The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.

Device Description

The TRULYL Infrared thermometer TET-351 is a hand-held, battery powered device designed to measure the body temperature through receiving infrared energy radiation via the ear canal or forehead. The thermometer has the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The results measured by TET-351 can also be transmitted to APP to record and display through Bluetooth.

AI/ML Overview

This is an infrared thermometer (TET-351) that measures human body temperature from the auditory canal and forehead. The device is intended for home use for people of all ages.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. While the document states that the clinical study demonstrated compliance, it does not explicitly list the specific numerical acceptance criteria (e.g., accuracy limits) from ASTM E1965-98 within the provided text, nor does it provide detailed numerical results for the device's performance against those criteria beyond a general statement of compliance.

However, the comparison table with the predicate device does offer some insight into the accuracy specification, which would likely be the basis of the acceptance criteria:

Feature	Predicate Device (K190873) Accuracy	TET-351 (Subject Device) Accuracy	Note
Accuracy	Ear/Forehead mode: ±0.2°C (0.4°F) during 35.5°C ~ 42.0°C (95.9°F ~ 107.6°F) at 15°C~~35°C (59.0°F~~95.0°F) operating temperature range; ±0.3°C (0.5°F) for other measuring and operating temperature range	Ear/Forehead mode: ±0.2°C (0.4°F) (Outside 34~42°C (93.2°F ~ 107.6°F) measurement range, accuracy ±0.3°C (0.5°F)).	Different

Note: The "Different" note here implies that while the general accuracy ranges are similar, there might be slight variations in the specified temperature ranges where the higher accuracy applies. The report states that the clinical study demonstrated compliance with ASTM E1965-98 (Reapproved 2016), which would inherently define the specific acceptance criteria for accuracy.

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

Sample Size for Test Set: A minimum of 150 subjects.
- 1/3 children
- 1/3 adults
- The remaining 1/3 (implicitly infants) are not explicitly stated but are covered by the age categories: "Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old."
Data Provenance: The document does not explicitly state the country of origin of the data. It refers to "This clinical study" without specifying the location.
Retrospective or Prospective: Not explicitly stated, but the description "This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation" strongly suggests a prospective study.

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

This information is not provided in the document. The study involves measuring patient temperature, which typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., rectal or oral core temperature measurement, depending on the standard). The role of "experts" as ground truth adjudicators in the sense of image interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the context of "adjudication" as it might apply to subjective assessments. For temperature measurement studies, the ground truth is typically established by measurements from a validated reference device, not by expert consensus or adjudication. The study design is described as "randomization, simple blind homologous control, pairing design," but this refers to the overall study methodology rather than a specific ground truth adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the traditional sense of evaluating human readers with and without AI assistance, as this device is a standalone thermometer, not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance

A standalone performance study was done. The entire clinical study for the Infrared Thermometer TET-351 is a standalone performance evaluation, as it assesses the accuracy of the device itself (algorithm + hardware) against a reference standard in patients.

7. Type of Ground Truth Used

The ground truth implicitly used for clinical accuracy assessment for thermometers is a reference temperature measurement obtained from a highly accurate clinical reference device (e.g., glass thermometer, electronic thermometer, or other gold-standard method for core body temperature measurement). The standard ASTM E1965-98 outlines how these reference measurements should be obtained. The document does not explicitly state the specific reference method used, but it's central to the standard's methodology.

8. Sample Size for the Training Set

This information is not provided. As this is a medical device and not an AI/ML imaging algorithm that requires a separate training set, the concept of a "training set" in this context is not directly applicable for the device's primary function of temperature measurement. Any internal calibration or algorithm development would have been done prior to the clinical validation.

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

Given that this is an infrared thermometer and not an AI/ML imaging algorithm, a separate "training set" with established ground truth in the AI sense is not applicable. The device's underlying physics and calibration would be based on established temperature measurement principles.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 17, 2023

Truly Instrument Limited % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K220276

Trade/Device Name: Infrared Thermometer TET-351 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 23, 2023 Received: January 23, 2023

Dear Kevin Wang:

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

{1}------------------------------------------------

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,

David Walloschek

David Wolloscheck, Ph.D. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220276

Device Name Infrared Thermometer TET-351

Indications for Use (Describe)

The TRUL YL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K220276 - 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2023/1/23

1. Submission sponsor

Name: Truly Instrument Limited Address: Truly Industrial Area, Shan Wei City, Guang Dong Province, PEOPLE'S REPUBLIC OF CHINA 516600 Contact person: Liu JingTing Title: R&D Manager E-mail: liujinting.rd@truly.cn

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang

E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Infrared Thermometer		Predicate device K190873Infrared Ear/Foreheadthermometer: DET-218	Subject deviceInfrared thermometer: TET-351	Note
Model	TET-351	Features
Common Name	Infrared Thermometer	Regulation number	21 CFR 880.2910	21 CFR 880.2910	Same
Regulatory Class	Class II	Product code	FLL	FLL	Same
Classification	21CFR 880.2910 / Clinical electronic thermometer	Intended Use &Indications for use	Infrared Ear/ForeheadThermometer DET-218 isintended for the intermittentmeasurement of human bodytemperature by people of allages. The devices are reusablefor home use only. Thethermometer detecting infraredheat from non-contact (about 1-2cm distances) with the forehead.	The TRULYL Infraredthermometer TET-351 isintended for the intermittentmeasurement of human bodytemperature from the auditorycanal and from the forehead forpeople of all ages used in thehome setting. The non-contactthermometer detects infraredhead from the forehead atdistance of about 1-2cm.	Same
Product Code	FLL	MeasurementMethod	Infrared radiation detection	Infrared radiation detection	Same
Submission type	Traditional 510(K)	Rx/OTC	OTC	OTC	Same
PatientPopulation	Adult, pediatric	Adult, pediatric	Same
MeasurementRange	Ear/Forehead mode: 34.0°C~~43.0°C(93.2°F~~109.4°F)	Ear/Forehead mode: 32.0°C~~43.0°C(89.6°F~~109.4°F)	Different
Accuracy	Ear/Forehead mode:±0.2°C (0.4°F) during 35.5°C~~42.0°C (95.9°F~~107.6°F ) at15°C~~35°C(59.0°F~~95.0°F)operating temperature range±0.3°C (0.5°F) for othermeasuring and operatingtemperature range	Ear/Forehead mode:±0.2°C(0.4°F)(Outside 34~42°C(93.2°F~107.6°F ) measurement range,accuracy ±0.3°C(0.5°F)).	Different

ર Subiect Device Information

4. Predicate Device

Joytech Healthcare Co., Ltd. Infrared Ear/Forehead Thermometer, DET-218 under K190873.

5. Device Description

{4}------------------------------------------------

Intended use & Indication for use 6.

7. Comparison to the Predicate Device

510(k) Summary

{5}------------------------------------------------

	Predicate device K190873Infrared Ear/Foreheadthermometer: DET-218	Subject deviceInfrared thermometer: TET-351	Note
Features
Display	0.1°C(0.1°F)	0.1°C(0.1°F)	Same
MeasurementMode	adjusted	adjusted	Same
Measurementplace	ForeheadEar	ForeheadEar	Same
Foreheadmeasurementmethod	non-contact	non-contact	Same
Reference bodysite	Oral	axillary	Different
ForeheadMeasurementdistance	Not available	1-2cm	Different
Ingressprotection rating	IP22	IP22	Same
Time until Autopower-off	60s	60s	Same
Response Time	Approx. 1s	1s	Same
Sensor type	Thermopile	Thermopile	Same
Scale Selection	°C /°F	°C /°F	Same
Signal processingand display	-Internal firmware and localLCD display-Also able to transfer transmitdata to mobile device forsecondary display	-Internal firmware and localLCD display-Also able to transfer transmitdata to mobile device forsecondary display	Same
Wireless Interface	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)	Same
Bluetooth RFcharacteristics	Not available	operating frequency: 2.4GHzfrequency bandwidth:2402MHz~2480MHztransmission power:8.0 dBm	Different
Memory	Ear/forehead/ objectmeasurements sharing 30memories	30 sets	Same
Signaltransmission	Bluetooth 4.0	Bluetooth 4.1	Different
Buzzer	Yes	Yes	Same
	Predicate device K190873Infrared Ear/Foreheadthermometer: DET-218	Subject deviceInfrared thermometer: TET-351	Note
Features
Auto power-offwhile nooperation	Yes	Yes	Same
Power supply	2 * 1.5V AAA	2 * 1.5V AAA	Same
Display screen	LCD	LCD	Same
Patient contactmaterials	Enclosure:ABS;Probe: Stainless steel&.ABS;	Enclosure:ABS-750Probe: cooperl&.ABS;	Different
Biocompatibility	Cytotoxicity, Skin irritation,Skin sensitization	Cytotoxicity, Skin irritation,Skin sensitization	Same
OperationEnvironment	\	Ambient temperature: 10°C~40° C(50 to 104 ° F);Relative humidity :15% to90%;Atmospheric pressure : 70kPa ~106kPa	Notavailable
Conformancestandard	ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)IEC 60601-1-11ASTM E1965-98ISO 10993-5 and ISO 10993-10(Biocompatibility)	ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)IEC 60601-1-11ASTM E1965-98ISO 10993-5 and ISO 10993-10(Biocompatibility)	Same

510(k) Summary

{6}------------------------------------------------

As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, which do not raise different questions of safety or effectiveness.

Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the TET-351 Infrared thermometer.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

{7}------------------------------------------------

. Cytotoxicity
Skin Sensitization .
Irritation .

Non-clinical data

The Infrared thermometer has been tested according to the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and ● essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-11: 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: Medical electrical equipment - Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

The test was selected to show substantial equivalence between the subject device and the predicate.

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." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical data

Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016).

9. Conclusion

It has been shown in the 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any new or different questions regarding safety and effectiveness.

510(k) Summary

{8}------------------------------------------------

Performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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.