(715 days)
No
The description details a standard infrared thermometer operation and data display via an app. There is no mention of AI or ML being used for temperature calculation, interpretation, or any other function.
No.
The device is strictly for measuring body temperature and does not mention any therapeutic capabilities or intended uses.
No.
The device is an infrared thermometer designed for intermittent measurement of human body temperatures. While it provides a measurement that can be used in diagnosis, the device itself simply measures temperature and does not interpret results or diagnose any medical condition.
No
The device description clearly states it consists of an IR sensor and associated circuit, which are hardware components, in addition to the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RII Smart IR Thermometer measures body temperature by detecting infrared radiation emitted from the forehead. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is for "intermittent measurement of human body temperatures," which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the RII Smart IR Thermometer falls under the category of a medical device, specifically a thermometer, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intermittent measurement of human body temperatures and is to be used at home for people of all ages.
Product codes
FLL
Device Description
The RII Smart IR Thermometer, Model TMS-01A is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from center of forehead. The principle of operation is based on measuring the natural thermal radiation from the center of forehead.
The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and an associated circuit. TMS-01A can only be used with an APP called "Radiant Forehead" which is available on APP store for iOS devices with version 7.0 or above. The APP is designed for use with TMS-01A to take forehead temperature by plugging the TMS-01A in the phone jack of the iOS devices.
To measure body temperature, simply aim the device within 1 cm from the center of forehead. Press the "MEASURE" button on the smart phone touch screen, the temperature sensor detects the infrared thermal energy emitted from the targeted area. The electrical signal is sent to the circuit for amplification and calculation. The final measured temperature can be display on smart phone. The time consuming for measurement might be 1 second.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
forehead
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
at home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test Data:
The clinical tests evaluated 198 of subjects. Each model was evaluated in three groups: 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults greater than five years old. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98. The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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December 6, 2018
Radiant Innovation Inc. Monica Chung Product Certification Engineer 1F, No.3 Industrial E. 9th Road, Science-Based, Industrial Park HsinChu, 30075 Taiwan
Re: K163601
Trade/Device Name: RII Smart IR Thermometer, Model TMS-01A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 29, 2018 Received: November 5, 2018
Dear Ms. Monica Chung:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163601
Device Name
RII Smart IR Thermometer, Model TMS-01A
Indications for Use (Describe)
The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intermittent measurement of human body temperatures and is to be used at home for 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/3/Picture/0 description: The image shows the logo for Radiant Innovation. The word "RADIANT" is written in large, bold, blue letters, with the "I" in "RADIANT" being red. Above the word "RADIANT" is the word "INNOVATION" in smaller, gray letters. Below the word "RADIANT" are four Chinese characters.
熱映光電股份有限公司
510(K)SUMMARY
K163601 The assigned 510(k) number is:
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: 11/10/2018
2. Device:
Trade Name/Device Name: RII, Smart IR Thermometer, Model TMS-01A. Common Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Classification Panel: General Hospital
3. Predicate Device :
Primary predicate: 510(k) #K121428
Device Name: RII, Non-Contact Clinical Thermometer, Model THB0F Common Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Classification Panel: General Hospital
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Image /page/4/Picture/0 description: The image shows the logo for RADIANT Innovation. The word "RADIANT" is in large, blue letters, with the "I" in red. Above the word "RADIANT" is the word "INNOVATION" in smaller, gray letters. Below the word "RADIANT" are four Chinese characters.
Reference device: 510(k) #K132514
Device Name: Kinsa Smart Thermometer Common Name: Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Classification Panel: General Hospital
4. Device Description:
The RII Smart IR Thermometer, Model TMS-01A is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from center of forehead. The principle of operation is based on measuring the natural thermal radiation from the center of forehead.
The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and an associated circuit. TMS-01A can only be used with an APP called "Radiant Forehead" which is available on APP store for iOS devices with version 7.0 or above. The APP is designed for use with TMS-01A to take forehead temperature by plugging the TMS-01A in the phone jack of the iOS devices.
To measure body temperature, simply aim the device within 1 cm from the center of forehead. Press the "MEASURE" button on the smart phone touch screen, the temperature sensor detects the infrared thermal energy emitted from the targeted area. The electrical signal is sent to the circuit for amplification and calculation. The final measured temperature can be display on smart phone. The time consuming for measurement might be 1 second.
ട്. Indications for Use:
The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intended for the intermittent measurement of human body temperatures and is to be used at home for people of all ages.
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Image /page/5/Picture/0 description: The image shows the logo for RADIANT Innovation. The word "RADIANT" is in large, bold, blue letters, with a red vertical line in the middle of the "A". Above the right side of the word "RADIANT" is the word "INNOVATION" in smaller, gray letters. Below the word "RADIANT" are four Chinese characters.
電 股 份 7
INNOVATIO
6. Technological Characteristics and Substantial Equivalence:
The subject device TMS-01A is substantially equivalent to the two predicate devices. The substantial equivalence chart is provided as follows:
IANT
| Characteristics | Subject device
(TMS-01A) | Primary Predicate
device (THBOF) | Reference
device (Kinsa) | Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------|
| 510(k)# | K163601 | K121428 | K132514 | -- |
| Indications for
Use | The RII Smart IR
Thermometer, Model
TMS-01A is a non-contact
infrared forehead
thermometer and can only
be used with an APP since
the display only on a device
with the APP. It is intended
for the intermittent
measurement of human
body temperatures and is to
be used at home for people
of all ages. | 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. | -- | Similar |
| Manufacturer | Radiant Innovation Inc. | Radiant Innovation Inc. | -- | -- |
| Measurement
Method | Infrared radiation
detection | Infrared radiation
detection | -- | Same |
| Measuring
Range | Forehead mode:
93.2108°F (3442.2°C) | Forehead mode:
93.2108°F (3442.2°C) | -- | Same |
| Accuracy for
body
temperature
measurement | ±0.4°F (0.2°C) within
95107.6°F (3542°C),
±0.5°F (0.3°C) for
other range. | ±0.4°F (0.2°C) within
95107.6°F42°C), ±0.5°F
(35
(0.3°C) for other range. | -- | Same |
| Performance | Meets ASTM E1965-98
and EN ISO 80601-2-56 | Meets ASTM E1965-98
and EN ISO 80601-2-56 | -- | Same |
| Display
Resolution | 0.1°F (0.1°C) | 0.1°F (0.1°C) | -- | Same |
| Measurement
Distance | Non-contact within 1 cm | 2~3cm | -- | Different |
| Scale Selection | °F/°C | °F/°C | -- | Same |
| Display Type | Smart phone display | LCD | Smart phone display | Different |
| Key | 0 | 4 buttons | 0 | Different |
| Memory | Full temperature history
available on mobile
device | 60 sets | Full temperature
history available on
mobile device | Similar |
| Sensor Type | Thermopile | Thermopile | -- | Same |
| Materials | ABS | ABS | -- | Same |
| Power Source | Smart Phone | AAA(1.5V)*2 | Smart Phone | Different |
| Bio-
compatibility | Meets ISO 10993-1, ISO
10993-5 and ISO
10993-10 | Meets ISO 10993-1,
ISO 10993-5 and ISO
10993-10 | -- | Same |
| Safety | Comply with IEC
60601-1 | Comply with IEC
60601-1 | Comply with IEC
60601-1 | Same |
| EMC | Comply with IEC
60601-2 | Comply with IEC
60601-2 | Comply with IEC
60601-2 | Same |
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Image /page/6/Picture/0 description: The image shows the logo for RADIANT INNOVATION. The word "RADIANT" is in blue, except for the letter "I", which is in red. Above the word "RADIANT" is the word "INNOVATION" in a smaller font. Below the word "RADIANT" are four Chinese characters.
Discussion:
The differences exist between the subject and predicate devices are as follows:
- Indications for Use – The subject device measurement temperature displays on a device with an APP. It is different from the predicate which the measurement temperature displays on the device itself. It is same as reference device. The subject device complied with the standard ISO 80601-2-56, ASTM E1965-98, IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2, so this difference does not cause any new safety or performance issue.
- Measurement Distance - The measurement distance of subject device is shorter than predicate device, the subject device complied with the standards ISO 80601-2-56 and ASTM E1965-98. This difference does not cause any new performance issue.
- Display Type and Key - The subject device is inserted into smart phone's phone jack and measurement will be displayed through app on the smart phone which is same as reference device. In addition, the subject device complied with the standard ISO 80601-2-56, ASTM E1965-98, IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2, so this difference does not cause any new safety or performance issue.
- Power Source –The power supply of the subject device is from smart phone which is same as reference device. In addition, the subject device complied with the standard IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2, so this difference does not cause any new safety issue.
The differences described in the comparison table demonstrate that the Smart IR Thermometer, Model TMS-01A is substantially equivalent to predicate device and does not raise any new question.
Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: 7.
Non-clinical test were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- 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
- · 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
- · ASTM E1965-98, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- · The software verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
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Image /page/7/Picture/0 description: The image shows the logo for RADIANT Innovation. The word "RADIANT" is written in blue, with the "I" in red. Above the word "RADIANT" is the word "INNOVATION" in a smaller, gray font. Below the word "RADIANT" are four Chinese characters.
Clinical Test Data: 8.
The clinical tests evaluated 198 of subjects. Each model was evaluated in three groups: 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adultsgreater than five years old. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98. The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98.
9. Conclusions:
Verification and validation tests were conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission, the RII Smart IR Thermometer, Model TMS-01A is substantially equivalent to the predicate device.
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