INFRARED BODY THERMOMETER (Model: YK-001)

K210118 · Longnan Renzhong Medical Equipment Co., Ltd. · FLL · Sep 15, 2021 · General Hospital

Device Facts

• Record ID: K210118
• Device Name: INFRARED BODY THERMOMETER (Model: YK-001)
• Applicant: Longnan Renzhong Medical Equipment Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.

Device Story

Hand-held, battery-powered, non-contact infrared thermometer; detects infrared energy radiated from forehead (3-5cm distance). Thermopile sensor converts infrared energy to electronic signal; signal amplified and converted to digital via MCU AD module. MCU calculates temperature; displays result on LCD with 3-color background. Features: 99-memory recall, °C/°F switchable, auto-shutoff, low battery indicator. Used by consumers (home) or clinicians (clinic) for intermittent temperature monitoring. Provides rapid (approx. 2s) temperature readings to assist in clinical decision-making and patient health assessment.

Clinical Evidence

Clinical accuracy study conducted on 137 subjects across three age groups: >1 month to <1 year, 1-5 years, and >5 years. Febrile subjects comprised 30-50% of each group. Exclusions: inflammation at measurement site, temperature-altering medications. Results confirmed accuracy within ISO 80601-2-56:2017 requirements.

Technological Characteristics

ABS plastic enclosure; thermopile infrared sensor; 3.0V DC (2x AAA batteries). Dimensions: 138x95x40mm; weight: ~90g. Standards: ISO 80601-2-56:2017, ASTM E 1965-98, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility per ISO 10993-5/10. Software: IEC 62304 compliant.

Indications for Use

Indicated for intermittent human body temperature measurement via center of forehead. Population: individuals over one month old. Suitable for household and clinical use.

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

• Non-contact Infrared Thermometer (K131243)

Submission Summary (Full Text)

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September 15, 2021

Longnan RenZhong Medical Equipment Co., Ltd. % Iris Fung Regulation Manager SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development District Guangzhou, Guangdong, 510000 China

Re: K210118

Trade/Device Name: Infrared Body Thermometer (Model: YK-001) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 6, 2021 Received: August 16, 2021

Dear Iris Fung:

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.

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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 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.

For Payal Patel 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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# Indications for Use

510(k) Number (if known) K210118

Device Name INFRARED BODY THERMOMETER (Model: YK-001)

Indications for Use (Describe)

INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.

| 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. Summary Prepared Date

15 September 2021

#### Submitter Information 2

Sponsor Company Name: Longnan Renzhong Medical Equipment Co., Ltd.

- Address: Information Industry Technology City, Longnan Economic � Development Zone, Longnan, Ganzhou, Jiangxi Province, 341000, China
- Phone: [phone] �
- Contact Person (including title): Liangping Liao (Manager) �
- � E-mail: [e-mail]

Application Correspondent: SGS-CSTC Standards Technical Services Co., Ltd.

- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology � Development District, Guangzhou, Guangdong, 510000, China
- � Contact Person: Ms. Iris Fung
- Tel: [phone] �
- Email: [e-mail] �

#### Subject Device Information ನ

Trade Name: INFRARED BODY THERMOMETER (Model: YK-001) Common Name: Clinical Electronic Thermometer Requlation Name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: II

## 4. Predicate Device Information

Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Trade Name: Non-contact Infrared Thermometer 510(k) number: K131243 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: II

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## 5. Device Description

The proposeddevice, INFRARED BODY THERMOMETER, which includes model YK-001 hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead. The proposed device measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the human forehead temperature, object temperature and environment temperature; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display. The device has the following features: About two-second measuring time, measuring Body or Ambient temperature, 99-memory recalls, ℃/ί unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen. The device will display 3 different background colors according to the result.

The powersupply of INFRARED BODY THERMOMETER (YK-001)is 3.0V DC, it is powered by two AAA batteries.

The reference body site of INFRARED BODY THERMOMETER (Model: YK-001) is armpit.

## 6. Indications for Use

INFRARED BODY THERMOMETER (Model: YK-001) is a non-contactinfrared thermometer intended f or the intermittentmeasurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.

#### 7. Comparison to Predicate Device

A comparison of key technological characteristics between the subject device and predicate device was listed as below:

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Longnan Renzhong Medical<br>Equipment Co.,Ltd. | Shenzhen Jumper Medical<br>Equipment Co., Ltd | -- |
| 510 (k) Number | K210118 | K131243 | -- |
| Product Name | INFRARED BODY<br>THERMOMETER | Non-contact<br>Infrared<br>Thermometer | -- |
| Models | YK-001 | JPD-FR100 | -- |
| Intended Use | INFRARED BODY<br>THERMOMETER (Model: YK-001) is<br>a non-contact infrared thermometer<br>intended for the intermittent<br>measurement of human body<br>temperature using the center of the<br>forehead as the measurement site. | The Non-contact<br>Forehead Thermometer<br>is an infrared<br>thermometer intended for<br>the intermittent<br>measurement of human<br>body temperature in<br>people of all ages. | Note 1 |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| | The device is indicated for use by<br>people over one month old. It can<br>be used by consumers in<br>household environment and<br>doctors in clinic as reference. | | |
| Sensor | Infrared Sensor | Infrared Sensor | Identical |
| Principle<br>operation | The proposed device measure<br>temperatures of people by detecting<br>the infrared energy radiated directly<br>from the forehead without physical<br>contact.<br>The proposed device uses a<br>temperature sensor, which can<br>detect the human forehead<br>temperature, object temperature<br>and environment temperature; these<br>temperatures are then transfer to<br>electronic signal and amplified; and<br>then it is transferred to digital signal<br>by AD module in MCU of the<br>proposed device. MCU will calculate<br>the body temperature,<br>and then transfer to screen for<br>display. | The device uses infrared<br>sensor(thermopile)to detect<br>the radiated infrared energy<br>emitted by the object, solid,<br>liquid orgas. The intensity of<br>the emitted energy depends<br>on the temperature of the<br>object and the infrared sensor<br>can recognize it to transfer to<br>the proper electronic signal.<br>The signal can be processed<br>in the subject device to convert<br>to the temperature reading. | Identical |
| Measurement<br>Mode | Forehead measurement Mode | Forehead measurement<br>Mode | Identical |
| Measurement<br>type | Non-contact type | Non-contact type | Identical |
| Measurement<br>Distance | 3-5cm | 1-6 cm | Note 2 |
| Measuring<br>Range | $32°C~42.9°C (89.6°F~109.2°F)$ | $32.2°C~43.3°C(90.0°F~109.9°F)$ | Note 3 |
| Accuracy | Forehead mode: $±0.2°C (±0.4°F)$ , for range $35.0°C ~42.0°C(95°F ~107.6°F)$ ;<br>$±0.3°C(±0.5°F)$ , outside this<br>temperature range | Forehead mode:<br>$±0.2°C (0.4°F)$ | Note 3 |
| Sensor type | Thermopile | Thermopile | Identical |
| High<br>temperature<br>prompt | Yes | Yes | Identical |
| Buzzer | Yes | Yes | Identical |
| Display type | LCD | LCD | Identical |
| Auto power-off<br>while no<br>operation | Yes | Yes | Identical |
| °C/°F<br>switchable | Yes | Yes | Identical |
| Memory | 99 sets | 20 sets | Note 4 |
| Power Supply | DC 3V, 2×AAA Batteries | DC 3V, 2 x AAA Batteries | Identical |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Operating<br>Conditions | Temperature: +15°C~+40°C<br>(59°F<br>~104°F)<br>Humidity: 15% to 95%<br>non-condensing<br>Atmospheric pressure<br>:<br>70kPa~106kPa | 10~40°C(50°F ~104 °F) RH<br><<br>85% | Note 5 |
| Storage<br>Conditions | Temperature: -20℃~50℃ (-4°F<br>~122 °F)<br>Humidity: ≤95% non-condensing<br>Atmospheric pressure:<br>70kPa~106kPa | -25°C ~ +55°C (-13° F-+131<br>) RH<br>≤ 90% | Note 5 |
| Dimension (Lx<br>W x H) | 138x95x40mm (L* W * H) | 145X60X50 mm | Note 6 |
| Weight | About 90g(without battery) | 180 g | Note 6 |
| Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
| Performance | Complied with ISO 80601-<br>2- 56:2017 | Complied with ISO 80601-2-56 | Identical |
| | Complied with ASTM E 1965 -98<br>(2016) | Complied with ASTM E 1965 -<br>98<br>(2003) | Identical |
| Components | It composed by a measuring<br>sensor, set buttons, battery<br>compartment, Buzzer, a LCD and<br>a ABS plastic enclosure, and<br>measuring without probe cover. | It composed by a measuring<br>sensor, set buttons, battery<br>compartment, Buzzer, a<br>LCD and a ABS plastic<br>enclosure, and measuring<br>without probe cover. | Identical |
| Biocompatibility | All the patient contacting<br>materials<br>are compliance with ISO 10993-<br>5; ISO10993-10 | All the patient contacting<br>materials are compliance<br>with ISO 10993-5;<br>ISO10993-10 | Identical |
| Materials | ABS for enclosure | ABS for enclosure | Identical |
| Labeling | OTC | OTC | Identical |

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## Note 1

The patient population between the subject device and predicate is different. The clinical accuracy test was conducted in accordance with ISO 80601-2-56:2017. The test result complies with the standard. The difference does not raise new safety and effectiveness questions.

## Note 2

Measurement distance of the subject device is 3-5cm whereas the predicate device's is in the range of 1- 6cm. But the performance testresult of subject device shows the accuracy meets the requirements within the distance range. The difference does not raise new safety and effectiveness questions.

## Note 3

The subject device and predicate device have different measurement range, but they have the same accuracy. The measurement range of subject device meet the requirements of ASTM E 1965-98. The difference does not raise new safety and effectiveness questions.

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## K210118 Summary

#### Note 4

The memory capacity of predicate device and subject device is different, but the memory function does not affectaccuracy of measurement and does not impact the performance of subject device.

#### Note 5

The operating condition and storage condition are different between the subject device and predicate. The operating condition and storage condition met the requirements of ISO 80601-2-56 and performance test was conducted in accordance with the standard. The difference does not impact the performance of subject device.

#### Note 6

There is minor difference on the size and weight between predicate device and subject device. But they both are portable device; such minor difference would not cause issue of safety and effectiveness.

#### 8. Test Summary

#### Non-clinical test:

INFRARED BODY THERMOMETER conforms to applicable standards that include:

- � ASTM E 1965-98 Standard Specification for Infrared Thermometers for Internittent Determination of Patient Temperature
- � IEC 60601-1:2012, 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
- � ISO 10993-1:2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- � ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- � ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- � IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes
- � IEC 60601-1-11:2015 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
- � ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment-part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

#### Clinical Data:

The clinical accuracy study for the non-contact thermometer was performed to determine the clinical accuracy. The three groups of subjects being tested were: 1) over 1 month to under 1 year old, 2) children between 1 and 5 years old, and 3) patients over 5 years old.

The study includes 137 subjects. For each age group, theratio of febrile subjects was more than 30% and less than 50%. The study excluded subjects with medical conditions such as inflammation at the

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## K210118 Summary

measuring sites and subjects using medications known to affect body temperature. The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56.

## 9. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the performance testing, comparison and analysis, the subject device INFRARED BODY THERMOMETER (Model: YK-001) is substantially equivalent to the Non-contact Infrared Thermometer cleared under K131243.