The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.

Device Description

The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working 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 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 devices are normally applied to adult, adolescent, child and infant in hospital and home environments.

The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

AI/ML Overview

The provided document describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CG11/MD300CG51 and its substantial equivalence to a predicate device (MD300CB3).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides a detailed comparison table between the proposed devices (MD300CG11/MD300CG51) and the predicate device (MD300CB3). This table essentially serves as the acceptance criteria for the proposed device, demonstrating that its performance characteristics are substantially equivalent to the legally marketed predicate.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Proposed Device)
Intended Use	Spot checking SpO2 and pulse rate of adult, adolescent, child, and infant patients in hospital	Spot checking SpO2 and pulse rate of adult, adolescent, child, and infant patients with fingers between 0.9 - 2.2 cm thick in hospital
Design Principle	Same (light absorption by pulsating arteriolar beds)	Same (light absorption by pulsating arteriolar beds)
Components	Power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit	Power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit
Power	Internal powered equipment (1 AAA-size alkaline battery)	Internal powered equipment (1 AAA-size alkaline battery)
Display Screen Type	OLED	MD300CG11: LED, MD300CG51: LCD
Display Mode	6 directions for display	MD300CG11: 1 direction, MD300CG51: 2 directions
Interface Display	SpO2, PR, SpO2 Waveform, Pulse bar graph, Low power indicator	MD300CG11/MD300CG51: SpO2, PR, Pulse bar graph, Low power indicator
LED Specification (RED)	660±2nm	660±2nm
LED Specification (IR)	940±10nm	940±10nm
SpO2 Display Range	0-100%	0-99%
SpO2 Measurement Range	70-100%	70-99%
SpO2 Accuracy	70%-100%: ±2%; 0%-69% no definition	70%-99%: ±2%; 0%-69% no definition
SpO2 Resolution	1%	1%
PR Display Range	0-254BPM	0-254BPM
PR Measurement Range	30-235BPM	30-235BPM
PR Accuracy	30-99bpm, ±2bpm; 100-235bpm, ±2%	30-99bpm, ±2bpm; 100-235bpm, ±2%
PR Resolution	1bpm	1bpm
Patient Contacting Material	Medical silicone gel, ABS plastic	Medical silicone gel, ABS plastic
Material of Shell	Medical silicone gel, ABS plastic	Medical silicone gel, ABS plastic

Key takeaway on acceptance criteria and performance: The acceptance criteria are implicitly defined by the specifications of the predicate device (MD300CB3). The reported performance shows that the proposed devices (MD300CG11/MD300CG51) meet or are substantially equivalent to these criteria. Minor differences in display type, direction, and SpO2 display/measurement range (99% vs 100%) are noted, but these are considered not to affect the substantial equivalence for regulatory purposes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical Test: The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2."

Therefore, no clinical test set was used for the demonstration of substantial equivalence given the product's classification and similarity to the predicate. The device's performance was evaluated through non-clinical testing. The provenance of any underlying test data from these non-clinical tests is not specified, but the applicant company is based in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical test set was used, there were no experts required to establish ground truth from clinical data. The accuracy claims for SpO2 and PR are based on engineering performance tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method was used for clinical data as no clinical test set was deemed necessary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a standalone medical device (Fingertip Pulse Oximeter) and does not involve AI assistance for human readers or interpretation of medical images.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device's performance was evaluated as a standalone product. The non-clinical tests described (SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test, Performance Test after Disinfection, Shelf-life Test) evaluate the device's intrinsic performance against established standards like ISO 80601-2-61.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical performance tests, the "ground truth" is defined by the calibrated reference measurements and standards outlined in ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment. This standard specifies a method for evaluating pulse oximeter accuracy against a co-oximeter or other reference method under controlled hypoxia conditions. The document mentions that performance tests were conducted "in accordance with ISO 80601-2-61."

8. The sample size for the training set

This is not applicable. The Fingertip Pulse Oximeter is a hardware device that directly measures and displays physiological parameters. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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

October 14, 2016

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

Re: K160268

Trade/Device Name: Fingertip Pulse Oximeter MD300CG11/MD300CG51 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 13, 2016 Received: September 16, 2016

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, 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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,

Tejashri Purohit-Sheth, M.D.

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

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 Indication for Use Statement

Indication for Use

510(k) Number (if known): K160268

Device Name: Fingertip Pulse Oximeter MD300CG11/MD300CG51

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(K) number is _ K160268

3.1 Date of Submission: Sep. 13, 2016

3.2 Sponsor Information

Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104, No.A12 Yuquan Road, Haidian District, Beijing 100143, 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, P.R. China, 100041 Phone: +86-10-88798300 Ext 6020 Fax: 215-4052545

3.3 Proposed Device Information

Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CG11/MD300CG51 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology Class: II

3.4 Predicate Device

510(k) Number: K131047 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CB3 Classification Name: Oximeter

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Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology

3.5 Device Description

The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 share the same measurement principle, 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.

Table 3-1
	MD300CG11	MD300CG51
Display Screen Type	LED	LCD
Display Mode	1 direction for display	2 direction for display
Appearance	Blue top shell	Blue top shell

Table 3-1

The proposed devices are not for life-supporting or life-sustaining, not for implant and not sterile. They are reusable and do not need sterilization or re-sterilization.

The devices are for prescription.

The devices do not contain drug or biological products.

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3.6 Intended Use

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Characteristic	Proposed Device	Predicate Device
Product Name	Fingertip Pulse Oximeter	Fingertip Pulse Oximeter(K131047)
Model	MD300CG11/MD300CG51	MD300CB3
Intended Use	The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a portable, non-invasive deviceintended for spot checking of oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate of adult,adolescent, child and infant patient with the fingersbetween 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.	The Fingertip Pulse Oximeter MD300CB3 is aportable, non-invasive device intended for spotchecking of oxygen saturation of arterialhemoglobin (SpO2) and pulse rate of adult,adolescent, child and infant patient in hospital.
Design Principle	Skin, bone, tissue, and venous vessels normallyabsorb a constant amount of light over time. Thephoto detector in finger sensor collects and convertsthe light into electronic signal which is proportionalto the light intensity. The arteriolar bed normallypulsates and absorbs variable amounts of light duringsystole and diastole, as blood volume increases anddecreases. The ratio of light absorbed at systole anddiastole is translated into an oxygen saturationmeasurement. This measurement is referred to asSpO2.	Skin, bone, tissue, and venous vessels normallyabsorb a constant amount of light over time. Thephoto detector in finger sensor collects andconverts the light into electronic signal which isproportional to the light intensity. The arteriolar bednormally pulsates and absorbs variable amounts oflight during systole and diastole, as blood volumeincreases and decreases. The ratio of light absorbedat systole and diastole is translated into an oxygensaturation measurement. This measurement isreferred to as SpO2.
Components	The Proposed devices MD300CG11 andMD300CG51 consist of power supply module,detector and emitter LED, signal collection andprocess module, display module, user interface andbutton control circuit.	Power supply module, detector and emitter LED,signal collection and process module, displaymodule, user interface and button control circuit
Power	Internal powered equipment	Internal powered equipment

		1 AAA-size alkaline battery	1 AAA-size alkaline battery
Display Screen Type		MD300CG11: LEDMD300CG51: LCD	OLED

Display Mode		MD300CG11: 1 direction for displayMD300CG51: 2 directions for display	6 directions for display

Interface Display		MD300CG11: SpO2, PR, Pulse bar graph, Lowpower indicatorMD300CG51: SpO2, PR, Pulse bar graph, Lowpower indicator	SpO2, PR, SpO2 Waveform, Pulse bar graph, Lowpower indicator
LEDSpecification	RED	660±2nm	660±2nm
	IR	940±10nm	940±10nm
	Display Range	0-99%	0-100%
SpO2	MeasurementRange	70-99%	70-100%
	Accuracy	70%-99%: ±2%;0%-69% no definition	70%-100%: ±2%;0%-69% no definition
	Resolution	1%	1%
PR	Display Range	0-254BPM	0-254BPM
	MeasurementRange	30-235BPM	30-235BPM
	Accuracy	30-99bpm, ±2bpm; 100-235bpm, ±2%	30-99bpm, ±2bpm; 100-235bpm, ±2%
	Resolution	1bpm	1bpm
Patient Contacting Material		Medical silicone gel	Medical silicone gel
	ABS plastic
Material of Shell	Medical silicone gelABS plastic	Medical silicone gel

3.7 Technological Characteristics Comparison:

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Fingertip Pulse Oximeter

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Fingertip Pulse Oximeter

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3.8 Test Conclusion

Non-clinical Test

The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is designed and tested and will be manufactured in accordance with the following standards, including:

IEC 60601-1:2005 Medical Electrical Equipment - Part1: General requirements for safety.
IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment
IEC 60601-1-11 : 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

We have conducted performance test for the proposed device in accordance with ISO 80601-2-61. We have also conducted other performance tests for proposed device, including SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test. Performance Test after Disinfection, Shelf-life Test per Guidance for Industry and FDA Staff: Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The test reports are presented in Performance Testing.

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. We have conducted the cytotoxicity, sensitization, and irritation tests which are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".

The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Test

The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2.

3.9 Determination of substantial equivalence

The proposed device has the same classification information, similar intended use, same design principle, similar product design and specifications, same performance effectiveness as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the

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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).