FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B

K081445 · Taidoc Technology Corporation · FLL · Aug 11, 2008 · General Hospital

Device Facts

• Record ID: K081445
• Device Name: FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B
• Applicant: Taidoc Technology Corporation
• Product Code: FLL · General Hospital
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal in the home. It is also available to detect object's surface temperature including human skin temperature.

Device Story

Infrared thermometer for ear canal body temperature measurement and object/skin surface temperature detection; utilizes infrared sensor to detect energy emitted from eardrum, surrounding tissues, or object surfaces; intended for home use by patients of all ages; provides digital temperature output; assists users in monitoring body temperature; supports clinical decision-making regarding fever management.

Clinical Evidence

Clinical and non-clinical studies conducted to validate effectiveness. Results demonstrated compliance with ASTM E1965-98, IEC 60601-1, and IEC 60601-1-2. Clinical results showed differences within clinical acceptability; repeatability was statistically and clinically acceptable.

Technological Characteristics

Infrared sensor technology; handheld form factor; intended for home use. Complies with ASTM E1965-98, IEC 60601-1, and IEC 60601-1-2 standards.

Indications for Use

Indicated for people of all ages for the measurement of human body temperature via the ear canal in a home setting. Also indicated for measuring object and skin surface temperatures.

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

• Clever TD-1112 Ear/Skin/Surface IR Thermometer (K061800)

Submission Summary (Full Text)

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K081445

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# 510 (k) Summary

| | AUG 11 2008 | Page 1-of-2 |
|--------------------------|---------------------------------------------------------------------------------|-------------|
| 1. Submitter Information | | |
| Company name | TaiDoc Technology Corporation | |
| Contact person | Yuhua Chen | |
| Address | 6F, No.127, Wugong 2nd Rd.,<br>Wugu Township, Taipei County,<br>248, Taiwan | |
| Phone | (886-2) 6625-8188 | |
| FAX | (886-2) 6625-0288 | |
| E-mail | [e-mail] | |
| 2. Name of Device | | |
| Trade Names | - Fora ComfortScan Ear<br>Thermometer | |
| Common Names | - Clinical electronic thermometer | |
| Classification Names | - Class II devices<br>- 21 CFR 880.2910, FLL-clinical electronic<br>thermometer | |
| 3. Predicate Device | | |
| Trade/Proprietary Name: | Clever TD-1112 Ear/Skin/Surface IR<br>Thermometer | |
| Common/Usual Name: | - Clinical electronic thermometer | |
| Manufacturer | TaiDoc Technology Corporation | |
| 510 (k) Number | K061800 | |

. .

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K081445

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#### 4. Device Description

The Fora ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

#### 5. Intended Use

The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal in the home. It is also available to detect object's surface temperature including human skin temperature.

### 6. Comparison to Predicate Device

Fora ComfortScan Ear Thermometer has equivalent technological characteristics and intended use as the Clever TD-1112 Ear/Skin/Surface IR Thermometer (K061800).

#### 7. Performance Studies

The clinical and non-clinical studies were conducted to validate the effectiveness of use. The results were compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements. For clinical results, differences were within clinical acceptability and repeatability was statistically and clinically acceptable.

## 8. Conclusion

Fora ComfortScan Ear Thermometer demonstrates satisfactory performance and are suitable for their intended use.

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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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2008

Mr. Yuhua Chen Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County 248, TAIWAN

Re: K081445

Trade/Device Name: Fora ComfortScan Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 19, 2008 Received: May 22, 2008

Dear Mr. Chen:

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. Chen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

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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#### Indications for Use

510(k) Number:

Device Name: Fora ComfortScan Ear Thermometer

Indications for Use:

The Fora ComfortScan Ear 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 (21 CFR Part 801 Subpart D) And/Or Over the Counter Use __ X . (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Liana-Ai for ADW

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Kostinat 510(k) Number:

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