Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

K243049 · Hunan Accurate Bio-Medical Technology Co., Ltd. · DQA · Jan 2, 2025 · Cardiovascular

Device Facts

• Record ID: K243049
• Device Name: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
• Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, 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. The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, 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 pulse oximeter; models FS20P, FS20C, FS10C. Device uses transmittance optical sensor (red 660nm, infrared 905nm) to measure SpO2 and pulse rate via fingertip. Signal collection/processing module (MCU) calculates values; results displayed on OLED/LED screen. Used in hospitals, hospital-type facilities, and homecare by clinicians or patients for spot-checking. Not for continuous monitoring, motion, or low perfusion. Provides immediate physiological data to assist in clinical assessment of oxygenation status.

Clinical Evidence

Clinical studies conducted per ISO 80601-2-61. FS20P study: 10 healthy adult volunteers (ages 22-30, Fitzpatrick 1-6), ARMS 1.70% (70-100% range). FS20C study: 13 healthy adult volunteers (ages 22-30, Fitzpatrick 1-6), ARMS 1.71% (70-100% range). Comparator: arterial blood CO-Oximetry. Bench testing included IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-61.

Technological Characteristics

Battery-powered (2xAAA). Transmittance optical sensor (660nm/905nm). Materials: ABS (enclosure/button), PC (lens), Silica gel (fingertip cushion). Connectivity: None. Sterilization: Not specified. Software: Embedded MCU for signal processing. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate. FS20P: adolescent, child, and infant patients. FS20C/FS10C: adult patients. Settings: hospitals, hospital-type facilities, homecare. Contraindications: continuous monitoring, use during motion, use with 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

• Pulse Oximeter, Model: MD300C19 (K230172)

Submission Summary (Full Text)

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January 2, 2025

Hunan Accurate Bio-Medical Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K243049

Trade/Device Name: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: September 27, 2024 Received: December 6, 2024

Dear Jie Yang:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 Anesthesia, Respiratory, and Sleep 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

Submission Number (if known)

### K243049

Device Name

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Indications for Use (Describe)

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, 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.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, 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.

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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# 510(K) Summary

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

## Prepared Date: 2024/09/27

#### 1. Submission sponsor

Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, 410208 Changsha, Hunan Province, PEOPLE'S REPUBLIC OF China Contact person: Zhang Li Title: General Manager E-mail: [e-mail] Tel: [phone]

#### 2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China

Contact person: Yang Jie

E-mail: yangjie(@chonconn.com

Tel: [phone]

| Trade/Device Name | Pulse Oximeter |
|-------------------|---------------------------------|
| Model | FS20P, FS20C,FS10C |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |

#### Subiect Device Information 3.

#### 4. Predicate Device

Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Device name: Pulse Oximeter, Model: MD300C19 510(K) Number: K230172

#### 5. 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

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device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.

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

The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, 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.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult 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.

| ITEM | Proposed Device<br>Pulse Oximeter<br>Model: FS20P,<br>FS20C,FS10C | Predicate Device<br>Pulse Oximeter<br>Model: MD300C19<br>K230172 | Comparison Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacture | Hunan Accurate Bio-Medical<br>Technology Co., Ltd. | Beijing Choice Electronic<br>Technology Co., Ltd. | Same |
| Indications for Use | The Pulse Oximeter FS20P is<br>a handheld non-invasive<br>device intended for spot-<br>checking of oxygen saturation<br>of arterial hemoglobin<br>(SpO2) and Pulse Rate of<br>adolescent, child and infant<br>patients in hospitals, hospital-<br>type facilities and<br>homecare. The device is not<br>intended for continuous<br>monitoring, use during<br>motion or use with low<br>perfusion. The device is | The Pulse Oximeter is a<br>handheld non-invasive device<br>intended for spot-checking of<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and Pulse<br>Rate of adult, adolescent child<br>and infant patients in hospitals,<br>hospital-type facilities and<br>homecare. The device is not<br>intended for continuous<br>monitoring, use during motion<br>or use with low perfusion. The<br>device is intended for reuse. | Same |
| | | | |
| | intended for reuse. The<br>device is wearing on<br>fingertips while using.<br><br>The Pulse Oximeter FS20C<br>and FS10C is a handheld non-<br>invasive device intended for<br>spot-checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and Pulse<br>Rate of adult patients in<br>hospitals, hospital-type<br>facilities and homecare. The<br>device is not intended for<br>continuous monitoring, use<br>during motion or use with<br>low perfusion. The device is<br>intended for reuse. The<br>device is wearing on<br>fingertips while using. | The device is wearing on<br>fingertips while using. | |
| Population | FS20C and FS10C: adult<br>FS20P: adolescent, child and<br>infant patients. | adult, adolescent, child and<br>infant patients | Similar |
| Components | Power supply module,<br>detector and emitter LED,<br>signal collection and<br>processor module, display<br>module, user interface and<br>button control. | Power supply module, detector<br>and emitter LED, signal<br>collection and processor<br>module, display module, user<br>interface and button control. | Same |
| Type of SpO2<br>Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | Same |
| Application<br>Site | Finger | Finger | Same |
| Measurement | Red (660 nm)<br>Infrared (905 nm) | Red (660 nm)<br>Infrared (905 nm) | Same |
| Display Type | OLED or LED | LED | Similar |
| Power<br>Supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | Same |
| Display Data | SPO2 , PR | SPO2 , PR | Same |
| SPO2 | FS20C,FS20P:<br>SpO2 Display Range:<br>0%~100%<br>Measurement range:<br>70~100%<br>Accuracy: 70%~100%: ±2%;<br>0~69% no definition<br>FS10C:<br>SpO2 Display Range:<br>0%~99%<br>Measurement range:<br>70~99%<br>Accuracy: 70%~99%: ±2%;<br>0~69% no definition | SpO2 Display Range:<br>0%~100%<br>Measurement range:<br>70%~100%<br>Accuracy: 70%~100%: ±2%;<br>0~69% no definition | Similar |
| PR | PR Display Range<br>25~250bpm<br>Measurement range:<br>25~250bpm<br>Resolution: 1bpm<br>Accuracy:±3bpm; | PR Display Range<br>0~255bpm<br>Measurement range:<br>30~250bpm<br>Resolution: 1bpm<br>Accuracy: 30~99bpm, ±2bpm;<br>100~250bpm, ±2% | Similar |
| Environment<br>Requirements | Operating Temperature:<br>5~40°C<br>Ambient Humidity:<br>10%~95%, no condensation<br>Storage/Transportation: -<br>20°C~60°C Ambient<br>Humidity: 10%~95% no<br>condensation | Operating Temperature:<br>0~40°C<br>Ambient Humidity: 15%~93%,<br>no condensation<br>Storage/Transportation: -<br>25°C~70°C Ambient Humidity:<br><=93% no condensation | Similar |
| Contacting<br>Material | Enclosure/Battery cover/<br>Button: ABS<br>Lens: PC<br>Fingertip cushion: Silica gel | Enclosure/Battery cover: ABS<br>Lens: PMMA<br>Button/Fingertip cushion:<br>Silica gel pad | Similar |
| Electrical<br>Safety | Conformed to IEC60601-1,<br>IEC 60601-1-11 | Conformed to IEC60601-1,<br>IEC 60601-1-11 | Same |

#### 7. Comparison to the Predicate Device

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#### 8. Non-clinical 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".

## Bench testing

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
- . IEC 60601-1-11 Edition 2.0 2015-01Medical 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
- 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

After Institutional Review Board (IRB) approval, 10 healthy female adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6) were included in the study to evaluate the SpO2 accuracy performance of the FS20P Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood

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oxygen saturation levels as compared to arterial blood CO-Oximetry.

The SpO2 accuracy performance results showed FS20P Pulse Oximeter to have an ARMS of 1.70% during steady state conditions over the range of 70-100%.

After Institutional Review Board (IRB) approval, 13 healthy adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6) were included in the study to evaluate the SpO2 accuracy performance of the FS20C Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.

The SpO2 accuracy performance results showed FS20C Pulse Oximeter to have an ARMS of 1.71% during steady state conditions over the range of 70-100%.

## 9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.