Pulse Oximeter (MD300M/MD300K2)

K152563 · Beijing Choice Electronic Technology Co., Ltd. · DQA · Apr 18, 2016 · Cardiovascular

Device Facts

• Record ID: K152563
• Device Name: Pulse Oximeter (MD300M/MD300K2)
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Pulse oximeter (MD300M, MD300K2) monitors SpO2 and pulse rate; uses photoelectric oxyhemoglobin inspection technology; inputs light signals (660nm red, 905nm near-infrared) via finger-clamping sensor; processes signals via microprocessor using Lambert-Beer Law; outputs SpO2%, pulse rate, pulse amplitude index, and alarm status to TFT display; used in hospitals/clinics by clinicians; provides physiological/technical alarms; aids clinical assessment of patient oxygenation status.

Clinical Evidence

Clinical study conducted on 12 healthy adult volunteers (diverse pigmentation, ages 21-43) per ISO 80601-2-61. Evaluated SpO2 accuracy (70-100% range) for three probe types. Results showed Arms of 1.75 (M-50E012CS09), 1.48 (M-50B008CS09), and 1.75 (M-50J033CS045).

Technological Characteristics

Photoelectric sensor (660nm/905nm); ABS plastic case; medical silicone/microfoam finger cushions; 3 AA batteries or 5V adapter; TFT color display; microprocessor-based signal processing; software-driven; complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-61, and ISO 10993.

Indications for Use

Indicated for continuous monitoring and spot-checking of functional SpO2 and pulse rate in adult, adolescent, child, and infant patients in hospital and clinical settings.

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

• Pulse Oximeter MD300K1 (K090599)

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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)

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.

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: [phone] Ext 6020 Fax:[phone] Email: [e-mail]

- 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 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.

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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 | |
| | | Characteristics<br>Absorption<br>of<br>Reductive | source and photo detector. The one wavelength | |
| | | (RHb) and<br>Oxyhemoglobin<br>hemoglobin | of light source is 660nm, which is red light; the | |
| | | red and near-infrared zones.<br>(HbO2) in | other is 940nm, which is ultra red light. Skin, | |
| | | principle<br>Operation<br>of<br>the<br>instrument: | bone, tissue, and venous normally absorb a | |
| | | Oxyhemoglobin<br>Photoeletric<br>Inspection | 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. | | |
| | | signal<br>measured<br>obtained<br>A<br>by<br>ದ | | |
| | | photosensitive element, will be shown on the | | |
| | | display through process<br>oximeter's<br>in | | |
| | | 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 similar<br>measurement 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 measurement<br>range | 0~100% | 0~100% | | |
| SpO2 accuracy | 70%~100%, $ \u00b1 $ 2%;<br>0~69% no definition | 70%~100%, $ \u00b1 $ 3%;<br>0~69% no definition | | |
| PR display range | 0~250bpm | 0~235bpm | | |
| PR measurement<br>range | 30~250bpm | 30~235bpm | | |
| PR accuracy | 30bpm~99bpm, $ \u00b1 $ 2bpm<br>100bpm~250bpm, $ \u00b1 $ 2% | 30bpm~99bpm, $ \u00b1 $ 2bpm<br>100bpm~235bpm, $ \u00b1 $ 2% | | |
| PR Resolution | 1% | 1% | | |
| Pulse amplitude<br>index measurement<br>range | 0.1%~20% | --- | | |
| Operating<br>temperature | 0°C~40°C | 5°C~40°C | | |
| Relative humidity | $ \le $ 80% no condensation in operation;<br>$ \le $ 93% no condensation in storage | $ \le $ 80% no condensation in operation;<br>$ \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%<br>PR 30bpm~250bpm | SpO2 70%~100%<br>PR 30bpm~235bpm | |
| Default<br>Limit | 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. | |
| Contacting<br>Material | 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. The<br>clinical test report and protocol are provided<br>in 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 |
| | EMC<br>and<br>Safety | Software | Moderate level of concern | |
| | | | Compliance with FDA Guidance for the<br>content of Premarket Submissions for<br>Software Contained in Medical Devices | |
| | | | Risk Management in Compliance with<br>ISO14971:2007 | |
| 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 for<br>continuous monitoring, spot-checking of<br>functional pulse oxygen saturation (SpO2) and<br>pulse rate (PR) of single adult, adolescent,<br>child and infant patients in hospitals and<br>clinics. | MD300K1 Pulse Oximeter is intended for<br>continuous monitoring, spot-checking of<br>functional pulse oxygen saturation (SpO2)<br>and pulse rate (PR) of single adult and<br>pediatric patients in hospitals and home care. |

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| | Comparison Statement | The proposed device and the predicated device have the similar intended use and<br>classification. The only difference is that the proposed device cannot be used in the home<br>care environment while the predicated device can be used in the home care environment. | | |
|--|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Components | Photo detector, display screen, signal amplify<br>unit, CPU, display unit and power unit. | Photo detector, display screen, signal amplify<br>unit, CPU, display unit and power unit. | |
| | Design Principle | Principle of the oximeter is as follows: A<br>mathematic formula is established making use<br>of Lambert Beer Law according to Spectrum<br>Absorption Characteristics of Reductive<br>hemoglobin (RHb) and Oxyhemoglobin<br>(HbO2) in red and near-infrared zones.<br>Operation principle of the instrument:<br>Photoeletric Oxyhemoglobin Inspection<br>Technology is adopted in accordance with<br>Capacity Pulse Scanning and Recording<br>Technology, so that two beams of different<br>wavelength of lights (660nm red and 905nm<br>near infrared light) can be focused on a human<br>nail tip through a clamping finger-type sensor.<br>A measured signal obtained by a photosensitive<br>element, will be shown on the oximeter's<br>display through process in electronic circuits<br>and microprocessor. | The MD300K1 Pulse Oximeter works by<br>applying a sensor to a pulsating arteriolar<br>vascular bed. The sensor contains a dual light<br>source and photo detector. The one<br>wavelength of light source is 660nm, which<br>is red light; the other is 940nm, which is ultra<br>red light. Skin, bone, tissue, and venous<br>normally absorb a constant amount of light<br>during systole and diastole, as blood volume<br>increases and decreases. The ratio of light<br>absorbed at systole and diastole is translated<br>into an oxygen saturation measurement. This<br>measurement is referred to as SpO2. | |
| | Measurement<br>Wavelength | Red | 660±3nm…