(90 days)
The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.
The thermometer (Mode: TH48FE, TH09F, THD2FE) are electronic thermometer using an IR sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to an oral temperature value. The thermometer consists of an IR sensor with a built-in ambient temperature sensor, Application-Specific Integrated Circuitry including software, LCD display, buttons, and batteries.
The provided text describes a 510(k) premarket notification for a non-contact forehead thermometer. While it discusses the device's accuracy and clinical validation, it does not detail a study that proves the device meets complex acceptance criteria for an AI/ML-driven medical device, as typically outlined for such systems. The acceptance criteria and study described are for a traditional medical device (a thermometer), focusing on its accuracy and safety standards rather than AI performance metrics.
Therefore, for AI/ML specific criteria like MRMC studies, ground truth establishment for AI training/testing, or separate human-in-the-loop vs. standalone AI performance, the provided document does not contain this information. The questions will be addressed based on the information available in the document, and limitations will be noted where information is absent.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
The device in question is a Non-contact Forehead Thermometer (Models TH48FE, TH09F, THD2FE), which is a traditional electronic medical device, not an AI/ML system. Therefore, the "acceptance criteria" and "study" described in the document relate to the performance of a thermometer, primarily its accuracy and compliance with relevant standards, rather than the complex AI/ML evaluation metrics (like sensitivity, specificity, MRMC studies, etc.) typically associated with AI-driven devices.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
For a non-contact forehead thermometer, the primary performance criterion is accuracy.
| Acceptance Criteria (from ISO 80601-2-56) | Reported Device Performance (TH48FE/TH09F/THD2FE) |
|---|---|
| Forehead mode accuracy: | |
| - Within 95 | ± 0.4 °F (0.2°C) |
| - Other ranges | ± 0.5 °F (0.3°C) |
| Surface mode accuracy (TH48FE/THD2FE): | |
| - Within 93.2 | ± 0.5°F (± 0.3°C) |
| - Others | ±4% or ±4°F (2°C), whichever is greater |
| Clinical Accuracy Validation | Complied with the requirement of ISO 80601-2-56 |
Note: The document implies these are "acceptance criteria" by stating the device "met all design specifications" and "complied with" or "meet" the standards.
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Accuracy Validation (Test Set): 113 subjects.
- Data Provenance: Not explicitly stated, but the submission is from a Taiwan-based manufacturer (Radiant Innovation Inc.). It also doesn't specify if the clinical trial was retrospective or prospective, but clinical accuracy validation trials per ISO standards are typically prospective.
3. 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 ground truth for the thermometer's clinical accuracy. For thermometer testing, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal thermometer in a controlled setting) against which the test device's readings are compared. This usually involves clinical staff following a standardized protocol rather than a panel of "experts" as in AI image interpretation.
4. Adjudication method for the test set
Not applicable/not specified. For simple temperature measurement, "adjudication" in the sense of resolving disagreements between multiple readers (as in AI image analysis) is not relevant. The ground truth would be established by the reference standard measurement.
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
Not applicable. This device is a standalone non-AI thermometer. There is no AI component or human-in-the-loop aspect for which an MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a "standalone" device in the sense that it provides a temperature reading without human interpretation beyond reading the display. Its "algorithm" is the internal software that converts IR signals to an oral temperature value. The document states:
- "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"."
- "The software for this device was considered as a "Basic" documentation level."
This confirms that the device's internal software/algorithm performance was validated.
7. The type of ground truth used
The ground truth for the clinical accuracy validation would be a reference body temperature measurement, typically obtained using a highly accurate clinical thermometer (e.g., a rectal thermometer) under controlled clinical conditions, as per the methodology outlined in ISO 80601-2-56 for clinical accuracy validation of medical thermometers. This is implicit in "Clinical Accuracy Validation."
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set" for model development. The internal software/firmware is developed and verified, not "trained" on data in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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June 5, 2024
Radiant Innovation Inc. Lynn Chen OA Manager 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park HsinChu, 300 Taiwan
Re: K240648
Trade/Device Name: Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 26, 2024 Received: March 7, 2024
Dear Lynn Chen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
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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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Non-contact Forehead Thermometer (TH48FE, TH09F, THD2FE)
Indications for Use (Describe)
The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.
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)
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Image /page/4/Picture/0 description: The image contains a logo for Radiant Innovation. The logo is in blue and white, with the word "RADIANT" in large, bold letters. Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the logo is the text "RADIANT INNOVATION INC." and the website address "http://www.radiantek.com.tw".
K240648 – 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submitter's Identification:
Radiant Innovation Inc., 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan Name of contact person: Ms. Lynn Chen TEL: +886 3 6111666 Ext. 8123 FAX: +886 3 5670089 E-mail: lynnchen@radiantek.com.tw Date Summary Prepared: Jun/05/2024
2. Device:
Device Trade Name: Non-contact Forehead Thermometer (TH48FE, TH09F, THD2FE) Classification Name: Thermometer, Electronic, Clinical Device Classification: Class II Regulation Number: 21CFR 880.2910 Device Panel: General Hospital Product Code(s): FLL
3. Predicate Device :
510(k) #K121428 Device Trade Name: RII, Non-Contact Clinical Thermometer, Model THB0F Classification Name: Thermometer, Electronic, Clinical Device Classification: Class II Regulation Number: 21CFR 880.2910 Device Panel: General Hospital Product Code(s): FLL
4. Device Description:
The thermometer (Mode: TH48FE, TH09F, THD2FE) are electronic thermometer using an IR sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to an oral temperature value.
The thermometer (Mode: TH48FE, TH09F, THD2FE), consists of the following parts:
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Image /page/5/Picture/0 description: The image contains a logo for Radiant Innovation Inc. The logo features the word "RADIANT" in white letters on a blue rectangle, with the word "INNOVATION" in smaller letters above it. Below the rectangle, the words "RADIANT INNOVATION INC." are printed in black, followed by the URL "http://www.radiantek.com.tw".
- (1) IR sensor with a built-in ambient temperature sensor (Function: Receives infrared signals radiated by temperature)
- (2) Application-Specific Integrated Circuitry include software (Function: Calculate the infrared signal from the forehead and convert it into oral temperature)
- (3) LCD display (Function: Display measurement results)
- (4) 2 buttons (Star button, Scan button), 1 button for TH09F (Function: Start booting and measuring actions)
- (5) 2x1.5V AAA dry batteries, 1 x 3.0V CR2032 battery for TH09F) (Function: Provide product power)
5. Indications for Use:
The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.
| Characteristics | Subject device(TH48FE/TH09F/THD2FE) | Predicate device (THB0F) | Comment |
|---|---|---|---|
| 510(k)# | K240648 | K121428 | / |
| Manufacturer | Radiant Innovation Inc. | Radiant Innovation Inc. | Same |
| Indications for use | The non-contact foreheadthermometer is an electronicthermometer using an infrareddetector (thermopile detector)to detect body temperaturefrom forehead center inpeople of all ages. | The Non-contact ClinicalThermometer, Model THB0Fis an infrared thermometerintended for the intermittentmeasurement of human bodytemperature in people of allages. | Same |
| Intended user | Lay person | Lay person | Same |
| Measuring Range | Forehead mode:82.4 | Forehead mode:93.2 | Different 1 |
| Accuracy | Forehead mode:$\pm$ 0.4 °F (0.2°C) within95 | Forehead mode:$\pm$ 0.4°F(0.2°C) within96.8 |
6. Comparison of technological characteristics with the predicate device:
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Image /page/6/Picture/0 description: The image features the word "RADIANT" in large, bold, white letters against a blue background. Above the word "RADIANT" is the word "INNOVATION" in smaller, white letters. The overall design is simple and modern, with a focus on the company name and its association with innovation.
RADIANT INNOVATION INC.
| 93.2 | |||
|---|---|---|---|
| Display Resolution | 0.1°F(0.1°C) | 0.1°F(0.1°C) | Same |
| Memory | 25 sets for TH48FE/THD2FE1 set for TH09F | 60 sets | Different 2 |
| Scale Selection | °F/°C | °F/°C | Same |
| Display Type | LCD | LCD | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| Case | ABS | ABS | Same |
| Power Source | AAA(1.5V)*2 forTH48FE/THD2FECR2032(3V)*1 for TH09F | AAA(1.5V)*2 | Different 3 |
| OperatingCondition | 50 | 50 | Same |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Same |
| Performance | ASTM 1965-98ISO 80601-2-56 | ASTM 1965-98ISO 80601-2-56 | Same |
| Electric SafetyandEMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Same |
Justification for the differences:
-
- Different Measurement range/ Accuracy:
The measurement range and accuracy of the device under evaluation is different from the marked equivalent device. While the device under evaluation have been tested and validated according to standard ISO 80601-2-56 including accuracy and the measuring range of the device under evaluation meet the accuracy and the minimum rated output range of clinical thermometer requirement, therefore, such difference will not affect the safety and performance of the device under evaluation.
- Different Measurement range/ Accuracy:
-
- Different of Memory:
The memory function of subject devices has been validated in accordance IEC 62304 and FDA Guidance for the Content of Premarket Submissions for Software Contained. The difference will not raise safety or effectiveness issues on the subject devices.
- Different of Memory:
-
- Different of Power Supply:
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Image /page/7/Picture/0 description: The image contains the logo for Radiant Innovation Inc. The logo is in blue and white, with the word "RADIANT" in large, bold letters. Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the logo is the text "RADIANT INNOVATION INC." and the website address "http://www.radiantek.com.tw".
The power supply of TH09F is 1 x CR2032 battery that different from other models, all devices have been proven to be safe and effective based on the IEC 60601-1 and IEC 60601-1-2 testing.
The Non-contact Forehead Thermometer, Model TH48FE, TH09F, THD2FE have the similar characteristics as the predicate device. Moreover, the subject devices demonstrate product safety by successful completion of testing to the IEC 60601-1 standard and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the TH48FE, TH09F, THD2FE meet the ISO 80601-2-56 standard and concludes that any difference in their characteristics do not raise any safety and effectiveness issues. Thus, the Non-contact Forehead Thermometer, Model TH48FE, TH09F, THD2FE are substantially equivalent to the predicate device.
7. Summary of non-clinical testing (Performance testing-bench):
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in according with ISO 14971:2019 -
- The recognized consensus standards for safety of medical electrical equipment: IEC 60601--1, IEC 60601-1-11 for safety and IEC 60601-1-2 for electromagnetic compatibility are complied.
- Biocompatibility Evaluation for patient contacting components: ISO 10993-5, ISO 10993--10 and ISO 10993-23 are complied.
- Bench testing was conducted on the thermometer device. The system complies with the ISO -80601-2-56.
- -Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions". The software for this device was considered as a "Basic" documentation level.
8. Summary of clinical Accuracy Validation Test:
Clinical testing is conducted per ISO 80601-2-56 Clause 201.102 Clinical Accuracy Validation. The Clinical tests were evaluated on 113 subjects and thermometer was evaluated in three age groups including subgroup A1 and A2: A1-one month up to three months and A2-three months to one year, B-older than one years and younger than five years and C-older than five years old. Subjects selected for each model in this clinical trial are: A1) group 15, A2) group 21, B) group 38 and C) group 39. Total number of subjects is 113.
The test report showed the clinical performance of the subject devices complied with the
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Image /page/8/Picture/0 description: The image contains the logo for Radiant Innovation Inc. The logo features the word "RADIANT" in white letters on a blue background, with the word "INNOVATION" above it in smaller letters. Below the logo is the text "RADIANT INNOVATION INC." and the website address "http://www.radiantek.com.tw".
requirement of ISO 80601-2-56.
9. Conclusions:
Based on comparison of the Indications for use and technological characteristics applicable safety standards, verification and validation testing, the differences between Non-contact forehead thermometer (TH48FE, TH09F, THD2FE) and predicate device do not raise new or different questions of safety and effectiveness. Thus, the Non-contact Forehead Thermometer, Model TH48FE, TH09F, THD2FE are substantially equivalent to the predicate device.
§ 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.