U-RIGHT TD-1240 THERMOMETER

K113159 · Taidoc Technology Corporation · FLL · Jan 6, 2012 · General Hospital

Device Facts

• Record ID: K113159
• Device Name: U-RIGHT TD-1240 THERMOMETER
• Applicant: Taidoc Technology Corporation
• Product Code: FLL · General Hospital
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

U-RIGHT TD-1240 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature 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

U-RIGHT TD-1240 is an infrared electronic thermometer for home use. Device detects infrared radiation emitted from human skin or object surfaces; converts radiation into temperature value. Operated by patient or caregiver; provides digital temperature readout. Modifications from predicate include physical appearance, user interface, increased memory capacity, and removal of data transmission function. Device provides non-invasive temperature monitoring to assist in health assessment.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including system accuracy performance comparisons and software verification/validation against the predicate device.

Technological Characteristics

Infrared sensor technology; electronic thermometer. Measures infrared energy emitted from skin/surfaces. Features increased memory storage compared to predicate. No specific materials or connectivity standards provided.

Indications for Use

Indicated for detection of human body temperature in patients of all ages in a home-use setting. Also indicated for detection of object surface temperature, including human skin.

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

• FORA ComfortScan Ear Thermometer, model TD-1261 (K081445)

Submission Summary (Full Text)

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K113159

JAN - 6 2012

# Section 11. 510(k) Summary

### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

- l. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondence: Linda Ko Regulatory Affairs Specialist Tel: [phone] #1158 Fax: [phone] Email: [e-mail]

Date of submission: October 20, 2011

- 2. Device name:
Proprietary name: U-RIGHT TD-1240 Thermometer

Regulatory information:

- Regulation section: 21 CFR 880.2910 A.
- Classification: Class II B.
- C. Product Code: FLL, Clinical electronic thermometer
- D. Panel: General Hospital (80)

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### 3. Intended Use:

. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

U-RIGHT TD-1240 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

#### 4. Device Description:

U-RIGHT TD-1240 Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

Substantial Equivalence Information:

A. Predicate device name:

FORA ComfortScan Ear Thermometer, model TD-1261

Predicate K number: K081445 B.

#### Comparison with predicate: C.

The modified U-RIGHT TD-1240 Thermometer has the following similarities to the predicate device:

- same operating principle,
- B same fundamental scientific technology,
- . incorporate the same basic circuit design,
- I incorporate the same materials,
- l same shelf life
- packaged using the same materials, and
- . manufactured by the same process.

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The modifications encompass:

- B modification in the physical appearance
- a modification in the user interface
- 1 increased memory storage capacity
- 이 removed the data transmission function
- . labeling change due to the modifications
- 5. Test Principle:

The thermometer measures temperature by reading infrared radiation emitting from the skin and converts it into a temperature value.

- 6. Performance Characteristics:
U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (cleared under K081445) are substantially equivalent.

Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the U-RIGHT TD-1240 Thermometer are equivalent to the predicate device.

- 7. Conclusion:
Based on the information provided in this submission, the U-RIGHT 1240 Thermometer is substantially equivalent to the predicate Fora ComfortScan Ear Thermometer, model TD-1261.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

JAN - 6 2012

Ms. Linda Ko Regulatory Affairs Specialist TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Road Wugu District New Taipei City CHINA 24888

Re: K113159

Trade/Device Name: U-RIGHT TD-1240 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 20, 2011 Received: December 21, 2011

Dear Ms. Ko:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 -- Ms. Ko

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Section 8. Indications for Use

# Indications for Use

510(k) Number:

Device Name: U-RIGHT TD-1240 Thermometer

Indications for Use:

U-RIGHT TD-1240 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature 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 _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation (ODE) 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Ald C. Chypman 1/3/2012
(Division Sign-Uff)

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K113159

A/P 1-5-12

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