K Number

Device Name

Wrist Pulse Oximeter

Manufacturer

Beijing Choice Electronic Technology Co., Ltd.

Date Cleared

2018-03-16

(224 days)

Product Code

DQA DOA

Regulation Number

870.2700

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 Description

The proposed devices Wrist Pulse 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K081125

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard pulse oximeter with signal processing and data storage capabilities, but there is no mention of AI, ML, or related concepts.

Therapeutic

No.
The device is indicated for measuring, displaying, storing, and transmitting physiological parameters (SpO2 and pulse rate), not for providing treatment or therapy.

Diagnostic

Yes

The device is a pulse oximeter that measures and displays functional oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's condition for diagnostic purposes.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, and data storage and transmission module.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The description clearly states that the device measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These measurements are taken directly from the patient's body (via a wrist sensor), not from a sample taken from the body.
Method of measurement: The device uses a sensor placed on the wrist to collect data, which is a non-invasive method of measurement, not an in vitro test.
Intended Use: The intended use describes monitoring physiological parameters directly from the patient.

Therefore, the MD300W512 / MD300W314/ MD300W314B4 Wrist Pulse Oximeter is a non-IVD medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQA

Device Description

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.

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, adolescent, child and infant patients

Intended User / Care Setting

sleep labs, long-term care, hospitals and home use.

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 study of MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe was conducted in accordance to ISO 14155-1, -2, ISO 80601-2-61:2011 and the FDA Guidance Document for Pulse Oximeters.

Subjects:
After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-43yr, 47-82kg, 155-185cm, with light to dark pigmentation) were included in the study conducted Sep. 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe.

Method:
Each system was evaluated during steady state/ non-motion conditions with various levels induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Test: The Clinical study of MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe was conducted.
Sample Size: 12 healthy adult volunteer subjects.
Key Results: The SpO2 accuracy performance results showed the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe to have an ARMS of 1.71 during steady state conditions over the range of 70-100%. The results show the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe is compliance to the accuracy specification claimed by the manufacturer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SpO2 accuracy ARMS of 1.71 during steady state conditions over the range of 70-100%.

Predicate Device(s)

K081125

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Section II Indications for Use Statement

Indications for Use

510(k) Number (if known):_K172366

Device Name: Wrist Pulse Oximeter

Indications for 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)

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: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com

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

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.

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

Table 3-1

| Data
transmission | By USB cable | By Bluetooth or USB
cable | By Bluetooth |
|----------------------|--------------|------------------------------|--------------|
| Bluetooth
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.

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
module, detector and emitter LED, signal collection
and process module, display module, user interface,
button control circuit, data storage and transmission
module.	The predicate device consists of sensor, signal
amplify unit, CPU, data display unit, data transmit
unit, storage and power unit.
Design Principle		The pulse oximeter works by applying a sensor to a
pulsating arteriolar vascular bed. The sensor contains
a dual light source and photo detector. The one
wavelength of light source is 660nm, which is red
light; the other is 905nm, which is infrared-red light.
Skin, bone, tissue and venous vessels normally
absorb a constant amount of light over time. The
photo detector in finger sensor 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 wrist oximeter works by applying a sensor to
a pulsating arterial vascular bed. The sensor
contains a dual light source and photo detector.
The one wavelength of light source is 660nm,
which is red light; the other is 940nm, which is
ultra red light. Skin, bone, tissue and venous
vessels normally absorb a constant amount 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.
Measurement
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%;