(64 days)
Not Found
No
The description details a standard infrared thermometer using basic signal processing and calculation, with no mention of AI or ML terms or concepts.
No
The device is used to measure human body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
Explanation: The device is described as an infrared thermometer used for the intermittent measurement of human body temperature. While temperature measurement can be part of a diagnostic process, the device itself is a measurement tool, not a diagnostic device that interprets data to determine the presence or nature of a disease or condition.
No
The device description explicitly details hardware components such as an IR sensor, thermo-mass, associated circuit, and LCD display, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intermittent measurement of human body temperature". This is a direct measurement of a physiological parameter of the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device measures "natural thermal radiation emanating from the temples to hairline upper eyebrows". This is a non-invasive measurement of the body's heat, not an analysis of a biological sample.
- Lack of IVD Characteristics: IVD devices typically involve:
- Analyzing samples (blood, urine, tissue, etc.).
- Detecting or measuring substances within those samples (analytes).
- Providing information about a disease state, condition, or physiological state based on the sample analysis.
This device is a clinical thermometer, which is a medical device used for direct physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Non-contact Clinical Thermometer, Model THB0F is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Product codes
FLL
Device Description
The RII Non-contact Clinical Thermometer, Model THB0F is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the Forehead. Its operation is based on measuring the natural thermal radiation emanating from the temples to hairline upper eyebrows. The thermometer consists mainly of the following parts: an IR sensor with a built-in ambient temperature sensor, a thermo-mass, and the associated circuit. The forehead skin, which is thin and beneath, which is the temporal artery, with blood very near to the core temperature. The forehead skin must cover the whole FOV(Field of View) of the sensor. When measuring, radiation fluxes transfer from the skin to the IR detector. The ambient sensor is mounted in the IR sensor package, and near the IR detector element to monitor the ambient temperature. To measure core temperature, the probe of the thermometer are slide through the skin of the a patient's forehead. A activation button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appear on a LCD display. The total operation takes a few seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
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
The clinical investigation report and data analysis followed the requirements of ASTM E 1965-98. The test report showed the three group's temperature readings difference between digital thermometer and the subject device, THB0F, are within acceptable range. It can be concluded that the Non-contact Clinical Thermometer, Model THB0F is acceptable to measure human body's temperature.
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 word "RADIANT" in large, bold letters. Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the word "RADIANT" are four Chinese characters.
EXHIBIT # 1
510(K) SUMMARY
JUL 1 7 2012
This 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: 12 14 28
1. Submitter's Identification:
Radiant Innovation Inc., 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan
Contact:
Ms. Monica Chung Product Certification Engineer Radiant Innovation Inc. TEL: +886 3 6111666 Ext. 8128 FAX:+886 3 5670089 E-mail: monicachung@radiantek.com.tw
Date Summary Prepared: May/11/2012
2. Name of the Device:
Non-contact Clinical Thermometer, Model THBOF. Classification Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910
3. Predicate Device :
TECNIMED srl, Thermofocus 01500 series Thermometer.(510(k) #K072108)
4. Device Description:
The RII Non-contact Clinical Thermometer, Model THBOF is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the Forehead. Its operation is based on measuring the natural thermal radiation emanating from the temples to hairline upper eyebrows.
1
Image /page/1/Picture/0 description: The image shows the logo for Radiant Innovation Inc. The logo is divided into two parts, with the left side featuring the word "RADIANT" in bold, stylized letters and the word "INNOVATION" above it in smaller letters. The right side of the logo contains the company name in Chinese characters, followed by "RADIANT INNOVATION Inc." in English.
The thermometer consists mainly of the following parts: an IR sensor with a built-in ambient temperature sensor, a thermo-mass, and the associated circuit. The forehead skin, which is thin and beneath, which is the temporal artery, with blood very near to the core temperature. The forehead skin must cover the whole FOV(Field of View) of the sensor. When measuring, radiation fluxes transfer from the skin to the IR detector. The ambient sensor is mounted in the IR sensor package, and near the IR detector element to monitor the ambient temperature.
To measure core temperature, the probe of the thermometer are slide through the skin of the a patient's forehead. A activation button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appear on a LCD display. The total operation takes a few seconds.
క. Intended Use:
The Non-contact Clinical Thermometer, Model THB0F is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Technological Characteristics and Substantial Equivalence: 6.
The subject device is substantially equivalent to the predicate devices. Thermofocus 01500 series Thermometer (K072108) marketed by TECNIMED srl. The substantial equivalence chart is provided as follows:
| Characteristics | Subject device(THB0F) | Predicate device (THP series) |
|---|---|---|
| 510(k)# | K | K072108 |
| Measurement Method | Infrared radiation detection | |
| Measuring Range | Forehead mode: | |
| 93.2 | ||
| Surface mode: | ||
| -7.6 | Forehead mode: | |
| 93.2 | ||
| Surface mode: | ||
| 33.8 | ||
| Accuracy | Forehead mode: | |
| ±0.4°F(0.2°C) within 96.8~102°F | ||
| (36~39℃), ±0.5°F(0.3°C) for | ||
| other range | ||
| Surface mode: | ||
| ±4% of reading or ±4°F(2°C) | ||
| whichever is greater | Forehead mode: | |
| ±0.4°F(0.2°C) within 96.8 | ||
| ±0.5°F(0.3°C ) for other range | ||
| Surface mode: | ||
| ±0.4°F(0.2°C) within 96.9 | ||
| ± 0.5°F(0.3℃) within 68 | ||
| and 102.3 | ||
| ± 1.8°F(1°C) within 33.8 | ||
| and 108.1 | ||
| Display Resolution | 0.1°F(0.1°C) | |
| Measurement Distance | 2~3cm | 2.5cm |
| Scale Selection | °F/°C | |
| Display Type | LCD | |
| Key | 4 button(Mode/ Memory, On/Off, | |
| Light/Set, Scan) | 3 button(Face, Memory, Home) | |
| Memory | 60 sets | 9 sets |
| Sensor Type | Thermopile | |
| Case | ABS |
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1F, No.3, Industrial E. 9th Rd., Science-Based TEL: +886 3 5644185 Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170
2
Image /page/2/Picture/0 description: The image contains two logos side by side. The logo on the left says "RADIANT INNOVATION" in a stylized font. The logo on the right contains Chinese characters and the text "RADIANT INNOVATION Inc.,".
| Weight | 104.7g | 90g |
|---|---|---|
| Dimension (LxWxH) | 180.3x47.5x29.2mm | 165x40x21.9 mm |
| Power Source | AAA(1.5V)*2 | AAA(1.5V)*4 |
| Operating Condition | 50 | 60.8 |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: .
- · Compliance to applicable voluntary standard ASTM E1965-98.
- · The recognized consensus standards for safety of medical electrical equipment: EN 60601-1 (IEC 60601-1) for safety and EN 60601-1-2 (IEC 60601-1-2) for electromagnetic compatibility are complied.
- · Guidance Documents included the "FDA Guidance On The Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers".
8. Discussion of Clinical Tests Performed:
The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, THBOF are within acceptable range. It can conclude that the Non-contact Clinical Thermometer, Model THBOF is acceptable to measure human body's temperature.
9. Conclusions:
The RII Non-contact Clinical Thermometer, Model THB0F, has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the EN 60601-1(IEC 60601-1) standard and electromagnetic standard EN 60601-1-2(IEC 60601-1-2). The performance test demonstrates the THB0F meets the ASTM E1965-98 standard and concludes that any differences in their characteristics do not raise any safety and effectiveness issues. Thus, the RII Non-contact Clinical Thermometer, Model THBOF is substantially equivalent to the predicate devic.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines extending from its body, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 7 2012
Mr. James Huang Quality Assurance Radiant Innovation, Incorporated 1F, No.3 Industrial East 9th Road Science-Based, Industrial Park HsinChu, Taiwan 30075
Re: K121428
Trade/Device Name: Non-Contact Clinical Thermometer, Model THB0F Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May, 14, 2012 Received: May 14, 2012
Dear Mr. Huang:
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. 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.
4
Page 2- Mr. Huang
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fr. A. Betti, S.J.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
EXHIBIT # B
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Radiant Innovation Inc. Non-contact Clinical Thermometer, Model THB0F
Indications For Use:
:
The Non-contact Clinical Thermometer, Model THBOF is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use ਕਿ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off) | 7/9/12 |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | Page 1 of 1 |
| 510(k) Number: | K121428 |
Page 12300 新竹科學園區工業東九路 3 號 1 樓 http://www.radiantek.com.tw
1F, No.3, Industrial E. 9" Rd., Science-Based TEL: +886 3 5644185 Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170