(122 days)
The Fingertip Pulse Oximeters M70A, M70C and M70D, are intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospital type facilities as well as in the home care environment.
The oximeters are not suitable to monitor patient continuously for long term.
The proposed devices of Fingertip Pulse Oximeters M70A, M70C and M70D are fingertip devices, which can display %SpO2, pulse rate value, waveform pulse amplitude bar indication.
The four models share the same configuration, function, intended use, safety and performance, the only difference is external appearance.
The provided document describes a 510(k) submission for a Fingertip Pulse Oximeter, asserting its substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria or a detailed study description proving the device meets those criteria.
510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting new studies against predefined acceptance criteria for novel devices. The information provided focuses on the administrative aspects of the submission and the declaration of substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC study details, or standalone performance data based on the provided text. These details would be found in a more comprehensive clinical study report or a different section of a full 510(k) submission, which is not present here.
The document states:
- "The proposed devices, Fingertip Pulse Oximeters M70A, M70C and M70D, are determined to be Substantially Equivalent (SE) to the predicate device, M70 Fingertip Pulse Oximeter (K081712), in respect of safety and effectiveness." (Section 7. Substantially Equivalent Conclusion)
This indicates that the study performed (or the data presented) aimed to show equivalence rather than meeting specific performance acceptance criteria for a new device type.
§ 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).