(62 days)
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
AViTA Radar Thermo NT1 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AViTA Radar Thermo NT1 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Making use of an IR Emitter/Deector Operation Distance Detecting System, the AViTA Radar Thermo NT1 Series IR Thermometer takes the temperature at distance. without any contact with the patient.
The provided text describes a 510(k) summary for the AViTA Radar Thermo IR Thermometer, Model no.: NT1 Series. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study description with sample sizes, expert qualifications, or ground truth establishment.
The document primarily states general conformity to international standards and substantial equivalence to a predicate device based on intended use and technological characteristics.
Here's an attempt to answer your request based only on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance
The submission states that the device conforms to applicable standards. For an infrared thermometer, the key performance acceptance criteria typically relate to accuracy. While the specific numerical acceptance criteria (e.g., maximum allowable error) are not provided in this summary, the relevant standards would define these.
| Acceptance Criteria (Inferred from Standard) | Reported Device Performance |
|---|---|
| Conformance with ASTM E1965-98(2003) | Device conforms |
| Conformance with IEC 60601-1 | Device conforms |
| Conformance with IEC 60601-1-2 | Device conforms |
| Substantial equivalence to predicate device (Thermofocus 01500 Series Thermometer) | Device is substantially equivalent based on intended use and similar technological characteristics. Bench testing demonstrated that technological differences do not raise new questions of safety or effectiveness. |
| Specific Accuracy Metrics (e.g., bias, limits of agreement) | Not reported in this summary. |
| Clinical Performance Metrics | Not reported in this summary. |
Study Details
The document refers to "bench testing" but does not provide specific details about any clinical or performance study that would typically establish the quantitative performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "bench testing contained in this submission." This implies laboratory testing rather than data from human subjects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For a thermometer, "ground truth" might refer to a reference thermometer reading, not an expert assessment.
- Adjudication method for the test set: Not applicable/Not specified. This is typically relevant for studies involving qualitative assessments by multiple experts.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is involved.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone thermometer; its performance would inherently be "standalone." However, specific performance data (e.g., accuracy compared to a reference standard) is not provided in this summary.
- The type of ground truth used: Not explicitly stated, but for a thermometer, the ground truth would typically be temperature readings obtained from a highly accurate reference thermometer (e.g., a laboratory-grade blackbody calibration source or a rectal thermometer for clinical settings, although the document only mentions "bench testing").
- The sample size for the training set: Not applicable/Not specified. The device appears to be a hardware-based infrared thermometer, not a machine learning algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and conformity to general safety and performance standards (ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2). It mentions "bench testing" but does not provide detailed results, specific acceptance criteria beyond standard conformity, or the methodology of the study, including sample sizes, expert involvement, or ground truth establishment in a way that would allow for a comprehensive answer to your questions. The information typically found in a detailed study report (e.g., a clinical study or a detailed bench performance report) is not present in this FDA summary.
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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
JUN 2 4 2008 1. Submitter's Name: AViTA Corporation Address: 9F , No. 78 , SEC. 1 , Kwang-Fu Rd., San-Chung, Taipei County., Taiwan , 241 +886-2-8512-1568 Phone: Fax: 4886-2-8512-1347 Contact: Mr. Nelson Lin / R&D Manager 2. Device Name : Trade Name: AVITA Radar Thermo IR Thermometer, Model no .: NT1 Series Common Name: IR Thermometer Classification name thermometer, electronic, clinical 3. DEVICE CLASS The AViTA Radar Thermo IR Thermometer, (Model no .: NT1 Series) has been classified as Regulatory Class: II Panel: 80 Product Code: FLL Regulation Number: 21CFR 880.2910 4. Predicate Device: The predicate device is the Thermofocus 01500 Series Thermometer (K033790) marketed by TECNIMED S,R.L.. 5. Intended Use: AViTA Radar Thermo NT1 Series IR Forehead Thermometer is an infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages. 6. Device Description: AViTA Radar Thermo NT1 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AViTA Radar Thermo NT1 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Product: AViTA Radar Thermo NT1 Series IR Thermometer
Section 4 - 510(k) Summary Page 1 of 2 REV. [A]
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Making use of an IR Emitter/Deector Operation Distance Detecting System, the AViTA Radar Thermo NT1 Series IR Thermometer takes the temperature at distance. without any contact with the patient.
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- Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
The AVITA Radar Thermo NT1 Series IR Forehead Thermometer has the same intended use and similar technological characteristics as the Thermofocus 01500 Series Thermometer (K033790)marketed by TECNIMED S,R.L. 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 NT1 Series IR Forehead Thermometer is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2008
AVITA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001
Re: K081160
Trade/Device Name: AVITA Radar Thermo IR Thermometer Model no .: NT1 Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 15, 2008 Received: April 23, 2008
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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Bonner
Chiu Lin, Ph.D. 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 .: NT1 Series AVITA Corporation
Indications For Use:
The device 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 V (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
Cunther Veen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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§ 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.