RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES

K063185 · Radiant Innovation, Inc. · FLL · Nov 17, 2006 · General Hospital

Device Facts

• Record ID: K063185
• Device Name: RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Nov 17, 2006
• 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; detects natural thermal radiation from tympanic membrane and adjacent auditory canal surfaces via thermopile detector. User inserts device into outer ear canal; presses start button. Internal circuitry amplifies and calculates electrical signals from detector. Measured temperature displayed on LCD. Used in home setting by patients or caregivers. Provides rapid temperature readings to assist in clinical decision-making regarding fever management.

Clinical Evidence

Bench testing only. Compliance with ASTM E1965-98, EN12470-5:2003, IEC 60601-1, and EN 60601-1-2 standards.

Technological Characteristics

Infrared thermopile detector; electronic circuitry for signal amplification and calculation; LCD display. Standards: ASTM E1965-98, EN12470-5:2003, IEC 60601-1, EN 60601-1-2.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for body temperature measurement via the auditory canal in home settings.

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 TH00XY series (K051269)
• THXXN series (K040377)
• TH1 series (K030324)
• TH88 series (K020504)
• TH8 series (K011059)

Submission Summary (Full Text)

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# SPECIAL 510(K) SUMMARY

NOV 17 2006

This summary of Special 510(k) safety and effectivencss information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92.

The assigned 510(k) number is:

### Submitter's Identification: 1.

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

## Contact:

Mr. Frank Lin QA Dept. Manager

Date Summary Prepared: Sep/27/2006

### 2. Name of the Modification Device:

Infrared Ear Thermometer TH5XY series (TH500/50Z, TH520 and TH560/56Z)

### 3. Current Clearance Device:

Radiant Innovation Infrared Ear Thermometer, Models TH00XY series (FDA#: K051269), THXXN series (FDA#: K040377), TH1 series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA#: K011059).

### 4. Device Description:

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH5XY series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

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 fed to the circuit for amplification and calculation. The measured temperature then appears on a 1.CD display. The total operation takes a few sconds.

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### ડા 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.

### 6. 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 IEC 60601 -1 and EN 60601-1-2 requirements.

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

### 9. Conclusions:

The RII Infrared Ear Thermometer TH5XY series, have the same intended use and similar characteristics as the cleared device TH00XY series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectivencss. Thus, the RII Infrared Ear Thermometer, Models TH5XY series is substantially equivalent to the predicate device.

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Lin Quality Assurance Department Manager Radiant Innovation, Incorporated 1F, No. 3, Industrial East 9th Road Science-Based Industrial Park HsinChu, Taiwan 300 Republic of China

NOV 1 7 2006

Re: K063185

Trade/Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH5XY Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 26, 2006 Received: October 20, 2006

Dear Mr. Lin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Lin

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 Incan that I DA mas made a aves and regulations administered by other Federal agencies. or the Act of any I ouchar the Act's requirements, including, but not limited to: registration 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quality tion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyour to began finding of substantial equivalence of your device to a premarket notification. - The Pre results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rryou donto specific at no room innee at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overnit oner gater gaternational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sujata Y. Michaud DMD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Radiant Innovation Inc. The logo is split into two parts, with the English version on the left and the Chinese version on the right. The English version of the logo is "RADIANT INNOVATION", with "INNOVATION" in a smaller font above "RADIANT". The Chinese version of the logo is arranged in two lines, with the first line in traditional Chinese characters and the second line being "RADIANT INNOVATION Inc."

K063185

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Radiant Innovation Inc. Infrared Ear Thermometer TH5XY 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 _ 网

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of Anesthesiology, General Hospital, | |
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300 新竹科學園區工業東九路3號1樓 1F, No.3, Industrial E. 9^th Rd., Science-Based TEL:[phone]

Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: [phone] http://www.radiantek.com.tw