Infrared Ear Thermometer

K180387 · Hetaida Technology Co., Ltd. · FLL · Jan 10, 2019 · General Hospital

Device Facts

• Record ID: K180387
• Device Name: Infrared Ear Thermometer
• Applicant: Hetaida Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jan 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.

Device Story

Handheld infrared ear thermometer; measures natural thermal radiation from tympanic membrane. User inserts probe into auditory canal; presses button to initiate measurement. Thermopile sensor detects infrared radiation; electrical signal amplified and processed by internal circuitry. Device displays temperature on LCD within 5 seconds. Used in home settings by patients or caregivers. Output provides body temperature reading to assist in clinical decision-making regarding fever management.

Clinical Evidence

Clinical evaluation performed on 140 subjects across four age groups (0-3 months, 3-12 months, 1-5 years, >5 years). Testing conducted per ASTM E1965-98 and ISO 80601-2-56 requirements. Results demonstrated compliance with clinical performance standards for infrared thermometers.

Technological Characteristics

Handheld infrared ear thermometer; thermopile sensor; ABS plastic patient-contact components. Powered by 2x AAA alkaline batteries. Complies with ASTM E1965-98 and ISO 80601-2-56. Biocompatibility per ISO 10993-5 and ISO 10993-10. Electrical safety per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Software lifecycle per IEC 62304.

Indications for Use

Indicated for body temperature detection via the auditory canal in people of all ages 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

• INFARED EAR THERMOMETER, Model: TH839 (K011059)

Submission Summary (Full Text)

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January 10, 2019

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

Re: K180387

Trade/Device Name: Infrared Ear Thermometer, Model HTD8208C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 19, 2018 Received: November 23, 2018

Dear Yijie You:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Sapana Patel -S

for 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) K180387

Device Name

Infrared Ear Thermometer, Model: HTD8208C

Indications for Use (Describe)

The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the 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

## K180387

#### 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: Yijie You 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: January 9, 2019

### 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|---------------------------------|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Ear Thermometer |
| Model: | HTD8208C |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |

### 3. Predicate Device Information

| 510(k) submitter/holder: | Radiant Innovation Inc. |
|--------------------------|---------------------------------------|
| 510(K) Number: | K011059 |
| Device: | INFARED EAR THERMOMETER, Model: TH839 |
| Trade name: | TH839 Ear-Type Thermometer |

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# 4. Device description

Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal.

The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button 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 display on the device's LCD. The total operation takes less than 5 seconds.

## 5. Indications for Use

The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.

| | Subject device<br>K180387<br>(Infrared Ear<br>Thermometer,<br>model: HTD8208C) | Predicate device<br>(K011059, INFARED<br>EAR<br>THERMOMETER,<br>Model: TH839) | Discussion of difference |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Infrared Ear<br>Thermometer, Model:<br>HTD8208C, is an<br>electronic clinical<br>thermometer using an<br>infrared sensor to<br>detect body<br>temperature from the<br>auditory canal in people<br>of all ages for home<br>setting use. | The device is an<br>electronic clinical<br>thermometer using an<br>infrared sensor to<br>detect body<br>temperature from the<br>auditory canal in the<br>neonatal, pediatric and<br>adult population used in<br>the home setting. | Similar<br>The device name is<br>included in the subject<br>device. |
| Principle of<br>operation | Measure temperature<br>by reading infrared<br>radiation emitting from<br>the eardrum tissue<br>when the thermometer<br>is inserted into the ear<br>canal. | Measure temperature<br>by reading infrared<br>radiation emitting from<br>the eardrum tissue<br>when the thermometer<br>is inserted into the ear<br>canal. | Same |
| | | | |
| target<br>population | people of all ages | Neonatal, pediatric, and<br>adult | Same |
| Measurement<br>site | auditory canal | auditory canal | Same |
| Material of<br>Patient contact<br>components | ABS | ABS | Same |
| Biocompatibility | Comply with ISO<br>10993-5, ISO<br>10993-10 | Comply with ISO<br>10993-5, ISO<br>10993-10 | Same |
| Environment | 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 | Ear measure mode | Same |
| Key | 2 button(scan,<br>ON/Memory button) | 2 button(scan,<br>ON/Memory button) | Same |
| Scale<br>selection | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | Same |
| High<br>temperature<br>warning | Yes | Yes | Same |
| Low battery<br>indicator | Yes | Yes | Same |
| Case Material | ABS | ABS | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| Performance | Meet ASTM E1965-98<br>and ISO 80601-2-56 | Meet ASTM E1965-98 | Similar<br>The proposed device<br>complies with standards<br>ASTM E1965-98 and<br>ISO 80601-2-56. The<br>difference does not<br>affect the determination<br>of substantial<br>equivalence. |
| 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<br>affect the determination<br>of substantial<br>equivalence. |
| 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) within<br>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 | 10 set | 9 set | Similar<br>The memory capacity<br>will not affect the<br>determination of<br>substantial<br>equivalence |
| Measure time | ≤5S | About 1 second | Similar<br>The Measure time will<br>not affect the<br>determination of<br>substantial equivalence |
| Power source | DC 3V (Alkaline AAA<br>size battery x 2) | DC 3V, One lithium<br>cell (CR2032 x 1). | Similar<br>The proposed device<br>was demonstrated<br>electromagnetic<br>compatibility and<br>electrical safety by the<br>testing. The difference<br>does not affect the<br>determination of<br>substantial equivalence. |
| Operating<br>condition | 15°C~35°C (59~95°F),<br>Relative<br>Humidity≤85% | 10~40°C<br>(50~104°F),15%~85%<br>RH | Similar<br>The operating<br>condition of subject<br>device has passed the<br>safety test, and the<br>Instructions for Use<br>provides the operating<br>condition, so the<br>difference between the<br>operating conditions of<br>subject device and<br>predicate device will<br>not affect the<br>determination of<br>substantial<br>equivalence. |

# 6. Summary of technological characteristics of device compared to the predicate devices (K011059)

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

| Standards | Standards Name |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1: 2005+A1:2012 | Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance -- Collateral Standard: Electromagnetic<br>Disturbances -- Requirements And Tests |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements And Tests |
| ISO 80601-2-56: 2009 | Medical Electrical Equipment - Part 2-56: Particular<br>Requirements For Basic Safety And Essential<br>Performance Of Clinical Thermometers For Body<br>Temperature Measurement. |
| ASTM E1965-98 | Standard Specification For Infrared Thermometers For<br>Intermittent Determination Of Patient Temperature |
| ISO 10993-5:2009 | Biological Evaluation Of Medical Devices - Part 5: Tests<br>For In Vitro Cytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation Of Medical Devices - Part 10:<br>Tests For Irritation And Skin Sensitization |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |

The subject device is a non-sterile device. The validation testing result for cleaning and disinfection of the subject device is adequate.

Software validation and verification test:

The software contained in the subject device complies with the applicable requirements set forth in the referenced guidance document, "Guidance for the Content of Premarket Submissions for Software Contained, issued on May 11, 2005.

# 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 clinical tests evaluated 140 of subjects. Each model was evaluated in each of the following age groups: 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years. The clinical performance test protocol and data analysis was conducted as the requirement of

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ASTM E1965-98 (2009). The test report demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009).

### 9. Conclusions

Infrared Ear Thermometer, model HTD8208C, has the same intended use and similar characteristics as the predicate device. Based on performance testing and compliance with standards demonstrate the subject device Infrared Ear Thermometer, model HTD8208C is substantially equivalent to the predicate device.