Pulse Oximeter

K220101 · Beijing Choice Electronic Technology Co., Ltd. · DQA · Mar 8, 2023 · Cardiovascular

Device Facts

• Record ID: K220101
• Device Name: Pulse Oximeter
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 8, 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 hospitals, hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).

Device Story

Handheld, battery-powered pulse oximeter (models MD300CN130, MD300CN356) for non-invasive spot-checking of SpO2 and pulse rate. Uses dual-wavelength LED (660nm red, 905nm infrared) and photodetector to measure light absorption in pulsating arteriolar vascular bed; calculates SpO2 based on systolic/diastolic absorption ratios. Operated by clinicians or patients in hospitals or homecare. Displays SpO2, pulse rate, pulse bar, and (for MD300CN356) perfusion index and waveforms. Provides immediate physiological data to assist in patient monitoring. Benefits include portable, non-invasive assessment of oxygenation status.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61 Annex EE. 11 healthy adult volunteers (ages 20-42, diverse pigmentation) evaluated under steady-state, non-motion conditions. Induced hypoxia levels ranged from 100% to 70% SaO2. SpO2 accuracy compared against arterial blood co-oximeter reference. Results confirmed performance specifications met.

Technological Characteristics

ABS enclosure, silicone gel fingertip cushion. Dual-wavelength LED (660nm/905nm) sensing. Battery-powered (2xAAA). Dimensions accommodate finger thickness 0.8-2.2cm. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-5/10.

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 use under motion or low perfusion conditions.

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 (K181503)

Submission Summary (Full Text)

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March 8, 2023

Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director 2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan Beijing, Beijing 100041 China

Re: K220101

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 21, 2023 Received: March 2, 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.

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

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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 mediation-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,

James J. Lee -S

James J. Lee, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220101

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 to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).

Type of Use (Select one or both, as applicable)

| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------|
| ☐ 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.

#### Submitter Information 1.

### Manufacturer

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 BEIJING, 100041, P.R. China.

#### Contact Person

Haiying Zhao

Beijing Choice Electronic Technology Co., Ltd.

2nd Floor, 3rd Floor and Room 410-412 4th Floor, No. 9 Shuangyuan Road, Shijingshan District BEIJING, 100041, P.R. China.

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Date prepared: November 10, 2021

#### 2. Identification of Proposed Device

Device Common Name: Oximeter

Device Trade/Proprietary Name: Pulse Oximeter

Model: MD300CN130, MD300CN356

Classification Name: Oximeter

Regulation Number: 870.2700

Product Code: DQA

Regulatory Class: Class II

Panel: Anesthesiology

#### 3. Device Description

The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted

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1-10 level.

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.

The enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel.

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.

The device is for prescription.

The device does not contain drug or biological products.

#### 4. Identification of Predicate Device

Trade/Proprietary Name: Fingertip Pulse Oximeter

Model: MD300CI218

Common Name: Pulse Oximeter

K-number: K181503

Regulation Number: 21 CFR 870.2700

Device Class: II

Product Code: DQA

Panel: Anesthesiology

Manufactured by: Beijing Choice Electronic Technology Co., Ltd.

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#### ડ. Substantially Equivalent (SE) Comparison

Table 1 Comparison Table between the Proposed Device and Predicate Device

| Comparison Elements | Proposed Device | | Predicate Device<br>(K181503) | Remark | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | MD300CN130 | MD300CN356 | | | |
| Product Name | Pulse Oximeter | Pulse Oximeter | Fingertip Pulse Oximeter | / | |
| Model | MD300CN130 | MD300CN356 | MD300CI218 | / | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | Same | |
| Regulatory Class | II | II | II | Same | |
| Classification Name | Oximeter | Oximeter | Oximeter | Same | |
| Product Code | DQA | DQA | DQA | Same | |
| 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 hospitals, hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches). | | 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 hospitals, hospital-type facilities and homecare environment. | Similar 1 | |
| Intended Population | Adult, adolescent, child and infant patients | | Adult, adolescent, child and infant patients | Same | |
| Components | Power supply module, detector and emitter LED, signal collection and processor module, display module, user interface and button control. | | Power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. | Similar, Analysis 2 | |
| Design Principle | The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains | | The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular | Same | |
| Comparison Elements | Proposed Device | | Predicate Device<br>(K181503) | Remark | |
| | MD300CN130 | MD300CN356 | | | |
| | a dual light source and photo detector. The one<br>wavelength of light source is 660nm, which is red<br>light; the other is 905nm, which is infrared-red light.<br>Skin, bone, tissue and venous vessels normally<br>absorb a constant amount of light over time. The<br>photo detector in finger sensor collects and converts<br>the light into electronic signal which is proportional<br>to the light intensity. The arteriolar bed normally<br>pulsates and absorbs variable amounts of light during<br>systole and diastole, as blood volume increases and<br>decreases. The ratio of light absorbed at systole and<br>diastole is translated into an oxygen saturation<br>measurement. This measurement is referred to as<br>SpO2. | | bed. The sensor contains a dual light<br>source and photo detector. The one<br>wavelength of light source is 660nm,<br>which is red light; the other is 905nm,<br>which is infrared-red light. Skin, bone,<br>tissue and venous vessels normally absorb<br>a constant amount of light over time. The<br>photo detector in finger sensor collects<br>and converts the light into electronic<br>signal which is proportional to the light<br>intensity. The arteriolar bed normally<br>pulsates and absorbs variable amounts of<br>light during systole and diastole, as blood<br>volume increases and decreases. The ratio<br>of light absorbed at systole and diastole is<br>translated into an oxygen saturation<br>measurement. This measurement is<br>referred to as SpO2. | | |
| Measurement | Red | 660± 3nm | | 660± 3nm | |
| Wavelength | Infrared | 905± 10nm | | 905± 10nm | |
| Design | Display Type | LED | LCD | OLED | Different □ Analysis 3 |
| Features | Working Time | continuously operated<br>as long as 18 hours | continuously operated as<br>long as 20 hours | continuously operated as long as 18 hours | Similar □ Analysis 4 |
| | Display Mode | 2 display modes | 7 display modes | 2 display modes | Similar, Analysis 5 |
| Power supply | | 2*AAA alkaline batteries | | 2*AAA alkaline batteries | Same |
| Performance Data | | SpO2. PR | SpO2. PR. PI | SpO2. PR | Similar, Analysis 6 |
| Comparison Elements | Proposed Device | | Predicate Device<br>(K181503) | Remark | |
| | MD300CN130 | MD300CN356 | | | |
| SpO2 | 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 | PR Display Range | 30 bpm~250 bpm | 30 bpm~250 bpm | | |
| | PR Measurement Range | 30 bpm~250 bpm | 30 bpm~250 bpm | | |
| | PR Accuracy | 30 bpm~99 bpm, ± 2 bpm;<br>100 bpm~250 bpm, ± 2% | 30 bpm~99 bpm, ± 2 bpm;<br>100 bpm~250 bpm, ± 2% | | |
| | PR Resolution | 1 bpm | 1 bpm | | |
| PI | Display range | NA | 0.1%~20% | NA | |
| | Measure range | NA | 0.3~20.0% | NA | |
| | Resolution | NA | 0.1% | NA | |
| Transmitter | | NA | Bluetooth Compliance: Version 4.0…