Pulse Oximeter

K190869 · Shenzhen Aeon Technology Co., Ltd. · DQA · Sep 13, 2019 · Cardiovascular

Device Facts

• Record ID: K190869
• Device Name: Pulse Oximeter
• Applicant: Shenzhen Aeon Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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

Battery-powered fingertip pulse oximeter; measures SpO2 and pulse rate via photoplethysmography. Sensor uses dual-wavelength light (660 nm red, 905 nm infrared) applied to arteriolar vascular bed. Photodetector converts light intensity into electronic signals; ratio of light absorption during systole and diastole determines SpO2. Device consists of PCB, OLED/LED screen, and plastic shell. Used for spot-checking by patients or clinicians in home or clinical settings. Provides numerical display of SpO2 and PR; no alarms; not for life support. Benefits include non-invasive, portable monitoring of oxygenation status.

Clinical Evidence

Clinical validation performed per ISO 80601-2-61 on 12 healthy adult volunteers (4 male, 8 female) with varying skin pigmentations. 1440 data points compared against laboratory CO-Oximeter reference. SpO2 accuracy (Arms) was ±3% across 70-100% range. Bland-Altman analysis confirmed agreement within 95% limits.

Technological Characteristics

Battery-powered (2 AAA) fingertip device. Sensing: dual-wavelength (660 nm red, 905 nm IR) photoplethysmography. Materials: plastic shell, PCB. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-5/10. Connectivity: None (standalone). Display: OLED/LED.

Indications for Use

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

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

• AMEMO INC. Fingertip Pulse Oximeter (K153021)

Submission Summary (Full Text)

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September 13, 2019

Shenzhen Aeon Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District Shenzhen, 518067 Cn

Re: K190869

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 5, 2019 Received: August 5, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 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,

for 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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Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

Device Name Pulse Oximeter

## K190869

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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) Summary

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

# K190869

## Prepared Date: 2019/03/29

### Submission sponsor 1.

Name: Shenzhen Aeon Technology Co., Ltd.

Address: RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong, No.133 of Yiyuan road, Nantou Street, Nanshan District, Shenzhen, P.R China.

Contact person: Xie Hua

Title: General Manager

E-mail: [e-mail]

Tel: [phone]

### 2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A. NanShan Medical devices Industrial Park Nanshan District, Shenzhen,

Guangdong, P.R. China 518067

Contact person: Kevin Wang

E-mail: [e-mail]

Tel: [phone]

| Trade/Device Name | Pulse Oximeter |
|-------------------|---------------------------------------------------|
| Model | A310, A310L, A320, A330, A330N, A340, A340L, A350 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |

### 3. Subject Device Information

### Predicate Device 4.

By submission of the Traditional 510(k), Shenzhen Aeon Technology Co., Ltd. is requesting clearance for Pulse Oximeter. It is comparable to the following legally marketed system:

- 1. AMEMO INC. Fingertip Pulse Oximeter under K153021.

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### 5. Device Description

The Pulse Oximeter is a battery powered device 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 a dual light source and photo detector. The one wavelength of light source is 660 mm, 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.

This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell.

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

### 6. Intended use & Indication 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.

| Features | Subject Device<br>Pulse Oximeter | Predicate Device K153021<br>Fingertip Pulse Oximeter | Remark |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant | Shenzhen Aeon Technology Co., Ltd. | AMEMO INC | / |
| Classification<br>Regulation | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Classification<br>and Code | Class II,<br>DQA | Class II,<br>DQA | Same |
| Common<br>name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | Same |
| Intended use | The Pulse Oximeter is a<br>non-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 is<br>indicated for use in adult patients<br>in clinical institution and home | Fingertip Pulse Oximeter A310 is<br>a non-invasive device intended<br>for spot checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate<br>(PR). This portable device is<br>indicated for use in adult patients<br>in hospitals. | Different 1) |
| Features | Subject Device<br>Pulse Oximeter<br>environments. | Predicate Device K153021<br>Fingertip Pulse Oximeter | Remark |
| Patient<br>Populations | Adults | Adults | Same |
| Principle | The device displays numerical<br>values for functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate by<br>measuring the absorption of red<br>and infrared (IR) light passing<br>through perfused tissue. Changes<br>in the absorption caused by the<br>pulsation of blood in the vascular<br>bed are used to determine oxygen<br>saturation and pulse rate. | The device displays numerical<br>values for functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate by<br>measuring the absorption of red<br>and infrared (IR) light passing<br>through perfused tissue. Changes<br>in the absorption caused by the<br>pulsation of blood in the vascular<br>bed are used to determine oxygen<br>saturation and pulse rate. | Same |
| LED<br>wavelength | Red=660 nm;<br>Infrared=905 nm; | Red= 660 nm;<br>Infrared=905 nm; | Same |
| Power source | 2 AAA alkaline batteries | 2 AAA alkaline batteries | Same |
| Display data | SpO2%, PR | SpO2%, PR | Same |
| SpO2<br>Measuring<br>Range | 35%-100% | 0%-100% | Similar |
| SpO2<br>Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70~100%, ±3%;<br>0-69%, unspecified; | 70~100%, ±3%;<br>0-69%, unspecified; | Same |
| PR Measuring<br>Range | 30-250 bpm | 30-235 bpm | Similar |
| PR Resolution | 1 bpm | 1 bpm | Same |
| PR Accuracy | ± 2 bpm | 30-99 bmp, ± 2 bpm<br>100-235 bmp, ± 2% | Different 2) |
| Standard | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61<br>ISO 10993-5<br>ISO 10993-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61<br>ISO 10993-5<br>ISO 10993-10 | Same |

### 7. Comparison to the Predicate Device

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Justification of difference:

Different 1): The subject device is intended for use in hospital and home environments. The performance testing shows that the subject device complies with home-used standard IEC 60601-1-11. This difference does not raise any different questions of safety or effectiveness.

Different 2): The subject device is more accurate than predicate over the declared pulse rate range. According to pulse rate testing results, the subject device is demonstrated compliant with the declared range and accuracy.

### Performance Data 8.

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 battery of testing included the following tests:

- . Cytotoxicity
- . Sensitization
- Irritation ●

The Pulse Oximeter is considered surface contacting for a prolonged duration (24 hours to 30 days).

# Non-clinical data

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

- IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2: 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: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- IEC 60601-1-11: 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
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- FDA Guidance for Pulse Oximeters - Premarket Notification Submissions [510(k)s]

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## Clinical data

The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult volunteers (4 men and 8 women) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The subjects include 3 people with medium skin, and 3 with dark skin pigmentation. Total 1440 data points were sampled for analysis.

The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range 70%-100%.

Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the standard; and the Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement.

The SpO2 accuracy result showed that the root-mean-square (Arms) value of the Fingertip Pulse Oximeter is ±3% with the saturations from 70% to 100%.

#### 9. Conclusion

It has been shown in this 510(k) submission that the subject device and the predicate device have the same intended use, and the difference in technological characteristics do not raise different questions regarding safety or effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the predicate device in terms of design, components, materials, principals of operation, biocompatibility, and performance characteristics.