CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER

K061800 · Taidoc Technology Corporation · FLL · Jul 7, 2006 · General Hospital

Device Facts

• Record ID: K061800
• Device Name: CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
• Applicant: Taidoc Technology Corporation
• Product Code: FLL · General Hospital
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clever TD-1112 ear/skin/surface IR thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

Device Story

Clever TD-1112 is an infrared (IR) thermometer; detects IR radiation from ear canal or surfaces. Device converts thermal radiation into electrical signals; processes signals to calculate temperature; displays result on integrated screen. Intended for home use by patients or caregivers. Provides non-invasive temperature monitoring; aids in fever detection and general health assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared sensor-based electronic thermometer. Handheld form factor. Battery-powered. Measures temperature via IR radiation detection. No specific materials or software algorithm architecture detailed.

Indications for Use

Indicated for measuring human body temperature via the ear canal in patients of all ages. Also indicated for measuring surface temperatures of objects and human skin. Intended for home use.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Mr. Pi-Shiou Li Management Representive TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang Fu Road San Chung, Taipei, REPUBLIC OF CHINA (TAIWAN) 241

Re: K061800

Trade/Device Name: Clever TD-1112 Ear/Skin/Surface IR Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 22, 2006 Received: June 26, 2006

Dear Mr. Li:

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. Li

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 (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.

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 your 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/industry/support/index.html.

Sincerely yours.

Suptie G. Michael Davis.

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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## Attachment 2

## Indications for Use

510(k) Number: 06 (SDD

Device Name: Clever TD-1112 Ear/Skin/Surface IR Thermometer

Indications for Use:

The Clever TD-1112 ear/skin/surface IR thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _> (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Authin Dint

Anesthesiology, General Hospital, Control Denta

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