MicrO2+. Testing with VA2 software indicates no new issues relative to safety and efficacy.
The provided text is a 510(k) summary for the Draeger MicrO2+ device. It describes modifications to the device (software version VA2 for re-labeling and recognition of Masimo LNOP sensors) and asserts that these changes do not alter the fundamental technology or introduce new safety/efficacy issues. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study (clinical or non-clinical) that demonstrates the device meets acceptance criteria.
Therefore, I cannot extract the requested information. The document focuses on regulatory approval for minor modifications based on the assumption that the new version maintains the safety and efficacy established for the predicate device.
To address your request, I would need a different document that outlines the performance testing and results for this medical device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).