RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES

K040377 · Radiant Innovation, Inc. · FLL · Sep 16, 2004 · General Hospital

Device Facts

• Record ID: K040377
• Device Name: RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 16, 2004
• 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

Infrared ear thermometer (THxxN series) measures natural thermal radiation from tympanic membrane and adjacent auditory canal surfaces. Device uses thermopile infrared detector to capture thermal radiation; electrical signals are amplified and processed by internal circuitry to calculate temperature. User inserts probe into outer ear canal and presses start button. Measured temperature is 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. No clinical data provided. Compliance with ASTM E1965-98, IEC 60601-1, and EN 60601-1-2 standards demonstrated.

Technological Characteristics

Infrared ear thermometer using thermopile detector. Form factor: handheld unit with probe for auditory canal insertion. Output: LCD display. Standards: ASTM E1965-98, IEC 60601-1, EN 60601-1-2. Power: electronic circuitry for signal amplification and calculation.

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, Models TH1 series (K030324)
• Radiant Innovation Infrared Ear Thermometer, Models TH8 series (K011059)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "RADIANT" in large, bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller, bold, black letters. Below the word "RADIANT" are four Chinese characters in black.

熱映光電股份有限公司
RADIANT INNOVATION Inc.

### SEP 1 6 2004

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: K040377 (0. 1 of )

#### 1. Submitter's Identification:

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

### Contact:

Mr. Frank Lin QA Dept. Manager

Date Summary Prepared: Jan/15/2004

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

Infrared Ear Thermometer THxxN series (TH10N(E),TH83N(E),TH83N(E) and TH88N(E))

#### 3. Current Clearance Device:

Radiant Innovation Infrared Ear Thermometer, Models TH1 series (FDA#: K030324) and TH8 series (FDA#: K011059).

#### Device Description: 4.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THxxN 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 word "RADIANT" in bold, black letters on the left and the Chinese characters for "Radiant Innovation Inc." on the right. Below the English name, there are also Chinese characters that translate to "Radiant Innovation."

#### ನ. 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.

#### Tests Performed for Determination of Substantial Equivalence are as follows: 6.

Compliance to applicable voluntary standards includes ASTM E1965-98, 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 THxxN series, have the same intended use and similar characteristics as the cleared device TH1 and TH8 series. Moreover, bench testing contained in this submission supplied demonstrate that the modification of THxxN do not raise any new questions of safety or effectiveness. Thus, the RII Infrared Ear Thermometer, Models THxxN series is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the left side of the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Mr. Frank Lin Quality Assurance Manager Radiant Innovation, Incorporated 1F, No. 3, Industrial E. 9th Road Science-Based Industrial Park, HsinChu, TAIWAN, R.O.C.

Re: K040377

Trade/Device Name: RII Infrared Ear Thermometer, Model THXXN Series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 6, 2004 Received: September 10, 2004

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinene, or to active 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 approvisions 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 (1 Writ), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Lin

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease oc acressed that 1 Dr. determination that your device complies with other requirements Incall that I Dri nas made a autes and regulations administered by other Federal agencies. of the Act of ally I ouchar banks as requirements, including, but not limited to: registration 1 ou intist comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labeling (21 CFR Part 820); and if requirements as bet form in are quadiation 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) This letter will and in J o The FDA finding of substantial equivalence of your device to a premaired predicate device 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), 11 you desire 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 may obtain 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,

Carls

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 word "RADIANT" in bold, black letters. Above the word "RADIANT" is the word "INNOVATION" in smaller, black letters. Below the word "RADIANT" are four Chinese characters.

EXHIBIT # B

# Indications for Use

510(k) Number (if known): K640377

Device Name: Radiant Innovation Inc. Infrared Ear Thermometer THxxN 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 _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use ... 凶...

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Einthen Dars

General Hospital,

510(k) Number:

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