TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

K090564 · Truly Instrument Limited · FLL · Jun 24, 2009 · General Hospital

Device Facts

• Record ID: K090564
• Device Name: TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
• Applicant: Truly Instrument Limited
• Product Code: FLL · General Hospital
• Decision Date: Jun 24, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Truly TET-350 TET-370 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

The Truly Infrared Ear Thermometer (models TET-350, TET-360, TET-370) is a handheld device used to measure body temperature. It utilizes an infrared sensor to detect thermal radiation from the auditory canal. The device is intended for home use by patients or caregivers. It processes the infrared signal to provide a digital temperature reading, which is displayed to the user to assist in monitoring health status. The device operates as a non-invasive clinical thermometer.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared sensor-based clinical electronic thermometer. Handheld form factor. Battery-powered. Intended for auditory canal temperature measurement.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for the measurement of body temperature 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

• Braun IRT 3020

Submission Summary (Full Text)

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K090564

JUN 2 4 2009

## 510(k) Summary

Submitter's Name:

Address:

Truly Intrument Limited Truly Industrial Area .ShanWei City. Guangdong

Province ,China

86-0660-3380070

Telephone:

Fax:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

86-0660-3380377

Establishment Registration#: 3003980573

**Proprietary Name:**

Contact Person:

Model:

Classification Panel:

Common/Usual Name:

Product Code :

Device Classification:

Contraindications:

Predicate Device:

Submitted by:

TRULY Infrared Ear Thermometer TET-350 TET-360 TET-370

General Hospital

Infrared Ear Thermometer

Manager Yang Jian-Hao

Class II

N/A

FLL

Truly Infrared Ear Thermometer TET-350 TET-360 TET-370 is substantially equivalent to Braun IRT 3020,which is sold and in common use in the United States.

Hu Guo-Chung

General Manager

Truly Instrument Limited

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DEPARTMENT OF HEALTH & HUMÁN SERVICES

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Public Health Service

JUN 2 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Truly Instrument, Limited Mr. Yang Jian-Hao Manager R&D Department Truly Industrial Area Shanwei City, Guangdong CHINA 516600

Re: K090564

Trade/Device Name: Truly Infrared Ear Thermometer, Model TET-350, TET-360 and TET-370 Regulation Number: 21 CFR 880.2910

Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 28, 2009 Received: May28, 2009

Dear Mr. Jian-Hao:

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 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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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 clectronic 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner, D.D.S., M

D.S., M.A. Acting 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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## Truly Instrument Limited

Indication for Use

510(k) Number (if known):

Device Name: Truly Infrared Ear Thermometer

Model:TET-350, TET-360, TET-370

Indication For Use:

The Truly TET-350 TET-370 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

OR Over the Counter Use

×

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH

Chach 22

Division Sign-off

510(k) KD90564

HongKong: 2/F, Chung Shun Knitting Centre, 1-3 Wing Yip Street, Kwai Chung, N.T., Hong Kong TEL: [phone] (20 Lines) FAX: [phone] URL: http://www.trulyinstrument.com E-MAIL: [e-mail] China: Truly Industrial Area .ShanWei City. Guangdong Province ,China