(207 days)
No
The device description and performance studies focus on standard pulse oximetry technology and signal processing, with no mention of AI or ML.
No.
The device is intended for "spot checking, data collection and recording of arterial oxygen saturation (SpO2) and pulse rate," which are diagnostic or monitoring functions, not therapeutic ones. The description explicitly states, "The proposed device is not for life-supporting or life-sustaining," further indicating it does not provide treatment.
Yes
The device is described as a non-invasive device for "spot checking, data collection and recording of arterial oxygen saturation (SpO2) and pulse rate," which are physiological parameters used in diagnosing various medical conditions.
No
The device description explicitly lists multiple hardware components (MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit, sensor, battery) and describes its physical operation using light sources and a photodetector. While it is software-driven, it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body.
- Device Function: The MD300W4 wrist pulse oximeter is a non-invasive device that measures SpO2 and pulse rate by applying a sensor to the skin. It works by analyzing light absorption through the skin and tissue, not by testing a sample taken from the body.
The description clearly states it's a "portable non-invasive device" and describes how it works by applying a sensor to the skin and using light. This is a direct measurement on the body, not an in vitro test.
N/A
Intended Use / Indications for Use
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).
Product codes
DQA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical test is conducted according to ISO9919:2005 Annex EE in Yue Bei Pepople's Hospital. 12 health adults are selected as the subjects. The system is evaluated during steady state / non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. The SpO2 are compared to arterial blood sample oxygen saturation (functional SaO2) as measured by CO-Oximetry.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical test is conducted according to ISO9919:2005 Annex EE in Yue Bei Pepople's Hospital. 12 health adults are selected as the subjects. The system is evaluated during steady state / non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. The SpO2 are compared to arterial blood sample oxygen saturation (functional SaO2) as measured by CO-Oximetry. There are no adverse events during the study. It can be determined from the study results that the SpO2 accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with "Golden Standard" Co-Oximeter. So the proposed device is safe and effective as well as the predicate device. The accuracy claimed by the manufacturer is identical to that of the predicate device. And the test result indicates that the safety and effectiveness of the proposed devices is identical to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 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).
0
Exhibit F 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: ___K122046
Statement
Wrist Pulse Oximeters MD300W4 is a modification device to Wrist Pulse Oximeter
| MD300W4 | MD300W | |
|---|---|---|
| Display Creen | OLED | Segment LCD |
| Transmission mode | USB and GPRS | USB |
| Power supply | lithium-ion rechargeable battery | 1 AAA |
| Enclosure | 133mm×63mm×33mm | 60mm×50mm×20mm |
MD300W (K081125). Their differences between them are listed below:
1. 510(k) Owner's Information
Establishment Registration Number: 3005569927
Beijing Choice Electronic Technology Co., Ltd.
Room 1127-1128 Building B, Bailangyuan
Fuxing Road, No. A36,
100039 Beijing, China
Contact Person: Mr. Lei Chen /Quality Director
Phone: +86-10-88790480
Fax: 215-4052545
Email: cc@choicemmed.com
2. Prepared Date: Aug. 8, 2012
3. Proposed Device Information
Device Common Name: Pulse Oximeter -
Device Trade Name: Wrist Pulse Oximeter
Model: MD300W4
1
Classification Name: Oximeter
Class: II
Regulation Number: 21 CFR 870.2700
Product Code: DQA
Panel: Anesthesiology
4. Predicate Device
Wrist Pulse Oximeter MD300W (K081125)
Beijing Choice Electronic Technology Co., Ltd.
Room 1127-1128 Building B, Bailangyuan
Fuxing Road, No. A36
100039 Beijing, China
5. Device Description
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
2
2
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.
| Proposed Device | Predicate Device | |
|---|---|---|
| ITEM | Wrist Pulse Oximeter | |
| MD300W4 | Wrist Pulse Oximeter MD300W | |
| (K081125) | ||
| Composition | A main unit, SpO2 sensor | A main unit, SpO2 sensor |
| Design principle | Skin, bone, tissue, and venous | |
| vessels normally absorb a constant | ||
| amount of light over time. The | ||
| photodetector in probe collects and | ||
| converts the light (660nm red light | ||
| and 940nm near infrared 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. | Skin, bone, tissue, and venous | |
| vessels normally absorb a constant | ||
| amount of light over time. The | ||
| photodetector in probe collects and | ||
| converts the light (660nm red light | ||
| and 940nm near infrared 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 | ||
| Patient Contact | ||
| Material | Medical Silica gel and Nylon | Medical Silica gel and Nylon |
| Display | ||
| unit | ||
| specification | OLED | Segment LCD |
| Working time | Work for 10h continuously | Work for 12h continuously |
| Power | 4.2V Li-battery | 1 *AAA |
| Display Parameter | SpO2, pulse rate | SpO2, pulse rate |
| SpO2 display | ||
| range | 0%-100% | 0%-100% |
| SpO2 measuring | ||
| range | 70%-100% | 70%-100% |
| SpO2 Resolution | 1% | 1% |
| SpO2 Accuracy | 70%-100%+3% | 70%-100%+3% |
| 90%-100%±2%, 80%-90%±3%, 70%-80%±3%, |