(382 days)
Not Found
No
The summary describes a standard infrared thermometer that measures temperature and displays it. There is no mention of AI, ML, or any complex algorithms beyond basic temperature calculation and display. The performance studies focus on standard medical device testing and clinical validation against a predicate device, not on AI/ML model training or evaluation.
No
A therapeutic device is used to treat a disease or condition. This device is an infrared thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one.
No
The device is an infrared thermometer intended for intermittent measurement of human body temperature. While temperature can be a symptom of illness, the device itself provides a single measurement and does not interpret that measurement to diagnose a condition.
No
The device description explicitly states it is a "hand-held, battery powered device" that measures temperature through "receiving infrared energy radiation via the ear canal or forehead." This indicates it is a physical hardware device, not software only. While it mentions transmitting data to an APP via Bluetooth, the core function of temperature measurement is performed by the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The TRULYL Infrared thermometer TET-351 measures body temperature by detecting infrared radiation emitted from the ear canal or forehead. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, the TRULYL Infrared thermometer TET-351 is a medical device, but it falls under the category of a non-invasive thermometer rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal and from the forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
"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 K190873
Infrared Ear/Forehead
thermometer: DET-218 | Subject device
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 &
Indications for use | Infrared Ear/Forehead
Thermometer DET-218 is
intended for the intermittent
measurement of human body
temperature by people of all
ages. The devices are reusable
for home use only. The
thermometer detecting infrared
heat from non-contact (about 1-2
cm distances) with the forehead. | 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
head from the forehead at
distance of about 1-2cm. | Same |
| Product Code | FLL | Measurement
Method | Infrared radiation detection | Infrared radiation detection | Same |
| Submission type | Traditional 510(K) | Rx/OTC | OTC | OTC | Same |
| Patient
Population | Adult, pediatric | Adult, pediatric | Same | | |
| Measurement
Range | Ear/Forehead mode: 34.0°C
43.0°C(93.2°F109.4°F) | Ear/Forehead mode: 32.0°C
43.0°C(89.6°F109.4°F) | Different | | |
| Accuracy | Ear/Forehead mode:
±0.2°C (0.4°F) during 35.5°C
42.0°C (95.9°F107.6°F ) at
15°C35°C(59.0°F95.0°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 | | |
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.
4
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
5
| | Predicate device K190873
Infrared Ear/Forehead
thermometer: DET-218 | Subject device
Infrared thermometer: TET-
351 | Note |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Features | | | |
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement
Mode | adjusted | adjusted | Same |
| Measurement
place | Forehead
Ear | Forehead
Ear | Same |
| Forehead
measurement
method | non-contact | non-contact | Same |
| Reference body
site | Oral | axillary | Different |
| Forehead
Measurement
distance | Not available | 1-2cm | Different |
| Ingress
protection rating | IP22 | IP22 | Same |
| Time until Auto
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
and display | -Internal firmware and local
LCD display
-Also able to transfer transmit
data to mobile device for
secondary display | -Internal firmware and local
LCD display
-Also able to transfer transmit
data to mobile device for
secondary display | Same |
| Wireless Interface | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same |
| Bluetooth RF
characteristics | Not available | operating frequency: 2.4GHz
frequency bandwidth:
2402MHz2480MHz40° C(50 to 104 ° F);
transmission power:8.0 dBm | Different |
| Memory | Ear/forehead/ object
measurements sharing 30
memories | 30 sets | Same |
| Signal
transmission | Bluetooth 4.0 | Bluetooth 4.1 | Different |
| Buzzer | Yes | Yes | Same |
| | Predicate device K190873
Infrared Ear/Forehead
thermometer: DET-218 | Subject device
Infrared thermometer: TET-351 | Note |
| Features | | | |
| Auto power-off
while no
operation | Yes | Yes | Same |
| Power supply | 2 * 1.5V AAA | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| Patient contact
materials | Enclosure:ABS;
Probe: Stainless steel&.ABS; | Enclosure:ABS-750
Probe: cooperl&.ABS; | Different |
| Biocompatibility | Cytotoxicity, Skin irritation,
Skin sensitization | Cytotoxicity, Skin irritation,
Skin sensitization | Same |
| Operation
Environment | \ | Ambient temperature: 10°
C
Relative humidity :15% to
90%;
Atmospheric pressure : 70kPa ~
106kPa | Not
available |
| Conformance
standard | ISO 80601-2-56(Performance)
IEC 60601-1(Safety)
IEC 60601-1-2(EMC)
IEC 60601-1-11
ASTM E1965-98
ISO 10993-5 and ISO 10993-10
(Biocompatibility) | ISO 80601-2-56(Performance)
IEC 60601-1(Safety)
IEC 60601-1-2(EMC)
IEC 60601-1-11
ASTM E1965-98
ISO 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.