(63 days)
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.
The AVITA Radar Thermo NT152 IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT152 IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation 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.
The provided text for K.092955 does not contain detailed information regarding specific acceptance criteria for performance, the design of a study to demonstrate compliance with such criteria, or the results of such a study.
The summary primarily states:
- Conformance to standards: "In terms of operating specification, Safety & EMC performance requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements."
- Bench testing: "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."
- Substantial equivalence to predicate device: The conclusion is that the device is substantially equivalent to the predicate device (K081160) because it has the same intended use and similar technological characteristics, and bench testing shows no new safety or effectiveness concerns.
Without further details, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.
Here's what can be inferred or explicitly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ASTM E1965-98(2003)) | Reported Device Performance |
|---|---|
| Accuracy specifications (e.g., maximum error) | Conforms to ASTM E1965-98(2003) |
| Operating specifications | Conforms to applicable standards |
| Safety & EMC performance requirements | Conforms to applicable standards: IEC 60601-1 and IEC 60601-1-2 |
Note: The specific numerical acceptance criteria (e.g., accuracy bounds) from ASTM E1965-98(2003) are not provided in this summary. The summary only states conformance to the standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified. The summary mentions "bench testing" but does not detail the test set size, data provenance, or study type (retrospective/prospective clinical data vs. purely lab-based testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as a clinical study with human ground truth establishment is not described. The testing appears to be based on engineering and performance standards (bench testing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical study with human expert adjudication is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone infrared thermometer, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation appears to be of the standalone device, as it is a medical device (thermometer) that performs its function without a human interpretation loop in the way AI algorithms are typically evaluated. The "bench testing" assesses the device's inherent performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For bench testing against ASTM E1965-98(2003), the ground truth would typically be a reference temperature measured by a highly accurate, calibrated reference thermometer according to the specified test methodology within the standard. It's not based on expert clinical consensus, pathology, or outcomes data in the traditional sense.
8. The sample size for the training set
Not applicable. This device is an infrared thermometer, not an AI/machine learning model that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 CorporationAddress: 9F, No. 78, SEC. 1, Kwang-Fu Rd., San-Chung, TaipeiCounty., 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,Model no.: NT 152 |
| Common Name: | IR Thermometer |
| Classification name | thermometer, electronic, clinical |
| 3. DEVICE CLASS | The AVITA Radar Thermo IR Thermometer (Model no.NT 152) has been classified asRegulatory Class: IIPanel: 80Product Code: FLLRegulation Number: 21CFR 880.2910 |
| 4. Predicate Device: | The predicate device is the AVITA RADAR THERMO IRTHERMOMETER, NT1 SERIES (K081160) marketed byAVITA CORPORATION. |
| 5. Intended Use: | The AVITA Radar Thermo IR Thermometer (Model no.NT 152) is an infrared thermometer intended for theintermittent measurement of human body temperature inpeople of all ages. |
| 6. Device Description: The AVITA Radar Thermo NT152 IR Thermometer is | |
| hand-held and battery-operated, taking skin temperaturemainly in the middle of the forehead. The AVITA RadarThermo NT152 IR Thermometer uses the principle ofsurveying the natural emission of infrared thermal radiation | |
| Product: AVITA Radar Thermo IR Thermometer (Model no. NT 152)Page 1 of 2 Section 4 - 510(k) Summary REV [A] |
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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.
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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.
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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); 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
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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:
§ 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.