INFRARED EAR THERMOMETER, MODELS TH88 SERIES

K020504 · Radiant Innovation, Inc. · FLL · Feb 28, 2002 · General Hospital

Device Facts

• Record ID: K020504
• Device Name: INFRARED EAR THERMOMETER, MODELS TH88 SERIES
• Applicant: Radiant Innovation, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Feb 28, 2002
• 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

Electronic infrared ear thermometer; detects thermal radiation from tympanic membrane and auditory canal via thermopile detector. User inserts probe into outer ear canal; presses start button. Device amplifies electrical signal; performs calculation; displays temperature 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, IEC 60601-1, and IEC 60601-1-2 standards.

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.

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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### EXHIBIT#1

# FEB 2 8 2002

# 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:

#### Submitter's Identification: 1.

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: Feb/07/2002

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

Infrared Ear Thermometer, Models TH88 series

#### 3. Current Clearance Device:

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

#### Device Description: 4.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH88 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 The total The measured temperature then appears on a LCD display. calculation. 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 in black and white and features the company name in both English and Chinese. The English name is in a bold, sans-serif font, while the Chinese name is in a traditional, serif font. The logo also includes a small graphic of a lightbulb.

#### Intended Use: 5.

The device is an electronic clinical thermometer using an infrared sensor to detect body The device is an crocronic childed in the neonatal, pediatric and adult population used in the home setting.

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

The RII Infrared Ear Thermometer, Models TH88 series are substantially equivalent to THE CHI Intrared Dar Internice 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 TH88 series Infrared Ear Thermometer are the outer appearance and addition operation procedures for probe cover installation on the user's manual which will not significantly change the safety and effectiveness .

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

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 Satuation (51 0(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, Models TH88 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 TH88 do not Thus, the RII Infrared Ear raise any new questions of safety or effectiveness. Thermometer, Models TH88 series is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.

# FEB 2 8 2002

Radiant Innovation, Incorporated C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K020504

Trade/Device Name: Infrared Ear Thermometer, Models TH88 Series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 13, 2002 Received: February 15, 2002

Dear Ms. Falk:

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.

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.

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### Page 2 - Ms. Falk

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Part 800); and i and listing (21 CFK Part 807), laboling (21 CFR Pat 820); and if (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 This letter will anow you to begin manoung your substantial equivalence of your device to 510(K) premiarket notification. The I Drivinalig as ification 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 II you desire specific ad rior for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 607.10 Ios in 100 milly, for questions on the promotion and
Office of Compliance at [phone]. Additionally, for questions on 1 (301) 504-4 Office of Comphance at [phone]. The Office of Compliance at [phone]. advertising of your ar agulation entitled, "Misbranding by reference to premarket Also, prease note the regulation on other general information on your responsibilities under nothication (ZTCPN Part 007.97). Oaks gold Manufacturers, International and the Act may be obtained from all Drivision of 2011 or [phone] or at its
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,

Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### #EXHIBIT B

## Indications for Use Statement

### Special 510(k) Number (if known):

Device Name: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH88 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)

Patricio Cucurete

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number __ 020504

PrescriptionUse (Per 21 CFR 801.109)

OR

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

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