Infrared Body Thermometer

K180385 · Hetaida Technology Co., Ltd. · FLL · May 11, 2018 · General Hospital

Device Facts

• Record ID: K180385
• Device Name: Infrared Body Thermometer
• Applicant: Hetaida Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.

Device Story

The Infrared Body Thermometer (HTD8216C) is a handheld electronic device for home use. It utilizes an infrared thermopile sensor to measure natural thermal radiation from the central forehead skin or the tympanic membrane (ear canal). The user initiates measurement via an activation button; the device captures infrared radiation, converts it into an electrical signal, and processes this signal through internal circuitry for amplification and calculation. The final temperature is displayed on an LCD. The device provides a fever warning and low battery indication. It is intended for use by patients or caregivers to monitor body temperature, aiding in clinical decision-making regarding health status.

Clinical Evidence

Clinical investigation followed ASTM E1965-98 and ISO 80601-2-56 requirements. The study compared temperature readings between a digital thermometer and the subject device across three groups. Results confirmed the HTD8216C readings were within acceptable ranges, demonstrating clinical performance for human body temperature measurement.

Technological Characteristics

Handheld infrared thermometer; thermopile sensor; ABS plastic housing; LCD display; powered by 2x 1.5V AAA alkaline batteries. Complies with ASTM E1965-98, ISO 80601-2-56 (performance), IEC 60601-1, IEC 60601-1-11 (safety), IEC 60601-1-2 (EMC), and ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for people of all ages for the measurement of body temperature via the central forehead or auditory canal in a home setting.

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

• RII Multi-Function Infrared Thermometer, Model TH52Z (K162083)

Submission Summary (Full Text)

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May 11, 2018

HeTaiDa Technology Co., Ltd. % You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley, Guangzhou, 510663 CHINA

Re: K180385

Trade/Device Name: Infrared Body Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 10, 2017 Received: February 15, 2018

Dear You Yijie:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Tina Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180385

Device Name Infrared Body Thermometer

Indications for Use (Describe)

The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) Summary

#### 1. Submitter's Information

#### Establishment Registration Information

Name: HeTaiDa Technology Co., Ltd Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. 523820

#### Contact Person of applicant

Name: Tom Chen Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China TEL: [phone] FAX: [phone] Email: [e-mail]

#### Contact Person of the Submission:

Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail]

#### Contact Person to prepare summary:

Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail] Date to prepare: May. 9, 2018

## 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|-----------------------------------|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8216C |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |

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# 3. Predicate Device Information

| 510(k) submitter/holder: | Radiant Innovation Inc. |
|--------------------------|------------------------------------------------------|
| 510(K) Number: | K162083 |
| Device: | RII Multi-Function Infrared Thermometer, Model TH52Z |
| Trade name: | TH52Z Multi-function Infrared Thermometer |

## 4. Device description

Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.

The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.

The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.

To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

## 5. Intended Use

The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.

## 6. Summary of technological characteristics of device compared to the predicate devices (K162083)

| SE<br>Comparisons | Subject device<br>Present application<br>(Infrared Body<br>Thermometer,<br>model: HTD8216C) | Predicate device<br>(K162083, RII<br>Multi-Function<br>Infrared<br>Thermometer, Model:<br>TH52Z) | Discussion of difference |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| FDA Class | II | II | Same |
| Intended Use | The Infrared Body<br>Thermometer,<br>Model: HTD8216C,<br>is an electronic<br>clinical thermometer<br>using an infrared<br>sensor to detect<br>body temperature<br>from the forehead or<br>auditory canal in<br>people of all ages<br>for home setting<br>use. | The RII Multi-function<br>Infrared<br>Thermometer, Model<br>TH52Z is intended for<br>the intermittent<br>measurement of<br>human body<br>temperatures. The<br>device is intended for<br>the use at home by<br>people of all ages<br>including neonates<br>and it can be selected<br>Ear mode or<br>Forehead mode. | Same |
| target<br>population | people of all ages<br>who need to detect<br>body temperature | people of all ages<br>who need to detect<br>body temperature | Same |
| anatomical<br>site | central forehead<br>auditory canal | central forehead<br>auditory canal | Same |
| where used | home | home | Same |
| Design | Handheld | Handheld | Same |
| Measurement<br>method | Infrared radiation<br>detection | Infrared radiation<br>detection | Same |
| Display Type | LCD | LCD | Same |
| Measurement<br>mode | Ear measure mode/<br>Forehead mode | Ear measure mode/<br>Forehead mode | Same |
| Key | 2 button(ON / scan<br>button,<br>measurement unit<br>switch button is<br>behind the battery<br>cover) | 3 button("ear button",<br>"forehead button"<br>ON/Memory button) | Acceptable<br>The Key number will not<br>affect the safety and<br>effectiveness of the<br>proposed device |
| Scale<br>selection | °C/°F | °C/°F | Same |
| Fever warning | Yes | Yes | Same |
| Low battery<br>indicator | Yes | Yes | Same |
| Case Material | ABS | ABS | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| Performance | Meet ASTM<br>E1965-98<br>and ISO 80601-2-56 | Meet ASTM<br>E1965-98 and ISO<br>80601-2-56 | Same |
| Measuring<br>range | 34.0°C~42.9°C;<br>(93.2~109.22°F) | 34~42.2°C<br>(93.2~108.0°F) | Similar<br>The proposed device<br>meets ASTM E1965-98,<br>ISO 80601-2-56 and the<br>difference does not raise |
| | | | |
| | | | the issue of product's<br>safety and effectiveness. |
| Display<br>resolution | 0.1 °F (0.1 °C) | 0.1 °F (0.1 °C) | Same |
| Measuring<br>accuracy | ±0.2 °C (0.4 °F)<br>within 35~42°C<br>(95~107.6°F),<br>±0.3°C (0.5°F) for<br>other range | ±0.2°C (0.4°F) within<br>35~42°C<br>(95~107.6°F),<br>±0.3°C (0.5°F) for<br>other range | Same |
| Memory | 1 set | 9 set | Acceptable<br>The memory capacity will<br>not affect the safety and<br>effectiveness of the<br>proposed device |
| Measure time | ≤5S (ear mode) | Ear: 1sec. | Acceptable<br>The Measure time will not<br>affect the safety and |
| | ≤2S (Forehead mode) | Forehead Mode:<br>5~30sec. | effectiveness of the<br>proposed<br>device |
| Power source | 1.5V (AAA) Alkaline<br>batteryX2 | DC 3V, One lithium<br>cell (CR2032 x 1). | Acceptable<br>The proposed device was<br>demonstrated<br>electromagnetic compatibility<br>and electrical safety by the<br>testing. The difference<br>does not raise the issue of<br>product's safety and<br>effectiveness. |
| Operating<br>condition | 15°C~35°C<br>(59~95°F),<br>Relative<br>Humidity≤85% | 10~40°C (50~104°F),<br>15%~85% RH | Similar<br>The operating condition of<br>subject device has passed<br>the performance test, and<br>the Instructions for Use<br>provides the operating<br>condition, so the difference<br>between the operating<br>conditions of subject<br>device and predicate<br>device will not affect the<br>safety and effectiveness of<br>subject device. |

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# 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ASTM E 1965-98 and ISO 80601-2-56 for performance, ISO 10993-5 and ISO

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10993-10 for Biocompability are complied.

Guidance Documents included the "FDA Guidance on the Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers".

#### 8. Discussion of Clinical Tests Performed:

The clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 and ISO 80601-2-56. The test report shows the three group's temperature readings difference between digital thermometer and the subject device. HTD8216C is within acceptable range. It is concluded that the Infrared Body Thermometer, model HTD8216C is acceptable to measure human body's temperature.

#### 9. Conclusions

Infrared Body Thermometer, models HTD8216C, has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates compliance with the IEC 60601 -1, IEC 60601-1-11standards and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the HTD8216C meets the ASTM E 1965-98 and ISO 80601-2-56 standard and concludes that any differences in their characteristics do not raise different questions of safety and effectiveness. Thus, Infrared Body Thermometer, model new HTD8216C is substantially equivalent to the predicate device.