(68 days)
The AVITA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages in the home.
The AViTA Scanéo TS2x/TS3x series IR Thermometer is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature.
The AVITA TS2x series IR Ear Thermometer measures human body temperature natural thermal emitted from the ear tympanic.
The AViTA TS3x series IR Ear / Forehead Thermometer can measure human body temperature in 2 ways:
(1) The temporal artery over forehead.
(2) Tympanic temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.
Here's an analysis of the provided text regarding the AViTA Scanéo IR Thermometer's acceptance criteria and study, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for temperature accuracy or other performance metrics. Instead, it refers to conformance to established standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ASTM E1965-98(2003) | Conforms |
| IEC 60601-1 (Safety) | Conforms |
| IEC 60601-1-2 (EMC) | Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical or performance test set. It mentions "bench testing" but provides no details on the number of subjects or measurements. There is no information regarding the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The approval is based on conformance to standards and substantial equivalence to a predicate device, rather than a study involving expert-established ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there's no described clinical test set with human ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device is an infrared thermometer, which typically does not involve human readers interpreting results in the same way an imaging AI would.
6. Standalone Performance Study
A standalone performance study was done in the sense that the device was tested to conform to the specified standards (ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2) through "bench testing." However, the specific results of these tests (e.g., exact accuracy values, repeatability, etc.) are not provided in this summary. The summary only states that the device "conforms to applicable standards."
7. Type of Ground Truth Used
For the non-clinical performance (conformance to ASTM, IEC standards), the ground truth would be the defined specifications and measurement methods within those standards. For example, ASTM E1965-98(2003) sets out specific methods for evaluating the accuracy of infrared thermometers against a traceable reference.
8. Sample Size for the Training Set
This device is not an AI/ML device in the context that would typically require a "training set" for an algorithm. It is a traditional hardware device for temperature measurement. Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set Was Established
As above, no training set is applicable for this type of device.
Summary of Key Gaps in Information for an AI/ML Device Context:
From the perspective of evaluating an AI/ML medical device, the provided 510(k) summary is significantly lacking in the details you've requested. This is primarily because the device (an infrared thermometer) is a traditional medical device, not an AI/ML-driven diagnostic or interpretative system. Therefore, concepts like "training set," "test set" with expert ground truth, "adjudication," and "MRMC studies" are generally not applicable to its regulatory submission. Its performance is demonstrated through conformance to established engineering and performance standards rather than clinical studies with human expert interpretation.
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510(K) SUMMARY
DEC - 2 2009
1492958
This summary of 510(k) safety and effectiveness information is being submitted in )ccordance with the requirements of SMDA and 21 CFR §807.92
1. Submitter's Name: AViTA Corporation
9F , No. 78 , SEC. 1 , Kwang-Fu Rd., San-Chung, Taipei Address: County., Taiwan , 241 Phone: +886-2-8512-1568 Fax: +886-2-8512-1347 i Contact: Mr. Nelson Lin / R&D Manager
2. Device Name :
| Trade Name: | AVITA Scanéo IR Thermometer |
|---|---|
| Model no.: TS2x/TS3x series | |
| Common Name: | IR Thermometer |
| Classification name | thermometer, electronic, clinical |
- The AViTA Scanéo IR Thermometer (Model no. 3. DEVICE CLASS TS2x/TS3x 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 AViTA TS8/TS9 series Scanéo IR Ear/Forehead Thermometer (K031503) marketed by AVITA CORPORATION.
5. Intended Use: The AViTA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.
6. Device Description: The AViTA Scanéo TS2x/TS3x series IR Thermometer is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature.
The AVITA TS2x series IR Ear Thermometer measures
Product: AVITA Scanéo IR Thermometer (Model no. TS2x/TS3x series) Page 1 of 2 Section 4 - 510(k) Summarv RFV TRI
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human body temperature natural thermal emitted from the ear tympanic.
The AViTA TS3x series IR Ear / Forehead Thermometer can measure human body temperature in 2 ways:
(1) The temporal artery over forehead.
(2) Tympanic temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.
7. Performance Summary:
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements. /
Conclusions: 8.
The AVITA Scanéo IR Thermometer (Model no. TS2x/TS3x series) has the same intended use and similar technological characteristics as the AVITA TS8/TS9 series Scanéo IR Ear/Forehead Thermometer (K031503) 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 AVTA Scanéo IR Thermometer (Model no. TS2x/TS3x series) is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, which is a common emblem associated with health and medical services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
AVITA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001
DEC - 2 2009
Re: K092958
Trade/Device Name: AViTA Sanéo IR Thermometer, Model no .: TS2x/TS3x Series A ViTA Corporation Regulation Number: 21CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 29, 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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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/CDRH/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susa Runner
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): K092958
Device Name: AViTA Sanéo IR Thermometer, Model no .: TS2x/TS3x series AViTA Corporation
Indications For Use:
The AVITA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages in the home.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
. V 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)
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510(k) Number: K092958
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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.