(84 days)
Replacement battery for NOVAMETRIX MEDICAL 9366-01 Models 500A, 515A, 7000A Pulse Oximeter, 510(k) Number K893643. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Replacement Battery Part Number GL9366
I apologize, but the provided text from the FDA 510(k) clearance letter for the GL9366 Replacement Battery does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) or machine learning (ML) models.
This document is a standard FDA clearance letter for a medical device (a replacement battery) based on a determination of substantial equivalence to a legally marketed predicate device. It addresses regulatory classification, general controls, and other administrative aspects.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the information is not present in the provided text.
To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation report for an AI/ML medical device, or a regulatory submission that details such studies for a 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).