INFRARED EAR THERMOMETER

K111637 · Radiant Innovation, Inc. · FLL · Dec 6, 2011 · General Hospital

Device Facts

• Record ID: K111637
• Device Name: INFRARED EAR THERMOMETER
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Dec 6, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Electronic infrared ear thermometer; uses thermopile detector to measure infrared radiation from tympanic membrane and auditory canal. Device inserted into outer ear canal; user presses start button to initiate measurement. Hardware amplifies electrical signal from detector; microprocessor processes signal to calculate temperature. Output displayed on LCD. Used in home setting by patients or caregivers for intermittent temperature monitoring. Benefits include non-invasive, rapid temperature assessment.

Clinical Evidence

Clinical study evaluated repeatability of THP series. Results showed repeatability < 0.3°C, meeting criteria of EN12470-5 and ASTM E1965-98 standards.

Technological Characteristics

Infrared thermopile sensor; ABS plastic case; LCD display; 3V CR2032 battery; 2-phase battery alarm. Standards compliance: ASTM E1965-98, EN12470-5:2003, IEC 60601-1, IEC 60601-1-2. Dimensions: 14.5 x 4 x 4.9 cm; Weight: 70g.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for intermittent monitoring of human body temperature via the auditory canal in a home setting.

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

• Radiant Innovation Infrared Ear Thermometer, Models TH8 series (K011059)

Submission Summary (Full Text)

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K111637

11

## Attachment 2

## SPECIAL 510(K) SUMMARY

This Special 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:

#### 1. Submitter's Identification:

Radiant Innovation Inc. 1F, No.3 Industrial E. 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan

Contact:

Ms. LynnChen QA Department Manager Radiant Innovation Inc. TEL: [phone] Ext. 8123 FAX:[phone] E-mail: lynnchen(@radiantek.com.tw

Date Summary Prepared: May/13/2011

### 2. Name of the Device:

Infrared Ear Thermometer THP series Classification Name: Thermometer, Electronic, Clinical Regulation Number: 21 CFR 880.2910

#### 3. Predicate Device :

Radiant Innovation Infrared Ear Thermometer, Models TH8 series (510(k)#: K011059).

### 4. Device Description:

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THP series are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiation from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

Page 1

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To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

INNOVATION

I A N T

#### 5. Intended Use:

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.

#### . Technological Characteristics and Substantial Equivalence:

Both the subject device (THP series) and the predicate device (TH8 series) have the same intended use as well as same fundamental technology. The comparison table showing the differences between the subject device (THP series) and the predicate device (TH8 series) is included in the 510(k) submission. The subject device (THP series) is substantially equivalent to the predicate device (TH8 series) since they have the same intended use, indications for use and similar technological characteristics.

| Features | Predicate device(TH8 series) | Subject device (THP series) |
|-----------------------|-------------------------------------------------------------------|-----------------------------|
| 510(k)# | K011059 | K |
| Accuracy | 35.5~42°C (95.9~107.6°F)+/-0.2°C (0.4°F), other +/-0.3°C (0.5°F). | |
| Temp. Range | 34.0-42.2°C | |
| Ambient Range | 10-40°C | |
| Response Time | 1 sec | |
| Read modes | Ear (Oral) | |
| Scale Selection | °C/°F | |
| Display Type | LCD | |
| Probe Cover | With | |
| Activation | Scan Button | Start Button |
| Memory | 9 sets | 25 set |
| Sensor Type | Thermopile | |
| Case | ABS | |
| Weight | 70g | 70g |
| Dimension (LxWxH) | 14*3.8*3 cm | 14.5*4*4.9 cm |
| Battery | 3V Battery, CR2032 * 1 | |
| 2 Phase Battery Alarm | Yes | |

The basic technological characteristics between subject device vs. predicate device.

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003. as well as EN 60601-1 (IEC 60601-1) and EN 60601-1-2 (IEC 60601-1-2) requirements.

Guidance Documents included the FDA "Guidance On The Content of Premarket Notification

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# 電股份有限 IANT INNOVATIO

(510(k)) Submissions for Clinical Electronic Thermometers", "How to Prepare A Special 510(k)", "Deciding When to Submit a 510(k) for a Change to an Existing Device".

#### 8. Summary of Clinical Investigation:

According the clinical report, the repeatability of THP series are less than 0.3degC. The result meets the criteria of EN12470-5 and ASTM 1965-98, so the THP series passes this clinical study.

#### 9. Conclusions:

The RII Infrared Ear Thermometer THP series, have the same intended use and similar characteristics as the cleared device TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of THP series do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Model THP series is substantially equivalent to the predicate device

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Lynn Chen QA Department Manager Radiant Innovation Incorporated 1F, No. 3 Industrial E. 9th Road Science-Based Industrial Park, HsinChu CHINA (TAIWAN) 30075

DEC - 6 2011

Re: K111637

Trade/Device Name: Radiant Innovation Inc. Infrared Thermometer THP Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 7, 2011 Received: November 8, 2011

Dear Ms. Chen:

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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Page 2 - Ms. Chen

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K 111637

Image /page/5/Picture/1 description: The image shows the word "RADIANT" in large, bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller letters. Below the word "RADIANT" are four Chinese characters.

# |Attachment 1 |

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Radiant Innovation Inc. Infrared Ear Thermometer THP Series

Indications For Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 807 Subpart C)

Over-The-Counter Use &

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

12/6/11

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

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510(k) Ni

1F, No.3, Industrial E. 9th Rd., Science-Based TEL:[phone] Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: [phone]