AViTA Radar Thermo NT16 Series IR Thermometer

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April 19, 2018 AViTA Corporation Steven Jhou Engineer 9F, No.78, Sec. 1, Kwang-Fu Road, San-Chung District New Taipei City, 24158 TW Re: K172427 Trade/Device Name: AViTA Radar Thermo NT16 Series IR Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 12, 2018 Received: March 22, 2018 Dear Steven Jhou: 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. 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 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {3}------------------------------------------------ ### 510(k) Summary ### K172427 ### 1. Date Prepared: 11/05/2017 - Type of Submission: Traditional 2. ### 3. Submission Correspondent: Submitter's Name: AViTA Corporation Address: 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District, New Taipei City 24158, Taiwan Phone: +886-2-85121568 Fax: +886-2-85121347 Contact: Mr. Steven Jhou / Engineer Establishment Registration Number: 9617543 ### 4. Identification of the Device: Device Classification Name: Thermometer, Electronic, Clinical Device Name: AViTA Radar Thermo NT16 Series IR Thermometer Applicant: AViTA Corporation 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District, New Taipei City 24158, Taiwan Applicant Contact: Mr. Steven Jhou / Engineer Correspondent: Tarpley, Texas, 78883, United States Phone: +830-5623001 Fax: +830-712998 Correspondent Contact: John Belistreri Regulation Number: 880.2910 Classification Product Code: FLL Device Classification: II #### 5. Predicate Device: Predicate Device Name: AVITA Radar Thermo IR Thermometer {4}------------------------------------------------ Model No. NT1 series Manufacturer: AViTA Corporation 510(k) Number or Clearance Information: K081160 #### Intended Use : 6. AViTA Radar Thermo NT16 Series IR Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature from the forehead in people of all ages. # 7. Device Description: AViTA Radar Thermo NT16 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT16 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from the forehead of human body. #### Substantial Equivalent Devices 8. Based on the performance testing and compliance with acceptable voluntary standards, we believe that the AVITA Radar Thermo NT16 IR Thermometer is substantially equivalent to its predicated device (i.e. AVITA Radar Thermo NT1 IR Thermometer). The technology of the AViTA Radar Thermo NT16 IR Thermometer is identical to the predicate device. The key difference is that the NT16 uses a new compensate algorism. | SE<br>Comparisons | Subject<br>(AVITA Radar Thermo NT16 IR<br>Thermometer) | Predicate<br>(AVITA Radar Thermo NT1<br>series IR Thermometer)<br>K081160 | Comment | |-------------------|--------------------------------------------------------|---------------------------------------------------------------------------|---------| | Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same | | Product Code | FLL | FLL | Same | | FDA Class | II | II | Same | Comparison table between test and Predicate Devices {5}------------------------------------------------ | Intended Use | The device is an IR<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature in<br>people of all ages. | The device is an IR<br>thermometer intended for the<br>intermittent measurement of human<br>body temperature in<br>people of all ages. | Same | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Operation | Hand held-Manually operated | Hand held-Manually operated | Same | | Sensor | Infrared | Infrared | Same | | Materials | Common Materials-including<br>an impact resistant casing.<br>Biocompatible metals and<br>resins. | Common<br>Materials-including an<br>impact resistant casing.<br>Biocompatible metals and<br>resins. | Same | | Dimensions | 52.4mm x 44.5mm x 129.9mm | 134.5mm x 85.2mm x 31.7mm | Similar | | Accuracy | Human Body(Forehead)<br>$\pm$ 0.2 °C for 34°C ~ 43 °C | Human Body(Forehead) :<br>$\pm$ 0.3 °C for 10 °C ~ 50 °C | Similar<br>Meets ASTM<br>E1965, ISO<br>80601-2-56 | | Precision (SD) | <0.6 °C | <0.6 °C | Same | | Repeatability | <0.3 °C | <0.3 °C | Meet EN<br>12470-5 | | Ambient<br>Temperature<br>Environment | 1. Operating : 15 °C ~ 35 °C<br>2. Storage/Transportation :<br>-25°C ~ 55°C | 1. Operating : 16°C ~ 35 °C<br>2.<br>Storage/Transportation :<br>-25°C ~ 55 °C | Similar<br>Meets ASTM<br>E1965, ISO<br>80601-2-56 | | Measurement<br>Range(Display<br>ed<br>Temperature<br>Range) | 1. Human Body(Forehead) :<br>34°C ~ 43 °C<br>2. Object : 0°C ~ 100°C | 1. Human<br>Body(Forehead) :<br>10°C ~ 50°C<br>2. Object : 0°C ~ 100 °C | Similar | | Display | LCD | LCD | Similar | | Response Time | 1 sec | 1 sec | Same | | Measurement Site | Forehead | Forehead | Same | | Scale | °F / °C | °F / °C | Same | | Power Supply | 2x1.5V alkaline AAA size batteries (3Vd.c.) | 2x1.5V alkaline AAA size batteries(3Vd.c.) | Same | | Standards Met for Bench and Clinical Performance | 1) ASTM E1965-98:2009 Infrared Thermometers for Intermittent Determination of Patient temperature<br>2) Clinical accuracy test requirements established in the standard ASTM E1965-98 (Clinical part only)- Standard Specification for Infrared Thermometer For Intermittent Determination of Patient Temperature;<br>3) IEC 60601-1 3rd edition: 2005+A1:2012 Medical Electrical Equipment: General requirements for Safety and Essential Performance.<br>4) IEC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for Safety, Electromagnetic Compatibility- Requirements and Tests.<br>5) ISO 14971:2012 Application of Risk Management to Medical Devices<br>6) EN IEC 62304:2006 Medical Devices Software – Software life-cycle processes | Same | All standards verified and validated for test device and met acceptance criteria. | | | Practice (also includes<br>21CFR812, parts 50 and 56) | | | | Resolution | 0.1°C(0.1 °F) | 0.1°C(0.1 °F) | Same | {6}------------------------------------------------ {7}------------------------------------------------ # 9. Non-Clinical Testing The AVITA Radar Thermo NT16 IR Thermometer conforms of the following Performance Standards: - (1) EN 60601-1; - (2) EN 60601-1 -2; - (3) ASTM E 1965-98; - (4) EN 60601-1-11; - (5) EN 62304; - (6) ISO 80601-2-56. # 10. Clinical Testing Clinical evaluation for accuracy was conducted according to ISO 80601-2-56 for the AviTA Radar Thermo NT16IR Thermometer. It demonstrated substantial equivalence to the predicate device currently in commercial distribution in the USA. # 11. Conclusion Based on the nonclinical and clinical tests conducted, the subject device demonstrated that it is as safe, as effective, and performs as well as the legally marked predicate device. Therefore, it is substantially equivalent to the predicate device.