Wrist Pulse Oximeter

K172366 · Beijing Choice Electronic Technology Co., Ltd. · DQA · Mar 16, 2018 · Cardiovascular

Device Facts

• Record ID: K172366
• Device Name: Wrist Pulse Oximeter
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

Device Story

Wrist-worn pulse oximeter; measures SpO2 and pulse rate via photoplethysmography. Inputs: light absorption signals from pulsating arteriolar vascular bed using dual-wavelength LEDs (660nm red, 905nm/940nm infrared) and photo detector. Transforms light intensity ratios into SpO2/PR values. Output: visual display (OLED or LCD) and stored/transmitted data (USB or Bluetooth). Used in hospitals, sleep labs, long-term care, or home environments; operated by clinicians or patients. Provides spot-check measurements to assist healthcare providers in assessing patient oxygenation status. Benefits: non-invasive, portable monitoring of arterial hemoglobin saturation.

Clinical Evidence

Clinical study conducted on 12 healthy adult volunteers (ages 21-43) under steady-state induced hypoxia (70-100% SaO2). Primary endpoint: SpO2 accuracy compared to reference CO-Oximetry. Results: ARMS of 1.71% over the 70-100% range. Study conformed to ISO 80601-2-61 and FDA guidance. Clinical data from MD300W512 applied to other models (MD300W314/MD300W314B4) due to shared electro-optical components and SpO2 modules.

Technological Characteristics

Internally powered wrist-worn oximeter. Materials: medical silicone (fingertip cushion), nylon (wrist belt), ABS (case). Sensing: dual-wavelength (660nm/905-940nm) LED and photo detector. Connectivity: USB or Bluetooth (2.0/4.0). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993. Software-driven; non-sterile.

Indications for Use

Indicated for measuring, displaying, storing, and transmitting SpO2 and pulse rate in adult, adolescent, child, and infant patients. Intended for spot-check and data collection in sleep labs, long-term care, hospitals, and home settings.

Regulatory Classification

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.

Predicate Devices

• Pulse Oximeter Model MD300W (K081125)

Submission Summary (Full Text)

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March 16, 2018

Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist, Beijing, 100041 CHINA

Re: K172366

Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 12, 2018 Received: February 14, 2018

#### Dear Lei Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Tina Kiang -2

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section II Indications for Use Statement

# Indications for Use

510(k) Number (if known):_K172366

Device Name: Wrist Pulse Oximeter

Indications for Use:

MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

| Prescription Use | √ |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Section III 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

There is no prior submission for the device.

# 3.1Submitter Information

- Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China

#### ● Contact Person:

Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: [phone] Ext 6020 Fax:[phone] Email: [e-mail]

- Date prepared: February 12, 2018
# 3.2Proposed Device Information

Device Common Name: Wrist Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300W512/MD300W314/MD300W314B4 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA

Class: II

Panel: Anesthesiology

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# 3.3Predicate Device

510(k) Number: K081125 Common Name: Wrist Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300W Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700

Device Class: II

Panel: Anesthesiology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

Intended Use: The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

# 3.4Device Description

Pulse The proposed devices Wrist Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission.

The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.

The proposed devices Wrist Pulse Oximeter MD300W512/MD300W314/MD300W314B4 share the same measurement principle, appearance, structure design, electro-optical components, SpO2 module and equivalent sensor characteristics. The differences among each model of the proposed devices are shown in the table 3-1.

| | MD300W512 | MD300W314 | MD300W314B4 |
|------------------------|-----------------------------|-------------------------------------|-------------------------------------|
| Display<br>Screen Type | OLED | LCD | OLED |
| Power Supply | 2 AAA alkaline<br>batteries | Lithium-ion<br>rechargeable battery | Lithium-ion<br>rechargeable battery |

Table 3-1

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| Data<br>transmission | By USB cable | By Bluetooth or USB<br>cable | By Bluetooth |
|----------------------|--------------|------------------------------|--------------|
| Bluetooth<br>module | No | 2.0 | 4.0 |

Premarket Notification 510(k) Submission-Section III 510(k) Summary

The device is not for life-supporting or life-sustaining, not for implant. The device or sensor is not sterile and the sensor does not need sterilization and the sensor is reusable but does not need re-sterilization since it is not sterile. 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 software.

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# 3.5 Comparison list of the technological characteristics

| Parameter | Proposed Device | Predicate Device | | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Product Name | Wrist Pulse Oximeter | Wrist Pulse Oximeter | | | |
| Model | MD300W512/MD300W314/MD300W314B4 | MD300W | | | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | | | |
| Classification | II | II | | | |
| Classification Name | Oximeter | Oximeter | | | |
| Product Code | DQA | DQA | | | |
| Indications for use | MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use. | The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring. | | | |
| Comparison Statement | The proposed device and the predicate device have the same intended use and classification. The minor | | | | |
| | | differences in the indication statements do not raise different questions of safety or effectiveness. | | | |
| Components | | The proposed devices consist of power supply<br>module, detector and emitter LED, signal collection<br>and process module, display module, user interface,<br>button control circuit, data storage and transmission<br>module. | The predicate device consists of sensor, signal<br>amplify unit, CPU, data display unit, data transmit<br>unit, storage and power unit. | | |
| Design Principle | | The pulse oximeter works by applying a sensor to a<br>pulsating arteriolar vascular bed. The sensor contains<br>a dual light source and photo detector. The one<br>wavelength of light source is 660nm, which is red<br>light; the other is 905nm, which is infrared-red light.<br>Skin, bone, tissue and venous vessels normally<br>absorb a constant amount of light over time. The<br>photo detector in finger sensor collects and converts<br>the light into electronic signal which is proportional<br>to the light intensity. The arteriolar bed normally<br>pulsates and absorbs variable amounts of light during<br>systole and diastole, as blood volume increases and<br>decreases. The ratio of light absorbed at systole and<br>diastole is translated into an oxygen saturation<br>measurement. This measurement is referred to as<br>SpO2. | The wrist oximeter works by applying a sensor to<br>a pulsating arterial vascular bed. The sensor<br>contains a dual light source and photo detector.<br>The one wavelength of light source is 660nm,<br>which is red light; the other is 940nm, which is<br>ultra red light. Skin, bone, tissue and venous<br>vessels normally absorb a constant amount of<br>light during systole and diastole, as blood volume<br>increases and decreases. The ratio of light<br>absorbed at systole and diastole is translated into<br>an oxygen saturation measurement. This<br>measurement is referred to as SpO2. | | |
| Measurement<br>Wavelength | Red | 660±3nm | 660±2nm | | |
| | Infrared | 905 ± 10nm | 940±10nm | | |
| Comparison Statement | | The proposed device and the predicate device have the same design principle and similar measurement wavelength. | | | |
| Performance Specification | Display Type | MD300W512/MD300W314B4 | OLED | LCD | |
| | | MD300W314 | LCD | | |
| | Power Supply | MD300W512 | 2 AAA alkaline batteries | One AAA alkaline battery | |
| | | MD300W314/MD300W314B4 | Lithium rechargeable batteries | | |
| | SpO2 measurement range | 70%~100% | | 70%~100% | |
| | SpO2 accuracy | 70%~100%, ±2%; <70%: unspecified | | 70%~100%, ±3%; <70%: unspecified | |
| | PR display range | 30-255bpm | | 0~254bpm | |
| | PR measurement range | 30-250bpm | | 30~235bpm | |
| | PR accuracy | 30-99bpm, ±2bpm; 100~250bpm, ±2% | | 30-99bpm, ±2bpm; 100~250bpm, ±2% | |
| | PR Resolution | 1bpm | | 1bpm | |
| | Operating temperature | 5~40°C | | 5~40°C | |
| | Storage and transportation environment | -25~70°C | | -20~70°C | |
| | Relative humidity | ≤93%, no condensation | | ≤93%, no condensation | |
| | Atmosphere pressure | 70kPa~106kPa | | 86kPa~106kPa | |
| | Dimensions ( L x W x<br>H) | MD300W512 | 70mm x 67mm x 30mm | 50mm x 60mm x20mm | |
| | | MD300W314 | 67mm x 66mm x 28mm | | |
| | | MD300W314B4 | 67mm x 66mm x 28mm | | |
| Bluetooth Technology | | MD300W512 | Not apply…