This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

Device Description

The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.

AI/ML Overview

Based on the provided FDA 510(k) summary for the Infrared Forehead Thermometer (Model IR-FT), here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

Core Information Regarding Acceptance Criteria and Study Performance

The device under review is an Infrared Forehead Thermometer, and its performance is primarily evaluated against established standards for temperature measurement accuracy. The predicate device (K134043) sets the benchmark for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance aspect tested for this device is temperature measurement accuracy. The acceptance criteria are derived from the referenced voluntary standards, particularly ASTM E1965 and ISO 80601-2-56.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance	Source of Criteria
Temperature Range	32.0°C ~43.0°C (89.6°F - 109.4°F)	32.0°C ~43.0°C (89.6°F - 109.4°F)	Device Specification (note: this is a stated operating range, not an accuracy criterion to meet for equivalence, but it's compared to predicate)
Accuracy for Body Temp (35°C - 42°C / 95°F - 107.6°F)	≤±0.2°C (0.4°F)	≤±0.2°C (0.4°F)	ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards)
Accuracy for Body Temp (32°C - 34.9°C / 89.6°F - 94.8°F)	≤±0.3°C (0.5°F)	≤±0.3°C (0.5°F)	ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards)
Accuracy for Body Temp (42.1°C - 43°C / 107.8°F - 109.4°F)	≤±0.3°C (0.5°F)	≤±0.3°C (0.5°F)	ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards)
Resolution of Display	0.1°C / 0.1°F	0.1°C / 0.1°F	Device Specification (Same as predicate)
Clinical Acceptability (Bias & Repeatability)	Within clinical acceptability as defined in ISO 80601-2-56	Demonstrated "highly related" temperatures and within clinical acceptability.	ISO 80601-2-56 (Clinical Comparison Study)
Safety (Electrical/EMC)	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11	Compliance achieved	ANSI/AAMI ES60601-1, AAMI/ANSI ES60601-1-2, IEC 60601-1-11
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10	Compliance achieved	ISO 10993-1, -5, -10
Cleaning Validation	Cleaning method meets requirements	Validation result shows method meets requirements	Instruction for Use (IFU) Protocol

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

Test Set (Clinical Accuracy Validation): The document states that a "comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older".
- Specific Sample Size: The exact number of subjects within each age group, or the total number of subjects, is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state whether the study was retrospective or prospective, but clinical comparison studies for medical device clearance are typically prospective in nature.

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

This device is a thermometer, and the ground truth for temperature measurement is typically established using a calibrated reference thermometer (e.g., a Vitreous thermometer as mentioned), rather than expert consensus on interpretation of diagnostic images. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for imaging studies) is not directly applicable here. The "experts" in this context would be the technicians or clinicians trained in using the reference thermometer and conducting the study according to the specified standards (ISO 80601-2-56).
Qualifications: Not specified for the personnel conducting the clinical validation, but it's implied they followed standard clinical trial and instrument calibration procedures as per the referenced ISO standard.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) is subjective and requires consensus. For a physical measurement device like a thermometer, the "ground truth" is established by a more precise, calibrated measurement standard.
Adjudication Method: Not applicable in the sense of expert consensus on interpretation. The "adjudication" is the direct numerical comparison of the device's readings against the reference thermometer's readings, as outlined by the standards.

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: No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic aids where the AI assists human readers (e.g., radiologists interpreting images). This device is a standalone measurement tool.
Effect Size: Not applicable.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: While the device relies on embedded algorithms/firmware for temperature calculation, the performance study described is the standalone performance of the device itself (measurement accuracy), without a human interpretation "loop" in the sense of a diagnostic aid. The "human-in-the-loop" for this device would be the user taking the temperature reading, but the study focuses on the instrument's accuracy regardless of the interpretive skill of the user. The "clinical accuracy validation" assesses the device's inherent ability to measure temperature correctly compared to a standard.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical accuracy validation was established using a Vitreous thermometer. This implies an established, highly accurate reference measurement tool as the gold standard for body temperature.
This falls under the category of using a clinical reference standard/device rather than expert consensus, pathology, or outcomes data directly.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not stated. This device is a physical measurement instrument, not a machine learning (AI) algorithm that requires a separate training set of data. Its "training" is inherent in its design and manufacturing, and its performance is validated through non-clinical and clinical testing, not model training.

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

Ground Truth for Training Set: Not applicable. As mentioned above, there isn't a "training set" for a traditional AI algorithm in the context of this device. The accuracy of the device is validated against the specified standards using a reference thermometer, not "trained" on a dataset with ground truth.

Summary

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October 18, 2019

Comper Chuangxiang (Beijing) Technology Co., Ltd. Han Du Official Correspondent Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District, Beijing 100176 China

Re: K191668

Trade/Device Name: Infrared Forehead Thermometer (Model IR-FT) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 13, 2019 Received: September 13, 2019

Dear Han Du:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191668

Device Name

Infrared Forehead Thermometer (Model IR-FT)

Indications for Use (Describe)

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intermittent determination of human body temperature through a touch on the center of the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

Type of Use (Select one or both, as applicable)
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| | 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

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 18 October 2019

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Comper Chuangxiang (Beijing) technology Co., Ltd.
Address:	Room 102-103 1st Floor, Building 4 No.1 Kangding Street,Daxing District Beijing, CHINA 100176
Contact person:	Han Du
Title:	Manager
E-mail:	registration@comper.com
Tel:	+86-10-57480968

2. Device Identification

Trade/Device Name:	Infrared Forehead Thermometer
Models:	IR-FT
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

3. Predicate Device

510(K) number:	K134043
Device Name:	No Touch + Forehead Thermometer
Manufacturer:	KAZ USA, Inc.
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

4. Device Description

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5. Indication for use

6. Comparison of technological characteristics with the Predicate Device

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table

Feature	Subject device	Predicate device	Discussion
510(k) Number	K191668	K134043
Indication foruse	This device is a non-sterile, reusable, contactInfrared ForeheadThermometer (Model IR-FT) intended forintermittent determinationof human bodytemperature through atouch on the center of theforehead as themeasurement site onpeople of all ages. TheInfrared ForeheadThermometer (Model IR-FT) can be used inclinical and homeenvironments.	The No Touch + ForeheadThermometer (ModelNTF3000US) is a non-sterile,reusable clinicalthermometer intended for theintermittent determination ofhuman body temperature ina touch and no touch on thecentre of the forehead as themeasurement site on peopleof all ages.	The intended use issimilar to the predicatedevice, however, thesubject device may beused only in contactmode. Additionally thesubject device definesthe use environment asboth clinical and home-use.
Thermometertype	Infrared forehead	Infrared forehead	Same
Components	The product is mainlycomposed of atemperature sensor, ahousing, a circuit boardand a batterycompartment.	The product is mainlycomposed of a temperaturesensor, a housing, a circuitboard and a batterycompartment.	The same structure
TemperatureMeasurementTechnology	The thermometer uses athermopile sensor withintegrated thermistor forthe target reading, athermistor mounted in thehead of the thermometerfor ambient temperaturereadings, and an infrared	The thermometer uses athermopile sensor withintegrated thermistor for thetarget reading, a thermistormounted in the head of thethermometer for ambienttemperature readings, aparabolic mirror to help focus	Similar, our devicehave not a parabolicmirror, but theperformance has beenverified according tothe ISO 80601-2-56and ASTM E1965, theresult shows that our
	proximity sensor fordetection of contact useand compensation of thetemperature reading.	the infrared energy emittedfrom the forehead, and aninfrared proximity sensor fordetection of contact or non-contact use andcompensation of thetemperature reading.	device has the samespecification topredicate device.
KeyTemperatureSensor	Thermopile SensorOTP-336 manufacturedby Oriental systemtechnology inc.	Thermopile Sensor	Same type, butdifferent manufacturer.We performed theperformance testaccording to the ISO80601-2-56 and ASTMD1965, therefore it donot raise differentquestions of safety andeffectiveness.
Powerrequirements	D.C. 3 V (2 AAA drybatteries)	D.C. 3 V (2 AAA drybatteries)	Same
Materials	Patient contactingmaterials include PC (Topcover, battery cover,chamber, button power)and ABS+TPU (frontcover).	Patient contacting materialsinclude ABS (device housing/ handle and power button)andTPR (temperature button andnose / forehead touchbumper).	Different, but both ofour device andpredicate device haveperformed theBiocompatibility testaccording to the ISO10993-1, both twodevices meet therequirements of ISO10993. therefore it issubstantially equivalenton Biocompatibilityrisk.
Temperaturerange	32.0°C ~43.0°C (89.6°F -109.4°F)	34.4°C to 42.2°C(93.9°F to 108.0°F)	Our measurementrange is greater thanpredicate device, butwe performed accuracytest according to theASTM E1965 and ISO80601-2-56, thereforeit is substantiallyequivalent onperformance.

Accuracy forbodytemperaturemeasurement	≤±0.2°C (0.4°F), for therange 35°C -42°C (95°F -107.6°F);≤±0.3°C (0.5°F),for therange 32°C -34.9°C(89.6°F -94.8°F) and42.1-43°C (107.8°F -109.4°F).	± 0.2°C / 0.36°F35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C / 0.54°F31.0°C to 35.0°C(87.8°F to 95.0°F);± 0.3°C / 0.54°FAbove 42.0°C(Above 107.6°F)	Same
	Resolution ofdisplay	0.1°C / 0.1°F	0.1°C / 0.1°F	Same
		Signal outputAnd display	LCD, Buzzer	LCD, Buzzer
	Biocompatibility		ISO 10993-1	ISO 10993-1
Voluntarystandardsfor ClinicalElectronicThermometers,	ISO 80601-2-56ASTM E1965	ASTM E 1965 andISO 80601-2-56	Same
	MedicalElectricalSafety andEMC	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2	Same

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Comper Chuangxiang (Beijing) technology Co., Ltd

The required testing demonstrated that the differences do not raise new questions of safety and

effectiveness between the subject and the predicate device.

8. Performance Data

Non-clinical data

Cleaning Validation:

We performed the cleaning validation according to the method of instruction for use, the validation result shows that the method of cleaning meets the cleaning requirements.

Safety:

1. ANSI/AAMI ES60601-1:2005/(R)2012 AND A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
1. AAMI/ANSI ES60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests

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1. IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: 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

Performance:

1. ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
1. ASTM E1965-98(2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Clinical accuracy validation:

A comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer (Model IR-FT) with Vitreous thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer (Model IR-FT) were highly related when compared to the Vitreous thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability, the results shows substantial equivalence.

Biocompatibility:

1. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

The tests were selected to show substantial equivalence between the subject device and the predicate.

9. Conclusion

Based on the safety and performance testing and compliance with acceptable voluntary standard, we believe that the Infrared Forehead Thermometer (Model IR-FT) is substantially equivalent to the predicate device (K134043), and does not raise any new safety and effectiveness issues.

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.