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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: RII Multi-function Infrared Thermometer, Model TH52Z
Intended Use: Intermittent measurement of human body temperatures for home use by people of all ages, including neonates, with selectable Ear mode or Forehead mode.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (from predicate & ASTM E1965-98)	Reported Device Performance (TH52Z)
Accuracy for Body Temperature Measurement	±0.4°F (0.2°C) within 95~~107.6°F (35~~42°C), ±0.5°F (0.3°C) for other ranges.	Meets Criteria: The clinical investigation reported that temperature readings difference between a digital thermometer and the TH52Z were "within acceptable range" which implies adherence to these accuracy standards.
Measuring Range	Ear / Forehead mode: 93.2~~108°F (34~~42.2°C)	Ear / Forehead mode: 93.2~~108°F (34~~42.2°C)
Performance Standard	Meet ASTM E1965-98 and EN ISO 80601-2-56	Meets Criteria: Performance test demonstrates TH52Z meets ASTM E1965-98 standard.
Safety (Electrical)	Compliance with EN 60601-1 (IEC 60601-1)	Meets Criteria: Successful completion of testing to EN 60601-1 standard.
Safety (EMC)	Compliance with EN 60601-1-2 (IEC 60601-1-2)	Meets Criteria: Successful completion of testing to EN 60601-1-2 standard.
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10 for patient contacting components	Meets Criteria: Biocompatibility evaluation for patient contacting components complied with ISO 10993-5 and ISO 10993-10.

2. Sample Size for the Test Set and Data Provenance

The document states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98." ASTM E 1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," typically specifies minimum sample sizes for clinical accuracy studies, usually involving a certain number of subjects across different age groups. While the exact number of subjects is not explicitly stated in this document, the reliance on ASTM E 1965-98 implies that an appropriate sample size was used to meet that standard.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical investigations for medical devices are generally prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not explicitly stated in the provided text. For a clinical thermometer study, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated reference thermometer (e.g., a rectal or oral electronic thermometer as per ASTM standards), rather than expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. For clinical accuracy studies of thermometers, an adjudication method in the typical sense (e.g., 2+1 for reviewing discordant readings) is not applicable. The comparison is against a physically measured reference temperature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study is not relevant for the evaluation of a clinical thermometer, as it is not an imaging device requiring human interpretation of cases. The device directly provides a numerical measurement.

6. Standalone Performance Study

Yes. A standalone performance study was conducted. The clinical investigation directly assessed the accuracy of the RII Multi-function Infrared Thermometer, Model TH52Z, by comparing its readings against a digital thermometer (acting as the reference/ground truth). The report states, "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."

7. Type of Ground Truth Used

Reference Standard Measurement. The ground truth for the clinical accuracy study was established using a "digital thermometer." This implies a comparison against a calibrated, highly accurate reference thermometer, as prescribed by standards like ASTM E1965-98 for clinical accuracy evaluation.

8. Sample Size for the Training Set

Not applicable. This device is a traditional infrared thermometer, not an AI / machine learning-based algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this device does not use an AI/ML algorithm requiring a training set.

Summary

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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.

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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)

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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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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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:

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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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 forUse	The RII Multi-functionInfrared Thermometer,Model TH52Z isintended for theintermittentmeasurement of humanbody temperatures. Thedevice is intended forthe use at home bypeople of all ages and itcan be selected Earmode or Foreheadmode.	The device is anelectronic clinicalthermometer using aninfrared sensor to detectbody temperature fromthe auditory canal in theneonatal, pediatric andadult population used inthe home setting.	The Non-contactClinical Thermometer,Model THB0F is aninfrared thermometerintended for theintermittentmeasurement of humanbody temperature inpeople of all ages.	Similar
Manufacturer	Radiant Innovation Inc.	Radiant Innovation Inc.	Radiant Innovation Inc.	Same
MeasurementMethod	Infrared radiationdetection	Infrared radiationdetection	Infrared radiationdetection	Same
MeasuringRange	Ear / Forehead mode:93.2~~108°F(34~~42.2°C)	Ear mode:93.2~~108°F(34~~42.2°C)	Forehead mode:93.2~~108°F(34~~42.2°C)	Same
Accuracy forbodytemperaturemeasurement	±0.4°F (0.2°C) within95~~107.6°F (35~~42°C),±0.5°F (0.3°C) forother range.	±0.4°F (0.2°C) within95~~107.6°F (35~~42°C),±0.5°F (0.3°C) forother range.	±0.4°F (0.2°C) within95~~107.6°F (35~~42°C),±0.5°F (0.3°C) forother range.	Same
Performance	Meet ASTM E1965-98and EN ISO 80601-2-56	Meet ASTM E1965-98and EN ISO 80601-2-56	Meet ASTM E1965-98and EN ISO 80601-2-56	Same
DisplayResolution	0.1°F(0.1°C)	0.1°F(0.1°C)	0.1°F(0.1°C)	Same
MeasurementDistance	Within 1 cm	NA	2~3cm	Acceptable
Scale Selection	°F/°C	°F/°C	°F/°C	Same
Display Type	LCD	LCD	LCD	Same
Key	3button(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
PowerSource	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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Regulation Number and Section

§ 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.