The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.

Device Description

The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value.

The Infrared Forehead Thermometer (Model: T80、T81、T84、T85),consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries

The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.

AI/ML Overview

The Infrared Forehead Thermometer (Models: T80, T81, T82, T83, T84, T85) has acceptance criteria primarily based on the ASTM E 1965-98 standard for infrared thermometers and ISO 80601-2-56 for clinical thermometers.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the referenced standards (ASTM E 1965-98, ISO 80601-2-56) and are demonstrated through performance tests.

Acceptance Criteria (from ASTM E 1965-98 and ISO 80601-2-56)	Reported Device Performance (Infrared Forehead Thermometer)
Temperature Measurement Accuracy	Forehead mode:
	±0.2°C (0.4°F) for the range 35.0°C ~ 42.0°C (95.9°F ~ 109.2°F);
	±0.3°C (0.5°F) for the range 32°C - 34.9°C (89.6°F - 94.8°F) and 42.1-42.9°C (107.8°F - 109.2°F).
Clinical Bias with Stated Uncertainty	Evaluated as per ISO 80601-2-56; concrete values not provided in the summary but stated that "the clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56."
Clinical Repeatability	Evaluated as per ISO 80601-2-56; concrete values not provided in the summary but stated that "the clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56."
Measurement Time	≤ 3 seconds
Measurement Distance	1-5 cm
Operating Conditions	Temperature: 15°C ~ 40°C (60.8°F ~ 95°F) Relative humidity: ≤85% RH
Storage Conditions	Temperature: -20°C ~ 55°C (-4°F ~ 131°F) Relative humidity: ≤93%RH, non-condensing
Other Standards Conformance	IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-2 (Electromagnetic compatibility), IEC 62304 (Medical Device Software), IEC60601-1-11 (Home Healthcare Environment), ISO 10993-5 (In Vitro cytotoxicity), ISO 10993-10 (Irritation and skin sensitization). The device is stated to conform to these standards, implying it meets their respective acceptance criteria for safety, performance, and biocompatibility.

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

Sample Size: 150 subjects.
- Divided into three age groups: Infants (less than 1 year), Children (1 to 5 years old), and Adults (greater than 5 years old).
- No less than 50 subjects in each group.
- 30% of the subjects had a temperature equaling or exceeding 37.5°C.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, "Clinical tests were conducted" and "The study excluded subjects..." indicate a prospective clinical trial involving human subjects.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It can be inferred that standard clinical temperature measurement methods (e.g., rectal or oral thermometry, depending on age group) were used as the reference standard against which the infrared forehead thermometer was compared, consistent with the requirements of ISO 80601-2-56 and ASTM E 1965.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. Clinical accuracy studies for thermometers typically compare the device's readings directly against a trusted reference method, rather than requiring expert adjudication of the disease state itself.

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. The device is an Infrared Forehead Thermometer, which is a standalone medical device for temperature measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, a standalone performance evaluation of the device was conducted. The clinical accuracy study evaluated the device's ability to measure temperature accurately directly against a reference standard, without human interpretation for diagnosis. The device itself is the "algorithm only" in the context of its function as a measurement instrument.

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

The ground truth for temperature measurement would be established by simultaneous measurements using a highly accurate and validated reference thermometer (e.g., a clinical reference thermometer, such as a rectal thermometer for infants, or an oral/tympanic thermometer for older children/adults, adhering to the requirements of the standards). The document refers to "clinical bias with stated uncertainty and clinical repeatability" evaluated against ISO 80601-2-56, which implies comparison to a reference standard for body temperature.

8. The sample size for the training set

The document only describes a clinical test set. No information about a separate "training set" is provided because this device is a physical measurement instrument, not a machine learning algorithm that requires a training set. The device's internal calibration and algorithms are developed during its engineering and manufacturing process, optimized through testing against known temperature sources, not through a "training set" in the AI sense.

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

Not applicable, as there is no training set in the context of an infrared thermometer as described in the document. The ground truth for the device's internal calibration would be established through highly accurate laboratory-grade temperature references.

Summary

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June 4, 2021

Guandong Genial Technology CO., LIMITED % Jet Li Regulation Manager Guangzhou KINDA Biology Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China

Re: K210014

Trade/Device Name: Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 19, 2021 Received: May 4, 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 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 mediation-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,

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) K210014

Device Name

Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85)

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 K210014

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

Submitter Information 1.

Sponsor Company Name: GUANGDONG GENIAL TECHNOLOGY CO., LIMITED.

Establishment Registration Number: Applying

� Address: 1-6-05-02, 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County, Zhaoging City, Guangdong, 526437, China
Phone: +86-020-37236838 �

Fax: +86-020-37236838

Contact Person (including title): Jun Yu (General Manager) �
E-mail: admin@genial.cn �

Application Correspondent: Guangzhou KINDA Biology Technology Co., Ltd.

Address: 6F, No.1 TianTairoad, Science City, LuoGangDistrict, GuangZhouCity, China �
Contact Person: Mr. JetLi �
� Tile: Regulation Manager
� Tel: +86-18588874857
Email: med-jl@foxmail.com �

3 Subject Device Information:

� Type of 510(k) submission: Traditional
� Common Name: Infrared Forehead Thermometer
� Trade Name: Infrared Forehead Thermometer(Model: T80、T81、T82、T83、T84、T85)
� Classification Name: Clinical Electronic Thermometer
� Review Panel: General Hospital
� Product Code: FLL
� Regulation Number: 21 CFR880.2910
� Regulation Class: 2

4 Predicate Device Information:

Sponsor: Dongguan SIMZO Electronic TechnologyCo.Ltd. �

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� Trade Name: Non-contact Forehead Thermometer
� 510(k) number: K173048
� Review Panel: General Hospital
� Product Code: FLL
� Regulation Number: 21 CFR880.2910
� RequlationClass: 2

2. Device Description

The Infrared Forehead Thermometer (Model: T80、T81、T84、T85),consists of the following parts:

a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries

3. Intended Use

4. Test Summary

Infrared Forehead Thermometer conforms to applicable standards that include:

� ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
� IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

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� IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
� IEC 62304:2006+AMD1:2015 Medical Device Software -Software Life Cycle Processes
� 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
� ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements f or basic safety and essential performance of clinical thermometers for body temperature measurement
� 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

5. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, sensor, measurement mode, measuring range, accuracy and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	GUANGDONG GENIALTECHNOLOGY CO., LIMITED.	Dongguan SIMZO ElectronicTechnology Co.Ltd.	--
510 (k) Number	K210014	K173048	--
Product Name	Infrared Forehead Thermometer	Non-contact ForeheadThermometer	--
Models	Model: T80、T81、T82、T83、T84、T85	HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303	--
Intended Use	The Infrared ForeheadThermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used tomeasurement forehead temperatureat home or hospital. The device isindicated for use on people of allages except for neonates/newborns	The Non-contact ForeheadThermometer is an infraredthermometer intended for theintermittent measurement of humanbody temperature in people of allages.	Note 1
Sensor	Infrared Sensor	Infrared Sensor	SE
MeasurementMode	Forehead measurement Mode	Forehead measurement Mode	SE
Measurementtype	Non-contact type	Non-contact type	SE
Measurementmethod	Infrared radiation detection	Infrared radiation detection	SE
Elements ofComparison	Subject Device	Predicate Device	Verdict
Measurementtime	<3S	1S	Note 2
MeasurementDistance	1-5cm	HW-2/HW-2S/HW-3/HW-302/ HW-303:5-8cm HW-4/HW-4S:1-2cm	Note 3
MeasuringRange	32°C ~ 42.9°C (89.6°F ~ 109.2°F)	Forehead mode: 35.5°C ~42.9°C(95.9°F ~109.2°F)	Note 4
Accuracy	Forehead mode: ±0.2°C , forrange 35.0°C ~ 42.0°C (95.9°F~109.2°F);±0.3°C (0.5°F),for the range32°C - 34.9°C (89.6°F -94.8°F)and 42.1-42.9°C (107.8°F -109.2°F)	Forehead mode:±0.2°C (0.4°F) within 35.5°C~42.9°C(95.9°F ~109.2°F),±0.3°C(0.5°F) other range	Note 5
DisplayResolution	0.1℃/0.1°F	0.1℃/0.1°F	SE
Sensor type	Thermopile	Thermopile	SE
Hightemperature hint	Yes	Yes	SE
Buzzer	Yes	Yes	SE
Display screen	LCD	LCD	SE
Auto power-offwhile nooperation	Yes	Yes	SE
°C/°F switchable	Yes	Yes	SE
Memory	32 sets	HW-2/2S:32 setsHW-3/4/4S: 1 setHW-302/303:64 Sets	Note 6
Power Supply	3.0V DC, offered by two AAbatteries	2 x AAA	Note 7
OperatingConditions	Temperature: 15°C ~ 40°C (60.8°F~ 95°F)Relative humidity: ≤85% RH	10~40°C(50°F ~104 °F) RH < 85%	Note 8
StorageConditions	Temperature: -20°C ~55°C (-4°F ~131°F)Relative humidity: ≤93%RH,non-condensing	-25°C - +55°C (-13° F-+131° F)RH≤90%	Note 8
Dimension	150(L) x 48(W) x 105(H) mm	9315341mm	Similar
Weight	Approximately 125 g	90-125 g	Similar
Conformancestandard	EN60601-1(Safety), IEC60601-1-2(EMC) ASTME1965-98(performance)	EN60601-1(Safety), IEC60601-1-2(EMC) ASTME1965-98(performance)	SE

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Note 1

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Even there is minor difference subject group difference between subject device and predicate device, but the labelling had provided detail statement for applicable subject group. This difference does not affect the safety and effectiveness.

Note 2

Measurement time of the subject devices is ≤ 3S , the predicate device's will be 1S. But both of them are complied with ASTM E 1965 and the measure time will not affect the measurement accuracy. This difference does not affect thesafety and effectiveness.

Note 3

Measurement distance of the subject devices is 1-5cm, the predicate device's will be in the range of 5-8cm or 1-2cm. But the performance test result of subject device shows the accuracy meets the requirements within thedistance range.

Note 4

Although there is little difference for the contact type of the subject device and predicate device, both of them are complied with ASTM E 1965 . This difference does not affect the safety and effectiveness.

Note 5

Both devices have different measurement range, but they have the same accuracy and the measurement range of subject devices meet the requirements of ASTME 1965-98.

Note 6

The memory capacity of predicate devices (HW-3/4/4S,HW-302/303)are difference from subject

devices ,but that does not impact the performance of subject devices.

Note 7

Although the battery size between the predicate device and subject device is different, the power requirements are similar (voltage outputs are the same), and both of them are complied with IEC 60601-1. This difference does not affect thesafety and effectiveness.

Note 8

There is minor difference on operation environment and storage condition between predicate device and subject device, but both device comply with IEC60601-1-11 and ASTM E1965, so This difference does not affect the safety and effectiveness.

Summary of Clinical Test 6.

Clinical tests were conducted on Model: T80、T81、T82、T85、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 150 subjects which were divided into three group age ranges-Infants (less than 1 year), children (1 to 5 years old)and adult (greater than 5 years old). No less than 50 subjects in each group and 30% of them got temperature equaling or exceeding 37.5℃.

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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).

7. Conclusion

The subject device Infrared Forehead Thermometer has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

8. Summary Prepared Date

28 May 2021

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.