(207 days)
The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc).
The proposed device MD300W4 consists of MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit.
It can measure, store, review and display the SpO2% and pulse rate value, time, ID number, pulse bar and battery power status, the connection of probe, and transmit data by GPRS or USB cable.
The power supply is 4.2V Li-battery with capacity 1250mAh. The device can not be used to measure when it charges for the Li- battery.
The Pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in probe collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device has one model detachable sensor as the accessory of which the skin-contacting material is silicon. It is listed below:
M-50G (510(k) number: K082487)
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or probe is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in Section 14 Software on page 14-1.
Here's an analysis of the provided text to fulfill your request:
Acceptance Criteria and Device Performance Study for Wrist Pulse Oximeter MD300W4 (K122046)
Based on the provided 510(k) summary, the device is a modified Wrist Pulse Oximeter, MD300W4, and its performance is evaluated against the predicate device, MD300W (K081125), and established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MD300W4 are largely aligned with its predicate device and industry standards for pulse oximeters. The reported device performance is presented as compliance with these specifications.
| Characteristic | Acceptance Criteria (Target/Standard) | Reported Device Performance (MD300W4 Results) |
|---|---|---|
| SpO2 Accuracy | 70%-100% ±3% (General) | 70%-100% ±3% (Claimed by manufacturer) |
| 90%-100% ±2%, 80%-90% ±3%, 70%-80% ±3% (Specific ranges) | `90%-100% ±2%, 80%-90% ±3%, 70%-80% ±3%, |
§ 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).