The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.

Device Description

The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.

The Non-contact Forehead Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.

AI/ML Overview

The provided document is a 510(k) Summary for a Non-contact Forehead Thermometer (Model TH1009N). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of acceptance criteria and the reported device performance

Criteria Category	Acceptance Criteria (Stated by standard or implicitly accepted by FDA)	Reported Device Performance (from the document)
Accuracy	±0.2 °C (0.4°F) for 35.0°C (95.0°F)-42.0°C (107.6°F), ±0.3 °C (0.5°F) for other ranges (This matches the predicate's accuracy range in the comparison table, implicitly setting the acceptance criteria)	±0.2 °C (0.4°F) for 35.0°C (95.0°F)-42.0°C (107.6°F), ±0.3 °C (0.5°F) for Other range
Body Measuring Range	Wider than 34.4 - 42.2 °C (93.9 -108 °F) (Predicate's range, the subject device aims to meet or exceed relevant standards)	32.0-42.9 °C (89.6-109.3°F)
Ambient Range	Wider than 15 °C - 40°C (59.0°F-104.0°F) (Predicate's range, the subject device aims to meet or exceed relevant standards)	5.0 °C-59.9°C (41.0°F-104°F)
Operating Temperature	15.0°C - 40.0°C (59.0°F - 104.0°F) with a relative humidity of 15%~85%, Atmosphere pressure: 700hPa-1060hPa	15.0°C - 40.0°C (59.0°F - 104.0°F) with a relative humidity of 15%~85%, Atmosphere pressure: 700hPa-1060hPa
Storage & Transport Temperature	Wider than -25 °C to 60 °C (-13 °F to 140 °F) Humidity: 15 - 95% non condensing, 700-1060hPA (0.7-1.06 atm) (Predicate's range, the subject device aims to meet or exceed relevant standards)	-20°C - 55°C (-4°F - 131°F) with a relative humidity of 15%~90%, Atmosphere pressure: 700hPa-1060hPa
Electrical Safety	Compliance with IEC 60601-1:2005+A1:2012 and ISO 80601-2-56:2009	"Results of these tests demonstrate compliance to the requirements..." for these standards.
EMC	Compliance with IEC 60601-1-2:2007	"Results of these tests demonstrate compliance to the requirements..." for this standard.
Biocompatibility	Compliance with ISO 10993-5:2009 and ISO 10993-10:2010	"Results of these tests demonstrate compliance to the requirements..." for these standards.
Software Verification & Validation	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (FDA guidance) and IEC 62304 for a "Moderate" level of concern.	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... IEC 62304 was followed."

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

Sample Size: Not explicitly stated for the clinical evaluation. The document mentions a "clinical evaluation..." conducted in compliance with ASTM E1965-98. ASTM E1965-98 specifies the clinical accuracy requirements for infrared thermometers (e.g., in Section 8), which typically involves a minimum number of subjects (e.g., 50 subjects for clinical accuracy studies, as per older versions of similar standards, but the exact number isn't in this document).
Data Provenance: The "Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd". This implies the study was conducted by the manufacturer, likely in China. The document does not specify if the data was retrospective or prospective, but clinical evaluations are typically 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. For thermometer accuracy, "ground truth" is typically established by comparing the device reading against a highly accurate reference thermometer (e.g., an oral or rectal thermometer with known accuracy, or a blackbody simulator), rather than expert interpretation.

4. Adjudication method for the test set

This information is not applicable and therefore not provided, as the ground truth for thermometer accuracy is typically a direct measurement from a reference device, not an interpretation 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

This is not applicable. This device is a non-contact forehead thermometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

This is not applicable in the context of "algorithm only" performance as commonly discussed for AI/ML devices. The device itself is standalone in that it provides a temperature reading without human interpretation for the result. Its "performance" is its accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical evaluation, the ground truth would be established by measurements from a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer) as specified by the ASTM E1965-98 standard. The document states the clinical evaluation was in compliance with this standard.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device described does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on infrared sensing and internal algorithms, not on learning from a large dataset.

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

This information is not applicable as there is no mention of a training set for machine learning or AI algorithms within the provided documentation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan, Shenzhen, 518108 CHINA

Re: K161735

Trade/Device Name: Non-contact Forehead Thermometer TH1009N Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 11, 2016 Received: October 13, 2016

Dear Siping Yuan:

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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K161735

Device Name

Non-contact Forehead Thermometer TH1009N

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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001_510 (k) Summary ് Version: 1.6

510(k) Summary

K161735

Non-contact Forehead Thermometer

Date of Prepared:	06/17/2016
Submitter's Name:	Shenzhen Dongdixin Technology Co., Ltd
Address:	No. 3 Building, xilibaimang Xusheng Industrial EstateNanshan, Shenzhen, CHINA 518108
Contact person:	Siping Yuan
TEL:	+86(755) 27652471
FAX:	+86(755) 27652674
E-mail:	yuansp@dundex.com

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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a traditional font. The logo is simple and modern, and it conveys a sense of technology and innovation.

This 510(K) Summary of information is being submitted in accordance with requirements of Title 21 CFR Section 807.92.

1. Proposed Device:

1.1. Device Trade Name: Non-contact Forehead Thermometer TH1009N
1.2. Regulation numbers and common names: 21 CFR 880.2910 Clinical electronic thermometer
1.3. Classification: Class II
1.4. Product Code: FLL

2. Predicate Device:

Legally Marketed Device: NTF 3000 No Touch+Forehead Thermometer 510(k) Number: K134043 Submitter: Kaz USA, Incorporated

Description of Proposed Device: 3.

4. Indications for Use

The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages.

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Technical and Performance Comparison 5.

The following table compares the device to the predicate device with basic technological characteristics.

Items	Subject device	Predicate device	Discussion
510K#	K161735	K134043	N/A
Classification	Clinical Electronic thermometerClass II 21 CFR 880.2910	Clinical Electronic thermometerClass II 21 CFR 880.2910	Same
Device Name	Non-contact ForeheadThermometer TH1009N	NTF 3000 No Touch+ForeheadThermometer	N/A
Manufacturer	Shenzhen DongdixinTechnology Co., Ltd.	Kaz USA, Incorporated	N/A
Indicationsfor use	The Non-contact ForeheadThermometer is a non-sterile,reusable clinical thermometerintended for the intermittentdetermination of human bodytemperature in a touch and notouch mode on the centre ofthe forehead as themeasurement site on people ofall ages.	The No Touch + ForeheadThermometer(Model NTF3000US)is a non-sterile, reusable clinicalthermometer intended for theintermittent determination ofhuman body temperature in atouch and no touch mode on thecentre of the forehead as themeasurement site on people of allages.	Same
TargetPopulation	People all ages	People all ages	Same
Components	Enclosure, Sensor, CPU, LCD	Enclosure, Sensor, CPU,LCD, Protective cap	Different
Principle ofoperation	Infrared Sensor technology	Infrared Sensor technology	Same
Material	ABS	ABS	Same
Measure site	Forehead	Forehead	Same
Measuredistance	0-5 cm	0-5 cm	Same
Unit ofmeasurement	°C/°F	°C/°F	Same
Body measuringrange	32.0-42.9 °C(89.6-109.3°F)	34.4 - 42.2 °C(93.9 -108 °F)	Different
Accuracy	±0.2 °C (0.4°F) for35.0°C (95.0°F)-42.0°C (107.6°F),±0.3 °C (0.5°F) for Other range	± 0.4°F for the range 95°-107.6°F(± 0.2°C for 35-42°C)	Same
Ambient range	5.0 °C-59.9°C (41.0°F-104°F)	15 °C - 40°C (59.0°F-104.0°F)	Different
Display type	LCD	LCD	Same
Powerrequirements	3V DC	3V DC	Same
Operating	15.0°C - 40.0°C (59.0°F - 104.0°F)	59 °F - 104 °F (15 °C - 40 °C)	Same
temperature	with a relative humidity of15%~85%, Atmosphere pressure:700hPa-1060hPa
Storage andtransporttemperature	-20°C - 55°C (-4°F - 131°F) with arelative humidity of 15%~90%,Atmosphere pressure:700hPa-1060hPa	-13 °F to 140 °F (-25 °C to 60 °C)Humidity: 15 - 95% non condensing,700-1060hPA (0.7-1.06 atm)	Different

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Discussion:

The following differences exist between the subject and predicate devices are as follows:

Components – There is no sensor protective cap with subject device. The cap protects thermometer sensor from dust. However, when there is dust on the sensor, user can clean it according to user manual. So this difference has no effect on functionality of the thermometer.
. Body measuring range — The subject device has wider measurement temperature range than predicate device, the subject device complies to the standard ISO 80601-2-56 and ASTM E1965-98. This difference does not pose any new performance questions.
. Ambient range – The subject device has wider displayed room temperature range than predicate device, the subject device complies to the standard ISO 80601-2-56 and ASTM E1965-98. The software verification and validation test met the requirements of the standards. This difference does not pose any new performance questions.
. Storage and transport temperature — The subject device has wider storage and transport conditions, the subject device complies to the standard IEC 60601-1-11. This difference does not pose any new performance questions.

The similarities and differences described in the comparison table demonstrate that the Non-contact forehead thermometer TH1009N is substantially equivalent to predicate and does not raise new performance questions.

6. Non-clinical performance data

The following non-clinical performance data are provided in support of the substantial equivalence determination. Performance testing was conducted to validate and verify that Non-contact Forehead Thermometer, model TH1009N meets all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product cleaning. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

ElectricalSafetyandperformancerequirements:

. IEC 60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
. ISO 80601-2-56:2009 Medical electrical equipment Part 2-56 Particular requirements for basic

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Image /page/7/Picture/1 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a more traditional font. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

TECHNOLOGY

safety and essential performance of clinical thermometers for body temperature measurement

. ASTM E1965-98(Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Home-usedmedicalequipmentrequirementsandenvironmentaltest:

. IEC 60601-1-11:2010 General requirements for basic safety and essential performance --Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Electromagneticcompatibilityrequirements:

. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

BiocompatibilityEvaluationforpatientcontactingcomponents:

. ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
. ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

SoftwareVerificationandValidationTesting:

In addition to the compliance of voluntary standards, Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

7. Clinical testing data

Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd in compliance with ASTM E1965-98(Reapproved 2009) Standard. The validation study demonstrated that the clinical accuracy of the Non-contact Forehead Thermometer is substantially equivalent to the predicate device.

Both the clinical and non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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Conclusions: 8.

The proposed device has the same intended use and similar characteristics as the predicate device, the NTF 3000 No Touch+Forehead Thermometer. Moreover, performance tests demonstrate that any differences in their technological characteristics do not raise any new performance questions. In the other words, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the device.

Thus, Non-contact Forehead Thermometer TH1009N 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.