(30 days)
Not Found
No
The document describes a standard infrared thermometer and does not mention any AI or ML capabilities. The performance studies section indicates equivalence to predicate devices and adherence to a standard for infrared thermometers, further suggesting a lack of advanced AI/ML features.
No
The device is described as an infrared thermometer intended for temperature measurement, not for treating any condition or disease.
Yes
The device is an infrared thermometer used for measuring human body temperature, which is a diagnostic indicator.
No
The device description explicitly states that the Thermofocus devices are "hand-held and battery-operated thermometers" and utilize the principle of surveying "natural emission of infrared thermal radiation," indicating a hardware component for sensing and measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Thermofocus devices measure human body temperature by detecting infrared thermal radiation emitted from the skin surface. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is for the "intermittent measurement of human body temperature," which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the Thermofocus 0800, 0900, 01500, 0700 Series are considered medical devices but not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Thermofocus 0700, 0800, 0900, 01500 series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Product codes
FLL
Device Description
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit.
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices. Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness.
Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
Administrative Information and Device Identification
| Name and address of the manufacturer and
sponsor of the 510(k) submission: | Tecnimed srl,
12 P.le Cocchi,
21040 Vedano Olona (VA) Italy |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Official contact person for all correspondence: | Francesco Bellifemine
E-mail: info@tecnimed.it |
| Date Prepared: | July 17, 2007 |
| Device Name: | Thermofocus 0700 series, Thermofocus
0800 series, Thermofocus 0900 series,
Thermofocus 01500 series. |
| Generic name of the device: | Clinical Electronic Thermometer |
| Classification of new device: | Class II |
| Classification Panel: | General Hospital |
| Product Code and CFR Regulation Number: | FLL and 21 CFR 880.2910 |
| Predicate Device Name and 510(k) Number: | THERMOFOCUS 0800, 0900, 01500 AND 0700
SERIES
K033790 |
Description of Device:
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
1
The modified devices incorporate improvements to the thermometers calibration capability and also include other minor "user-friendly" improvements. Specifically, these modifications include:
Comparison of Device Technological Characteristics to Precedent Device:
| Precedent Models | New Models |
|---|---|
| 20-30 minute time frame for the | |
| device to be stabilized in a new | |
| environment. | The user can choose between three different calibration |
| options depending on the model to lessen the amount of | |
| time for the stabilization of the thermometer. | |
| Backlighting of the display was | |
| not available. | Backlighting of the display is now available. |
| No option to disable the home | |
| button. | In the hospital versions, it is possible to disable the "home" |
| button. | |
| Toggle between settings using 2 | |
| buttons. | Toggle between settings using one button. |
| In the precedent versions, the | |
| display of the model 0700 turned | |
| off after 20 seconds of no use. | |
| While in all the other models the | |
| display remained on. | In the new models, it is possible to choose the display |
| always on or always off when not in use. | |
| It is also possible to set models 0800, 0900 and 01500 so | |
| that the display can turn off after 20 seconds. | |
| Protective cap and memory button | |
| on some models | Protective cap and memory button available on all models. |
Intended Use:
Thermofocus 0700, 0800, 0900, 01500 series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Non-Clinical /Clinical Testing
Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices. Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness.
Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them.
Conclusion:
We have demonstrated that the new Themofocus 0700, 0800, 0900, 01500 series are as safe and effective as our predicate device based on performance testing results as well as the risk analysis supplied with this submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tecnimed S.R.L. C/O Ms. Maria F. Griffin Official Correspondent Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
AUG 3 1 2007
Re: K072108
Trade/Device Name: Thermofocus 0800 Series, Thermofocus 0900 Series, Thermofocus 01500 Series, Thermofocus 0700 Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 31, 2007 Received: August 2, 2007
Dear Ms. Griffin:
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.
3
Page 2 - Ms. Griffin
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 (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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
Page __ 1 __ of __ 1
510(k) Number (if known): Not Assigned as of this time
Device Name: Thermofocus Professional 0800 series, Thermofocus 0900 series, Thermofocus 01500 series, Thermofocus 0700 series
Indications for Use:
Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use_ X (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)
Qurs
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072108