RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES

K030324 · Radiant Innovation, Inc. · FLL · Feb 27, 2003 · General Hospital

Device Facts

• Record ID: K030324
• Device Name: RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Infrared ear thermometer; detects natural thermal radiation from tympanic membrane and adjacent auditory canal surfaces. Uses thermopile infrared detector to convert radiation into electrical signals; internal circuitry amplifies and calculates temperature; displays result on LCD. Operated by user in home setting; inserted into outer ear canal; measurement initiated via start button. Provides rapid temperature reading to assist in clinical decision-making regarding patient health status.

Clinical Evidence

Bench testing only. Compliance with ASTM E1965, IEC 60601-1, and IEC 60601-1-2 standards demonstrated.

Technological Characteristics

Infrared thermopile detector; electronic circuitry for signal amplification and calculation; LCD display. Complies with ASTM E1965, IEC 60601-1, and IEC 60601-1-2. Handheld form factor.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for body temperature measurement 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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O N N O

KUBO2224 EXHIBIT#1

# Special 510(K) SUMMARY

This summary of 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:

FEB 2 7 2003

#### 1. Submitter's Identification:

Radiant Innovation Inc., No. 40, Lane 19, Bade Road Hsin-Chu City Taiwan, R.O.C.

### Contact:

Mr. Charles Chang Eng. Dep. Manager

Date Summary Prepared: Jan 24, 2003

#### 2. Name of the Modification Device:

Infrared Ear Thermometer, Models TH1 series

#### 3. Current Clearance Device:

Radiant Innovation Infrared Ear Thermometer, Models TH8 series. ( FDA# K011059)

#### 4. Device Description:

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH1 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 LCD display. The total operation takes a few seconds.

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Image /page/1/Picture/0 description: The image shows the logo for Radiant Innovation Inc. The logo is divided into two parts, with the left side featuring the word "RADIANT" in bold, stylized letters, and the word "INNOVATION" above it in smaller letters. Below "RADIANT" are the Chinese characters for "Radiant". The right side of the logo features the company's name in Chinese characters, followed by "RADIANT INNOVATION Inc.," in English.

#### 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.

#### 6. Comparison to the Cleared Devices:

The RII Infrared Ear Thermometer, Models TH1 series are substantially equivalent to RII's current clearance device: Infrared Ear Thermometer, Models TH8 series, on the principle of operation, scientific technology with the same intended use, technological characteristics and specifications.

The only differences between TH8 and TH1 series Infrared Ear Thermometer are the outer appearance and the user's manual which will not significantly change the safety and effectiveness .

#### 7. Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E1965, as well as IEC 60601 -1 and IEC 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" ..

#### 8. Conclusions:

The RII Infrared Ear Thermometer, Models TH1 series, have the same intended use and similar characteristics as the cleared device, Model TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of TH1 do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Models TH1 series is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

Mr. Charles Chang Eng. Department Manaager Radiant Innovations Incorporated No. 40, Lane 19, Bade Road Hsin-Chu City TAIWAN, R.O.C.

Re: K030324

Trade/Device Name: Radiant Innovations Inc. Infrared Ear Thermometer, Model TH1 series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 29, 2003 Received: January 31, 2003

Dear Mr. Charles Chang:

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. Chang

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): 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance 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 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Suzer Runoes

Susan Runner, DDS, MA Interim 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 left side showing the word "RADIANT" in bold, stylized letters, with the word "INNOVATION" above it in smaller letters. Below the word "RADIANT" are four Chinese characters. The right side of the logo shows the Chinese characters for "Radiant Innovation Inc.", with the English translation below it.

### #EXHIBIT B

## Indications for Use Statement

Special 510(k) Number (if known):

Device Name: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valerie Mura - PXC

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K030324

PrescriptionUse (Per 21 CFR 801.109)

OR

Over-The-Counter Use 1 (Optional Format 1-2-96)