Fingertip Pulse Oximeter

K181503 · Beijing Choice Electronic Technology Co., Ltd. · DQA · Oct 11, 2018 · Cardiovascular

Device Facts

• Record ID: K181503
• Device Name: Fingertip Pulse Oximeter
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.

Device Story

Handheld, battery-powered fingertip pulse oximeter; uses dual-wavelength LED (660nm red, 905nm infrared) and photodetector to measure light absorption in pulsating arteriolar vascular bed; calculates SpO2 and pulse rate based on systolic/diastolic absorption ratios; displays data on OLED screen; transmits data via Bluetooth 4.0 to mobile app for tracking; used in hospitals and homecare by clinicians or patients; provides real-time physiological monitoring to assist in health status assessment.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61:2011 with 12 healthy adult volunteers (ages 18-45, diverse skin tones). Primary endpoint was SpO2 accuracy during steady-state conditions (70-100% range). Results demonstrated an Arms of 1.66%. No adverse events reported.

Technological Characteristics

Battery-powered (2xAAA); OLED display; Bluetooth 4.0 connectivity; dual-wavelength sensor (660nm/905nm). Materials: ABS enclosure, medical silicone gel cushion. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61. Non-sterile, reusable.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult, adolescent, child, and infant patients in hospital and homecare 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

• Fingertip Pulse Oximeter MD300C318T2 (K142888)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing, 100041 China

Re: K181503

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 4, 2018 Received: September 4, 2018

#### Dear Haiying Zhao:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Todd D. Courtney -S

Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section II Indications for Use Statement

# Indications for Use

510(k) Number (if known): K181503

Device Name: _Fingertip Pulse Oximeter MD300CI218

Indications for Use:

The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.

| Prescription Use <span style="text-decoration: overline;">√</span> | AND/OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |
|--------------------------------------------------------------------|--------|-----------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.

# 3.1 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:

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: June 04, 2018
## 3.2 Proposed Device Information

Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CI218 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA

Class: II

Panel: Anesthesiology

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### 3.3 Predicate Device

510(k) Number: K142888 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C318T2 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 MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.

# 3.4 Device Description

The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low.

The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.

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

The fingertip 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

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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 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 | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | |
| Model | MD300CI218 | MD300C318T2 | |
| 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 MD300CI218 is a handheld non-invasive<br>device intended for spot-checking of oxygen<br>saturation of arterial hemoglobin (SpO2) and<br>Pulse Rate of adult, adolescent, child and<br>infant<br>patients in hospitals, hospital-type<br>facilities and homecare environment. | The MD300C318T2 is intended for spot-<br>checking in measuring and displaying<br>functional arterial hemoglobin (SpO2) and<br>pulse rate. It is intended for adult, adolescent,<br>child and infant users in hospitals, hospital<br>facilities and home healthcare environments. | |
| Comparison Statement | The proposed device and the predicated device have the same intended use and<br>classification | | |
| Components | Power supply module, detector and emitter<br>LED, signal collection and processor module,<br>display module,<br>Bluetooth<br>module,<br>user<br>interface and button control. | Power supply module, detector and emitter<br>LED, signal collection and process module,<br>display module, Bluetooth module, indicator<br>module, user interface. | |
| Design Principle | The fingertip 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. | | Principle of the oximeter is as follows: A mathematical 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: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 940nm near infrared light) can be focused onto 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. |
| Measurement | Red | 660±3nm | 660nm |
| Wavelength | Infrared | 905±10nm | 940nm |
| Comparison Statement | | The proposed device and the predicate device have the same design principle and similar measurement wavelength. The only difference is the wavelength of the infrared LED emitter, and we can verify that which will not effect the essential performance of the proposed device. | |
| Display Type | | OLED | OLED |
| | | | |
| User Interface | 2 display directions | 2 display directions | |
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | |
| Display Data | SpO2, PR | SpO2, PR | |
| SpO2 Display Range | 0~100% | 0%~100% | |
| SpO2 Measurement Range | 70%~100% | 70%~100% | |
| SpO2 Accuracy | 70%~100%, ±2%;<br>0~69% no definition | 70%~100%, ±2%;<br>0~69% no definition | |
| SpO2 Resolution | 1% | 1% | |
| PR Display Range | 30bpm~250bpm | 0bpm~235bpm | |
| PR Measurement Range | 30bpm~250bpm | 30bpm~235bpm | |
| PR Accuracy | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | 30bpm~99bpm, ±2bpm;<br>100bpm~235bpm, ±2% | |
| PR Resolution | 1% | 1% | |
| Wireless Transmission Range | 0~10m | 0~10m | |
| Antenna Type | Internal | Internal | |
| Transmitter | Bluetooth Compliance: Version 4.0 | Bluetooth Compliance: Version 2.1 | |

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

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| Premarket Notification 510(k) Submission-Section III 510(k) Summary |
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| Operating<br>Temperature | 5°C~40°C | 5°C~40°C | |
|---------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Relative Humidity | 15% ~93%, no condensation in operation;<br>≤93% no condensation in storage | 15% ~93%, no condensation in operation;<br>≤93% no condensation in storage | |
| Atmosphere<br>Pressure | 70kPa~106kpa | 86kPa~106kpa | |
| Comparison Statement | The proposed device has similar product specification as predicate device. | | |
| Contacting<br>Material | Battery Cover<br>Enclosure<br>Power Button | ABS<br>ABS | |
| | Fingertip Cushion | Medical Silicone Gel<br>Medical Silicone Gel | |
| Comparison Statement<br>Performance Testing | The contacting materials of the proposed device are same to those of the predicate device. | | |
| | Laboratory Testing | The laboratory tests include SpO2 and PR<br>accuracy Test, Weak Perfusion Test, High and<br>Low Temperature and Humidity Test,<br>Performance Test After Cleaning and<br>ISO80601-2-61<br>The laboratory tests include SpO2 and PR<br>accuracy Test, Weak Perfusion Test, High and<br>Low Temperature and Humidity Test,<br>Performance Test After Cleaning and<br>ISO80601-2-61 | |
| | Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11<br>Conformed to IEC60601-1, IEC 60601-1-11 | |
| EMC and Electrical Safety | Electromagnetic Compatibility | Conformed to IEC60601-1-2<br>Conformed to FCC certification | Conformed to IEC60601-1-2<br>Conformed to FCC certification |
| | | | |
| | Software and Cybersecurity | Moderate level of concern | Moderate level of concern |
| | | Compliance with:<br>FDA Guidance for the content of Premarket<br>Submissions for Software Contained in<br>Medical Devices and,<br>FDA Guidance for Content of Premarket<br>Submission for Management of Cybersecurity<br>in Medical Device<br>Risk Management in Compliance with<br>ISO14971:2007 | Compliance with FDA Guidance for the<br>content of Premarket Submissions for<br>Software Contained in Medical Devices<br>Risk Management in Compliance with<br>ISO14971:2007 |
| | | | |
| | |…