Pulse Oximeter

K230172 · Beijing Choice Electronic Technology Co., Ltd. · DQA · Aug 12, 2023 · Cardiovascular

Device Facts

• Record ID: K230172
• Device Name: Pulse Oximeter
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Pulse Oximeter 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. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

Device Story

Handheld, battery-powered, non-invasive pulse oximeter; measures SpO2 and pulse rate via fingertip sensor. Sensor uses dual-wavelength LEDs (660nm red, 905nm infrared) and photodetector to measure light absorption changes in arteriolar bed during systole/diastole. MCU processes signals to calculate SpO2 and pulse rate; results displayed on LED screen. Used by clinicians or patients for spot-checks in hospitals or homecare. Provides immediate physiological data to assist in patient assessment. Benefits include non-invasive, portable monitoring of oxygenation status.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61 on 11 healthy adult volunteers (ages 22-44, varied pigmentation). Evaluated SpO2 accuracy against arterial blood CO-Oximetry during stationary conditions. Results showed ARMS of 1.5 over 70-100% SpO2 range.

Technological Characteristics

Handheld pulse oximeter; ABS enclosure, silicone gel fingertip cushion, PMMA lens. Dual-wavelength sensor (660nm/905nm). Powered by 2x AAA alkaline batteries. LED display. Connectivity: None (Bluetooth removed). Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1/5/10.

Indications for Use

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

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 MD300CI218 (K181503)

Submission Summary (Full Text)

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August 12, 2023

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

Re: K230172

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2023 Received: July 12, 2023

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230172

Device Name Pulse Oximeter

### Indications for Use (Describe)

The Pulse Oximeter 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. The device is not intended for continuous monion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section II 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.

## 2.1 Submitter Information

#### ● Manufacturer Name:

Establishment Registration Number: 3005569927

Beijing Choice Electronic Technology Co., Ltd.

2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA

#### ● Contact Person:

Haiying Zhao

Beijing Choice Electronic Technology Co., Ltd.

2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Date prepared: February 10,2023 ●

## 2.2 Subject Device Information

Device Trade/Proprietary Name: Pulse Oximeter

Regulation Medical Specialty: Cardiovascular

Device Classification Name: Oximeter

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### Premarket Notification 510(k) Submission—Section II 510(k) Summary

Model: MD300C19

Purpose of submission: 510 (k)

Regulation Number: 21 CFR 870.2700

Product Code: DQA

Class: II

Panel: Anesthesiology

## 2.3 Predicate Device

510(k) Number: K181503 Device Trade/Proprietary Name: Fingertip Pulse Oximeter Regulation Medical Specialty: Cardiovascular Device Classification Name: Oximeter Model: MD300CI218 Product Code: DQA Regulation Number: 21 CFR 870.2700 Device Class: II Panel: Anesthesiology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

## 2.4 Device Description

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection

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### Premarket Notification 510(k) Submission—Section II 510(k) Summary

process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit.

Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. 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 enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel.

The subject 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.

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## 2.5 Comparison list of the technological characteristics

Table II-1 Performance Specification Comparison Table between the Subject Device and Predicate Device

| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------|
| Model | MD300C19 | MD300CI218 | - | |
| Item | Pulse Oximeter | Fingertip Pulse Oximeter | - | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | √ | |
| Classification | II | II | √ | |
| Device Classification Name | Oximeter | Oximeter | √ | |
| Product Code | DQA | DQA | √ | |
| Indications for use | The Pulse Oximeter is a handheld<br>non-invasive device intended for<br>spot-checking of oxygen saturation of<br>arterial hemoglobin (SpO2) and Pulse<br>Rate of adult, adolescent child and infant<br>patients in hospitals, hospital-type<br>facilities and homecare. The device is not | The Fingertip Pulse Oximeter<br>MD300CI218 is a handheld<br>non-invasive device intended for<br>spot-checking of oxygen saturation of<br>arterial hemoglobin<br>(SpO2) and Pulse Rate of adult,<br>adolescent, child and infant patients in | Difference | |
| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
| Model | MD300C19 | MD300CI218 | - | |
| | intended for continuous monitoring, use<br>during motion or use with low perfusion.<br>The device is intended for reuse. The<br>device is wearing on fingertips while<br>using | hospitals, hospital-type facilities and<br>homecare environment. | | |
| Components | Power supply module, detector and<br>emitter LED, signal collection and<br>processor module, display module, user<br>interface and button control. | Power supply module, detector and<br>emitter LED, signal collection and<br>processor module, display module,<br>Bluetooth module, user interface and<br>button control. | Difference<br>2 | |
| Design Principle | The pulse oximeter works by applying a<br>sensor to a fingertip. The sensor contains<br>a dual light source and photo detector.<br>The one wavelength of light source is<br>660nm, which is red light; the other is<br>905nm, which is infrared-red light. Skin,<br>bone, tissue and venous vessels normally<br>absorb a constant amount of light over | The fingertip pulse oximeter works by<br>applying a sensor to a pulsating<br>arteriolar vascular bed. The sensor<br>contains a dual light source and photo<br>detector. The one wavelength of light<br>source is 660nm, which is red light; the<br>other is 905nm, which is infrared-red<br>light. Skin, bone, tissue and venous | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
| Model | MD300C19 | MD300CI218 | - | |
| | time. The photo detector in finger sensor<br>collects and converts the light into<br>electronic signal which is proportional to<br>the light intensity. The arteriolar bed<br>normally pulsates and absorbs variable<br>amounts of light during systole and<br>diastole, as blood volume increases and<br>decreases. The ratio of light absorbed at<br>systole and diastole is translated into an<br>oxygen saturation measurement. This<br>measurement is referred to as SpO2. | vessels normally absorb a constant<br>amount of light over time. The photo<br>detector in finger sensor collects and<br>converts the light into electronic signal<br>which is proportional to the light<br>intensity. The arteriolar bed normally<br>pulsates and absorbs variable amounts<br>of light during systole and diastole, as<br>blood volume increases and decreases.<br>The ratio of light absorbed at systole<br>and diastole is translated into an oxygen<br>saturation measurement. This<br>measurement is referred to as SpO2. | | |
| Measurement<br>Wavelength | Red | $660\pm3$ nm | $660\pm3$ nm | √ |
| | Infrared | $905\pm10$ nm | $905\pm10$ nm | √ |
| | Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different |
| Performance Specification | Model | MD300C19 | MD300CI218 | - |
| | Display Type | LED | OLED | Difference<br>3 |
| | 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<br>Range | 0~100% | 0~100% | - |
| | SpO2<br>Measurement<br>Range | 70%~100% | 70%~100% | √ |
| | SpO2 Accuracy | 70%~100%, ±2%;<br>0~69% no definition | 70%~100%, ±2%;<br>0~69% no definition | √ |
| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
| Model | MD300C19 | MD300CI218 | - | |
| SpO2<br>Resolution | 1% | 1% | √ | |
| PR Display<br>Range | 0bpm~255bpm | 30bpm~250bpm | Difference<br>4 | |
| PR<br>Measurement<br>Range | 30bpm~250bpm | 30bpm~250bpm | √ | |
| PR Accuracy | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | √ | |
| PR Resolution | 1bpm | 1bpm | √ | |
| Transmitter | NA | Bluetooth Compliance:<br>Version 4.0 | Difference<br>5 | |
| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
| Model | MD300C19 | MD300CI218 | - | |
| Environment | Operating<br>Temperature | 0°C~40°C | 5°C~40°C | |
| | Storage/<br>Transport<br>temperature | -25°C~+70°C | -25°C~+70°C | Difference<br>6 |
| | Relative<br>Humidity | 15%~93% no condensation in operation;<br>≤93% no condensation in<br>storage/transport | 15%~93% no condensation in<br>operation;<br>≤93% no condensation in<br>storage/transport | |
| | Atmosphere<br>Pressure | 70kPa~106kPa | 70kPa~106kPa | |
| Contacting<br>Material | Battery Cover | ABS | ABS | √ |
| | Enclosure | ABS | ABS | √ |
| | Lens | PMMA | PMMA | √ |
| Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | |
| Model | MD300C19 | MD300CI218 | - | |
| Button | Silica gel pad | ABS | Difference 7 | |
| Fingertip<br>Cushion | Silica gel pad | Silica gel pad | √ | |
| Testing | Laboratory<br>Testing | ISO 80601-2-61 | ISO 80601-2-61 | √ |
| | Electrical Safety | Conformed to IEC60601-1, IEC<br>60601-1-11 | Conformed to IEC60601-1, IEC<br>60601-1-11 | √ |
| | Electromagnetic<br>Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | √ |
| | Software | Compliance with FDA Guidance for the<br>content of Premarket Submissions for<br>Software Contained in Medical Devices | Compliance with FDA Guidance for the<br>content of Premarket Submissions for<br>Software Contained in Medical Devices | √ |
| Label and Labeling | Compliance with the Guidance of pulse<br>oximeter-premarket notification issued on<br>March 4 2013 | Compliance with the Guidance of pulse<br>oximeter-premarket notification issued<br>on March 4,2013 | √ | |

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### Premarket Notification 510(k) Submission-Section II 510(k) Summary

#### Difference 1: Indications for use ●

Compared with the intended use of predicate device, the subject device increases the description of the application location, application conditions and use frequency. The subject device has been verification and validation and the results could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

#### ● Difference 2: Components

The components of subject device are similar with predicate device but it does not have the Bluetooth module. The Bluetooth module is the independent module that does not affect other function of device. In addition, the subject device has been verification and validation and the results could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

#### ● Difference 3: Display Type

The subject device has the different display type with the predicate device. The subject device is configured with the LED display; the predicate device is using the OLED display. The varies display type is due to different marked strategy. In addition, the subject device has been verification and validation and the result could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

#### ● Difference 4: PR Display Range

The subject device has the different pulse rate display range with the predicate device. The subject device pulse rate display range is Obpm~255bpm which the predicate device is 30bpm~250bpm. The pulse rate display range of the subject device was verified according to IEC 60601-1 and ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

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

#### Difference 5: Transmitter ●

The subject device does not have the Bluetooth function which is different from predicate device. The Bluetooth is the independent function module; it will not affect other functions. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

#### ● Difference 6: Environment

The Operating Temperature of subject device is different with the predicate device and other environment requirements are same. The lower limit operating temperature of subject device is 0℃ which the predicate device is 5℃. However, the operating temperature of subject device has been verification according to standard ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.

#### ● Difference 7: Contacting Material

The contact material of subject device is different with the predicate device. All of the contact materials of the proposed device have been done the biocompatibility test per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safety and effectiveness.

## 2.6 Indications for use

The Pulse Oximeter 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. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

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The Pulse Oximeter MD300C19 was supported by both laboratory and clinical accuracy 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 Pulse Oximeter MD300C19 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- IEC60601-1-11: 2015, AMD1:2020 Medical electrical equipment-Part 1-11: General ● requirements for basic safety and essential performance- Collateral Standard : Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC60601-1-2:2014, AMD1:2020 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performan…