YUWELL infrared ear thermometer: YHT101, YHT200

K203583 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · FLL · May 20, 2021 · General Hospital

Device Facts

• Record ID: K203583
• Device Name: YUWELL infrared ear thermometer: YHT101, YHT200
• Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: May 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

Device Story

Hand-held, battery-powered infrared ear thermometer; measures body temperature via thermal radiation from tympanic membrane. Infrared sensor converts infrared light into electrical signals; internal circuitry and algorithm correct signals based on targeted emissivity to calculate temperature. Used in clinical or home settings by patients or clinicians. Provides 2-second measurement; displays results on LCD. Benefits include quick, non-invasive temperature monitoring. Device includes memory function for storing previous readings.

Clinical Evidence

Bench testing only. Performance validated against ASTM E1965 and ISO 80601-2-56 for clinical accuracy. Biocompatibility testing per ISO 10993-5 and ISO 10993-10. Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2. Home use testing per IEC 60601-1-11. All results passed.

Technological Characteristics

Infrared sensor; ABS/PC shell materials; powered by two AAA alkaline batteries. Dimensions: YHT101 (145x37x57mm), YHT200 (143x39x57mm). Connectivity: None. Sterilization: Non-sterile. Standards: ASTM E1965, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, ISO 10993-1/5/10.

Indications for Use

Indicated for body temperature measurement in the ear cavity for all ages, excluding preterm babies and newborns (1-29 days old).

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Braun Thermoscan® PRO 6000 Ear Thermometer (K152748)

Submission Summary (Full Text)

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May 20, 2021

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

Re: K203583

Trade/Device Name: YUWELL Infrared Ear Thermometer: YHT101, YHT200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 13, 2021 Received: April 20, 2021

### 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

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

510(k) Number (if known) K203583

#### Device Name

YUWELL® Infrared ear thermometer: YHT101,YHT200

Indications for Use (Describe)

The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

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

# OWNER/SUBMITTER'S INFORMATION

| Company Name: | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
|------------------|-------------------------------------------------------------------------|
| Company Address: | Yunyang Industrial Park, Danyang, Jiangsu Province,P.R<br>China, 212300 |
| Contact: | Wang, Yuzhuo |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | [e-mail] |
| Date prepared: | November 20, 2020 |

# TRADE NAME, COMMON NAME, CLASSIFICATION

| Trade Name: | YUWELL® Infrared ear thermometer |
|----------------------|-----------------------------------|
| Common Name: | Infrared ear thermometer |
| Model: | YHT101, YHT200 |
| Classification Name: | Thermometer, Clinical, Electronic |
| Product Code: | FLL |
| Regulation Number: | 880.2910 |
| Device Class: | Class II |

# IDENTIFICATION OF PREDICATE DEVICE(S)

The identification of predicates within this submission is as follow:

| Manufacturer: | KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) |
|----------------------|---------------------------------------------------|
| Trade Name: | Braun Thermoscan® PRO 6000 Ear Thermometer |
| Common Name: | Infrared Ear Thermometer |
| Product Code: | FLL |
| Classification Name: | Thermometer, Clinical, Electronic |
| Regulation Number: | 21 CFR 880.2910 |
| Classification: | Class II |
| FDA 510 (k) #: | K152748 |

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# DESCRIPTION OF THE DEVICE

The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.

The subject device is simple and convenient to use. The temperature measurement takes only 2 second. The YUWELL® Infrared ear thermometer is intended for use on people of all ages except preterm babies and newborns (1-29 days old).

## INTENDED USE

The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

## TECHNOLOGICAL CHARACTERISTIC

The ear thermometer is equipped with an infrared sensor, which can transform the infrared light released by human ear membrane into corresponding electrical signal. The signal is corrected by the amplifier and signal processing circuit according to the internal algorithm of the instrument and the targeted emissivity, and then transformed into the temperature value of the measured human body.

## SUBSTANTIAL EQUIVALENCE

| Description | Subject Device<br>(K203583) | Predicate Device<br>(K152748) | SE<br>Discussion |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Manufacturer | JiangSu YuYue | BRAUN (Germany) | - |
| Product name | Infrared ear thermometer | ThermoScan® Ear<br>Thermometer | - |
| Model | YHT101, YHT200 | PRO 6000 | - |
| Patients<br>population | People of all ages except<br>preterm babies and<br>newborns (1-29 days old). | People of all ages | Note No. 1 |
| Product Code | FLL | FLL | Same |
| Regulation<br>No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Classification | II | II | Same |
| Intended Use | The YUWELL® Infrared ear<br>thermometer is a<br>non-sterile, reusable<br>clinical thermometer. The<br>device is to display the | A non-sterile, re-useable<br>clinical thermometer<br>intended for the<br>intermittent determination<br>of the human's body | Note No. 2 |
| | body temperature in the ear<br>cavity by thermal radiation<br>for people of all ages<br>except preterm babies and<br>newborns (1-29 days old). | temperature for people of<br>all ages | |
| Product<br>principle | The ear thermometer is<br>equipped with an infrared<br>sensor, which can<br>transform the infrared light<br>released by human ear<br>membrane into<br>corresponding electrical<br>signal. The signal is<br>corrected by the amplifier<br>and signal processing<br>circuit according to the<br>internal algorithm of the<br>instrument and the targeted<br>emissivity, and then<br>transformed into the<br>temperature value of the<br>measured human body. | The ear thermometer is<br>equipped with an infrared<br>sensor, which can<br>transform the infrared light<br>released by human ear<br>membrane into<br>corresponding electrical<br>signal. The signal is<br>corrected by the amplifier<br>and signal processing<br>circuit according to the<br>internal algorithm of the<br>instrument and the<br>targeted emissivity, and<br>then transformed into the<br>temperature value of the<br>measured human body. | Same |
| Product<br>structure | Consists of shell, buttons,<br>circuit board, and batteries | Consists of shell, buttons,<br>circuit board, and batteries | Same |
| Operation | Hand held-Manually<br>operated | Hand held-Manually<br>operated | Same |
| Sensor | Infrared | Infrared | Same |
| Measurement<br>Range | 34.0°C to 42.2°C (93.2°F<br>~108.0°F) | 20°C to 42.2°C<br>(68°F to 108.0°F) | Note No. 3 |
| Accuracy | 34.0°C~34.9°C (93.2°F<br>~94.8°F), ±0.3°C(±0.5°F)<br>35.0°C~42.0°C(95.0°F<br>~107.6°F), ±0.2°C(±0.4°F)<br>42.1°C~42.2°C(107.7°F<br>~108.0°F), ±0.3°C(±0.5°F) | 0.3 °C for <35 °C<br>0.2 °C for 35 °C to<br>42 °C<br>0.3 °C for >42°C | Note No. 4 |
| Display | LCD | LCD | Same |
| Measurement<br>Site | Ear | Ear | Same |
| Dimensions | YHT101: 145mm x 37 mm<br>x 57mm<br>YHT200: 143mm x 39 mm<br>x 57mm | 150mm x 60 mm x 35mm | Similar |
| Materials | YHT101: Shell: ABS<br>material<br>Button: PC material | Common Materials-<br>including an impact<br>resistant casing. | Similar -<br>validated for<br>cytotoxicity<br>per |
| | YHT200: Shell: ABS<br>material<br>Button: ABS material | resins. | ISO10993-5<br>and irritation<br>as well as<br>sensitization<br>per ISO<br>10993-10 |
| Scale | °C/°F | °C/°F | Same |
| Resolution of<br>display | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| Operating<br>Mode | Adjusted mode | Adjusted mode | Same |
| Energy<br>Source | Two (2) AAA alkaline<br>batteries | Two (2) AA batteries or<br>Custom Nickel Metal<br>Hydride Battery Pack | Note No. 5 |
| Automatic<br>power off time | 60s±10s | 10s | Note No. 6 |
| Operating<br>Environment | Temperature: 10°C-40°C (50<br>°F-104 °F);<br>Humidity: 15% RH ~ 90%<br>RH (non-condensing);<br>Atmospheric pressure:<br>70kPa-106kPa; | Temperature: 10°C-40°C<br>(50 °F-104 °F) and up to<br>95% RH ; | Note No.7 |
| Storage<br>Environment | Temperature: -20 °C ~ +55<br>°C (-4 °F-131 °F)<br>Humidity: 15% RH ~ 90%<br>RH (non-condensing)<br>Atmospheric pressure:<br>70kPa-106kPa | Temperature: -25 °C ~<br>+55 °C (-13 °F-131 °F)<br>Humidity: 15% RH ~ 95%<br>RH (non-condensing) | Note No.8 |
| Control<br>button | Measure button<br>Memory button | Measure button<br>C/F button<br>Memory button<br>Timer button | Note No.9 |
| Memory<br>function | YHT101: 7 groups of<br>measured values can be<br>memorized<br>YHT200: 10 groups of<br>measured values can be<br>memorized | Memorize the last<br>temperature measured. | Note No.10 |
| Electrical<br>Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Same |
| EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same |
| Performance | Meets ASTM E 1965<br>and ISO 80601-2-56 | Meets ASTM E 1965<br>and ISO 80601-2-56 | Same |
| Biocompatibili<br>ty | Meets ISO 10993-1<br>(includes<br>US FDA Blue book memo<br>G95-1-100 Title)<br>ISO 10993-5<br>ISO 10993-10 | Meets ISO 10993-1<br>(includes<br>US FDA Blue book memo<br>G95-1-100 Title)<br>ISO 10993-5<br>ISO 10993-10 | Same |

### Comparison of technological characteristics

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# DISCUSSION OF DIFFERENCES

| Note ID | Justification |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note<br>and<br>No.2 | According to the literature 'Temperature Control in Preterm<br>Infants-Effect of Birthweight and Gestational Agenei, preterm<br>babies has a lower body temperature than a normal fetus just after<br>birth. Therefore, in order to reduce the risk of the product, the<br>scope of the applicable group of people has been narrowed down<br>to exclude: preterm babies and newborns (1-29 days old).The<br>subject device has a narrow applicable population and it will not<br>raise any new or different safety or effectiveness risks. |
| Note<br>and<br>No.4 | The measurement range of the predicate device is larger than that<br>of the subject device. The scale of clinical thermometer like<br>Mercury thermometer reads temperature from 35°C to 42°C. The<br>subject device measurement range is 34.0°C to 42.2°C meet the<br>normal clinical use. For the normal clinical measurement range of<br>34.0°C to 42.2°C, the accuracy of the subject device and the<br>predicate device are the same. So the measurement range and<br>accuracy difference does not bring additional clinical risks. |
| Note No. 5 | The subject device and the predicate device use different batteries.<br>The subject battery-related performance has been tested through<br>the applicable IEC standards, and the report proves that the subject<br>equipment powered by two AAA alkaline batteries is qualified. |
| Note No. 6 | The subject device has about 60 seconds automatic power off time<br>and it's longer than the 10 seconds of the predicate device. The<br>design purpose is to give the user more time to review or record the<br>data if needed. The difference will not raise any new safety or<br>effectiveness risk. |
| Note<br>and<br>No.8 | Although the operation and storage conditions of the subject device<br>are slightly different from the predicate device, they meet the same<br>standard requirements of ISO 80601-2-56 and IEC 60601-1-11.<br>Therefore, the operating and storage conditions will not influence<br>the safety and effectiveness of the product. |
| Note No.9 | The difference of button doesn't influence function of the device<br>according to the performance test, which will not raise issues in<br>safety and effectiveness. |
| Note No.10 | In terms of the memory function, it is to help patients remember and<br>check the previous results, so this would not raise any safety and<br>efficacy problems. |

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## SUMMARY OF TESTING (BENCH AND CLINICAL PERFORMANCE):

The design and manufacturing of YUWELL® Infrared ear thermometer are subject to verification and validation testing in conformance with requlatory quidance and recognized consensus standards.

- · Performance test according to ASTM E 1965 and ISO80601-2-56
- Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)
- · Software verification and validation according to the requirements of FDA "Guidance for the content of premarket submissions for software contained in Medical Devices"
- · Biocompatibility test according to ISO10993 and FDA Bluebook memo G95-1
- Electrical safety test according to IEC60601-1
- · Electromagnetic compatibility test according to IEC60601-1-2
- · Home use test according to IEC60601-1-11

### CONCLUSION :

The subject device has similar intended use, performance, equivalence testing standards, and all testing results have come back as positive results or pass for the subject device, which the subject device is as safety and effectiveness as the predicate device.

The differences above between the subject device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.