The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

Device Description

The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a hand-held, nonsterile, reusable, battery powered device designed to measure human body temperature wa body sites: the skin of the forehead.

The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that converts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.

lt is composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.

The power supply of the thermometer are 3.0V DC, it is supplied by two AA batteries.

The main functions of Non-Contact Forehead Thermometer are as follows:

Forehead measurement functions
Wide range of temperature readings: from 32.0℃ to 45.0℃ (89.6℃ -113.0℃ )
The big LCD display showing clear measurement results.
Memory function
Low battery indicator

AI/ML Overview

The provided text describes the clinical validation of a non-contact forehead thermometer. While it doesn't detail a study involving AI-assisted human readers or complex image analysis, it does describe the acceptance criteria and the study conducted to prove the device's performance.

Here's an analysis of the provided information, framed by your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Non-Contact Forehead Thermometer are primarily defined by adherence to international standards for clinical thermometers, specifically ISO 80601-2-56 and ASTM E 1965.

Acceptance Criterion (Standard Compliance)	Reported Device Performance (Clinical Test Outcome)	Details of Performance (from "Accuracy" row in table)
ISO 80601-2-56 compliance	Clinical test results showed accuracy within acceptable scope specified in ISO 80601-2-56.	±0.2℃ /0.4°F for 35.0℃ -42.0℃ (95.0°F -107.6°F);±0.3°C /0.5°F for 32.0°C -34.9°C (89.6°F -94.8°F) and 42.1°C -45.0°C (107.8°F -113.0°F)
ASTM E 1965-98(R)2016 compliance	Device conforms to applicable standards including ASTM E 1965.
Clinical Bias within specified limits (from ISO 80601-2-56)	Evaluated by clinical bias with stated uncertainty within acceptable scope.
Clinical Repeatability within specified limits (from ISO 80601-2-56)	Evaluated by clinical repeatability within acceptable scope.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: 150 subjects.
- Data Provenance: The document does not specify the country of origin. It does state that the study was a "clinical accuracy study" and doesn't explicitly mention "retrospective" or "prospective," but the description of subject enrollment ("three groups of subjects being tested") and data collection ("150 data sets were collected") strongly suggests a prospective study.
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 the "ground truth" (i.e., reference temperature measurements). For thermometer accuracy studies, ground truth is typically established using a highly accurate reference thermometer (e.g., rectal thermometer or equivalent) operated by trained medical personnel.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method. For a thermometer study, "adjudication" in the sense of expert consensus on image interpretation is not directly applicable. The ground truth is a direct physiological measurement.
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 conducted. This device is a standalone thermometer, not an AI diagnostic tool requiring human reader assistance for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical accuracy study described is a standalone performance test of the device. The device itself performs the measurement and provides a reading; there's no human "interpretation" of the device's output that would be assisted by an AI. The study's aim was to determine if the device's measurements themselves were accurate compared to a reference.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison to a reference method for body temperature measurement, implied by the context of "clinical accuracy study" and adherence to ISO 80601-2-56. While not explicitly stated, this usually involves simultaneous measurement with a highly accurate clinical thermometer (e.g., standard rectal or oral thermometer used as a reference) and comparing the device's reading to that reference.
The sample size for the training set:
- This document describes a clinical validation study for a medical device (thermometer), not an AI model. Therefore, there is no "training set" in the context of machine learning. The device's algorithms for temperature calculation are pre-programmed based on physics and calibration, not learned from data.
How the ground truth for the training set was established:
- As there is no training set mentioned in the context of an AI model, this question is not applicable. The device's internal calibration and temperature calculation methods are validated against physical standards and clinical data.

Summary

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January 25, 2021

Uni-Trend Technology (China) Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K203747

Trade/Device Name: Non-Contact Forehead Thermometer (Models UT306H & UT308H) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 18, 2020 Received: December 22, 2020

Dear Dave Yungvirt:

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,

CAPT Alan M. Stevens Director (acting) 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) K203747

Device Name

Non-Contact Forehead Thermometer, Model: UT306H,UT308H

Indications for Use (Describe)

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

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

1. Submitter Information

Sponsor Company Name: UNI-TREND TECHNOLOGY(CHINA) CO.,LTD

Establishment Registration Number: Applying �
� Address: No 6, Gong Ye Bei 1st Road, Songshan Lake National High-Tech Industrial Development Zone, Dongguan City, Guangdong Province, China
Phone: +86-769 85723888 �
Fax: +86-769 85725888 �
� Contact Person (including title): Mike Mao /Marketing Manager
� E-mail: mike@uni-trend.com.cn

Application Correspondent:

Company Name: Guangzhou KINDA Biology Technology Co., Ltd. �
� Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China
Contact Person: Mr. Jet Li/Regulation Manager �
Tel: +86-18588874857 �
� Email: med-jl@foxmail.com

Subject Device Information 2.

Type of 510(k) submission:	Traditional
Common Name:	Clinical Electronic Thermometer
Trade Name:	Non-Contact Forehead Thermometer (UT306H, UT308H)
Classification Name:	Clinical Electronic Thermometer
Review Panel:	General Hospital
Product Code:	FLL
Regulation Number:	21 CFR 880.2910
Regulation Class:	2

Predicate Device Information 3.

Sponsor:	Shenzhen Calibeur Industries Co., Ltd.
----------	----------------------------------------

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Subject Device:	Non-Contact Forehead Thermometer, model: UT306H,UT308H
-----------------	--------------------------------------------------------

Common Name:	Clinical electronic thermometer
Trade Name:	Infrared Thermometer DT-8836T, DT-8836P
510(k) number:	K191251
Review Panel:	General Hospital
Product Code:	FLL
Regulation Number:	21 CFR 880.2910
Regulation Class:	2

4. Device Description

lt is composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.

The power supply of the thermometer are 3.0V DC, it is supplied by two AA batteries.

The main functions of Non-Contact Forehead Thermometer are as follows:

� Forehead measurement functions
Wide range of temperature readings: from 32.0℃ to 45.0℃ (89.6℃ -113.0℃ ) �
� The big LCD display showing clear measurement results.
� Memory function
Low battery indicator �

Indication for use 5.

The Non-Contact Forehead Thermometer (Model:UT306H) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

6. Test Summary

Non clinical testing:

Non-Contact Forehead Thermometer conforms to applicable standards that include:

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Non-Contact Forehead Thermometer, model: UT306H,UT308H Subject Device:

� ASTM E 1965-98(R)2016 Standard Specification for Non-Contact Forehead Thermometers for Intermittent Determination of Patient Temperature
� AAMI/ANSIES 60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
� IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
� 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
� IEC 62304 Edition 1.1 2015-06 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 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Clinical Test

The clinical accuracy study for the non-contact themometer were performed to determine the clinical accuracy. The three groups of subjects being tested were: 1) infant under 1 year old, 2) children between 1 and 5 years old, and 3) patients over 5 years old.

The study included 150 subjects, with More than 30% febrile subjects. For each age group, the ratio of febrile subjects was more than 30%. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature. From each test site, a total of 150 data sets were collected. 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.

7. Comparison to Predicate Device

Compared 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

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UNI-TREND TECHNOLOGY(CHINA) CO.,LTD Sponsor:

Subject Device:

Non-Contact Forehead Thermometer, model: UT306H,UT308H

differences between subject device and predicate device do not raise new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	UNI-TRENDTECHNOLOGY(CHINA) CO.,LTD	Shenzhen Calibeur IndustriesCo., Ltd.	--
510 (k) Number	Pending	K191251	--
Product Name	Non-ContactForeheadThermometer	Infrared Thermometer	--
Models	UT306H,UT308H	DT-8836T, DT-8836P	--
Intended Use	The Non-Contact ForeheadThermometer (Model:UT306H,UT308H) is a non-contact infraredthermometer intended for theintermittent measurement of humanbody temperature from forehead forpeople of all ages. The device isreusable for home use and clinicaluse.	The Infrared thermometer is anon-contact infrared thermometerintended for the intermittentmeasurement of human bodytemperature from forehead forpeople of all ages. The device isreusable for home use andclinical use.	SE
Sensor	Infrared Sensor	Infrared Sensor	SE
MeasurementMode	Forehead measurement mode	Forehead measurement mode	SE
Measurementtype	Non-contact type	Non-contact type	SE
MeasurementDistance	1-5cm	≤3cm	Minor differenceNote 1
MeasuringRange	32.0°C to 45.0°C ;	Forehead mode:32.0° C ~42.5° C(89.6 to 108.5 ° F)	Minor differenceNote 2
Accuracy	±0.2℃ /0.4°F 35.0℃ -42.0℃(95.0°F -107.6°F);±0.3°C /0.5°F 32.0°C -34.9°C(89.6°F -94.8°F) and 42.1°C -45.0°C (107.8°F -113.0°F)	Forehead mode:±0.2°C (0.4°F) within35.0°C ~ 42.0°C(95.0°F ~ 107.6°F),±0.3°C(0.5°F) other range	SE
DisplayResolution	0.1°C/0.1°F	0.1°C/0.1°F	SE
SignalOutputand Display	LCD, Buzzer	LCD	SE
°C/°F switchable	Yes	Yes	SE
Memory	UT306H: 20 sets of measurementsUT308H: 32 sets of measurements	60 sets	Minor differenceNote 3
Power Supply	3.0V DC, offered by o two AAbatteries	Two 1.5V AAA batteries	SE
Low batteryindication	Yes	Not identified.	Minor differenceNote 4
Elements ofComparison	Subject Device	Predicate Device	Verdict
OperatingConditions	Temperature: 15 °C -40 °C; Relativehumidity: < 90% R.H (non-condensation);Atmospheric pressure: 70-106KPa	10~40°C (50°F ~~104 °F)RH 15~~95%	Minor differenceNote 5
Performance	Compliance with ASTM E 1965;ISO 80601-2-56	Compliance with ASTM E 1965;ISO 80601-2-56	SE
Biocompatibility	All the patient contacting materialsare compliance with ISO 10993-5;ISO10993-10	All the patient contactingmaterials are compliance with ISO10993-5; ISO10993-10	SE
Electrical Safety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	SE
EMC	Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2	SE
Response time	500ms	1s	Minor differenceNote 6
Components	It composed by a measuringsensor, set buttons, a start button,battery compartment, Buzzer, aLCD anda ABS plastic enclosure, andmeasuring without probe cover.	It composed by a measuringsensor, set buttons, a start button,battery compartment, Buzzer, aLCD and a ABS plastic enclosure,and measuring without probecover.	SE
Materials	ABS for enclosure	ABS for enclosure	SE
Labeling	OTC	OTC	SE

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Subject Device:

Non-Contact Forehead Thermometer, model: UT306H,UT308H

Note 1

There is minor difference for measurement distance, but the subject device clinical accuracy and its performance comply with ISO 80601-2-56 and ASTM E1965. This difference does not raise new questions of safety and effectiveness.

Note 2

Although there is minor difference of the measuring range between the subject device and predicate device, the temperature range 32.0℃ to 45.0℃ in subject device is enough for body

temperature measurement. And the subject device clinical accuracy comply with ISO 80601-2-56 and ASTM E1965. This difference does not raise new questions of safety and effectiveness.

Note 3

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Subject Device: Non-Contact Forehead Thermometer, model: UT306H,UT308H

Although the memory value of the subject device and predicate device is different, both of them are complied with ASTM E 1965. This difference does not raise new questions of safety and effectiveness.

Note 4

The subject device provided with low battery indicator, it is more helpful for operation and can remind user to replace the battery; and the subject device complied with IEC 60601-1. This difference does not raise new questions of safety and effectiveness.

Note 5

Although Operating environment of the predicate device and subject device is different. but the instruction for use had indicate such operating condition, and the test report ASTM E1965 verifies its performance in such operating condition. This difference does not raise new questions of safety and effectiveness.

Note 6

Although there is minor difference of responded time for stable measurement between the predicate device and subject, but the response time do not affect the measurement accuracy and

device performance. And the device pass the testing according to ISO 80601-2-56. This difference does not raise new questions of safety and effectiveness.

Conclusion

The subject device Non-Contact 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

13 November 2020

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.