AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES

K081160 · Avita Corporation · FLL · Jun 24, 2008 · General Hospital

Device Facts

• Record ID: K081160
• Device Name: AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
• Applicant: Avita Corporation
• Product Code: FLL · General Hospital
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

AViTA Radar Thermo NT1 Series IR Forehead Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.

Device Story

Hand-held, battery-operated infrared thermometer; measures human body temperature via natural infrared thermal radiation emitted from forehead skin. Features IR Emitter/Detector Operation Distance Detecting System for non-contact measurement. Used for intermittent temperature monitoring in all ages. Provides digital temperature output to user. Intended for over-the-counter use.

Clinical Evidence

Bench testing only. Device conforms to ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Hand-held, battery-operated IR thermometer. Sensing principle: IR thermal radiation detection. Includes IR Emitter/Detector distance sensing system. Conforms to ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for intermittent measurement of human body temperature in people of all ages.

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

• Thermofocus 01500 Series Thermometer (K033790)

Submission Summary (Full Text)

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## 510(K) SUMMARY

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

JUN 2 4 2008 1. Submitter's Name: AViTA Corporation Address: 9F , No. 78 , SEC. 1 , Kwang-Fu Rd., San-Chung, Taipei County., Taiwan , 241 [phone] Phone: Fax: [phone] Contact: Mr. Nelson Lin / R&D Manager 2. Device Name : Trade Name: AVITA Radar Thermo IR Thermometer, Model no .: NT1 Series Common Name: IR Thermometer Classification name thermometer, electronic, clinical 3. DEVICE CLASS The AViTA Radar Thermo IR Thermometer, (Model no .: NT1 Series) has been classified as Regulatory Class: II Panel: 80 Product Code: FLL Regulation Number: 21CFR 880.2910 4. Predicate Device: The predicate device is the Thermofocus 01500 Series Thermometer (K033790) marketed by TECNIMED S,R.L.. 5. Intended Use: AViTA Radar Thermo NT1 Series IR Forehead Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages. 6. Device Description: AViTA Radar Thermo NT1 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AViTA Radar Thermo NT1 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Product: AViTA Radar Thermo NT1 Series IR Thermometer

Section 4 - 510(k) Summary Page 1 of 2 REV. [A]

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Making use of an IR Emitter/Deector Operation Distance Detecting System, the AViTA Radar Thermo NT1 Series IR Thermometer takes the temperature at distance. without any contact with the patient.

- 7. Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements.
## 8. Conclusions:

The AVITA Radar Thermo NT1 Series IR Forehead Thermometer has the same intended use and similar technological characteristics as the Thermofocus 01500 Series Thermometer (K033790)marketed by TECNIMED S,R.L. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The AVITA Radar Thermo NT1 Series IR Forehead Thermometer is substantially equivalent to the predicate devices.

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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 consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2008

AVITA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001

Re: K081160

Trade/Device Name: AVITA Radar Thermo IR Thermometer Model no .: NT1 Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 15, 2008 Received: April 23, 2008

Dear Ms. Reich:

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 - Ms. Reich

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/dsma/dsmamain.html

Sincerely yours,

Susan Bonner

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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AViTA Radar Thermo IR Thermometer, Model no .: NT1 Series AVITA Corporation

Indications For Use:

The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Cunther Veen

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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