Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pulse oximetry principle based on light absorption and does not mention any AI/ML components or algorithms for signal processing or interpretation.

Therapeutic

No.
The device is intended for spot-checking of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions. The text explicitly states it's "not for life-supporting or life-sustaining."

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate". Measuring these physiological parameters to provide information about a patient's health status is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and process module, display module, and user interface and button control circuit. While it is software-driven, it is not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Fingertip Pulse Oximeter MD300CN310 is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the fingertip. It works by analyzing light absorption through the skin and tissue, not by testing a sample taken from the body.

The device description and intended use clearly indicate that it is a non-invasive physiological monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

Product codes

DQA

Device Description

The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

Principle of the oximeter is as follows:

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The 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 software validation is provided in Section XI Software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, adolescent and child patients

Intended User / Care Setting

hospitals, hospital-type facilities and homecare.

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

Not Found

Summary of Performance Studies

The Fingertip Pulse Oximeter MD300CN310 was supported by laboratory testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device. Non-clinical Test

The Fingertip Pulse Oximeter MD300CN310 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including: IEC 60601-1:2012 Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC 60601-1-11:2010 Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for mrdical 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.

We have also conducted other performance test including SpO2 and PR Accuracy Test, Device Output Time and Finger Out Time Test, Device Response Time Test, Weak Perfusion Test, High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].

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.

Test Name:

System Performance 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 IEC 60601-1-11

The test results indicate that the safety and effectiveness of the proposed device is identical to that of the predicate device.

Key Metrics

SpO2 Accuracy: 70%~~100%, ±2%; 0~~69% no definition
SpO2 Resolution: 1%
PR Accuracy: 30bpm~~99bpm, ±2bpm; 100bpm~~250bpm, ±2%
PR Resolution: 1%

Predicate Device(s)

K140682

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three profiles facing to the right, representing the department's focus on people and health.

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

October 5, 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: K161560

Trade/Device Name: Fingertip Pulse Oximeter MD300CN310 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 25, 2016 Received: August 29, 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 device

1

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/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

2

Section II Indications for Use Statement

Indications for Use

510(k) Number (if known): K161560

Device Name: Fingertip Pulse Oximeter MD300CN310

Indications for Use:

The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

Prescription Use	√
(Part 21 CFR 801 Subpart D)
	AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

Section III 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is K161560 .

3.1 Submitter 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: September 19, 2016

3.2 Proposed Device Information

Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CN310 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology

3.3 Predicate Device

510(k) Number: K140682

4

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

Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C29-H Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700

Device Class: II

Panel: Anesthesiology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

Intended Use: The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.

3.4 Device Description

The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

Principle of the oximeter is as follows:

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The 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.

5

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

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

6

3.5 Comparison list of the technological characteristics

Comparison Elements	Proposed Device	Predicate Device
Product Name	Fingertip Pulse Oximeter	Fingertip Pulse Oximeter
Model	MD300CN310	MD300C29-H
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 Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.	The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.
Comparison Statement	The proposed device and the predicated device have the same classification and similar intended use. The difference exists that the proposed device can be used in the homecare environment while the predicate device can not.
Components	detector and emitter LED, signal amplify unit, CPU, data display unit and power unit	detector and emitter LED, signal amplify unit, CPU, data display unit and power unit
Design Principle	The pulse oximeter works by applying a	The pulse oximeter works by applying a

		sensor to a pulsating arteriolar vascular bed.
The sensor contains a dual light source and	sensor to a pulsating arteriolar vascular
bed. The sensor contains a dual light
		photo detector. The one wavelength of light	source and photo detector.
The one
		source is 660nm, which is red light; the other	wavelength of light source is 660nm,
		is 905nm, which is infrared-red light. Skin,	which is red light; the other is 905nm,
		bone, tissue and venous vessels normally	which is infrared-red light. Skin, bone,
		absorb a constant amount of light over time.	tissue and venous vessels normally absorb
		The photo detector in finger sensor collects	a constant amount of light over time. The
		and converts the light into electronic signal	photo detector in finger sensor collects and
		which is proportional to the light intensity.	converts the light into electronic signal
		The arteriolar bed normally pulsates and	which is proportional to the light intensity.
		absorbs variable amounts of light during	The arteriolar bed normally pulsates and
		diastole, as blood
systole
and
volume	absorbs variable amounts of light during
		increases and decreases. The ratio of light	systole and diastole, as blood volume
		absorbed at systole and diastole is translated	increases and decreases. The ratio of light
		into an oxygen saturation measurement. This	absorbed
at systole and
diastole
is
		measurement is referred to as SpO2.	into an
oxygen saturation
translated
			is
This
measurement.
measurement
			referred to as SpO2.
Measurement	Red	660±3nm	660±3nm
Wavelength	Infrared	905 ± 10nm	905 ± 8nm
Comparison Statement
measurement wavelength.		The proposed device and the predicate device have the same design principle and
	Display Type	OLED	OLED
Performance Specification	Working Time	Approximately 24 hours of continuous operation	Approximately 25 hours of continuous operation
	User Interface	6 display modes	6 directions for display
	Power supply	2*AAA alkaline batteries	2*AAA alkaline batteries
	Display Data	SpO2, PR	SpO2 ,PR
	SpO2 Display Range	0%~100%	35%~100%
	SpO2 Measurement Range	70%~100%	70%~100%
	SpO2 Accuracy	70%~100%, ±2%;
0~69% no definition	70%~100%, ±2%;
0~69% no definition
	SpO2 Resolution	1%	1%
	PR Display Range	30bpm~250bpm	30bpm~250bpm
	PR Measurement Range	30bpm~250bpm	30bpm~250bpm
	PR Accuracy	30bpm~99bpm, ±2bpm;
100bpm~250bpm, ±2%	30bpm~99bpm, ±2bpm;
100bpm~250bpm, ±2%
	PR Resolution	1%	1%

Table 3-1 Performance Specification Comparison Table between the Proposed Device (MD300CN310) and Predicate Device

7

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

8

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

9

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

| | | Operating
Temperature | 5°C~~40°C | 5°C~~40°C |
|-------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | | Storage/Transport
temperature | -25°C~~70°C | -40°C~~55°C |
| | | Relative
Humidity | 15%93% no condensation in operation;
≤93% no condensation in storage/transport | ≤80% no condensation in operation;
≤93% no condensation in storage |
| | | Atmosphere
Pressure | 70kPa106kpa | 86kPa~106kpa |
| | The proposed device has similar product specification as predicate device.
Comparison Statement | | | |
| Contacting
Material | Battery Cover | ABS | ABS | |
| | Enclosure | | | |
| | Fingertip Cushion
Power Button | Laser Etching Medical Silicone Gel | Laser Etching Medical Silicone Gel | |
| Comparison Statement | | | The contacting materials of the proposed device are same to those of 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 |
| | | | | |
| | Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1 | |
| EMC
and
Electrical Safe | Electromagnetic
Compatibility | Conformed to IEC60601-1-2:2014 | Conformed to IEC60601-1-2:2007 | |
| | Software | Moderate level of concern | Moderate level of concern | |
| | | Compliance with FDA Guidance for the
content of Premarket Submissions for
Software Contained in Medical Devices | Compliance with FDA Guidance for the
content of Premarket Submissions for
Software Contained in Medical Devices | |
| | | Risk Management in Compliance with
ISO14971:2007 | Risk Management in Compliance with
ISO14971:2007 | |
| | Label and Labeling | Compliance with the Guidance of pulse
oximeter-premarket notification issued on
March 4.2013 | Compliance with FDA guidance | |

10

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

11

3.6 Intended use

The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

3.7 Testing