AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152

{0}------------------------------------------------ K.092955 ## 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 NOV 2 7 2009 | 1. Submitter's Name: | AVITA Corporation<br>Address: 9F, No. 78, SEC. 1, Kwang-Fu Rd., San-Chung, Taipei<br>County., Taiwan, 241 | |-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone: | +886-2-8512-1568 | | Fax: | +886-2-8512-1347 | | Contact: | Mr. Nelson Lin / R&D Manager | | 2. Device Name : | | | Trade Name: | AVITA Radar Thermo IR Thermometer,<br>Model no.: NT 152 | | Common Name: | IR Thermometer | | Classification name | thermometer, electronic, clinical | | 3. DEVICE CLASS | The AVITA Radar Thermo IR Thermometer (Model no.<br>NT 152) has been classified as<br>Regulatory Class: II<br>Panel: 80<br>Product Code: FLL<br>Regulation Number: 21CFR 880.2910 | | 4. Predicate Device: | The predicate device is the AVITA RADAR THERMO IR<br>THERMOMETER, NT1 SERIES (K081160) marketed by<br>AVITA CORPORATION. | | 5. Intended Use: | The AVITA Radar Thermo IR Thermometer (Model no.<br>NT 152) is an infrared thermometer intended for the<br>intermittent measurement of human body temperature in<br>people of all ages. | | 6. Device Description: The AVITA Radar Thermo NT152 IR Thermometer is | | | | hand-held and battery-operated, taking skin temperature<br>mainly in the middle of the forehead. The AVITA Radar<br>Thermo NT152 IR Thermometer uses the principle of<br>surveying the natural emission of infrared thermal radiation | | Product: AVITA Radar Thermo IR Thermometer (Model no. NT 152)<br>Page 1 of 2 Section 4 - 510(k) Summary REV [A] | | 29 {1}------------------------------------------------ from all objects, including the human body. The AViTA Radar Thermo IR Thermometer (Model no. NT 152) takes the temperature at distance, without any contact with the patient. - In terms of operating specification, Safety & EMC 7. Performance requirements, the device conforms to applicable standards Summary: included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements. ### 8. Conclusions: The AVITA Radar Thermo IR Thermometer (Model no. NT 152) has the same intended use and similar technological characteristics as the AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES (K081160) marketed by AVITA CORPORATION. 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 IR Thermometer (Model no. NT 152) is substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 A ViTA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001 NOV 2 7 2009 Re: K092959 Trade/Device Name: AVITA Radar Thermo IR Thermometer, Model No.: NT 152 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 2, 2009 Received: November 2, 2009 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 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. {3}------------------------------------------------ #### 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH1 /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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Ninfo< Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: AViTA Radar Thermo IR Thermometer, Model no. : NT 152 AVITA Corporation Indications For Use: The AViTA Radar Thermo IR Thermometer (Model no. NT 152) 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 > (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 Antony D. Moore (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: