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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Infrared Body Thermometer, Model: HTD8216C

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria	Acceptance Criteria	Reported Device Performance
Performance Standard Compliance	Meet ASTM E1965-98 and ISO 80601-2-56	Meets ASTM E1965-98 and ISO 80601-2-56
Measuring Range	Predicate: 34~~42.2°C (93.2~~108.0°F)	Proposed Device: 34.0°C~~42.9°C (93.2~~109.22°F) (Considered "Similar" and acceptable as it meets standards)
Measuring Accuracy	±0.2°C (0.4°F) within 35~~42°C (95~~107.6°F), ±0.3°C (0.5°F) for other range	±0.2°C (0.4°F) within 35~~42°C (95~~107.6°F), ±0.3°C (0.5°F) for other range (Same as predicate)
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-11	Complied (Demonstrated by testing)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Complied (Demonstrated by testing)
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10	Complied

2. Sample size used for the test set and the data provenance:

Sample Size: The document states that the clinical investigation report and data analysis followed the requirements of ASTM E 1965-98 and ISO 80601-2-56. These standards typically specify patient cohorts and measurements for clinical accuracy testing. However, the exact sample size for the test set is not explicitly stated in the provided text. It only mentions "three group's temperature readings difference".
Data Provenance: Not explicitly stated. The document is from a Chinese company (HeTaiDa Technology Co., Ltd. in Guangdong, China) and was submitted to the FDA. It does not clarify if the clinical study was conducted in China, the US, or elsewhere, nor whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study compares the device's readings to a "digital thermometer" (referred to as the "ground truth" or reference, typically a rectal or oral thermometer), but does not mention experts establishing a ground truth for individual cases. For clinical thermometer accuracy, the ground truth is usually established by a validated reference thermometer.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None explicitly mentioned. For clinical accuracy studies of thermometers, an adjudication method for human interpretation is not typically required, as the ground truth is a direct temperature measurement from a reference device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an infrared body thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this is essentially a standalone device performance study. The device itself measures and displays temperature. The clinical study evaluated the accuracy of the device's measurements relative to a reference (digital thermometer) without directly involving a human-in-the-loop for interpretation of the device's output.

7. The type of ground truth used:

Clinical temperature measurements from a reference device. The "digital thermometer" serves as the ground truth for comparison. This implies a standard clinical measurement method that is widely accepted for accuracy.

8. The sample size for the training set:

This information is not provided as there is no mention of a "training set" in the context of this device. Thermometers are typically calibrated during manufacturing and their accuracy is demonstrated through performance testing against established standards, rather than machine learning training.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +86 769-82658050 FAX: +86 769-82658050 Email: tomchen@hetaida.com.cn

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: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmig-med.com

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: (+86) 020-8224 5821 FAX: (+86) 020-8224 5821 Email: Jet.you@gimmig-med.com 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

5. Intended Use

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

SEComparisons	Subject devicePresent application(Infrared BodyThermometer,model: HTD8216C)	Predicate device(K162083, RIIMulti-FunctionInfraredThermometer, Model: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 BodyThermometer,Model: HTD8216C,is an electronicclinical thermometerusing an infraredsensor to detectbody temperaturefrom the forehead orauditory canal inpeople of all agesfor home settinguse.	The RII Multi-functionInfraredThermometer, ModelTH52Z is intended forthe intermittentmeasurement ofhuman bodytemperatures. Thedevice is intended forthe use at home bypeople of all agesincluding neonatesand it can be selectedEar mode orForehead mode.	Same
targetpopulation	people of all ageswho need to detectbody temperature	people of all ageswho need to detectbody temperature	Same
anatomicalsite	central foreheadauditory canal	central foreheadauditory canal	Same
where used	home	home	Same
Design	Handheld	Handheld	Same
Measurementmethod	Infrared radiationdetection	Infrared radiationdetection	Same
Display Type	LCD	LCD	Same
Measurementmode	Ear measure mode/Forehead mode	Ear measure mode/Forehead mode	Same
Key	2 button(ON / scanbutton,measurement unitswitch button isbehind the batterycover)	3 button("ear button","forehead button"ON/Memory button)	AcceptableThe Key number will notaffect the safety andeffectiveness of theproposed device
Scaleselection	°C/°F	°C/°F	Same
Fever warning	Yes	Yes	Same
Low batteryindicator	Yes	Yes	Same
Case Material	ABS	ABS	Same
Sensor Type	Thermopile	Thermopile	Same
Performance	Meet ASTME1965-98and ISO 80601-2-56	Meet ASTME1965-98 and ISO80601-2-56	Same
Measuringrange	34.0°C~~42.9°C;(93.2~~109.22°F)	34~~42.2°C(93.2~~108.0°F)	SimilarThe proposed devicemeets ASTM E1965-98,ISO 80601-2-56 and thedifference does not raise

			the issue of product'ssafety and effectiveness.
Displayresolution	0.1 °F (0.1 °C)	0.1 °F (0.1 °C)	Same
Measuringaccuracy	±0.2 °C (0.4 °F)within 35~~42°C(95~~107.6°F),±0.3°C (0.5°F) forother range	±0.2°C (0.4°F) within35~~42°C(95~~107.6°F),±0.3°C (0.5°F) forother range	Same
Memory	1 set	9 set	AcceptableThe memory capacity willnot affect the safety andeffectiveness of theproposed device
Measure time	≤5S (ear mode)	Ear: 1sec.	AcceptableThe Measure time will notaffect the safety and
	≤2S (Forehead mode)	Forehead Mode:5~30sec.	effectiveness of theproposeddevice
Power source	1.5V (AAA) AlkalinebatteryX2	DC 3V, One lithiumcell (CR2032 x 1).	AcceptableThe proposed device wasdemonstratedelectromagnetic compatibilityand electrical safety by thetesting. The differencedoes not raise the issue ofproduct's safety andeffectiveness.
Operatingcondition	15°C~~35°C(59~~95°F),RelativeHumidity≤85%	10~~40°C (50~~104°F),15%~85% RH	SimilarThe operating condition ofsubject device has passedthe performance test, andthe Instructions for Useprovides the operatingcondition, so the differencebetween the operatingconditions of subjectdevice and predicatedevice will not affect thesafety and effectiveness ofsubject 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.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.