The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

Device Description

The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The thermometers HTD8818A, HTD8816C and HTD8808C infer temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The thermometer design consists lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature. This permits temperature measurement from a distance without contact with the object to be measured.

AI/ML Overview

The provided document describes the acceptance criteria and the study that demonstrates the performance of the HeTaiDa non-contact infrared body thermometers (Models HTD8818A, HTD8816C, HTD8808C).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to standards like ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009) for clinical bias, clinical accuracy, and clinical repeatability. The document provides specific accuracy ranges for body and surface modes.

Metric / Characteristic	Acceptance Criteria (Implied by Standards / Predicate)	Reported Device Performance (HeTaiDa-thermometers)
Accuracy (Body Mode)
34.0~34.9°C (93.2-94.8°F)	±0.3°C (±0.5°F)	±0.3°C (±0.5°F)
35.0~42.0°C (95.0-107.6°F)	±0.2°C (±0.4°F)	±0.2°C (±0.4°F)
42.1~42.9°C (107.8-109.2°F)	±0.3°C (±0.5°F)	±0.3°C (±0.5°F)
Accuracy (Surface Mode)	N/A (Predicate varies, but this device states)	±2°C (±3.6°F)
Clinical Bias	Within clinically acceptable range (ISO 80601-2-56)	-0.027
Clinical Accuracy	Within clinically acceptable range (ISO 80601-2-56)	±0.14
Clinical Repeatability	Within clinically acceptable range (ISO 80601-2-56)	0.07

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

Sample Size for Test Set: The document states "The four groups of subjects being tested were: (1) 0-3 months, (2) 3 months-1 year old, (3) 1-5 years old, and (4) >5 years older." However, the specific number of subjects within each group or total number of subjects is not provided.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "clinical investigation was performed," which typically implies prospective data collection, but this is not explicitly confirmed.

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

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided. The ground truth was established by a "reference contact clinical electronic thermometer BT-21H," implying a standardized measurement rather than expert interpretation.

4. Adjudication Method for the Test Set

Adjudication Method: This information is not applicable/provided. The ground truth was based on measurements from a reference contact clinical electronic thermometer (axillary temperature) rather than subjective assessments requiring adjudication.

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

MRMC Study: This information is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or results. No MRMC study was conducted or is relevant for this type of device.

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

Standalone Performance: Yes, the clinical investigation evaluates the device's standalone performance directly by comparing its readings to a reference thermometer. The "clinical bias, clinical accuracy and clinical repeatability" are measures of the device's inherent performance.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical study was established using measurements from a reference contact clinical electronic thermometer BT-21H, which measured axillary temperatures. This serves as a point of comparison for the non-contact infrared thermometer.

8. The Sample Size for the Training Set

Sample Size for Training Set: This information is not provided and is generally not applicable in the context of a non-AI based medical device like a thermometer. Thermometers are typically designed and calibrated based on physical principles and standards, not through machine learning training data.

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

Ground Truth for Training Set: This information is not provided and is generally not applicable for a non-AI device. Calibration and design validation would follow established metrological practices and standards rather than a "training set" with ground truth in the machine learning sense.

Summary

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K171888

5. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 15th, 2018

1. Company making the submission: Name - HeTaiDa Technology Co., Ltd Address - 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. Tel: 86-13923426692 Contact – Tom ZhenGuang Chen General Manager Email - tomchen@hetaida.com.cn
1. U.S. Correspondent and Contact Name: Elliot Medical Solutions Address: 18586 Parkland Drive, Shaker Heights, Ohio, 44122, U.S.A. Contact: Roman Huang General Manager Tel: 216-262-0962 Email: support@elliotmd.com
1. Device Name: Non-contact Infrared Body Thermometer Trade name: HeTaiDa-Thermometer Models: HTD8818A,HTD8816C,HTD8808C Common Name: Clinical electronic thermometer Classification Name: Thermometer, electronic, clinical Regulatory Class: II Product Code: FLL Type of 510(k) submission: Traditional
1. Predicate Device.

Manufacturer	PredicateDevice	510(k)number
HangzhouUniversalElectronic Co.,Ltd.	Non-contactinfrared BodythermometerFT-100A	K160802

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1. Description.
  The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The three models HTD8818A,HTD8816C,HTD8808C are bundled in this one 510k submission based on the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission. The HTD8818A, HTD8816C, HTD8808C thermometers present scientific and regulatory issues that can be addressed during one review. Their indications for use, safety and performance data, biocompatibility, clinical evaluation data, and electromagnetic compatibility data are identical. The only differences among the HTD8818A, HTD8816C, HTD8808C thermometers are size, weight, shape of enclosure, printed circuit board (PCB) layout and measuring distances.

1. Indication for use.
  The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.
1. Similarities/Differences between the subject and predicate device.

Element ofComparison	Subject Device(s)	Predicate Device	Comparison
Type ofThermometer	Non-Contact Infraredforehead thermometer(Models: HTD8818AHTD8816CHTD8808C)	Non-contact Infraredforehead thermometer,(model: FT-100A)	Identical

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510(k)	N/A	K160802	N/A
Indication for Use	The HeTaiDa electronicthermometersHTD8818A, HTD8816Cand HTD8808C areinfrared thermometerswhich use infrared sensorto detect human bodytemperature of patients ofall ages. It is intended tobe used on forehead todetect body temperature.The HTD8818A,HTD8816C andHTD8808C are intendedfor use in the clinical andhomecare environment.	The FT-100AElectronicthermometer is aninfrared thermometerwhich uses an infraredsensor to detect humanbody temperature ofpatients of all ages. Itis intended to be usedon forehead to detectbody temperature. TheFT-100A is intendedfor home and clinicaluse.	Identical
Temperature unit	°C or °F	°C or °F	Identical
MeasurementRange	Forehead:34°C to 42.9°C (93.2°F to109.2°F)Surface (Object):0°C to 100°C (32°F to212°F)	Forehead:32°C to 43°C (89.6°Fto 109.4°F)Object:0°C to 100°C (32°F to212°F)	Similar
OperatingTemperature	15°C to 35°C (59°F to95°F)	16°C to 40°C (60.8°Fto 104°F)	Similar
Operatinghumidity	85% RH or less	95% RH or less	Similar
Storagetemperature	-20°C to 55°C (-4°F to131°F)	-25°C to 55°C (-13°Fto 131°F)	Similar
Storage humidity	93% RH or less	95% RH or less	Similar
Accuracy	FOR BODY MODE:34.0~~34.9°C: ±0.3°C(93.2-94.8°F: ±0.5°F);35.0~~42.0°C: ±0.2°C(95.0-107.6°F: ±0.4°F);42.1~42.9°C: ±0.3°C(107.8-109.2°F: ±0.5°F);FOR SURFACE MODE:± 2°C (± 3.6 °F)	FOR BODY MODE:±0.2°C (±0.4°F) from36.0°C (96.8°F) to39.0°C(102.2°F);±0.3°C (±0.54°F) from32.0°C (89.6°F) to35.9°C (96.6°F) andfrom 39.1°C (102.4°F)to 43.0°C (109.4°F)FOR OBJECTMODE:	Technologicalcharacteristicsare similar
		± 4°C (±7.2°F) from0°C (32°F) to 4.9°C(40.8°F)± 1°C (±2°F) from 5°C(40.8°F) to 60°C(140°F)± 4°C (±7.2°F) from60.1°C (140.1°F) to100°C (199.9°F)
Memory capacity	50 measurements	20 measurements	Technologicalcharacteristicsare similar
Power down time	18s or less	1 min	Similar
Battery type	1.5V AAA x 2	1.5V AAA x 2	Identical
LCD Backlight	Available	Available	Identical
Fundamentaltechnology	Infrared technology thatconverts a user's foreheadtemperature using theinfrared energy emitted inthe area around the user'sforehead to a referencesite equivalenttemperature.	Infrared technologythat converts a user'sforehead temperatureusing the infraredenergy emitted in thearea around the user'sforehead to a referencesite equivalenttemperature.	Identical
Display resolution	0.1°C/0.1°F	0.1°C/0.1°F	Identical

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1. Comparison of Technological Characteristics with Predicate Device.
  The technological characteristics of the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device (FT-100A) are similar. Both convert user's forehead temperature using the infrared energy emitted in the area around the user's forehead to a reference site equivalent temperature. The differences between the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device FT-100 do not raise different questions of safety and effectiveness. The HeTaiDa Technology Co., Ltd believes that the noncontact infrared body thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to the (K160802) non-contact infrared body thermometer FT-100A of Universal Electronic Co., Ltd.

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9. Safety and Performance Data.

Bench Data are listed in Table as below.

Model	Bench Tests	Standards	Results	ReportFile No.
HTD8818AHTD8808CHTD8816C	General requirementsfor basic safety andessential performance	IEC 60601-1:2005(Third Edition) +CORP. 1:2006 +CORP. 2:2007 +A1:2012	Pass	GZME160500034301-01
	General requirementsfor basic safety andessential performance– Collateral Standard:Requirements formedical electricalequipment andmedical electricalsystems used in thehome healthcareenvironment	IEC 60601-1-11 (FirstEdition): 2010	Pass	GZME160500034302-01
	General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticcompatibility	IEC 60601-1-2:2014	Pass	GZME170100001901
	EMC TEST	CFR 47 FCC Part 15,Subpart B, Class B2016	Pass	NTC1705146FV00
	Particularrequirements forbasic safety andessential performanceof clinicalthermometers forbody temperaturemeasurement	ISO 80601-2-56:2009(First Edition) for usein conjunction withIEC 60601-1:2005(Third edition)	Pass	GZME160500034303-01
	Standardspecification forinfraredthermometers forintermittentdetermination ofpatient temperature	ASTM E1965-98(Reapproved 2009)	Pass	GZME170100001801

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Biocompatibility data are listed in Table as below.

Model	BiocompatibilityTests of FinalFinished Device	Standards	Results	Report File No.
HTD8818AHTD8808CHTD8816C	In vitrocytotoxicity with10% FBS	ISO 10993-5:2009:Biologicalevaluation ofmedical devices:part 5: Tests for invitro cytotoxicity	Pass	SDWH-M201800599-1(HTD8808C),SDWH-M201800600-1(HTD8816C),SDWH-M201800601-1(HTD8818A)
	Skin sensitization0.9%SC	ISO 10993-10,Biologicalevaluation ofmedical device -Part 10: Tests forirritation and skinsensitization.	Pass	SDWH-M201800599-2and -3(HTD8808C),
	Skin sensitizationCotton seed oil			SDWH-M201800600-2and -3(HTD8816C),SDWH-M201800601-2and -3(HTD8818A)
	Skin irritation0.9%SC	ISO 10993-10,Biologicalevaluation ofmedical device -Part 10: Tests forirritation and skinsensitization.	Pass	SDWH-M201800599-4and -5(HTD8808C),SDWH-M201800600-4and -5(HTD8816C),SDWH-M201800601-4and -5(HTD8818A)
	Skin irritationCotton seed oil

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A clinical investigation was performed to evaluate the clinical bias, clinical accuracy and clinical repeatability. The four groups of subjects being tested were:

(1) 0 3 months, (2) 3 months 1 year old, (3) 1 5 years old, and (4) >5 years older.
Each group of subjects underwent a series of temperature measurement at their forehead using HTD8818A, HTD8816C and HTD8808C non-contact infrared body thermometers. All the subject groups also underwent a series of temperature measurement using a reference contact clinical electronic thermometer BT-21H, which temperatures were measured in the axillary of patients. These temperature measurements were then each compared to the temperature measurements taken by the HeTaiDa non-contact infrared body thermometers. The clinical bias, clinical accuracy and clinical repeatability of the HeTaiDa-thermometers are calculated to be -0.027, ±0.14, and 0.07, respectively, which are within the clinically acceptable range as required by ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009). These clinical results indicate that the HeTaiDa non-contact infrared thermometers produce effective and accurate temperature measurements.

The design of the submitted device specifications is substantially the same as the predicate, with minor difference in the operating temperature and humidity range, and storage temperature and humidity range.

11. Conclusions.

The HeTaiDa non-contact infrared body thermometers HTD8818A, HTD8816C and HTD8808C have similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Thus, in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part807 and based on the information provided in this premarket notification, HeTaiDa Technology Co., Ltd. concludes that the Infrared Forehead Thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to predicate device.

End.

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Image /page/8/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

July 23, 2018

Hetaida Technology Co., Ltd % Roman Huang Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights, Ohio 44122

Re: K171888

Trade/Device Name: Non-contact infrared body thermometer, HTD8818A, HTD8816C, and HTD8808C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 15, 2018 Received: July 6, 2018

Dear Roman Huang:

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.

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 (QS) regulation (21 CFR Part 820);

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Page 2 - Roman Huang

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 medical devices and radiation-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,

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

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.