Infrared Thermometer TET-351

K220276 · Truly Instrument Limited · FLL · Feb 17, 2023 · General Hospital

Device Facts

• Record ID: K220276
• Device Name: Infrared Thermometer TET-351
• Applicant: Truly Instrument Limited
• Product Code: FLL · General Hospital
• Decision Date: Feb 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Hand-held, battery-powered infrared thermometer; measures body temperature via thermopile sensor in ear canal or non-contact forehead mode (1-2cm distance). Device processes infrared radiation into temperature readings; displays results on integrated LCD; transmits data via Bluetooth Low Energy (BLE) to mobile app for secondary display/recording. Used in home settings by patients or caregivers. Output informs clinical decision-making regarding fever management. Benefits include non-invasive, rapid temperature assessment.

Clinical Evidence

Clinical study conducted per ASTM E1965-98; randomized, simple blind, homologous control, pairing design. Study included at least 150 subjects (1/3 children, 1/3 adults, 1/3 infants). Results demonstrated compliance with ASTM E1965-98 performance requirements.

Technological Characteristics

Thermopile sensor; ABS-750 enclosure; copper/ABS probe. Powered by 2x1.5V AAA batteries. Connectivity: Bluetooth 4.1 (BLE). Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ASTM E1965-98. Biocompatibility: ISO 10993-5/10. IP22 ingress protection.

Indications for Use

Indicated for intermittent human body temperature measurement via auditory canal or forehead in home settings for all ages (infants, children, adults).

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Infrared Ear/Forehead thermometer: DET-218 (K190873)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | <table><tr><td><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </td><td><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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# 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: [e-mail]

#### 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: [phone]

| Trade/Device Name | Infrared Thermometer | | Predicate device K190873<br>Infrared Ear/Forehead<br>thermometer: DET-218 | Subject device<br>Infrared 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 &<br>Indications for use | Infrared Ear/Forehead<br>Thermometer DET-218 is<br>intended for the intermittent<br>measurement of human body<br>temperature by people of all<br>ages. The devices are reusable<br>for home use only. The<br>thermometer detecting infrared<br>heat from non-contact (about 1-2<br>cm distances) with the forehead. | The TRULYL Infrared<br>thermometer TET-351 is<br>intended for the intermittent<br>measurement of human body<br>temperature from the auditory<br>canal and from the forehead for<br>people of all ages used in the<br>home setting. The non-contact<br>thermometer detects infrared<br>head from the forehead at<br>distance of about 1-2cm. | Same |
| Product Code | FLL | Measurement<br>Method | Infrared radiation detection | Infrared radiation detection | Same |
| Submission type | Traditional 510(K) | Rx/OTC | OTC | OTC | Same |
| Patient<br>Population | Adult, pediatric | Adult, pediatric | Same | | |
| Measurement<br>Range | Ear/Forehead mode: 34.0°C<br>~43.0°C(93.2°F~109.4°F) | Ear/Forehead mode: 32.0°C<br>~43.0°C(89.6°F~109.4°F) | Different | | |
| Accuracy | Ear/Forehead mode:<br>±0.2°C (0.4°F) during 35.5°C<br>~42.0°C (95.9°F~107.6°F ) at<br>15°C~35°C(59.0°F~95.0°F)<br>operating temperature range<br>±0.3°C (0.5°F) for other<br>measuring and operating<br>temperature range | Ear/Forehead mode:<br>±0.2°C(0.4°F)<br>(Outside 34~42°C(93.2°F<br>~107.6°F ) measurement range,<br>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

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.

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#### Intended use & Indication for use 6.

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.

#### 7. Comparison to the Predicate Device

510(k) Summary

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| | Predicate device K190873<br>Infrared Ear/Forehead<br>thermometer: DET-218 | Subject device<br>Infrared thermometer: TET-<br>351 | Note |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Features | | | |
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement<br>Mode | adjusted | adjusted | Same |
| Measurement<br>place | Forehead<br>Ear | Forehead<br>Ear | Same |
| Forehead<br>measurement<br>method | non-contact | non-contact | Same |
| Reference body<br>site | Oral | axillary | Different |
| Forehead<br>Measurement<br>distance | Not available | 1-2cm | Different |
| Ingress<br>protection rating | IP22 | IP22 | Same |
| Time until Auto<br>power-off | 60s | 60s | Same |
| Response Time | Approx. 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Scale Selection | °C /°F | °C /°F | Same |
| Signal processing<br>and display | -Internal firmware and local<br>LCD display<br>-Also able to transfer transmit<br>data to mobile device for<br>secondary display | -Internal firmware and local<br>LCD display<br>-Also able to transfer transmit<br>data to mobile device for<br>secondary display | Same |
| Wireless Interface | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same |
| Bluetooth RF<br>characteristics | Not available | operating frequency: 2.4GHz<br>frequency bandwidth:<br>2402MHz~2480MHz<br>transmission power:8.0 dBm | Different |
| Memory | Ear/forehead/ object<br>measurements sharing 30<br>memories | 30 sets | Same |
| Signal<br>transmission | Bluetooth 4.0 | Bluetooth 4.1 | Different |
| Buzzer | Yes | Yes | Same |
| | Predicate device K190873<br>Infrared Ear/Forehead<br>thermometer: DET-218 | Subject device<br>Infrared thermometer: TET-351 | Note |
| Features | | | |
| Auto power-off<br>while no<br>operation | Yes | Yes | Same |
| Power supply | 2 * 1.5V AAA | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| Patient contact<br>materials | Enclosure:ABS;<br>Probe: Stainless steel&.ABS; | Enclosure:ABS-750<br>Probe: cooperl&.ABS; | Different |
| Biocompatibility | Cytotoxicity, Skin irritation,<br>Skin sensitization | Cytotoxicity, Skin irritation,<br>Skin sensitization | Same |
| Operation<br>Environment | \ | Ambient temperature: 10°<br>C~40° C(50 to 104 ° F);<br>Relative humidity :15% to<br>90%;<br>Atmospheric pressure : 70kPa ~<br>106kPa | Not<br>available |
| Conformance<br>standard | ISO 80601-2-56(Performance)<br>IEC 60601-1(Safety)<br>IEC 60601-1-2(EMC)<br>IEC 60601-1-11<br>ASTM E1965-98<br>ISO 10993-5 and ISO 10993-10<br>(Biocompatibility) | ISO 80601-2-56(Performance)<br>IEC 60601-1(Safety)<br>IEC 60601-1-2(EMC)<br>IEC 60601-1-11<br>ASTM E1965-98<br>ISO 10993-5 and ISO 10993-10<br>(Biocompatibility) | Same |

510(k) Summary

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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:

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- . 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

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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.