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.

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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (from Subject Device)	Reported Device Performance (from Subject Device)
Accuracy (Human Body)	$\pm$ 0.2 °C for 34°C ~ 43 °C	Meets ASTM E1965, ISO 80601-2-56 (Implied that the device performs within this range)
Precision (SD)	<0.6 °C	<0.6 °C
Repeatability	<0.3 °C	<0.3 °C (Meets EN 12470-5)
Operating Temperature Env.	15 °C ~ 35 °C	15 °C ~ 35 °C (Meets ASTM E1965, ISO 80601-2-56)
Measurement Range	1. Human Body(Forehead) : 34°C ~ 43 °C2. Object : 0°C ~ 100°C	1. Human Body(Forehead) : 34°C ~ 43 °C2. Object : 0°C ~ 100°C

2. Sample Size for Test Set and Data Provenance:

The document mentions "Clinical evaluation for accuracy was conducted according to ISO 80601-2-56". However, the specific sample size used for the clinical test set is not explicitly stated in the provided text. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human reader improvement with AI assistance. This device is a thermometer, not an AI-assisted diagnostic tool for image interpretation.

6. Standalone Performance Study:

A standalone performance study was done for the device, as indicated by the "Clinical evaluation for accuracy was conducted according to ISO 80601-2-56 for the AviTA Radar Thermo NT16IR Thermometer." The results of this study are used to demonstrate substantial equivalence to the predicate device.

7. Type of Ground Truth Used:

For the clinical accuracy testing, the ground truth would typically be established by a reference standard thermometer (e.g., a rectal thermometer for core body temperature, or a highly accurate contact thermometer) in a controlled clinical setting, as dictated by standards like ISO 80601-2-56 and ASTM E1965-98 for clinical accuracy of infrared thermometers. The document does not explicitly state the exact method for establishing ground truth, but refers to these standards.

8. Sample Size for the Training Set:

The device is an infrared thermometer and is not described as using machine learning or AI that would typically involve a "training set" in the context of image analysis or similar AI applications. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a traditional "training set" for an AI algorithm, this question is not applicable to the information provided related to this device. The device's operation relies on infrared emission principles and an "algorism," which is likely a fixed mathematical algorithm rather than a machine learning model.

Summary

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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

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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:

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.

SEComparisons	Subject(AVITA Radar Thermo NT16 IRThermometer)	Predicate(AVITA Radar Thermo NT1series 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

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Intended Use	The device is an IRthermometer intended for theintermittent measurement ofhuman body temperature inpeople of all ages.	The device is an IRthermometer intended for theintermittent measurement of humanbody temperature inpeople of all ages.	Same
Operation	Hand held-Manually operated	Hand held-Manually operated	Same
Sensor	Infrared	Infrared	Same
Materials	Common Materials-includingan impact resistant casing.Biocompatible metals andresins.	CommonMaterials-including animpact resistant casing.Biocompatible metals andresins.	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	SimilarMeets ASTME1965, ISO80601-2-56
Precision (SD)	<0.6 °C	<0.6 °C	Same
Repeatability	<0.3 °C	<0.3 °C	Meet EN12470-5
AmbientTemperatureEnvironment	1. Operating : 15 °C ~ 35 °C2. Storage/Transportation :-25°C ~ 55°C	1. Operating : 16°C ~ 35 °C2.Storage/Transportation :-25°C ~ 55 °C	SimilarMeets ASTME1965, ISO80601-2-56
MeasurementRange(DisplayedTemperatureRange)	1. Human Body(Forehead) :34°C ~ 43 °C2. Object : 0°C ~ 100°C	1. HumanBody(Forehead) :10°C ~ 50°C2. 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 temperature2) 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;3) IEC 60601-1 3rd edition: 2005+A1:2012 Medical Electrical Equipment: General requirements for Safety and Essential Performance.4) IEC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for Safety, Electromagnetic Compatibility- Requirements and Tests.5) ISO 14971:2012 Application of Risk Management to Medical Devices6) 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 includes21CFR812, parts 50 and 56)
Resolution	0.1°C(0.1 °F)	0.1°C(0.1 °F)	Same

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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.

Regulation Number and Section

§ 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.