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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer, Model HTD8208C, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to international standards for performance, rather than explicit acceptance criteria with numerical targets in a direct comparison table. However, it indicates compliance with these standards.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance Statement)
Accuracy (ASTM E1965-98 & ISO 80601-2-56)	The clinical performance test protocol and data analysis was conducted as the requirement of ASTM E1965-98 (2009). The test report demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009). The proposed device meets ASTM E1965-98, ISO 80601-2-56.
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 (This is listed as a characteristic and matched between subject and predicate device, implying it is the accepted accuracy).
Biocompatibility (ISO 10993-5, ISO 10993-10)	Comply with ISO 10993-5, ISO 10993-10
Electrical Safety (IEC 60601-1)	Complies with IEC 60601-1: 2005+A1:2012
Electromagnetic Compatibility (IEC 60601-1-2)	Complies with IEC 60601-1-2: 2014, The proposed device was demonstrated electromagnetic compatibility...by the testing.
Software Life Cycle Processes (IEC 62304)	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.
Cleaning and Disinfection Validation	The validation testing result for cleaning and disinfection of the subject device is adequate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 140 subjects.
Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, the study "evaluated 140 of subjects" which suggests a prospective clinical investigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set. For a clinical thermometer, the ground truth would typically be established by highly accurate reference thermometers (e.g., rectally inserted electronic thermometers or mercury-in-glass thermometers, following a standardized protocol) rather than expert consensus on interpretation. The document indicates the clinical investigation followed the requirements of ASTM E1965-98 and ISO 80601-2-56, which specify methods for establishing reference temperatures.

4. Adjudication Method for the Test Set

Not applicable as this is not a diagnostic device requiring expert adjudication of outputs. The performance is assessed against a reference temperature.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images.
This device is a clinical thermometer, and its performance is evaluated against established temperature measurement standards, not against human reader interpretation of data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the performance study effectively evaluates the device in a standalone manner. The device measures temperature, and that measurement is compared directly to a "ground truth" reference temperature, without human interpretation influencing the device's output.

7. The Type of Ground Truth Used

The ground truth used for performance comparison would be reference body temperatures established according to the methods outlined in ASTM E1965-98 and ISO 80601-2-56. These standards specify how to obtain accurate, traceable reference temperature measurements against which the infrared ear thermometer's readings are compared. It's not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware-based thermometer with embedded firmware, not a machine learning algorithm that requires a separate "training set" in the conventional sense. Its "training" is in its design, calibration, and manufacturing processes, which ensure it adheres to physical measurement principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device in the machine learning context. The accuracy of the device is established during its design, calibration, and manufacturing, ensuring its measurements align with established physical standards for temperature measurement.

Summary

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

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

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

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

5. Indications for Use

	Subject deviceK180387(Infrared EarThermometer,model: HTD8208C)	Predicate device(K011059, INFAREDEARTHERMOMETER,Model: TH839)	Discussion of difference
Indications forUse	The Infrared EarThermometer, Model:HTD8208C, is anelectronic clinicalthermometer using aninfrared sensor todetect bodytemperature from theauditory canal in peopleof all ages for homesetting use.	The device is anelectronic clinicalthermometer using aninfrared sensor todetect bodytemperature from theauditory canal in theneonatal, pediatric andadult population used inthe home setting.	SimilarThe device name isincluded in the subjectdevice.
Principle ofoperation	Measure temperatureby reading infraredradiation emitting fromthe eardrum tissuewhen the thermometeris inserted into the earcanal.	Measure temperatureby reading infraredradiation emitting fromthe eardrum tissuewhen the thermometeris inserted into the earcanal.	Same

targetpopulation	people of all ages	Neonatal, pediatric, andadult	Same
Measurementsite	auditory canal	auditory canal	Same
Material ofPatient contactcomponents	ABS	ABS	Same
Biocompatibility	Comply with ISO10993-5, ISO10993-10	Comply with ISO10993-5, ISO10993-10	Same
Environment	home	home	Same
Design	Handheld	Handheld	Same
Measurementmethod	Infrared radiationdetection	Infrared radiationdetection	Same
Display Type	LCD	LCD	Same
Measurementmode	Ear measure mode	Ear measure mode	Same
Key	2 button(scan,ON/Memory button)	2 button(scan,ON/Memory button)	Same
Scaleselection	°C/°F	°C/°F	Same
Display unit	°C/°F	°C/°F	Same
Hightemperaturewarning	Yes	Yes	Same
Low batteryindicator	Yes	Yes	Same
Case Material	ABS	ABS	Same
Sensor Type	Thermopile	Thermopile	Same
Performance	Meet ASTM E1965-98and ISO 80601-2-56	Meet ASTM E1965-98	SimilarThe proposed devicecomplies with standardsASTM E1965-98 andISO 80601-2-56. Thedifference does notaffect the determinationof substantialequivalence.
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 notaffect the determinationof substantialequivalence.
Displayresolution	0.1°F (0.1°C)	0.1°F (0.1°C)	Same
Measuringaccuracy	±0.2°C (0.4°F) within35~~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	10 set	9 set	SimilarThe memory capacitywill not affect thedetermination ofsubstantialequivalence
Measure time	≤5S	About 1 second	SimilarThe Measure time willnot affect thedetermination ofsubstantial equivalence
Power source	DC 3V (Alkaline AAAsize battery x 2)	DC 3V, One lithiumcell (CR2032 x 1).	SimilarThe proposed devicewas demonstratedelectromagneticcompatibility andelectrical safety by thetesting. The differencedoes not affect thedetermination ofsubstantial equivalence.
Operatingcondition	15°C~~35°C (59~~95°F),RelativeHumidity≤85%	10~~40°C(50~~104°F),15%~85%RH	SimilarThe operatingcondition of subjectdevice has passed thesafety test, and theInstructions for Useprovides the operatingcondition, so thedifference between theoperating conditions ofsubject device andpredicate device willnot affect thedetermination ofsubstantialequivalence.

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: GeneralRequirements For Basic Safety And EssentialPerformance
IEC 60601-1-2: 2014	Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance -- Collateral Standard: ElectromagneticDisturbances -- Requirements And Tests
IEC 60601-1-11: 2015	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests
ISO 80601-2-56: 2009	Medical Electrical Equipment - Part 2-56: ParticularRequirements For Basic Safety And EssentialPerformance Of Clinical Thermometers For BodyTemperature Measurement.
ASTM E1965-98	Standard Specification For Infrared Thermometers ForIntermittent Determination Of Patient Temperature
ISO 10993-5:2009	Biological Evaluation Of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity
ISO 10993-10:2010	Biological Evaluation Of Medical Devices - Part 10: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.

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.