FINGERTIP PULSE OXIMETER

K131047 · Beijing Choice Electronic Technololgy Co., Ltd. · DQA · Oct 16, 2013 · Cardiovascular

Device Facts

• Record ID: K131047
• Device Name: FINGERTIP PULSE OXIMETER
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip Pulse Oximeter MD300CB3 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 in hospital.

Device Story

Battery-powered, portable fingertip pulse oximeter; uses dual-wavelength LED (660nm red, 940nm infrared) and photodetector to measure light absorption in pulsating arteriolar vascular bed. Device calculates SpO2 based on ratio of light absorption during systole and diastole. Operated by clinicians in hospital settings for spot-checking; displays SpO2, pulse rate, pulse bar graph, and waveform on OLED screen. Provides non-invasive physiological data to assist in clinical assessment. Not for life-supporting or life-sustaining use.

Clinical Evidence

Clinical accuracy testing conducted at Yue Bei People's Hospital following ISO 9919:2005, Annex EE.4. Accuracy compared against 'Golden Standard' Co-Oximeter. Results confirmed device accuracy meets claimed specifications.

Technological Characteristics

Materials: Medical silicone gel (fingertip cushion), ABS (enclosure/battery cover). Sensing: Dual-wavelength LED (660nm/940nm) and photodetector. Power: 1x AAA alkaline battery. Display: OLED with adjustable brightness and 6-direction interface. Connectivity: Standalone. Sterilization: Non-sterile, reusable. Standards: IEC 60601-1, IEC 60601-1-2, ISO 9919, ISO 10993-5/10.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult, adolescent, child, and infant patients in hospital settings. Not for continuous monitoring.

Regulatory Classification

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.

Predicate Devices

• Fingertip Pulse Oximeter Model MD300C (K070371)

Submission Summary (Full Text)

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#### Section 3 510(k) Summary

# (As required by 21 CFR 807.92)

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

There is no prior submission for the devices.

## The assigned 510(K) number is K131047

3.1 Date of Submission: Sept. 10, 2013

OCT 1 6 2013

# 3.2 Sponsor Information

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. P.R. China, 100041 Phone: [phone] Ext 6020 Fax: [phone] Email: [e-mail]

## 3.3 Proposed Device Information

Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CB3 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology Class: Il Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Intended Use : The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and

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pulse rate of adult, adolescent, child and infant patient in hospital.

### 3.4 Predicate Device

510(k) Number: K070371 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300C Classification Name: Oximeter Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Intended Use : Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check,

oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

## 3.5 Device Description

The applicant device of Fingertip Pulse Oximeter MD300CB3 is a battery powered fingertip device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, adolescent, child and infant patient in hospital.

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

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 660 nm, which is red light; the other is 940 nm, which is ultra 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 applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The devices are software -driven and the software validation is provided in Software.

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# 3.6 Intended Use

The Fingertip Pulse Oximeter MD300CB3 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 in hospital.

# 3.7 Contraindication

The Fingertip Pulse Oximeter MD300CB3 is not for continuous monitoring.

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Premarket Notification 510(k) Submission -- Sec 3 510(k) Summar

3.8 Comparison with the Predicate Device

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| | | | remarket Notification 510(k) Submission - Sec 3 510(k) Summary | |
|----------------------|--|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 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. | 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. |
| | | Measurement | Red | 660±2nm |
| | | wavelength | Infrared | 940±10nm |
| | | | Comparison Statement | The proposed devices have the same design principle and similar components. |
| Device Specification | | | Display Type | OLED |
| | | | Working time | Work for 8 hours continuously |
| | | | Brightness of backlight | Adjustable |
| | | | User Interface | 6 directions for display |
| | | | Power supply | 1*AAA alkaline battery |
| | | | Display Data | SpO2、PR |
| | | | SpO2 display range | 0~100% |
| | | | SpO2 measurement range | 70~100% |
| | | | | 70%~100%: 1.94; |
| | | | | 70%~80%: 2.32; |
| | | SpO2 Arms Accuracy | | 80%~90%: 1.95; |
| | | | | 90%~100%: 1.57; |
| | | | | 0%~69% no definition |
| | | Display Type | OLED | |
| | | Working time | Approximately 30 hours of continuous operation | |
| | | Brightness of backlight | Adjustable | |
| | | User Interface | 6 directions for display | |
| | | Power supply | 2*AAA alkaline battery | |
| | | Display Data | SpO2、PR | |
| | | SpO2 display range | 0~99% | |
| | | SpO2 measurement range | 70~99% | |
| | | | | 70%~99%: ±3% |
| | | | | 0%-69% no definition |

n - Sec 3 510(k) Su Premarket Notification 510(k) Sub

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| market Notification 510(k) Submission - Sec 3 510(k) Summary | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SpO2 resolution | 1% | |
| PR Display Range | 0-254bpm | |
| PR Measurement Range | 30~235bpm | |
| PR Accuracy | $\pm$ 2bpm (30-99bpm) and 2% (100-235bpm) | |
| PR resolution | 1bpm | |
| Operating temperature | 5°C~40°C | |
| Relative humidity | ≤80%, no condensation (operating)<br>≤93% no condensation (storage) | |
| Atmosphere pressure | 86kPa~106kPa | |
| Comparison Statement | The applicant device has similar device specifications as the predicate device. | |
| Battery cover | ABS | |
| Contacting<br>Material | Fingertip | Medical Silicon gel |
| | Cushion | Medical Silicon gel |
| | Enclosure | ABS |
| Comparison Statement | The contacting materials of applicant device are similar to that of the predicate device. | |
| Performance Testing | Bench Test | The bench tests include Test for Pulse signal strength<br>Indicator Bar、Pulse rate and SpO2 accuracy test after 3000<br>cycles disinfection, Test for Random vibration, wide band Meet the requirements of FDA Guidance<br>and Test according to ISO9919. All the bench test results are<br>provided in Performance Testing-Bench<br>Conformed to ISO 9919 |
| | Clinical Test | Clinical test for device accuracy is conducted in the Yue Bei<br>people's Hospital. The clinical test report and protocol are<br>provided in Performance Tasting Clinical<br>Conformed to ISO 9919 |

Premarket Notification 510(k) Submission – Sec 3 510(k) Summary

ﺑﺮ

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| Electrical Safety | Electromagnetic<br>Compatibility | Software | Biocompatibility | Label and Labeling | |
|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Conformed to IEC60601-1.<br>The test results are provided in Electromagnetic<br>Compatibility and Electrical Safety | Conformed to IEC60601-1-2.<br>The EMC test reports were provided in Electromagnetic<br>Compatibility and Electrical Safety | Moderate Level of Concern | Medical silicone gel | | Conformed to IEC60601-1 |
| | | Compliance with FDA Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical<br>Devices. | | | Conformed to IEC60601-1-2. |
| | | Risk Management in Compliance with IEC 60601-1-4 | | | Moderate Level of Concern |
| | | In Vitro Cytotoxicity | | | Compliance with FDA Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical<br>Devices. |
| | | Skin Irritation Test | | | Risk Management in Compliance with IEC 60601-1-4 |
| | | Animal skin irritation<br>test | | | In Vitro Cytotoxicity |
| | | | No cytotoxic potential | | |
| | | | No evidence of causing<br>sensitization | | |
| | | | No evidence of significant<br>irritation from the test extract to<br>rabbits | | |
| | | | | Compliance with FDA guidance | |
| | | | | Compliance with the Guidance of pulse oximeter-premarket<br>notification submission issued on March 4,2013 | |
| | | | | | Skin Irritation Test |
| | | | | | No cytotoxic potential |
| | | | | | No evidence of causing<br>sensitization |
| | | | | | No evidence of significant<br>irritation from the test extract<br>to rabbits |
| | | | | | Animal skin irritation test |

remarket Notification 510(k) Submission – Sec 3 510(k) Summar

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# 3.9 Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:1988 + A1(1991) + A2(1995), 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 9919:2005. Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment for medical use.

ISO10993-5: 2009, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity.

ISO10993-10: 2010, Biological evaluation of medical device - Part 10: Tests for irritation and delayed-type hypersensitivity.

The Clinical Test of MD300CB3 following ISO 9919:2005, Annex EE.4 was conducted in Yue Bei people's Hospital. The study protocol was subjected to ISO 9919:2005 Annex EE. Procedures of testing required in EE2 were adopted. It can be determined from the result of the study that the accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with "Golden Standard" Co-Oximeter.

# 3.9 Substantially Equivalent Conclusion

The proposed device, Fingertip Pulse Oximeter MD300CB3, is determined to be Substantially Equivalent (SE) to the predicate device, Fingertip Pulse Oximeter MD300C, K070371, in respect of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 16, 2013

Beijing Choice Electronic Technology Co., Ltd Mr. Lei Chen 3270 Alpine Road North Building 3F, No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District. Beijing, P.R. China, 100041

Re: K131047

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 13. 2013 Received: September 16, 2013

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. Ilsting 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

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Page 2 - Mr. Lei Chen

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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/Mcdicall.evices/Safety/ReportalProblem/default.hun 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

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Teiashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR

Kwame Ulmer, M.S. Acting Director Division of Anesthesiology, Respiratory, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 2 Indications for Use Statement

# Indications for Use

510(k) Number (if known): K131047

Device Name: Fingertip Pulse Oximeter MD300CB3

Indications for Use:

The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpOz) and pulse rate of adult, adolescent, child and infant patient in hospital.

V Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nayan J. Patel -S 2013.10.15 13:01:56 -04'00'

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