(217 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device is described as a standard infrared thermometer.
No
The device is an infrared thermometer intended for intermittent measurement of human body temperature, which is a diagnostic function, not a therapeutic one.
Yes
The device is an infrared thermometer intended for intermittent measurement of human body temperature, which is a diagnostic activity used to identify fever or other temperature-related health conditions.
No
The device is described as an infrared thermometer, which is a hardware device that measures temperature using infrared radiation. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intermittent measurement of human body temperature". This is a direct measurement of a physiological parameter (temperature) from the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health.
Infrared thermometers measure temperature externally and do not involve the analysis of biological samples.
N/A
Intended Use / Indications for Use
VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
Product codes
FLL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
March 13. 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
C/O Mr. Claude Berthoin President Thema USA 110 East Granada Boulevard, Suite 209 ORMOND BEACH FL 32176
Re: K122412
Tecnimed S.R.L.
Trade/Device Name: VisioFocus Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 8, 2013 Received: February 15, 2013
Dear Mr. Berthoin:
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.
1
Page 2 - Mr. Berthoin
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 devicerelated adverse events) (21 CFR 803); 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.
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/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image contains a stylized drawing with illegible text. The drawing includes a series of vertical lines on the left side, followed by a curved shape and some text in the middle. On the right side, there is a triangular shape with diagonal lines. The overall image appears to be a logo or signature.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
TECNIMED s.r.l.
SPECIAL 510(K) - VISIOFOCUS
Attachment #3
Indications for Use
Applicant: Tecnimed S.r.l.
510(k) Number: Not Assigned at this time
Device Name:
VisioFocus 06400 series; VisioFocus 06450 series; VisioFocus 06480 series; VisioFocus 06490 series.
Indications for Use: VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
Prescription Use And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division Sign-Off Office of Device Evaluation
·
510(k)
and and the same and security of the same and any and the may be and
Image /page/2/Picture/17 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in black and white and features the letters "FDA" in a stylized, outlined font. The letters are bold and slightly slanted to the right.
Richard C. Chapman 2013.03.12 09:32:42 -04'00'
A Book States Company Company Comments of Comments of