Pulse Oximeter

K201294 · Guangdong Long Yao Electronic Technology Co., Ltd. · DQA · Nov 27, 2020 · Cardiovascular

Device Facts

• Record ID: K201294
• Device Name: Pulse Oximeter
• Applicant: Guangdong Long Yao Electronic Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

Device Story

Device is a non-invasive, portable fingertip pulse oximeter; measures SpO2 and pulse rate via photoplethysmography. Sensor uses dual light sources (660 nm red, 905 nm infrared) applied to pulsating arteriolar vascular bed; photodetector converts light intensity into electronic signals. Ratio of light absorption during systole and diastole determines SpO2. Device powered by connection to smartphone; results displayed on Apple iPhone or Android phone. Used by clinicians or patients for spot-checking; no alarms; not for life-support. Output provides numerical SpO2 and PR values to assist in health monitoring.

Clinical Evidence

Clinical hypoxia testing performed on human adult volunteers per ISO 80601-2-61. Accuracy validated against co-oximetry (SaO2). Results support accuracy claims for the specified saturation range.

Technological Characteristics

Fingertip pulse oximeter; dual-wavelength (660nm/905nm) LED light source; photodetector sensor. Powered via smartphone connection. Biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 80601-2-61 (performance).

Indications for Use

Indicated for spot checking functional oxygen saturation (SpO2) and pulse rate (PR) in adult patients in clinical and home 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 (K190869)

Submission Summary (Full Text)

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November 27, 2020

Guangdong Long Yao Electronic Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K201294

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: October 28, 2020 Received: October 30, 2020

Dear Kevin Wang:

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 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,

Todd Courtney Assistant Director DHT1C: Division of ENT, 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

Device Name Pulse Oximeter

Indications for Use (Describe)

The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="border: 1px solid black; display: inline-block; width: 13px; height: 13px; text-align: center; vertical-align: middle;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black; display: inline-block; width: 13px; height: 13px; text-align: center; vertical-align: middle;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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## 510(K) Summary

### Prepared in accordance with the requirements of 21 CFR Part 807.92

# K201294

### Prepared Date: 2020/11/16

#### 1. Submission sponsor

Name: Guangdong Long Yao Electronic Technology Co., Ltd.

Address: Unit A03, 2nd Floor, No. 19, Huali Road, Tianhe District, Guangzhou, Guangdong, P.R. China Contact person: Lei Wang

Title: General Manager

E-mail: [e-mail]

Tel: [phone]

#### 2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang

E-mail: [e-mail]

Tel: [phone]

| Trade/Device Name | Pulse Oximeter |
|-------------------|---------------------------------|
| Model | LYOX01 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |

#### Subject Device Information 3.

#### 4. Predicate Device

Manufacturer: Shenzhen Aeon Technology Co., Ltd. Device name: Pulse Oximeter 510(K) Number: K190869

#### 5. Device Description

The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains

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a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 Pulse Oximeter is powered by smart phone and the measurement result will display on an Apple iPhone and Android phone.

The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for lifesupporting or life-sustaining.

#### Intended use & Indication for use 6.

The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

| Features | Subject Device<br>Pulse Oximeter | Predicate Device K190869<br>AEON Pulse Oximeter | Compariso<br>n | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Applicant | Guangdong Long Yao<br>Electronic Technology Co.,<br>Ltd. | Shenzhen Aeon Technology<br>Co., Ltd. | / | |
| Classification<br>Regulation | 21CFR 870.2700 | 21CFR 870.2700 | Same | |
| Classification and<br>Code | Class II, DQA | Class II, DQA | Same | |
| Common name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | Same | |
| Intended use | The Pulse Oximeter is a non-<br>invasive device intended for<br>spot checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR). This portable device<br>is indicated for use in adult<br>patients in clinical institution<br>and home environments. | The Pulse Oximeter is a non-<br>invasive device intended for<br>spot checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR). This portable device<br>is indicated for use in adult<br>patients in clinical institution<br>and home environments. | Same | |
| Patient populations | Adults | Adults | Same | |
| Principle | The device displays numerical<br>values for functional oxygen<br>saturation of arterial | The device displays numerical<br>values for functional oxygen<br>saturation of arterial | Same | |
| Features | | Subject Device | Predicate Device K190869<br>AEON Pulse Oximeter | Comparison |
| | | Pulse Oximeter | | n |
| | | hemoglobin (SpO2) and pulse<br>rate by measuring the<br>absorption of red and infrared<br>(IR) light passing through<br>perfused tissue. Changes in the<br>absorption caused by the<br>pulsation of blood in the<br>vascular bed are used to<br>determine oxygen saturation<br>and pulse rate. | hemoglobin (SpO2) and pulse<br>rate by measuring the<br>absorption of red and infrared<br>(IR) light passing through<br>perfused tissue. Changes in the<br>absorption caused by the<br>pulsation of blood in the<br>vascular bed are used to<br>determine oxygen saturation<br>and pulse rate. | |
| | Light Emitting | Red: 660<br>Infrared: 905nm | Red: 660<br>Infrared: 905nm | Same |
| | Power source | Cell phone | 2 AAA alkaline batteries | Different (1) |
| | Display data | SpO2%, PR | SpO2%, PR | Same |
| | SpO2 Measuring<br>Range | 50%-100% | 35%-100% | Different (2) |
| | SpO2 Resolution | 1% | 1% | Same |
| | SpO2 Accuracy | 70~100%, ±3%;<br>0-69%, unspecified; | 70~100%, ±3%;<br>0-69%, unspecified; | Same |
| | PR Range | 30 bmp – 240 bmp | 30 bmp – 250 bmp | Different (3) |
| | PR Resolution | 1 bpm | 1 bpm | Same |
| | PR Accuracy | ± 1 | ± 2 | Different (4) |
| | Sterile | No | No | Same |
| | Application site | Finger | Finger | Same |
| | Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| | EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| | Performance | Complied with ISO 80601-2-<br>61 | Complied with ISO 80601-2-<br>61 | Same |
| Biocompatibility | Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| | Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
| | Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |

#### Comparison to the Predicate Device 7.

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Justifications for differences between proposed device and the predicate device are shown as below: Different (1): The power source is different. The subject device is powered by cell phone through connector cable. The predicate device is powered by internal battery. The electricity safety testing was conducted according to IEC 60601-1: 2012. Thus, this difference does not raise different questions of safety and effectiveness.

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Different (2): The SpO2 measuring range is different. The SpO2 measurement of the subject device was validated according to ISO 80601-2-61. Thus, this difference does not raise different questions of safety and effectiveness.

Different (3) & (4): The pulse rate measuring range and accuracy is different. The PR measurement of the subject device was validated according to declared range and accuracy. Thus, this difference does not raise different questions of safety and effectiveness.

#### 8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The testing included the following:

- . Cytotoxicity
- Sensitization .
- Irritation .

The subject devices are considered surface contacting for a duration of not exceed 24 hours.

### Non-clinical data

The Pulse Oximeter has been tested according to the following standards:

- . IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment.

### Clinical data

Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:

- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and . Drug Administration Staff

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter

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versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

## 9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device. The subject device has the same intended use as the predicate device, and the technological differences do not raise different questions of safety and effectiveness.