(252 days)
No
The description focuses on standard infrared thermometry principles and does not mention any AI or ML components.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is an infrared thermometer intended for the measurement of human body temperature, which is a diagnostic function, not a therapeutic one.
No.
The device is used for temperature measurement, which is a physiological parameter, not for diagnosing a disease or condition.
No
The device description explicitly states it is a hand-held, battery-operated infrared thermometer, indicating it is a hardware device that measures infrared radiation.
Based on the provided information, the AViTA Radar Thermo NT16 Series IR Thermometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AViTA Radar Thermo NT16 Series IR Thermometer measures human body temperature from the forehead using infrared radiation. This is a non-invasive measurement taken directly from the body surface.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient.
Therefore, since the device measures a physiological parameter directly from the body and does not involve the analysis of in vitro samples, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Accuracy: Human Body(Forehead) ± 0.2 °C for 34°C ~ 43 °C
Precision (SD):
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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);
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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
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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
Comparisons | Subject
(AVITA Radar Thermo NT16 IR
Thermometer) | Predicate
(AVITA Radar Thermo NT1
series IR Thermometer)
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
thermometer intended for the
intermittent measurement of
human body temperature in
people of all ages. | The device is an IR
thermometer intended for the
intermittent measurement of human
body temperature in
people of all ages. | Same |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Operation | Hand held-Manually operated | Hand held-Manually operated | Same |
| Sensor | Infrared | Infrared | Same |
| Materials | Common Materials-including
an impact resistant casing.
Biocompatible metals and
resins. | Common
Materials-including an
impact resistant casing.
Biocompatible metals and
resins. | Same |
| Dimensions | 52.4mm x 44.5mm x 129.9mm | 134.5mm x 85.2mm x 31.7mm | Similar |
| Accuracy | Human Body(Forehead)
$\pm$ 0.2 °C for 34°C ~ 43 °C | Human Body(Forehead) :
$\pm$ 0.3 °C for 10 °C ~ 50 °C | Similar
Meets ASTM
E1965, ISO
80601-2-56 |
| Precision (SD) |