YUWELL Infrared Thermometer

K201864 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · FLL · Dec 7, 2020 · General Hospital

Device Facts

• Record ID: K201864
• Device Name: YUWELL Infrared Thermometer
• Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Dec 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

Device Story

Handheld, battery-powered, non-contact infrared thermometer; measures forehead temperature by detecting infrared energy emitted from arterial blood flow; uses thermopile sensor and thermistor for ambient temperature compensation; parabolic mirror focuses infrared energy; digital proximity sensor detects distance; measurement takes 1 second; output displayed on backlight LCD; includes buzzer and vibration alerts; some models feature memory storage for previous results; used in home or clinical settings by patients or healthcare providers; provides rapid temperature readings to assist in clinical decision-making.

Clinical Evidence

Bench testing only. Performance verified against ASTM E 1965 and ISO 80601-2-56. Additional testing includes software verification/validation, biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and home use testing (IEC 60601-1-11).

Technological Characteristics

Thermopile sensor; thermistor for ambient compensation; parabolic mirror for infrared focusing; digital proximity sensor; backlight LCD; battery-powered (2x AAA); non-contact operation; measurement range 32.5°C to 43.0°C; accuracy ±0.2°C (35.0°C-42.0°C) and ±0.3°C (outside range); meets ASTM E 1965, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for measuring human body temperature in non-contact mode on the center of the forehead for all ages, excluding preterm babies.

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 No touch + Forehead NTF3000 Thermometer (K163516)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2020

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Caixia Yang Quality Assurance Yunyang Industrial Park, Danyang, Jiangsu Danyang, 212300 China

Re: K201864

Trade/Device Name: YUWELL Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2020 Received: July 6, 2020

Dear Caixia 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 (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

{1}------------------------------------------------

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,

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K201864

Device Name

YUWELL Infrared Thermometer : YT-1,YT-1 A,YT-1 C,YT-2,YT-2,YT-2A,YT-2B,YT-2C

#### Indications for Use (Describe)

The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

Type of Use (Select one or both, as applicable)

D Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperw ork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information . Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperw ork Reduction Act (PRA) Staff PRAStaff @fda.hhs .gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

#### 510(K) SUMMARY: K201864

## This 510(k) Summary is in conformance with 21CFR 807.92

#### 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: | Yuzhuo Wang |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | [e-mail] |

## TRADE NAME, COMMON NAME, CLASSIFICATION

Trade Name: YUWELL® Infrared Thermometer, YT-1,YT-I A,YT-IB,YT-I

C,YT-2,YT-2A,YT-2B,YT-2C

Common Name: Infrared Thermometer

| Classification Name: | Thermometer, Clinical, Electronic |
|----------------------|-----------------------------------|
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Device Class: | Class II |

## IDENTIFICATION OF PREDICATE DEVICES(S)

The identification of predicates within this submission is as follow:

| Manufacturer: | Kaz USA, Inc., a Helen of Troy Company |
|----------------------|-----------------------------------------------|
| Trade Name: | Braun No touch + Forehead NTF3000 Thermometer |
| Common Name: | Infrared Forehead Thermometer |
| Product Code: | FLL |
| Classification Name: | Thermometer, Clinical, Electronic |
| Regulation Number: | 21 CFR 880.2910 |
| Classification: | Class II |
| FDA 510 (k) #: | K163516 |

## 5.4 DESCRIPTION OF THE DEVICE

The YUWELL® infrared thermometer is designed for measuring the body's frontal temperature, is a handheld non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's forehead area within 0-5cm that converts a user's forehead temperature. The measurement reference sites is the center of the brow.

The temperature measurement takes only 1 second, does not contact human skin. The infrared thermometer is intended for use on people of all ages except pre-term babies.

{4}------------------------------------------------

## 5.5 INTENDED USE

The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non- contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

## 5.6 TECHNOLOGICAL CHARACTERISTIC

Measure human body temperature. Therefore, once the operator approaches the specific part of the human body (forehead) according to the use method, and presses the measurement key, the infrared radiation receiving sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the infrared sensor, so as to accurately measure the human body temperature.

## 5.7 SUBSTANTIAL EQUIVALENCE

#### Comparison of technological characteristics

| | Subject Device | Predicate Device | SE |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Description | (K201864) | (K163516) | Discussion |
| Device Name | Infrared Thermometer | Infrared Thermometer | Same |
| Product Code | FLL | FLL | Same |
| Regulation No. | 880.2910 | 880.2910 | Same |
| Classification | II | II | Same |
| Intended Use | The YUWELL® Infrared<br>thermometer is a<br>nonsterile, reusable<br>clinical thermometer<br>intended for measuring<br>the human body<br>temperature in non-<br>contact mode on the<br>center of the forehead<br>as the measurement<br>site on people of all<br>ages except preterm<br>babies. | The Braun No Touch<br>+ Forehead NTF3000<br>Thermometer is a<br>nonsterile, reusable<br>clinical thermometer<br>intended for the<br>intermittent determinati<br>on of human body<br>temperature in a<br>touch and no touch<br>mode on the center of<br>the forehead as the<br>measurement site<br>on people of all ages. | Note No.1 |
| Patient<br>Population | People of all ages<br>except preterm<br>babies. | People of all ages | Note No.2 |
| Technological<br>Characteristics | The thermometer uses<br>a thermopile sensor<br>and thermistor for the<br>target reading.<br>A thermistor mounted | The thermometer uses<br>a thermopile sensor<br>with integrated<br>thermistor for the target<br>reading, a thermistor | Same |
| | in the head of the<br>thermometer for<br>ambient temperature<br>readings and<br>compensation of the<br>temperature reading.<br>A parabolic mirror to<br>help focus the infrared<br>energy emitted from<br>the forehead.<br>An infrared proximity<br>sensor for detection of<br>non-contact use. | mounted in the head of<br>the thermometer for<br>ambient temperature<br>readings, a parabolic<br>mirror to help focus the<br>infrared energy emitted<br>from the forehead, and<br>an infrared proximity<br>sensor for detection of<br>contact or non-contact<br>use and compensation<br>of the temperature<br>reading. | |
| 510 (k) Number | K201864 | K163516 | N/A |
| Design Method | Using infrared energy<br>conversion | Using infrared energy<br>conversion | Same |
| Display | Backlight LCD Digital<br>Display | Backlight LCD Digital<br>Display | Same |
| Sensor | Infrared sensor、<br>Digital Proximity<br>Sensor | Infrared sensor、Digital<br>Proximity Sensor | Same |
| Operation | Hand held-Manually<br>operated | Hand held-Manually<br>operated | Same |
| Measurement<br>Site | Forehead | Forehead | Same |
| Operating Mode | Adjusted Mode | Adjusted Mode | Same |
| Ranging<br>Function | YT-1, YT-1A, YT-2,<br>YT-2A have ranging<br>function, YT-1B, YT-<br>1C, YT-2B, YT-2C<br>have no ranging<br>function. | Have ranging Function | Note No.3 |
| Vibration<br>Function | YT-1, YT-1B, YT-2,<br>YT-2B have vibration<br>function, YT-1A, YT-<br>1C, YT-2A, YT-2C<br>have no vibration<br>function. | No vibration Function | Note No.4 |
| Scale | °C/°F | °C/°F | Same |
| Signal Output<br>and Display | LCD, Buzzer | LCD, Buzzer | Same |
| Measurement<br>Range | 32.5°C to 43.0°C<br>(90.5°F to 109.4°F) | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | Note No.5 |
| Accuracy | $\pm0.2\u00b0C(\pm0.4\u00b0F)$ in the<br>range of $35.0\u00b0C~42.0$<br>$\u00b0C(95.0\u00b0F~107.6\u00b0F)$<br>$\pm 0.3 \u00b0C (\pm0.5\u00b0F )$ in the<br>range of $32.5\u00b0C~34.9$<br>$\u00b0C (90.5 \u00b0F ~ 94.8$<br>$\u00b0F )$ and<br>$42.1\u00b0C~43.0\u00b0C(107.8$<br>$\u00b0F~109.4\u00b0F)$ | $\pm 0.2\u00b0C/0.4\u00b0F$ for the<br>range<br>$35.0\u00b0C$ to $42.0\u00b0C$<br>$(95.0\u00b0F to 107.6\u00b0F);$<br>$\pm 0.3\u00b0C /0.5\u00b0F$ (outside<br>this temperature range) | Note No.6 |
| Resolution of<br>display | $0.1\u00b0C/0.1\u00b0F$ | $0.1\u00b0C/0.1\u00b0F$ | Same |
| | Temperature: +10 °C ~<br>+40 °C (50 °F-104 °F) | Temperature: +15°C ~<br>+40 °C (59 °F-104 °F) | |
| Operating<br>Environment | Humidity: 15% RH ~<br>90% RH (no<br>condensation) | Humidity: 15% RH ~<br>95% RH (no<br>condensation) | Note No.7 |
| | Temperature: -20 °C ~<br>+55 °C (-4 °F-131 °F) | Temperature: -25 °C ~<br>+60 ℃ (-13 °F-140 °F) | |
| Storage<br>Environment | Humidity: 15% RH ~<br>90% RH (no<br>condensation) | Humidity: 15% RH ~<br>95% RH (no<br>condensation) | Note No.8 |
| Memory Size | No data stored for YT-<br>1, YT-1A, YT-1B, YT-<br>1C<br>Up to 10 sets of data<br>for YT-2, YT-2A, YT-<br>2B, YT-2C | No data stored | Note No.9 |
| Energy Source | Two (2) AAA batteries | Two (2) AA batteries | Note No.10 |
| Display Content | YT-1 Series:Distance<br>prompt/Voice<br>prompt/battery<br>reminder/result<br>display/temperature<br>unit/distance unit<br>YT- 2 Series:Distance<br>prompt/Voice<br>prompt/battery<br>reminder/result<br>display/temperature<br>unit/distance<br>unit/Memory symbol | Distance prompt/Voice<br>prompt/battery<br>reminder/result<br>display/temperature<br>unit/distance unit | Note No.11 |
| Controls | YT-1 Series:Power ON<br>Measurement<br>button/Prompt tone key<br>YT-2 Series:Power ON<br>Measurement<br>button/Memory button | Power<br>button/Temperature<br>button/Silent mode<br>switch | Note No.12 |
| Measurement<br>distance | Within 0-5cm | Within 0-5cm | Same |
| Touch aspect | Non contact | Non contact | Same |
| Performance | Meets ASTM E 1965<br>and ISO 80601-2-56 | Meets ASTM E 1965<br>and ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993<br>and FDA Bluebook<br>memo G95-1 | Meets ISO 10993<br>and FDA Bluebook<br>memo G95-1 | Same |
| Electrical Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Same |
| EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same |

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

# 5.8 DISCUSSION OF DIFFERENCES

| Note ID | Justification |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note No.1 and<br>Note No.2 | The infrared thermometer produced by our company can meet the<br>requirements of measuring all groups of people, but in order to<br>reduce the risk of the product, the scope of the applicable group of<br>people has been narrowed down to exclude: preterm babies. The<br>products are safe and effective and not affected within the applicable<br>scope. |
| Note No.3 and<br>Note No.4 | Vibration function: After the body temperature is measured, the<br>product body will vibrate to remind the user that the test has been<br>completed. Ranging function: When the measurement distance is<br>more than about 5 cm, the word "0- 5"will be displayed on the screen.<br>When the measurement distance is less than about 5 cm, the device<br>will automatically measure. The ranging and vibration assist function<br>of the device is only used as a reminder for measuring distance<br>requirements and after measurement. This does not affect the safety<br>or effectiveness of the device. |
| Note No.5 and<br>Note No.6 | The measurement range of the subject device is slightly larger than<br>that of the predicate device. At 34.4℃-42.2℃, the accuracy is the<br>same.Due to the difference in the measurement range, the accuracy<br>is different: the subject device has a larger measurement range than<br>the predicate device, so the subject device has increased the<br>accuracy requirements in the range of 32.5 ℃-34.3℃ and<br>42.3 ℃-43.0 ℃. The measurement range and accuracy have been<br>verified, so the efficacy and safety of the device will not be affected. |

{8}------------------------------------------------

| Note No.7 and<br>Note No.8 | The gaps of operating temperature and humidity are verified with<br>aging testing and transportation simulation testing, the results<br>demonstrated that the temperature and humidity are met the product<br>requirements, which will not influence the safety and effectiveness of<br>the devices. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note No.9 | The subject devices have 8 models. The functions of these models<br>are a little different. But all of the differences would not influence the<br>safety of the device. In terms of the memory function, it is to help<br>patients remember and check the previous results, so this would not<br>raise any safety and efficacy problems. |
| Note No.10 | Passing the aging test, use the new battery for no less than 3000<br>measurements, which will be enough for the patients. |
| Note No.11 | The main functions of the subject device and predicates are really<br>similar, so display of contents of the device depends on the functions<br>of the devices, In terms of the memory display, it is to help patients<br>remember and check the previous results, given the freedom of<br>choice to patients does not affect the safety and effectiveness of the<br>devices. |
| Note No. 12 | The difference of button doesn't influence function of the device,<br>which will not raise issues in safety and effectiveness. |

#### 5.9 SUMMARY OF NON-CLINICAL TESTING (BENCH):

The design and manufacturing of YUWELL® Infrared Thermometer are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.

- · Performance test according to ASTM E 1965 and ISO80601-2-56
- 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

#### 5.10 CONCLUSION:

The subject device has same intended use, similar 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.