RII Smart IR Thermometer

K163601 · Radiant Innovation, Inc. · FLL · Dec 6, 2018 · General Hospital

Device Facts

• Record ID: K163601
• Device Name: RII Smart IR Thermometer
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Dec 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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.

Device Story

Non-contact infrared forehead thermometer; uses thermopile sensor to detect natural thermal radiation from center of forehead. Device plugs into iOS smartphone jack; requires 'Radiant Forehead' app for operation and display. User aims device within 1 cm of forehead; presses 'MEASURE' on smartphone screen. Sensor detects infrared energy; converts to electrical signal; circuit amplifies and calculates temperature. Measurement time ~1 second. Used at home by patients of all ages. Output displayed on smartphone screen; provides temperature history. Benefits include convenient, non-contact temperature monitoring and digital tracking of body temperature trends.

Clinical Evidence

Clinical evaluation of 198 subjects across three age groups: infants (newborn to 1 year), children (>1 to 5 years), and adults (>5 years). Testing conducted per ASTM E1965-98 protocol. Results demonstrated compliance with ASTM E1965-98 requirements for clinical performance.

Technological Characteristics

Materials: ABS plastic. Sensing: Infrared thermopile with ambient temperature sensor. Energy source: Powered by connected smartphone. Form factor: Plug-in peripheral for iOS devices. Connectivity: Wired connection to smartphone jack; app-based data processing. Standards: ASTM E1965-98, EN ISO 80601-2-56, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2. Biocompatibility: ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for intermittent measurement of human body temperature in home settings for all ages.

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, Non-Contact Clinical Thermometer, Model THB0F (K121428)

Reference Devices

• Kinsa Smart Thermometer (K132514)

Submission Summary (Full Text)

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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.

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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 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 ([e-mail]) or phone [phone] 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

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# 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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: [phone] Ext. 8128 FAX:[phone] E-mail: [e-mail]

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<br>(TMS-01A) | Primary Predicate<br>device (THBOF) | Reference<br>device (Kinsa) | Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------|
| 510(k)# | K163601 | K121428 | K132514 | -- |
| Indications for<br>Use | The RII Smart IR<br>Thermometer, Model<br>TMS-01A is a non-contact<br>infrared forehead<br>thermometer and can only<br>be used with an APP since<br>the display only on a device<br>with the APP. It is intended<br>for the intermittent<br>measurement of human<br>body temperatures and is to<br>be used at home for people<br>of all ages. | 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. | -- | -- |
| Measurement<br>Method | Infrared radiation<br>detection | Infrared radiation<br>detection | -- | Same |
| Measuring<br>Range | Forehead 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<br>(35~42°C), ±0.5°F<br>(0.3°C) for other range. | -- | Same |
| Performance | Meets ASTM E1965-98<br>and EN ISO 80601-2-56 | Meets 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) | -- | Same |
| Measurement<br>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<br>available on mobile<br>device | 60 sets | Full temperature<br>history available on<br>mobile device | Similar |
| Sensor Type | Thermopile | Thermopile | -- | Same |
| Materials | ABS | ABS | -- | Same |
| Power Source | Smart Phone | AAA(1.5V)*2 | Smart Phone | Different |
| Bio-<br>compatibility | Meets ISO 10993-1, ISO<br>10993-5 and ISO<br>10993-10 | Meets ISO 10993-1,<br>ISO 10993-5 and ISO<br>10993-10 | -- | Same |
| Safety | Comply with IEC<br>60601-1 | Comply with IEC<br>60601-1 | Comply with IEC<br>60601-1 | Same |
| EMC | Comply with IEC<br>60601-2 | Comply with IEC<br>60601-2 | Comply with IEC<br>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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