RII Multi-function Infrared Thermometer, Model TH52Z

K162083 · Radiant Innovation, Inc. · FLL · Jan 9, 2017 · General Hospital

Device Facts

• Record ID: K162083
• Device Name: RII Multi-function Infrared Thermometer, Model TH52Z
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jan 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device uses infrared thermopile sensor to detect thermal radiation from tympanic membrane or central forehead; input signals processed by internal circuitry for amplification and calculation; output displayed on LCD. Operated by patient or caregiver at home; device provides temperature readings to assist in monitoring health status. Device features ear and forehead modes; includes memory for 9 sets of readings; powered by CR2032 battery.

Clinical Evidence

Bench testing performed per ASTM E1965-98 and EN ISO 80601-2-56. Clinical investigation compared temperature readings between a digital thermometer and the TH52Z across three groups; results confirmed differences were within acceptable ranges, supporting clinical performance.

Technological Characteristics

Infrared thermopile sensor; ABS plastic housing; LCD display; 0.1°F/°C resolution; measurement range 93.2-108°F (34-42.2°C); accuracy ±0.4°F (95-107.6°F); powered by 3V CR2032 battery. Complies with ASTM E1965-98, EN 60601-1, EN 60601-1-2, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for intermittent human body temperature measurement in home settings for all ages, including neonates, via ear or forehead modes.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• RII, Infrared Ear Thermometer, Model TH520 (K063185)
• RII, Non-Contact Clinical Thermometer, Model THB0F (K121428)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Ext. 8128 FAX:[phone] E-mail: [e-mail]

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<br>(TH52Z) | Predicate device<br>(Ear:TH520) | Predicate device<br>(Forehead:THB0F) | Comparison |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k)# | K | K063185 | K121428 | Similar |
| Indications for<br>Use | The RII Multi-function<br>Infrared Thermometer,<br>Model TH52Z is<br>intended for the<br>intermittent<br>measurement of human<br>body temperatures. The<br>device is intended for<br>the use at home by<br>people of all ages and it<br>can be selected Ear<br>mode or Forehead<br>mode. | The device is an<br>electronic clinical<br>thermometer using an<br>infrared sensor to detect<br>body temperature from<br>the auditory canal in the<br>neonatal, pediatric and<br>adult population used in<br>the home setting. | The Non-contact<br>Clinical Thermometer,<br>Model THB0F is an<br>infrared thermometer<br>intended for the<br>intermittent<br>measurement of human<br>body temperature in<br>people of all ages. | Similar |
| Manufacturer | Radiant Innovation Inc. | Radiant Innovation Inc. | Radiant Innovation Inc. | Same |
| Measurement<br>Method | Infrared radiation<br>detection | Infrared radiation<br>detection | Infrared radiation<br>detection | Same |
| Measuring<br>Range | Ear / Forehead mode:<br>93.2~108°F(34~42.2°C) | Ear mode:<br>93.2~108°F(34~42.2°C) | Forehead mode:<br>93.2~108°F(34~42.2°C) | Same |
| Accuracy for<br>body<br>temperature<br>measurement | ±0.4°F (0.2°C) within<br>95~107.6°F (35~42°C),<br>±0.5°F (0.3°C) for<br>other range. | ±0.4°F (0.2°C) within<br>95~107.6°F (35~42°C),<br>±0.5°F (0.3°C) for<br>other range. | ±0.4°F (0.2°C) within<br>95~107.6°F (35~42°C),<br>±0.5°F (0.3°C) for<br>other range. | Same |
| Performance | Meet ASTM E1965-98<br>and EN ISO 80601-2-56 | Meet ASTM E1965-98<br>and EN ISO 80601-2-56 | Meet ASTM E1965-98<br>and EN ISO 80601-2-56 | Same |
| Display<br>Resolution | 0.1°F(0.1°C) | 0.1°F(0.1°C) | 0.1°F(0.1°C) | Same |
| Measurement<br>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<br>button(On, Memory/Ear<br>/ Forehead) | 2 button(On,<br>Memory/Ear) | 4 button(Mode/<br>Memory, On/Off,<br>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<br>(LxWxH) | 146.4x38.3x54.8mm | 146.4x38.3x54.8mm | 180.3x47.5x29.2mm | Acceptable |
| Power<br>Source | CR2032 *1 | CR2032 *1 | AAA(1.5V)*2 | Acceptable |

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Image /page/6/Picture/0 description: The image shows the logo for RADIANT Innovation. The word "RADIANT" is in blue, with the "I" in red. Below the word "RADIANT" are four Chinese characters.

## 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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