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.

AI/ML Overview

The document describes the acceptance criteria and the study that proves the device (Fingertip Pulse Oximeter MD300C318T2) meets these criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device MD300C318T2)	Meets Criteria?
SpO2 Accuracy	70%~100%: ±3%	70%~100%: ±2% (specifically 70%~80%: ±2%; 80%~90%: ±2%; 90%~100%: ±1%)	Yes
PR Accuracy	30~~99bpm, ±2bpm; 100~~235bpm, ±2%	30~~99bpm, ±2bpm; 100~~235bpm, ±2%	Yes

Note: The document implies that meeting the predicate device's accuracy specifications is the acceptance criterion for the proposed device to demonstrate substantial equivalence. The proposed device shows better accuracy than the predicate in all SpO2 ranges.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Test Set): 12 healthy adult volunteer subjects
Data Provenance: Prospective clinical study, conducted in an unspecified country (Yue Bei People's hospital mentioned for the predicate device's clinical test, but the proposed device's clinical test states "conducted ... to evaluate..."). Given the submission is from Beijing Choice Electronic Technology Co., Ltd., it is highly probable the study was conducted in China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts involved in establishing the ground truth for the clinical test. It states "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." This indicates that the ground truth was established by laboratory analysis using a reference CO-Oximeter, rather than by human expert consensus or interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement with a reference CO-Oximeter. There was no mention of human adjudication for the clinical accuracy study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study focused on the device's standalone accuracy against a reference method.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone clinical performance study was done. The study measured the accuracy of the MD300C318T2 Fingertip Pulse Oximeter against a reference CO-Oximetry method.

7. The Type of Ground Truth Used

The ground truth used for the SpO2 accuracy assessment was Reference CO-Oximetry applied to arterial blood samples. This is considered an objective, gold-standard method for determining arterial oxygen saturation (SaO2).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" for the device. Pulse oximeters are typically hardware-based devices with embedded algorithms, and while those algorithms are developed and refined, the document does not break down data into training and test sets in the typical AI/ML sense. The performance study refers to the test data for demonstrating accuracy.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is outlined in the provided text for an AI/ML context, this question is not directly applicable. The development of the oximeter's algorithm would be based on physiological principles and likely extensive previous data, but the creation of a "ground truth" for a training set in the way a machine learning model would use it is not described.

Summary

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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.

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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

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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)

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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.

3.1 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

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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.

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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 spotcheckinginmeasuring anddisplayingfunctional arterial hemoglobin(SpO2) andIt isintendedpulse rate.for adult,	TheFingertipMD300C318PulseOximeter is indicated for continuous usechecking inmeasuringor spotandfunctionalarterialdisplayingoxygen
	infantandinchildusersadolescent,facilitiesandhospitals,hospitalhomehealthcare environments.	(SpO2) and PulseRate ofsaturationpatients in hospitals and home care. It isintended for adult and pediatric patients onfinger 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 powersupply module, detector and emitter LEDcollection and process module,signaldisplay module, Bluetooth® module, voice	The predicated device consists of detectorand emitter LED, signal amplify unit, CPU,data display unit, power unit andwithBluetoothcommunicationiswhich
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

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		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
PRmeasurement		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$ <85% in storage, none condensing $
		Atmospherepressure	86kPa~106kPa	86kPa~106kPa
	Comparison Statement		The applicant device has similar device specifications as the predicate device
	ConstructionMaterials	Battery Cover	ABS	ABS
		Fingertip Cushion	Medical Silicon gel	Medical Silicon gel
		Enclose	ABS	ABS
	Comparison Statement			The contacting materials of applicant device are as same as that of the predicatedevice.
Performance Testing	Performance Testing		Meet the requirements of FDA Guidance	Meet the requirements of FDA Guidance
		Clinical Test		Conformed to ISO 80601-2-61Clinical test for device accuracy isconducted by the Yue Bei People'shospital. The clinical test report andprotocol are provided in PerformanceTesting-Clinical
	Electromagneticompatibility	Electrical Safety		Conformed to IEC60601-1
	Electromagnetic Compatibility	Conformed to IEC60601-1-2		Conformed to IEC60601-1-2
Software	Moderate Level of Concern		Moderate Level of Concern
	Compliance with FDA Guidance for theContent of Premarket Submissions forSoftware Contained in Medical Devices.		Compliance with FDA Guidance for theContent of Premarket Submissions forSoftware Contained in Medical Devices.
Biocompatibility	Black Medical Silicon gel	InVitroCytotoxicity	Nocytotoxicpotential.	In Vitro Cytotoxicity	Nocytotoxicpotential.
		Skin Irritation Test	No evidence ofcausing sensitization.	Skin Irritation Test	No evidence ofcausingsensitization.
		AnimalSkinSensitization Test	No evidence ofsignificantsensitizationfromthe test extract torabbits.	AnimalSkinSensitization Test	No evidence ofsignificantsensitizationfromthe test extract torabbits.
	ABS plastic Enclosure	InVitroCytotoxicity	Nocytotoxicpotential.	In Vitro Cytotoxicity	Nocytotoxicpotential.
		Skin Irritation Test	No evidence ofcausing sensitization.	Skin Irritation Test	No evidence ofcausingsensitization.
	Sensitization Test	significantsensitization fromthe test extract torabbits.	Sensitization Test	significantsensitization fromthe test extract torabbits.
Label and Labeling	Compliance with FDA guidance		Compliance with FDA guidance

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3.6 Intended use

3.7 Test

Non-clinical Test

The Fingertip Pulse Oximeter MD300318T2 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC60601-1 Medical Electrical Equipment-Part 1: General requirements for safety.

IEC60601-1-2:2007 Medical Electrical Equipment-Part1-2: General requirements for safety, Collateral standard: Electromagnetic compatibility -Requirements and tests.

IEC60601-1-11:2010 Medical Electrical Equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ISO 80601-2-61:2011 Medical Electrical Equipment- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

The Software Validation is in compliance with FDA Guidance to Compliance with FDA

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".

No.	Test Name
1	System Performance Test
2	Shelf Life Test
3	Performance Test according to ISO 80601-2-61
4	Electromagnetic Compatibility Test According to IEC 60601-1-2
5	Electrical Safety Test According to IEC 60601-1
6	Used in the home healthcare environment test according to IEC60601-1-11
7	Irritation ,Sensitization and Cytotoxicity Test according to ISO 10993

The list of non-clinical test performed on the proposed device.

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

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.

Adverse events and complications:

There are no adverse events during the clinical test.

Conclusions:

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%.

3.8 Determination of substantial equivalence

The proposed device of Fingertip Pulse Oximeter MD300C318T2 has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicated device. The differences exist in storage temperature, relative humidity, Bluetooth compliance version and power supply type. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical and clinical test results, the proposed device is as safe as effective and performance as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

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).