(379 days)
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
The provided text is a 510(k) summary for the YUWELL® Finger Pulse Oximeter. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter, K101577). The key performance acceptance criteria can be inferred from the comparison table and the clinical study results.
Table of Acceptance Criteria and Reported Device Performance (Inferred from comparison and study results):
| Performance Characteristic | Acceptance Criteria (As per Predicate/Standards) | Reported Device Performance (YUWELL® Finger Pulse Oximeter) |
|---|---|---|
| SpO2 Accuracy (SpO2 Measurement Range) | 70%~100%, ± 2% (Predicate) | Arms less than 3% during steady states over the range of 70-100% (Clinical Study Result from ISO 80601-2-61) |
| SpO2 Accuracy (Specific Ranges) | 70% | 70%~80%, 80%~90%, 90%~100%, ± 2% (Subject Device listed values); |
§ 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).