The Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.

Device Description

The Pulse Oximeter MD300M/MD300K2 can display the SpO2%, pulse rate, Pulse Amplitude Index and other indication parameters, such as time, ID number, pulse amplitude bar and battery power status, alarm limits and the connections of sensors. It is used for adult, adolescent, child and infant patients. The device has physiological alarm and technology alarm function. There are two-level alarm priorities in oximeter. High priority: "Di-Di-Di-----------Di-Di" indicates the patient is in the very dangerous situation. Low priority: "Di" indicates the technical alarm caused by the device itself. The device also has visual alarm function to indicate users by lamp and information on the device. The power supply of the applicant device is 3 AA alkaline batteries, rechargeable batteries or adapter.

The proposed device consists of photo detector, display screen, signal amplify unit, CPU, display unit and power supply unit.

Principle of the oximeter is as follows: A mathematic 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: Photoeletric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on 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.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile and the transducers are reusable and do not need sterilization and 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 software.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Pulse Oximeter (MD300M, MD300K2) based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SpO2 and PR accuracy are presented as part of the device's technical specifications and were evaluated through a clinical study.

Parameter	Acceptance Criteria (Target/Claimed)	Reported Device Performance (MD300M with M-50E012CS09/M-50J033CS045 probes)	Reported Device Performance (MD300M with M-50B008CS09 probe)
SpO2 Accuracy (70-100%)	$\pm$ 2%	Arms of 1.75%	Arms of 1.48%
PR Accuracy	30bpm~~99bpm, $\pm$ 2bpm; 100bpm~~250bpm, $\pm$ 2%	(Implicitly met as accuracy results provided for SpO2)	(Implicitly met as accuracy results provided for SpO2)

Note: The document explicitly states the SpO2 accuracy (reported as Arms) as a result of the clinical study, which implicitly confirms it meets the claimed $\pm$ 2% accuracy. PR accuracy is listed as a specification but a specific Arms value from the clinical study is not provided in the summary, though it's implied to have been met. The relevant standard (ISO 80601-2-61) generally requires Arms to be less than or equal to the claimed accuracy.

2. Sample Size and Data Provenance for the Test Set

Sample Size: 12 healthy adult volunteer subjects.
Data Provenance: The study was conducted in Yue Bei People's Hospital (China). It was a prospective study.
Subject Demographics: 6 females and 6 males, ages 21-43 years, 47-82 kg, 155-185 cm. The subject pool included diverse pigmentation: 6 with light pigmentation from Asian, 3 with light (white) pigmentation from Caucasian, and 3 with dark pigmentation from African.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. For pulse oximetry clinical studies, the ground truth for SpO2 is typically established using a co-oximeter on arterial blood samples, which is a gold standard measurement, not usually based on expert consensus of visual or imaging data.

4. Adjudication Method

Not applicable. This is not a study involving expert readers or image interpretation requiring adjudication. The ground truth for SpO2 accuracy is based on objective laboratory measurements (co-oximetry).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging devices or AI-assisted diagnostic tools where human interpretation is a primary component. The Pulse Oximeter is a physiological monitoring device.

6. Standalone Performance Study

Yes, a standalone study was performed. The clinical test described evaluates the accuracy of the device itself (algorithm only, as there’s no human-in-the-loop interpretation) by comparing its SpO2 readings to arterial blood gas measurements (co-oximetry), which serve as the ground truth.

7. Type of Ground Truth Used

The ground truth for the clinical accuracy study was established using arterial blood co-oximetry, which is considered the gold standard for measuring arterial oxygen saturation (SaO2) in pulse oximeter validation studies.

8. Sample Size for the Training Set

The document does not specify a separate training set. For pulse oximeters, the core algorithm for SpO2 calculation is based on established physiological principles and spectrophotometry (Lambert Beer Law) rather than a deep learning model requiring a large training dataset in the same way an AI diagnostic algorithm would. While manufacturers develop and refine their algorithms, this development process is not typically detailed as a "training set" in a 510(k) in the way AI/ML algorithms are. The "training" in this context would be more analogous to calibration and algorithm refinement based on engineering principles and potentially internal validation data.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" with ground truth in the AI/ML sense is not described. The fundamental principle (Lambert Beer Law) and device design are based on established science. Any internal calibration or algorithm development would use similar ground truth methodologies (e.g., co-oximetry data from desaturation studies) as the validation study to ensure accuracy across the measurement range, but these details are not provided as a "training set ground truth" in this summary.

Summary

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

April 18, 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, China 100041

Re: K152563

Trade/Device Name: Pulse Oximeter (MD300M, MD300K2) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 7, 2016 Received: March 11, 2016

Dear Mr. 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

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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Indications for Use

510(k) Number (if known) K152563

Device Name Pulse Oximeter

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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

Date prepared: March 17, 2016

3.2Proposed Device Information

Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300M, MD300K2 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA

Class: II

Panel: Anesthesiology

3.3Predicate Device

510(k) Number: K090599

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Premarket Notification 510(k) Submission-Section III 510(k) Summary Common Name: Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300K1 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700

Device Class:

Panel: Anesthesiology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

Intended Use: MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

3.4Device Description

The proposed device consists of photo detector, display screen, signal amplify unit, CPU, display unit and power supply unit.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.

The device is for prescription.

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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

Comparison Elements	Proposed Device	Predicate Device
Product Name	Pulse Oximeter	Pulse Oximeter
Model	MD300M	MD300K1
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 MD300M pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.	MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
Comparison Statement	The proposed device and the predicated device have the similar intended use and classification. The only difference is that the proposed device cannot be used in the home care environment while the predicated device can be used in the home care environment.
Components	Photo detector, display screen, signal amplify unit, CPU, display unit and power unit.	Photo detector, display screen, signal amplify unit, CPU, display unit and power unit.
Design Principle	Principle of the oximeter is as follows: A mathematic formula is established making use	The MD300K1 Pulse Oximeter works by applying a sensor to a pulsating arteriolan

		of Lambert Beer Law according to Spectrum	vascular bed. The sensor contains a dual light
		CharacteristicsAbsorptionofReductive	source and photo detector. The one wavelength
		(RHb) andOxyhemoglobinhemoglobin	of light source is 660nm, which is red light; the
		red and near-infrared zones.(HbO2) in	other is 940nm, which is ultra red light. Skin,
		principleOperationoftheinstrument:	bone, tissue, and venous normally absorb a
		OxyhemoglobinPhotoeletricInspection	constant amount of light during systole and
		Technology is adopted in accordance with	diastole, as blood volume increases and
		Capacity Pulse Scanning and Recording	decreases. The ratio of light absorbed at systole
		Technology, so that two beams of different	and diastole is translated into an oxygen
		wavelength of lights (660nm red and 905nm	saturation measurement. This measurement is
		near infrared light) can be focused on a human	referred to as SpO2.
		nail tip through a clamping finger-type sensor.
		signalmeasuredobtainedAbyದ
		photosensitive element, will be shown on the
		display through processoximeter'sin
		electronic circuits and microprocessor.
Measurement	Red	660±3nm	660 nanometers
Wavelength	Infrared	905 ± 8nm	940 nanometers
Comparison Statement		The proposed device and the predicate device have the same design principle and similarmeasurement wavelength.

	Display Type	TFT (colorized)	OLED
	Battery	3*AA alkaline batteries, rechargeable	2*AA alkaline batteries
		batteries or adapter
Power adapter	5V 2A	Not available
SpO2 display range	0%~100%	0~100%
SpO2 measurementrange	0~100%	0~100%
SpO2 accuracy	70%~~100%, $ \u00b1 $ 2%;0~~69% no definition	70%~~100%, $ \u00b1 $ 3%;0~~69% no definition
PR display range	0~250bpm	0~235bpm
PR measurementrange	30~250bpm	30~235bpm
PR accuracy	30bpm~~99bpm, $ \u00b1 $ 2bpm100bpm~~250bpm, $ \u00b1 $ 2%	30bpm~~99bpm, $ \u00b1 $ 2bpm100bpm~~235bpm, $ \u00b1 $ 2%
PR Resolution	1%	1%
Pulse amplitudeindex measurementrange	0.1%~20%	---
Operatingtemperature	0°C~40°C	5°C~40°C
Relative humidity	$ \le $ 80% no condensation in operation;$ \le $ 93% no condensation in storage	$ \le $ 80% no condensation in operation;$ \le $ 93% no condensation in storage
Atmosphere pressure	86kPa~106kpa	86kPa~106kpa
Alarm type		Audio type, visual alarm and information	Audio type, visual alarm and information
Alarm limit range		SpO2 70%~~100%PR 30bpm~~250bpm	SpO2 70%~~100%PR 30bpm~~235bpm
DefaultLimit	SpO2	High 100%, Low 90%	High 99%, Low 90%
	PR	High 100bpm, Low 60bpm	High 100bpm, Low 60bpm
Comparison Statement			The proposed device has similar product specification as predicate device.
ContactingMaterial	Battery Cover	ABS	ABS
	Plastic Case Cover
	Fingertip Cushion	Medical Silicone Gel (Finger probe M-50E012CS09, M-50B008CS09)	Medical Silicone Gel (Finger probe M-50 series)
	Fingertip Cushion	Microfoam (Finger probe M-50J033CS045)	N/A
Comparison Statement			The contacting materials of the proposed device are similar to those of the predicate device. The only difference is that the material of MD300M supporting finger probe M-50J033CS045 is microfoam while which is not available to the predicate device.
Performance Testing	Laboratory Testing	The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61	Meet the requirements of FDA Guidance

	Clinical Testing	Conformed to ISO9919&ISO 80601-2-61	Conformed to ISO9919

		Clinical Test for the device accuracy is conducted in Yue Bei people's Hospital. Theclinical test report and protocol are providedin Performance Testing-Clinical Test Report
Electrical	Electrical Safety	Conformed to IEC60601-1, IEC 60601-1-8		Conformed to IEC60601-1
	Electromagnetic Compatibility	Conformed to IEC60601-1-2		Conformed to IEC60601-1-2
	EMCandSafety	Software	Moderate level of concern
			Compliance with FDA Guidance for thecontent of Premarket Submissions forSoftware Contained in Medical Devices
			Risk Management in Compliance withISO14971:2007
Biocompati	Microfoam	In Vitro Cytotoxicity	No cytotoxic potential	N/A
		Animal skin irritation test	No evidence of significant irritation from the test extract to rabbits
		Skin Sensitization Test	No evidence of sensitization was observed.
Comparison Statement			Compliance with ISO10993
Label and Labeling		Compliance with the Guidance of pulse oximeter-premarket notification issued on March 4,2013	Compliance with FDA guidance

Table 3-1 Performance Specification Comparison Table between the Proposed Device (MD300M) and Predicate Device

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Performance Specification

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

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Table 3-2 Performance Specification Comparison Table between the Proposed Device (MD300K2) and Predicate Device

Comparison Elements	Proposed Device	Predicate Device
Product Name	Pulse Oximeter	Pulse Oximeter
Model	MD300K2	MD300K1
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 MD300K2 pulse oximeter is intended forcontinuous monitoring, spot-checking offunctional pulse oxygen saturation (SpO2) andpulse rate (PR) of single adult, adolescent,child and infant patients in hospitals andclinics.	MD300K1 Pulse Oximeter is intended forcontinuous monitoring, spot-checking offunctional pulse oxygen saturation (SpO2)and pulse rate (PR) of single adult andpediatric patients in hospitals and home care.

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Comparison Statement	The proposed device and the predicated device have the similar intended use andclassification. The only difference is that the proposed device cannot be used in the homecare environment while the predicated device can be used in the home care environment.
Components	Photo detector, display screen, signal amplifyunit, CPU, display unit and power unit.	Photo detector, display screen, signal amplifyunit, CPU, display unit and power unit.
Design Principle	Principle of the oximeter is as follows: Amathematic formula is established making useof Lambert Beer Law according to SpectrumAbsorption Characteristics of Reductivehemoglobin (RHb) and Oxyhemoglobin(HbO2) in red and near-infrared zones.Operation principle of the instrument:Photoeletric Oxyhemoglobin InspectionTechnology is adopted in accordance withCapacity Pulse Scanning and RecordingTechnology, so that two beams of differentwavelength of lights (660nm red and 905nmnear infrared light) can be focused on a humannail tip through a clamping finger-type sensor.A measured signal obtained by a photosensitiveelement, will be shown on the oximeter'sdisplay through process in electronic circuitsand microprocessor.	The MD300K1 Pulse Oximeter works byapplying a sensor to a pulsating arteriolarvascular bed. The sensor contains a dual lightsource and photo detector. The onewavelength of light source is 660nm, whichis red light; the other is 940nm, which is ultrared light. Skin, bone, tissue, and venousnormally absorb a constant amount of lightduring systole and diastole, as blood volumeincreases and decreases. The ratio of lightabsorbed at systole and diastole is translatedinto an oxygen saturation measurement. Thismeasurement is referred to as SpO2.
MeasurementWavelength	Red	660±3nm	660 nm
	Infrared	905 ± 10nm	940 nm

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Comparison Statement		The proposed device and the predicate device have the same design principle and similar measurement wavelength.
Performance Specification	Display Type	TFT (colorized)	OLED
	Battery	3*AA alkaline batteries, rechargeable batteries or adapter	2*AA alkaline batteries
	Power adapter	5V 2A	Not available
	SpO2 Display Range	0~100%	0~100%
	SpO2 Measurement Range	0~100%	0~100%
	SpO2 Accuracy	70%~~100%, $\pm$ 2%; 0~~69% no definition	70%~~100%, $\pm$ 3%; 0~~69% no definition
	SpO2 resolution	1%	1%
	PR Display Range	0~250bpm	0~235bpm
	PR Measurement Range	30bpm~250bpm	30bpm~235bpm
	PR Accuracy	30bpm~~99bpm, $\pm$ 2bpm;100bpm~~250bpm, $\pm$ 2%	30bpm~~99bpm, $\pm$ 2bpm;100bpm~~235bpm, $\pm$ 2%
	PR Resolution	1%	1%
	Pulse amplitude index display range	0.1%~20%	---

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	OperatingTemperature	0°C~40°C	5°C~40°C
	Relative Humidity	≤80% no condensation in operation;≤93% no condensation in storage	≤80% no condensation in operation;≤93% no condensation in storage
	Atmosphere Pressure	86kPa~106kpa	86kPa~106kpa
	Alarm type	Audio type, visual alarm and information	Audio type, visual alarm and information
	Alarm limit range	SpO2 70%~~100%PR 30bpm~~250bpm	SpO2 70%~~100%PR 30bpm~~235bpm
DefaultLimits	SpO2	High 100%, Low 95%	High 99%, Low 90%
	PR	High 100bpm, Low 60bpm	High 100bpm, Low 60bpm
Comparison Statement		The proposed device has similar product specification as predicate device.
ContactingMaterial	Battery CoverPlastic Case Cover	ABS	ABS
	Fingertip Cushion	Medical Silicone Gel(Finger probeM-50E012CS09, M-50B008CS09)	Medical Silicone Gel(M-50 series)
	Fingertip Cushion	Microfoam(Finger probe M-50J033CS045)	N/A
Comparison Statement			The contacting materials of the proposed device are similar to those of the predicatedevice. The only difference is that the material of MD300K2 supporting finger probeM-50J033CS045 is microfoam while which is not available to the predicate device.

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PerformanceTesting	Laboratory Testing	The laboratory tests include SpO2 and PRaccuracy Test, Weak Perfusion Test, High andLow Temperature and Humidity Test,Performance Test After Cleaning andISO80601-2-61	Meet the requirements of FDA Guidance
EMC andElectricalSafe	Electrical Safety	Conformed to IEC60601-1, IEC 60601-1-8	Conformed to IEC60601-1
	ElectromagneticCompatibility	Conformed to IEC60601-1-2	Conformed to IEC60601-1-2
	Software	Moderate level of concernCompliance with FDA Guidance for the contentof Premarket Submissions for SoftwareContained in Medical DevicesRisk Management in Compliance withISO14971:2007	Moderate level of concernCompliance with FDA Guidance for thecontent of Premarket Submissions forSoftware Contained in Medical DevicesRisk Management in Compliance withISO14971:2007


Biocompatibility	Microfoam	In Vitro Cytotoxicity	No cytotoxicpotential	N/A
		Animal skin irritationtest	No evidence ofsignificant irritationfrom the test extractto rabbits

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	Skin Sensitization Test	No evidence ofsensitization wasobserved.
Comparison Statement	Compliance with ISO10993
Label and Labeling	Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4,2013	Compliance with FDA guidance

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3.6Intended use

The MD300M/MD300K2 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.

3.7 Functional and Safety Testing:

Non-Clinical Test

The Pulse Oximeter MD300M/MD300K2 is designed and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60601-1:2005/AC:2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-8:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

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 ISO10993. "Biological Evaluation of Medical Devices".

No.	Test Name
1	System Performance Test
2	Shelf Life Test
3	Performance Test after Cleaning
4	Performance Test according to ISO 80601-2-61
5	Electromagnetic Compatibility Test According to IEC 60601-1-2
6	Electrical Safety Test According to IEC 60601-1

The list of non-clinical test performed on the proposed device is shown as following:

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

7	Alarm System Tests According to IEC60601-1-8
8	Irritation,Sensitization and Cytotoxicity Test according to ISO 10993

Clinical Test

The Clinical Test was conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011 Medical electrical equipment- Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment.

The supporting Oximeter probes of Pulse Oximeter MD300M are adult finger probe M-50E012CS09, pediatric finger probe M-50B008CS09, single use probe M-50J033CS045. The clinical study of MD300M was conducted with its supporting finger probe respectively.

The Clinical Test of MD300M was conducted in Yue Bei people's Hospital. The clinical s study report was presented in Performance Testing-Clinical Test Report.

Subjects information:

12 healthy adult volunteer subjects (6 females and 6 males ages 21-43yr, 47-82kg, 155-185cm, among which 6 with light pigmentation from Asian, 3 with light (white) pigmentation from Caucasian, 3 with dark pigmentation from African) were included in the study connected Sep. 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300M Pulse Oximeter and its supporting M-50E012CS09/M-50B008CS09/ M-50J033CS045 Oximeter Probe.

Results:

The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50E012CS09 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.

The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50B008CS09 Oximeter probe to have an Arms of 1.48 during steady state conditions over the range of 70-100%.

The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50J033CS045 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.

Conclusion:

The results of the study provide supporting evidence that the pulse oximeter MD300M with its supporting finger probes was compliance to the accuracy specification claimed by the manufacturer.

The proposed device MD300K2 and MD300M have similar hardware and software design. They have same contain identical materials, electro-optical component, SpO2 module,

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same supporting finger probes and have equivalent sensor characteristics. The main difference between them is the appearance design (enclosure). So we think MD300M clinical study results can be to support clearance of the proposed device of MD300K2.

The clinical statement was presented in Performance Testing-Clinical Statement.

3.8Determination of substantial equivalence

The proposed device of Pulse Oximeter MD300M/MD300K2 has the same classification information, similar intended use, same design principle, similar product design and specifications as the predicated device. The differences exist in display screen, SpO2 accuracy and PR display range. The main difference is that the proposed device cannot be used in the homecare environment while the predicated device can be used in the home care environment. The differences are slight and do not influence the effectiveness and safety of the device. According to the laboratory and clinical test results, the proposed device is as safe and as effective 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).