The Medical infrared forehead thermometer (Model: HGO1, HGO1 V1, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.

Device Description

The proposed device. Medical infrared forehead thermometer, which includes model HGO1 VI, HGO6 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead of people aged over 1 year.

The proposed devices measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.

The devices have the following features: About one-second measuring Body or Ambient temperature, 32-memory recalls, 9 and 9F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen, and the buzzer will tell the measurement has been completed. The device will display 3 different background colors according to the result.

The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts:

2xAAA batteries, 1xManual and 1 pcs thermometer

AI/ML Overview

This document is a 510(k) summary for a Medical infrared forehead thermometer, demonstrating its substantial equivalence to a predicate device. The information provided focuses on the safety and effectiveness testing for regulatory clearance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
Biocompatibility:
ISO 10993-5:2009 (Cytotoxicity)	Complied
ISO 10993-10:2010 (Sensitization)	Complied
ISO 10993-10:2010 (Irritation)	Complied
Electrical Safety & EMC:
IEC 60601-1:2012	Complied
IEC 60601-1-11:2015	Complied
IEC 60601-1-2:2014	Complied
Software V&V:
FDA Guidance for Software in Medical Devices	Documentation provided
IEC 62304:2006+AMD1:2015	Documentation provided
Performance Testing:
ASTM E 1965-98 (Laboratory Accuracy)	Met requirements (Forehead mode ±0.3°C)
ISO 80601-2-56:2017 (Clinical Accuracy)	Clinical bias within acceptable scope; complied with requirements
ISO 80601-2-56:2017/AMD 1:2018 (Electrical safety)	Complied
Lifetime shelf life performance test	Not explicitly stated as "complied" but test was conducted

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

Sample Size for Test Set: 100 subjects for clinical tests.
Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the manufacturer's location in China, it is plausible the study was conducted in China.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. It mentions "clinical tests were conducted," and the "clinical accuracy of the proposed device was evaluated by ISO 80601-2-56 - clinical bias with stated uncertainty and clinical repeatability." This implies a comparison against a reference thermometer, but not necessarily against expert human readers.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The clinical study focused on comparing the device's temperature readings against a reference method as per ISO 80601-2-56, not on human interpretation or adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This device is an infrared thermometer, not an AI-assisted diagnostic device that would involve human readers interpreting images or data. The clinical study was to assess the accuracy of temperature measurement.

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

Yes, a standalone performance assessment was done for the device. The clinical trials evaluated the device's ability to measure temperature accurately on its own. The "device" in this context refers to the thermometer and its embedded algorithms/sensors, not a separate AI algorithm being applied to external data.

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

The ground truth for the clinical performance test was established by comparison with a reference thermometer, implied by the adherence to ISO 80601-2-56, which specifies accuracy testing against a traceable temperature standard. The document mentions "clinical bias with stated uncertainty and clinical repeatability."

8. The sample size for the training set

The document does not explicitly state a "training set" sample size. For simple medical devices like thermometers, there isn't typically a distinct "training set" in the machine learning sense. The device's internal algorithms are developed and calibrated during manufacturing and design, and then validated through laboratory and clinical testing.

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

Not applicable in the machine learning sense of a training set. The "ground truth" for the device's development and calibration would have been established through controlled laboratory measurements using highly accurate reference temperature sources and then verified in a clinical setting as described in point 7.

Summary

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February 26, 2021

Hunan Honggao Electronic Technolofy Co., Ltd. % Jet Li Regulation Manager Guangzhou Kinda Biological Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou, Guangdong China

Re: K202111

Trade/Device Name: Medical infrared forehead thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 12, 2021 Received: January 25, 2021

Dear Jet Li:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 Payal Patel 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) K202111

Device Name

Medical infrared forehead thermometer

Indications for Use (Describe)

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

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

Date Prepared: February 26, 2021

Submitter Information 1.

Sponsor Company Name: Hunan Honggao Electronic Technology Co., Ltd.

Address: Block 5, Comprehensive Industrial Park, Tenghui Pioneer Park, Nanxian Economic Development Zone, Yiyang, Hunan, China Phone: +86-0737-2762828 Contact Person (including title): Rongfang Hu (Manager) E-mail: hgdztechnology@126.com

Application Correspondent: Guangzhou KINDA Biological Technology Co., Ltd. Address: 6F, No.1 TianTairoad, Science City, LuoGang District, Guang Zhou City, China Contact Person: Mr. JetLi Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com

2. Subject DeviceInformation

Type of 510(k) submission: Traditional Common Name: Clinical Electronic Thermometer Trade Name: Medical infrared forehead thermometer Classification Name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: 2

3. Predicate Device Information

Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Trade Name: Non-contact Forehead Thermometer 510(k) number: K131243 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: 2

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4. Device Description

The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts:

2xAAA batteries, 1xManual and 1 pcs thermometer

5. Intended Use

The The Medical infrared forehead thermometer (Model: HGO1 VI, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.

6. Material

The Medical infrared thermometer (Model: HG01, HG01 V1,HG06) are with non-contact to measurement forehead temperature at home or hospital. The device is consists of plastic enclosure, PCB circuit and Infrared sensor. There are operator or patient contacting components in the subject device as the following list.

Operator/ Patientcontacting components	Material	Body ContactLocation	Contact Duration
Main enclosure (includingChassis-R, Chassis-L)	PC	Intact Skin	Less than 24 hours
Front cover	ABS w ith blue Colorant0.4%	Intact Skin	Less than 24 hours
Button	ABS w ith blue Colorant0.4%	Intact Skin	Less than 24 hours
Trigger	ABS w ith blue Colorant0.4%	Intact Skin	Less than 24 hours
Battery Cover	ABS w ith blue Colorant0.4%	Intact Skin	Less than 24 hours
Display screen	ABS	Intact Skin	Less than 24 hours

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7. Test Summary

Biocompatibility testing

� The biocompatibility evaluation for the Medical infrared forehead thermometer (Model: HG01, HG01 V1.HG06 ) was conducted in accordance with ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity; ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
The tests included the following:
Cytotoxicity
· Sensitization
Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Medical infrared forehead thermometer (Model: HG01,HG01 V1,HG06 ). The device complies with the IEC 60601-1:2012, Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance, IEC60601-1-11:2015 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.

The device complies with the IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility forEMC.

Software Verification and Validation Testing

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." and IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes.

Performance Testing

ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature test
ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for Electrical safetytest
Lifetime shelf life performance test

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Clinical Data:

Clinical tests were conducted on representative model (HG01 V1), since the software and infrared sensor

theory is the same between all the models: HG01, HG01 V1,HG06 .

The clinical tests evaluated 100 subjects which were divided into two group age ranges- children (greater than 1 to 5 years old) and adult (greater than5 years old). Each group has 30% of subjects got temperature equalling or exceeding37.5°C.

Based on the result, the clinical performance of the subject device complied with the requirement of

ISO 80601-2-56:2017.

8. Comparison to PredicateDevice

A comparison of key technological characteristics between the subject devices and predicate device was

listed as below:

Elements of	Subject Device	Predicate Device	Remark
Comparison	Medical infrared foreheadthermometer (K202111)	Non-contact ForeheadThermometer (K131243)	Remark
Manufacturer	Hunan Honggao ElectronicTechnology Co., Ltd.	Shenzhen Jumper MedicalEquipment Co., Ltd	--
Models	HG01, HG01 V1, HG06	JPD-FR100	--
Intended Use	The The Medical infrared foreheadthermometer (Model: HGO1,HGO1 VI, HGO6) is a non-contactthermometer intended for theintermittent measurement ofhuman body temperature fromforehead for people of one yearreusable for home use and clinicaluse.	The non-contact infraredthermometer, modelJPD-FR100, can measure bodytemperature for infants andadults without contact to humanbody. It can be used byconsumers in householdenvironmentand doctor in clinicas reference	Note 1
Sensor	Infrared Sensor	Infrared Sensor	SE
Measurement Mode	Forehead measurement Mode	Forehead measurement Mode	SE
Measurement type	Non-contact type	Non-contact type	SE
Measurement Distance	3-5cm	1-6 cm	Note 2
Measuring Range	32~~43 °C (89.6°F~~109.4°F)	32.2°C~~43.3°C (90.0°F~~109.9°F)	Note 3
Laboratory Accuracy	Forehead mode ±0.3°C	Forehead mode: ±0.2°C (0.4°F)	SE
Sensor type	Thermopile	Thermopile	SE
Fever alarm	Yes	Yes	SE
Buzzer	Yes	Yes	SE
Display type	LCD	LCD	SE
Auto power-off while nooperation	Yes	Yes	SE
°C/°F switchable	Yes	Yes	SE
Memory	32 sets	20 sets	Note 4
Power Supply	DC 3V, 2xAAA Batteries	Two 1.5V AAA batteries	SE
Elements ofComparison	Subject DeviceMedical infrared foreheadthermometer (K202111)	Predicate DeviceNon-contact ForeheadThermometer (K131243)	Remark
Operating Conditions	Temperature : +15°C~+40°CHumidity : ≤95% non-condensingAtmospheric pressure :70kPa~106kPa	10~40°C (50°F ~104 °F)RH <95%	Note 5
Storage Conditions	Temperature : -20°C~+55°CHumidity : ≤95% non-condensingAtmospheric pressure :70kPa~106kPa	-25°C - +55°C (-13° F- +131F)RH≤90%	SE
Dimension (Lx W x H)	149 × 77 × 43 mm	145X60X50 mm	Note 6
Weight	127 g (excluding battery)	180 g
Safety	Complied with IEC 60601-1	Complied with IEC 60601-1	SE
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2	SE
Performance	Complied with ISO 80601-2-56	Complied with ISO 80601-2-56	SE
Performance	Complied with ASTM E 1965 -98(2003)	Complied with ASTM E 1965-98(2003)	SE
Biocompatibility	Complied with ISO 10993-5Complied with ISO 10993-10	Complied with ISO 10993-5Complied with ISO 10993-10	SE
Contact location andduration	Intact skin (Less than 24 hours)	Intact skin (Less than 24 hours)	SE
Material	PC and ABS material	ABS material	Note 7

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Note 1

The subject device is used for ages 12 months and older. However, the predicate is used for infants and adults. The user population of the subject device is subset of the predicate. And the manufacturer had conducted clinical accuracy trial to verify measurement accuracy for declared patient population according to ISO 80601-2-56. Therefore, this difference does not raise new safety and effectiveness questions.

Note 2

Measurement distance of the subject devices is 3-5cm, the predicate device's will be in the range of 1-6cm. And the manufacturer had conducted clinical accuracy trial to verify measurement accuracy for declared patient population according to ISO 80601-2-56 based on the measurement distance 3-5 cm. The performance test result of subject device shows the accuracy meets the requirements within the distance range. Therefore, this difference does not raise new safety and effectiveness questions.

Note 3

The subject devices and predicate device have different measurement range and different laboratory accuracy specification, but the laboratory accuracy and the measurement range of subject devices meet the requirements of ASTME1965-98. And clinical accuracy also had been validated according to ISO 80601-2-56. Therefore, the difference does not raise new safety and effectiveness questions.

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Note 4

The memory capacity of predicate device is different from subject devices, but the memory function does not affect accuracy of measurement and does not impact the performance of subject devices.

Note 5

There is minor difference on the temperature operation condition between predicate device and subject device. But the subject device also had pass IEC60601-1-11 and the labelling will indicate the operation condition. Therefore, this difference does not impact of safety and effectiveness.

Note 6

There is minor difference on the size and weight between predicate device and subject device. But this difference does not impact of safety and effectiveness.

Note 7

There is minor difference on the material of device case and enclosure between predicate device and subject device. But the operator or patient contacting parts' in the subject device all complied with ISO 10993-5, ISO 10993-10. Therefore, the difference would not cause issue of safety and effectiveness.

9. Summary of Clinical Test

Clinical study for non-contact thermometer was performed to determine the clinical accuracy and to provide comparison with predicate device. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature.

The clinical tests evaluated 100 subjects which were divided into two group age ranges- children (1 to 5 years old) and adult (greater than 5 years old). The clinical accuracy of the proposed device was evaluated by ISO 80601-2-56 - clinical bias with stated uncertainty and clinical repeatability. The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56.

Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

10. Conclusion

Based on the performance testing, comparison and analysis provided it was concluded that the subject device Medical infrared forehead thermometer (Model: HG01, HG01 V1,HG06) is substantially equivalent to the cleared predicate Non-contact Forehead Thermometer (K131243) Model JPD-FR100.

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.