(166 days)
Not Found
No
The description details a standard infrared thermometer using an IR sensor and associated circuitry for temperature calculation, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an infrared thermometer used for measuring body temperature, not for treating illness or disease.
No
Explanation: The device is described as an infrared thermometer used for intermittent measurement of human body temperatures. While temperature is a vital sign often used in diagnosis, the device itself only measures temperature and does not interpret this measurement to diagnose a medical condition. Its intended use is for "measurement of human body temperatures," not for diagnosing diseases.
No
The device description explicitly details hardware components like an infrared sensor, associated circuitry, and an 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:
- 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.
- Device function: The RII Multi-function Infrared Thermometer, Model TH52Z, measures human body temperature by detecting infrared radiation emitted from the ear canal or forehead. This is a direct measurement of a physiological parameter in vivo (within the living body), not a test performed on a sample in vitro (outside the living body).
- Intended Use: The intended use clearly states "intermittent measurement of human body temperatures," which aligns with an in vivo measurement.
Therefore, this device falls under the category of a clinical thermometer, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The RII Multi-function Infrared Thermometer, Model TH52Z is intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The RII Multi-function Infrared Thermometer, Model TH52Z is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The end of ear canal is the tympanic membrane, which is thin and flooded with blood at the core temperature. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared 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
auditory canal or central forehead, tympanic membrane
Indicated Patient Age Range
all ages including neonates
Intended User / Care Setting
use at home by people of all ages
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)
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, TH52Z are within acceptable range. It can conclude that the Multi-function Infrared Thermometer. Model TH52Z is acceptable to measure human body's temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2017
Radiant Innovation Inc. Monica Chung Quality Assurance Engineer 1F, No. 3 Industrial E. 9th Rd. Science-based, Industrial Park Hsinchu, 30075 TAIWAN
Re: K162083
Trade/Device Name: RII Multi-function Infrared Thermometer, Model TH52Z Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 25, 2016 Received: November 28, 2016
Dear 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162083
Device Name
RII Multi-function Infrared Thermometer, Model TH52Z
Indications for Use (Describe)
The RII Multi-function Infrared Thermometer, Model TH52Z is intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X 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 in large, bold, 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.
EXHIBIT # 1
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.
The assigned 510(k) number is: K162083
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: Jan/04/2017
2. Device:
Trade Name/Device Name: RII Multi-function Infrared Thermometer, Model TH52Z. Common Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL Classification Panel: General Hospital
3. Predicate Device :
510(k) #K063185
Device Name: RII, Infrared Ear Thermometer, Model TH520 Common Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Thermometer, Electronic, Clinical 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, bold, 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.
510(k) #K121428 Device Name: RII, Non-Contact Clinical Thermometer, Model THB0F Common Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL Classification Panel: General Hospital
4. Device Description:
The RII Multi-function Infrared Thermometer, Model TH52Z is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The end of ear canal is the tympanic membrane, which is thin and flooded with blood at the core temperature. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
ട. Indications for Use:
The RII Multi-function Infrared Thermometer, Model TH52Z is intended for the intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
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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 the "I" in red. Above the word "RADIANT" is the word "INNOVATION" in smaller, black letters. Below the word "RADIANT" are four Chinese characters in black.
6. Technological Characteristics and Substantial Equivalence:
The subject device TH52Z is substantially equivalent to the predicate devices, Infrared Ear Thermometer, Model TH520 (K063185) and Non-Contact Clinical Thermometer, Model THB0F (K121428). The substantial equivalence chart is provided as follows:
| Characteristics | Subject device
(TH52Z) | Predicate device
(Ear:TH520) | Predicate device
(Forehead:THB0F) | Comparison |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k)# | K | K063185 | K121428 | Similar |
| Indications for
Use | The RII Multi-function
Infrared Thermometer,
Model TH52Z is
intended for the
intermittent
measurement of human
body temperatures. The
device is intended for
the use at home by
people of all ages and it
can be selected Ear
mode or Forehead
mode. | The device is an
electronic clinical
thermometer using an
infrared sensor to detect
body temperature from
the auditory canal in the
neonatal, pediatric and
adult population used in
the home setting. | 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. | Radiant Innovation Inc. | Same |
| Measurement
Method | Infrared radiation
detection | Infrared radiation
detection | Infrared radiation
detection | Same |
| Measuring
Range | Ear / Forehead mode:
93.2108°F(3442.2°C) | Ear 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°F (3542°C),
±0.5°F (0.3°C) for
other range. | ±0.4°F (0.2°C) within
95107.6°F (3542°C),
±0.5°F (0.3°C) for
other range. | Same |
| Performance | Meet ASTM E1965-98
and EN ISO 80601-2-56 | Meet ASTM E1965-98
and EN ISO 80601-2-56 | Meet ASTM E1965-98
and EN ISO 80601-2-56 | Same |
| Display
Resolution | 0.1°F(0.1°C) | 0.1°F(0.1°C) | 0.1°F(0.1°C) | Same |
| Measurement
Distance | Within 1 cm | NA | 2~3cm | Acceptable |
| Scale Selection | °F/°C | °F/°C | °F/°C | Same |
| Display Type | LCD | LCD | LCD | Same |
| Key | 3
button(On, Memory/Ear
/ Forehead) | 2 button(On,
Memory/Ear) | 4 button(Mode/
Memory, On/Off,
Light/Set, Scan) | Acceptable |
| Memory | 9 sets | 9 sets | 60 sets | Acceptable |
| Sensor Type | Thermopile | Thermopile | Thermopile | Same |
| Case | ABS | ABS | ABS | Same |
| Weight | 63.3g | 56.9g | 104.7g | Acceptable |
| Dimension
(LxWxH) | 146.4x38.3x54.8mm | 146.4x38.3x54.8mm | 180.3x47.5x29.2mm | Acceptable |
| Power
Source | CR2032 *1 | CR2032 *1 | AAA(1.5V)*2 | Acceptable |
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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.
- · Biocompatibility Evaluation for patient contacting components: ISO 10993-5 and ISO 10993-10 are complied.
- Guidance Documents included the "FDA Guidance On The Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers".
8. Summary of Clinical Investigation:
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, TH52Z are within acceptable range. It can conclude that the Multi-function Infrared Thermometer. Model TH52Z is acceptable to measure human body's temperature.
9. Conclusions:
The RII Multi-function Infrared Thermometer, Model TH52Z, 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 TH52Z 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 Multi-function Infrared Thermometer, Model TH52Z is substantially equivalent to the predicate device.
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