(361 days)
The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital. The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. Principle of the oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones. Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor. The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Targeted Device) |
|---|---|---|
| SpO2 Accuracy | ± 2% (70% - 100% SpO2), Unspecified for |
§ 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).