(321 days)
The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion. The patients are limited to adults with weight above 40 kg. This device is indicated for non-invasive spot checking.
The main function of Finger Type Pulse Oximeter is same as the predicate's to monitor the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Except for the general feature, Finger Type Pulse Oximeter also has the wireless data transmission function which transmits the readings of SpO2 and pulse rate from the Finger Type Pulse Oximeter to the personnel device via Bluetooth pairing. The personnel device may include the smart phone, tablet PC and so on.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Accuracy of Oximetry | ||
| 70% to 100% SpO2 | ± 2% | (Implied) ≤ ± 3% (70-79%) and ≤ ± 2% (80-100%) |
§ 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).