(106 days)
The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only.
The clinical value of trend data has not been demonstrated in disease states.
The ODI-Tech device should not be used as the sole basis for diagnosis or therapy.
In patients with darkly pigmented skin, measurements should be interpreted with can interfere with the reflected light signal and reduce the quality of measurements.
Not Found
While the provided FDA 510(k) clearance letter acknowledges the substantial equivalence of the ODI-Tech device and its intended use, it does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.
The 510(k) clearance is based on the device being substantially equivalent to a predicate device, meaning it performs as well as or better than a legally marketed device. However, the clearance letter itself does not include the specifics of the performance study. To answer your questions comprehensively, information from the actual 510(k) submission, specifically the sections detailing performance data and clinical studies, would be required.
Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The text only confirms the device's clearance and its intended use, but not the specifics of its performance testing.
To answer your request, I would need access to the actual 510(k) summary or the full submission document for K241393, which typically includes detailed performance data and study methodologies.
§ 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).