YUWELL Finger Pulse Oximeter

K212385 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · DQA · Aug 16, 2022 · Cardiovascular

Device Facts

• Record ID: K212385
• Device Name: YUWELL Finger Pulse Oximeter
• Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.

Device Story

Device is a portable, non-invasive fingertip pulse oximeter; measures SpO2 and pulse rate via photoelectric sensor. User inserts finger into clamp; device uses red and infrared light absorption (Lambert-Beer law) to detect hemoglobin oxygenation. Electronic circuits and microprocessor process signals; results displayed on OLED/LED screen. Used in home and hospital settings by patients or clinicians for spot-checking. No alarms; powered by two AAA batteries. Provides immediate physiological data to assist in health status assessment; benefits patient by enabling convenient, non-invasive oxygen saturation monitoring.

Clinical Evidence

Clinical study conducted on 12 healthy adult volunteers (ages 18-50, varying pigmentation) under steady-state, non-motion conditions. Induced hypoxia used to achieve saturation levels between 70-100%. Accuracy compared against arterial blood CO-Oximetry. Results demonstrated an Arms (root-mean-square error) of less than 3% over the 70-100% range.

Technological Characteristics

Photoelectric Oxyhemoglobin Inspection Technology using red (660nm) and infrared (905-940nm) light. Components: LED/OLED display, photosensitive element, microprocessor, ABS housing, medical silicone gel cushion. Powered by 2x AAA batteries. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for adults and children (weight >30 kg) for non-invasive, non-sterile, spot-checking of SpO2 and pulse rate in home and hospital settings. Not indicated for continuous monitoring, use during motion, or patients 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

• Fingertip Pulse Oximeter (K101577)

Submission Summary (Full Text)

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August 16, 2022

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Yuzhuo Wang Medical Device Registered Engineer Yunyang Industrial Park Danyang, Jiangsu 212300 China

Re: K212385

Trade/Device Name: YUWELL Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2022 Received: July 18, 2022

Dear Yuzhuo 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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

for Todd Courtney 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212385

Device Name

YUWELL® Finger Pulse Oximeter: YX102, YX103, YX301, YX306

Indications for Use (Describe)

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.

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

#### 1. OWNER/SUBMITTER'S INFORMATION

| Company Name: | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY<br>CO.,LTD. |
|------------------|------------------------------------------------------------------------------|
| Company Address: | Yunyang Industrial Park 212300 Danyang Jiangsu PEOPLE'S<br>REPUBLIC OF CHINA |
| Contact: | Wang, Yuzhuo |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | [e-mail] |
| Date prepared: | July 12, 2022 |

#### 2. TRADE NAME, COMMON NAME, CLASSIFICATION

| Trade Name: | YUWELL® Finger Pulse Oximeter |
|------------------------|-------------------------------|
| Common Name: | Finger Pulse Oximeter |
| Model: | YX102, YX103, YX301, YX306 |
| Product Code : | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K212385 |

#### 3. DENTIFICATION OF PREDICATE DEVICE(S)

The identification of predicates within this submission is as follow:

| Manufacturer: | Beijing Choice Electronic Technology Co., Ltd. |
|------------------------|------------------------------------------------|
| Trade Name: | Fingertip Pulse Oximeter |
| Common Name: | Pulse Oximeter |
| Product Code: | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K101577 |

#### 4、DESCRIPTION OF THE DEVICE

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.

The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured

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value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button

(YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.

#### 5、INTENDED USE

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.

#### 6、TECHNOLOGICAL CHARACTERISTIC

Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer law according to Spectrum Absorption Characteristics of deoxyhaemoglobin (HHb) and Oxyhemoglobin (O2Hb ) in glow and near-infrared zones. Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of light (red light and infrared light) can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown display through process in electronic circuits and microprocessor.

| Description | Subject Device<br>(K212385) | Predicate Device<br>(K101577) | Remark |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | JIANGSU YUYUE MEDICAL<br>EQUIPMENT & SUPPLY<br>CO.,LTD. | Beijing Choice Electronic<br>Technology Co., Ltd. | - |
| Product Name | Finger Pulse Oximeter | Fingertip Pulse Oximeter | - |
| Model | YX102,YX103,YX301,YX306 | MD300C63 | - |
| Intended Use | The YUWELL® Finger Pulse<br>Oximeter is a non-invasive, non-<br>sterile, reusable, spot checking<br>device which can measure and<br>display SpO2 and pulse rate<br>through finger. It is intended for<br>adults and children (weight ><br>30kg) and is expected for home<br>and hospital inspection. The<br>device is not for continuous<br>monitoring, use during motion or<br>for patients with low perfusion. | Fingertip pulse oximeter is a<br>portable, non-invasive devices<br>intended for spot- checking of<br>arterial hemoglobin oxygen<br>saturation (SpO2) and pulse<br>rate of adult and pediatric<br>patient at home, and hospital<br>(including clinical use in<br>internist/surgery, Anesthesia,<br>and intensive care units). Not<br>for continuous monitoring. | Note 1 |
| | | | |
| Patient populations | adults and children (weight >30<br>kg) | adult and pediatric patient | Note 1 |
| Measuring<br>characteristics | Spot-checking<br>Not for continuous monitoring,<br>use during motion or for patients<br>with low perfusion. | Spot-checking<br>Not for continuous<br>monitoring, using during<br>motion or using with low<br>perfusion. | Same |
| Application sites | Finger | Finger | Same |
| Components | Power supply module, detector<br>and emitter LED, signal collection<br>and processor module, display<br>module. | Detector and emitter LED,<br>signal amplify unit, CPU, data<br>display unit and power unit. | Same |
| Product principle | An experience formula of data<br>process is established taking use<br>of Lambert Beer law according to<br>Spectrum Absorption<br>Characteristics of<br>deoxyhaemoglobin(HHb) and<br>Oxyhemoglobin(O2Hb) in glow<br>and near-infrared zones. Operation<br>principle of the instrument is<br>Photoelectric Oxyhemoglobin<br>Inspection Technology is adopted<br>in accordance with Capacity Pulse<br>Scanning and Recording<br>Technology, so that two beams of<br>different wavelength of light (red<br>light and infrared light) can be<br>focused onto human nail tip<br>through perspective clamp finger-<br>type sensor. Then measured signal<br>can be obtained by a<br>photosensitive element,<br>information acquired through<br>which will be shown display<br>through process in electronic<br>circuits and microprocessor. | An mathematical formula is<br>established making use of<br>Lambert Beer Law according<br>to Spectrum Absorption<br>Characteristics of Reductive<br>hemoglobin (RHb) and<br>Oxyhemoglobin (HbO2 ) in<br>glow and near-infrared zones.<br>Operation principle of the<br>instrument: Photoelectric<br>Oxyhemoglobin Inspection<br>Technology is adopted in<br>accordance with Capacity<br>Pulse Scanning and Recording<br>Technology, so that two beams<br>of different wavelength of<br>light (660nm glow and 940nm<br>near infrared light) can be<br>focused onto a human nail tip<br>through a clamping finger-<br>type sensor. A measured signal<br>obtained by a photosensitive<br>element, will be shown on the<br>oximerer's display through<br>process in electronic circuits<br>and microprocessor. | Same |
| Measurement<br>wavelength Red | YX102, YX103, YX306:<br>660 ±8nm | 660± 2nm | Note 2 |
| light | YX301: 660 ± 20nm | | |
| Measurement<br>wavelength-Infrared<br>light | YX102, YX103, YX306: 905 ± 25nm | 940± 10nm | |
| | YX301: 940 ± 25nm | | |
| Display Type | YX102, YX103: LED | | Note 3 |
| | YX301, YX306: OLED | OLED | Same |
| Power Supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | Same |
| Battery Working<br>Time | YX102, YX103, YX306: Two AAA batteries can be operated continuously for 17 hours | Two AAA alkaline batteries can be operated continuously for 30 hours. | Note 4 |
| | YX301: Two AAA batteries can be operated continuously for 45 hours | | |
| Display Content | YX102, YX103: SpO2, PR, Pulse bar, Low battery | SpO2, PR, Power low indicator, Pulse bar graph, Waveform | Note 5 |
| | YX301, YX306: SpO2, PR, Pulse volume wave, Pulse bar, Battery level, Symbol of gravity sensing mode | | |
| User Interface | YX102, YX103: 1 display direction | 4 display directions | Note 6 |
| | YX301, YX306: 4 display directions | | Same |
| SpO2 Display Range | 0%~100% | 0~100% | |
| SpO2 Measurement<br>Range | 70%~100% | 70%~100% | Same |
| SpO2<br>Accuracy | 70%~80%, 80%~90%,<br>90%~100%, ± 2%;<br>< 70%, no definition | 70%~100%, ± 2%;<br>0~69% no definition | Same |
| SpO2 Resolution | 1% | 1% | Same |
| PR Display Range | 25bpm~250bpm | 0bpm~254bpm | |
| PR Measurement<br>Range | 25bpm~250bpm | 30bpm~235bpm | Note 7 |
| PR Accuracy | ±1% or ±1 bpm(larger) | 30bpm~99bpm, ± 2bpm;<br>100bpm~235bpm, ± 2% | |
| PR Resolution | 1bpm | 1bpm | Same |
| Sterile | No | No | Same |
| Operation<br>environment | Ambient temperature:<br>5°C~40°C;<br>Relative humidity: ≤80% ;<br>Atmospheric pressure:<br>860hPa~1060hPa. | Operation Temperature:<br>5°C ~40°C<br>Ambient Humidity: ≤80% no<br>condensation in operation;<br>Atmospheric pressure: Not<br>mentioned | Note 8 |
| Storage & Transport<br>environment | Ambient temperature:<br>-20°C~+55°C;<br>Relative humidity: ≤93%, no<br>condensation ;<br>Atmospheric pressure:<br>500hPa~1060hPa. | Storage Temperature:-20°C~<br>+55°C:<br>Ambient Humidity: ≤93% no<br>condensation in storage;<br>Atmospheric pressure: Not<br>mentioned | |
| Contacting<br>material | Enclosure: ABS | Enclosure: ABS | Same |
| | Fingertip Cushion: Medical<br>Silicone Gel | Fingertip Cushion and<br>Button : Medical Silicone Gel | Same |
| | YX301 Button: PC | | Note 9 |
| | YX102, YX103 Button: None<br>YX306 Button: ABS | | |
| | | | |
| Performance | ISO 80601-2-61 | ISO 9919…