K Number

Device Name

Fingertip Pulse Oximeter

Manufacturer

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.

Date Cleared

2015-02-20

(141 days)

Product Code

DQA

Regulation Number

870.2700

Intended Use

The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.

Device Description

The proposed device of Fingertip Pulse Oximeter MD300C318T2 is a battery powered fingertip device, with the Durable and Deluxe design. The new kind of fingertip pulse oximeter integrated with Bluetooth wireless technology is designed to monitor SpO2 and pulse rate and connect with telemedicine. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, user interface. 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 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device has low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable 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 of Software.

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

K092620

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pulse oximetry mechanism based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No
The device is described as measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate, which are diagnostic or monitoring functions, not therapeutic. It does not provide any treatment or intervention.

Diagnostic

Yes

The device measures and displays functional arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. While it's for spot-checking, the information it provides can contribute to a diagnosis or monitoring of a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components including a power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, and user interface. It is a physical fingertip device.

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 Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The MD300C318T2 Fingertip Pulse Oximeter measures SpO2 and pulse rate by applying a sensor to the finger and analyzing light absorption through the skin and blood vessels. It does not analyze a specimen taken from the body.
Intended Use: The intended use is for "spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate." This is a non-invasive measurement taken directly from the patient.
Device Description: The description details a device that interacts with the body externally (on the fingertip) and uses light to make measurements. It does not mention the analysis of any bodily fluids or tissues.

Therefore, the MD300C318T2 Fingertip Pulse Oximeter falls under the category of a non-invasive medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DQA

Device Description

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, user interface.

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 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device has low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds.

The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable 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 of Software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip

Indicated Patient Age Range

Adult, adolescent, child and infant.

Intended User / Care Setting

Hospitals, hospital facilities and home healthcare environments.

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

Subjects: After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-33yr, 46-75kg, 158-183cm, with light to dark pigmentation) were included in the study conducted July.5-6, 2013 to evaluate the SpO2 accuracy performance of the MD300C318T2 Fingertip Pulse Oximeter.

Methods: Each system was evaluated during steady state/non-motion conditions with various levels of 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 Test reports was conducted in accordance to EN ISO 14155-1:2009, EN ISO 14155-2:2009, ISO 9919:2005, EN ISO 9919:2009, BS EN ISO 80601-2-61:2011, and the FDA Guidance Document for Pulse Oximeters.
Subjects: 12 healthy adult volunteer subjects (ages 21-33yr, 46-75kg, 158-183cm, with light to dark pigmentation)
Key results: The results show the MD300C318T2 Fingertip Pulse Oximeter to pass a SpO2 accuracy specification of 2 which Beijing Choice Electronic Tech Co., Ltd. claims during steady state conditions over the range of 70-100%.

Non-clinical tests: System Performance Test, Shelf Life Test, Performance Test according to ISO 80601-2-61, Electromagnetic Compatibility Test According to IEC 60601-1-2, Electrical Safety Test According to IEC 60601-1, Used in the home healthcare environment test according to IEC60601-1-11, Irritation, Sensitization and Cytotoxicity Test according to ISO 10993.

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

SpO2 accuracy specification of 2% over the range of 70-100%.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K092620

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

Beijing Choice Electronic Technology Co., Ltd. Mr. Lei Chen Quality Director North Building 3F, No.9 Shuangyuan Road Badachu Hi-tech Zone, Shijingshan District Beijing 100041, China

Re: K142888

Trade/Device Name: Fingertip Pulse Oximeter MD300C318T2 Regulation Number: 21 CFR 820.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 20, 2015 Received: January 22, 2015

Dear Mr. 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, listing 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.

Page 2 - Mr. Chen

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The text is black and the background is white. The text appears to be a name and professional title.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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):

Device Name: Fingertip Pulse Oximeter MD300C318T2

Indications for Use:

OF NEEDED)

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

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.

3.1 Submitter Information

● Manufacturer Name:

Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 320,West Building 4, No.83 FuXing Road Beijing 100039, 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: Nov.06, 2014

3.2 Proposed Device Information

Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C318T2 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology

3.3 Predicate Device

510(k) Number: K092620 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter

Premarket Notification 510(k) Submission-Section III 510(k) Summary Model: MD300C318 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Device Class: II Panel: Anesthesiology Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

3.4 Device Description

The device is software-driven and the software validation is provided in Section of Software.

3.5 Comparison list of the technological characteristics

Comparison Elements	Proposed Device	Predicate Device
Product Name	Fingertip Pulse Oximeter	Fingertip Pulse Oximeter(K092620)
Model	MD300C318T2	MD300C318
Regulation No.	21 CFR 870.2700	21 CFR 870.2700
Classification	II	II
Classification Name	Oximeter	Oximeter
Product Code	DQA	DQA
Indications for Use	The MD300C318T2 is intended for spot
checking
in
measuring and
displaying
functional arterial hemoglobin
(SpO2) and
It is
intended
pulse rate.
for adult,	The
Fingertip
MD300C318
Pulse
Oximeter is indicated for continuous use
checking in
measuring
or spot
and
functional
arterial
displaying
oxygen
	infant
and
in
child
users
adolescent,
facilities
and
hospitals,
hospital
home
healthcare environments.	(SpO2) and Pulse
Rate of
saturation
patients in hospitals and home care. It is
intended for adult and pediatric patients on
finger between 0.3-1.0 inch ( 0.8 - 2.5 cm)
thick.
Comparison Statement	The proposed device has the same indications for use and classification as the
	predicate device.
Components	The proposed device consists of power
supply module, detector and emitter LED
collection and process module,
signal
display module, Bluetooth® module, voice	The predicated device consists of detector
and emitter LED, signal amplify unit, CPU,
data display unit, power unit and
with
Bluetooth
communication
is
which
Premarket Notification 510(k) Submission-	Section III 510(k) Summary
	indicator module, USB module, user interface.	integrated into a telemedicine system or other health data collection system through the wireless collection.
Design Principle	Principle of the oximeter is 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 near-infrared zones. Operation principle of the instrument: 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 glow and 940nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.	Principle of the oximeter is 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 near-infrared zones. Operation principle of the instrument: 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 glow and 940nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
Measurement Wavelength	Red	660nm	660nm
	Infrared	940nm	940nm
Comparison Statement	The proposed device has the same design and similar components as the predicate

Table 3-1 Performance Specification Comparison

		device.
Device	Display Type	OLED	OLED
specification	Power Supply	2 AAA-size alkaline batteries	Polymer Lithium-ion Rechargeable battery
	Display Data	SpO2, PR	SpO2, PR
	SpO2 display range	0~100%	0~100%
	Measurement range	70-100%	70~100%
	Accuracy	70%~100%: ±2%;	70%~100%: ±3%;
		70%~80%; ±2%	70%~80%; ±3%
		80%~90%; ±2%	80%~90%; ±3%
		90%~100%; ±1%	90%~100%; ±3%
		0%~69% no definition	0%~69% no definition
	Resolution	1%	1%
	PR display range	0~235BPM	0~235BPM
PR
measurement		30-235 BPM	30-235 BPM
	range
	PR Accuracy	30~~99bpm, ±2bpm; 100~~235bpm, ±2%	30~~99bpm, ±2bpm; 100~~235bpm, ±2%

	Resolution	1bpm	1bpm
	Wireless	0~10m	0~10m
	Transmission Range
	Antenna Type	Internal	Internal
	Transmitter	Bluetooth Compliance: Version 2.1	Bluetooth Compliance: Version 2.0
	Operating	2402 to 2480 MHz	2402 to 2480 MHz
	Frequency
	Operating	5~40°C	5~40°C
	Temperature
	Storage	-25~+70°C	-20~55°C
		Temperature
	Relative Humidity		15%~93% in operation
$ \le 93% in storage $	20%~85% in operation, none condensing
$