(182 days)
The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. In case of difficult to take the temperature on this area it is also possible to take the temperature on the navel 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. Thanks to an exclusive optic aiming system, the peculiarity of Thermofocus thermometers is to take the temperature at distance, without any contact with the patient.
The provided document is a 510(k) summary for the Tecnimed Thermofocus series of infrared thermometers. It describes the device, its intended use, and provides a summary of performance testing.
Here's an analysis of the acceptance criteria and study information contained within:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy tests | Pass | Pass |
| Repetability tests | Pass | Pass |
| °F vs °C tests | Pass | Pass |
| Error messages tests | Pass | Pass |
| Display limits tests | Pass | Pass |
| DFU evaluation | Pass | Pass |
| Current leakage tests | Pass | Pass |
| Variable voltage tests | Pass | Pass |
| EMC tests | Pass | Pass |
| Clinical Performance | Substantial equivalence to predicate (Sensortouch) | Substantial equivalence demonstrated |
Note: The document states "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." This ASTM standard would contain specific quantitative acceptance criteria for parameters like accuracy and repeatability, but these specific values are not explicitly detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The numerous tests conducted in our laboratories and also in hospital and clinics, on several subjects..." but does not specify the exact sample size for subjects or cases used in the clinical performance testing.
- Data Provenance: The tests were conducted in "our laboratories" and "hospital and clinics." This indicates prospective data collection through internal testing and clinical sites. The country of origin for Tecnimed srl is Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical performance testing focused on demonstrating "substantial equivalence between Thermofocus and the predicate Sensortouch," implying a comparison to the predicate device's readings rather than a separate expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device is an infrared thermometer, not an AI-powered diagnostic tool requiring human reader interpretation or improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a standalone thermometer (algorithm-only in its functional sense, as it autonomously measures and displays temperature). The document implicitly describes standalone performance testing as part of the "Summary of non-clinical Performance Testing" (e.g., accuracy, repeatability) and the comparative clinical testing against the predicate.
7. The Type of Ground Truth Used
For the clinical performance testing, the ground truth was based on comparison to a legally marketed predicate device (TemporalScanner thermometer, formerly known as SensorTouch). The study aimed to demonstrate "substantial equivalence" to this predicate. For the non-clinical performance tests (accuracy, repeatability, etc.), the ground truth would typically be established against calibrated reference standards or methods as defined by the ASTM E1965-98 standard, though not explicitly stated here.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Thermofocus is a physical electronic device that measures infrared radiation; it does not explicitly use a "training set" in the machine learning sense to develop an algorithm. Its "algorithm" is likely embedded mathematical adjustments based on physics and sensor readings, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above (no training set in the machine learning context).
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+39 0332 402350 r.a
+39 0332 402347
Tel:
TECNIMED srl
510K THERMOFOCUS 26-11-2003 12:00
UN - 3 7004
Research, development and production of electronic and electromedical equipments 12 p.le Cocchi, I 21040 Vedano O.(Varese) - ITALY - Vat number: IT 00767900129
Image /page/0/Picture/6 description: The image shows the logo for TECNIMED srl. The logo features the word "TECNIMED" in a bold, sans-serif font, with a registered trademark symbol to the right. Behind the word is a stylized atom symbol with six dark spheres connected by elliptical orbits. Below the word "TECNIMED" is the abbreviation "srl" in a smaller, sans-serif font.
510(k) Summary Tecnimed srl Submitter: 12, P.lc Cocchi Address: 21040 Vedano Olona (VA) Italy +39 0332 402350 Phone: Fax: +39 0332 402347 info(@tecnimed.it E-mail: Francesco Bellifemine Contact: October 19th, 2003 Date of Summary: Thermofocus 0800 series, Trade name: Thermofocus (1900 series, Thermofocus 01500 scries, Thermofocus 0700 series. Classification: Class II Panel 80 Medical specialty: General Hospital Procode: FFL -Clinical Electronic Thermometer Regulation number: 880.2910 TemporalScanner thermometer, formerly Predicate Device: known as SensorTouch (K011291) made by Exergen Corporation - Watertown - MA 02172
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| Device Description: | Thermofocus devices belonging to the 0800,0900, 01500, 0700 series are hand-held andbattery-operated, taking skin temperaturemainly in the middle of the forehead. In caseof difficult to take the temperature on thisarea it is also possible to take the temperatureon the navel or under the armpit.The Thermofocus devices use the principleof surveying the natural emission of infraredthermal radiation from all objects, includingthe human body.Thanks to an exclusive optic aiming system,the peculiarity of Thermofocus thermometersis to take the temperature at distance, withoutany contact with the patient. |
|---|---|
| Intended Use: | Thermofocus 0800, 0900, 01500, 0700 seriesare infrared thermometers intended for theintermittent measurement of human bodytemperature in people of all ages. |
| Characteristics: | The Thermofocus thermometers and thepredicate device are used to measure thetemperature of human body by means of athermopile sensor.To show the temperature in the LCD display,both devices make a mathematicaladjustment. Thermopile and thermistorsensors generate two signals that arenecessary to make the mathematicaladjustment.Both devices meet the ASTM E1965-98Standard for Infrared Thermometer forIntermittent Determination of PatientTemperature, as far as this standard appliesto them.SensorTouch is a skin surface contactthermometer, while Thermofocus is a non-contact thermometer detecting bodytemperature at an established distance that isindicated by a led aiming system.Sensor Touch can only display the familiarrectal temperature, while Thermofocus can |
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Summary of non-clinical Performance Testing:
| Performance test | Results |
|---|---|
| Accuracy tests | Pass |
| Repetability tests | Pass |
| °F vs °C tests | Pass |
| Error messages tests | Pass |
| Display limits tests | Pass |
| DFU evaluation | Pass |
| Current leakage tests | Pass |
| Variable voltage tests | Pass |
| EMC tests | Pass |
Summary of clinical Performance Testing: The numerous tests conducted in our laboratories and also in hospital and clinics, on several subjects and at several ambient temperatures, demonstrate a substantial equivalence between Thermofocus and the predicate Sensortouch. Conclusion: Since performance tests are similar, and both thermometers have the same basic characteristics and conform to the same standard, we can conclude that Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are substantially equivalent to the predicate Sensortouch.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
Tecnimed S.R.L. C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K033790
Trade/Device Name: Thermofocus Professional 0800 Series, ade Dovice Namer - Thermofocus 01500 Series, Thermofocus 0700 Series Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 28, 2004 Received: April 29, 2004
Dear Ms. Kotula:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your wetermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinor, of to do rough 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 approvisions of the Act. The general controls provisions of the Act include controls provisions for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it may of casyoo is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Kotula
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DT 3 issuares on that your device complies with other requirements Incall that I DX mas made a dotes and regulations administered by other Federal agencies. of the Act of ally I oderal bates and sequirements, including, but not limited to: registration 1 ou must comply with and the reveling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 087), addity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify in 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) This letter will anow yours began finding of substantial equivalence of your device to a premarket notification. - The PD Fresults 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), If you desire specific at not to: Joins we 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 may overn our gallery gallery, 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,
Ques
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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Indication of Use
510(k) Number (if known): K033790
Device Name: Thermofocus professional...0800 series, Thermofocus 0900 series, Thermofocus 01500 series, Thermofocus 0700 series.
Indications for Use:
Indications for Oss.
The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
TECNIMED Srl - ITALIA
21040 Vedano Olona (VA) - Dłe Cocchi, 12
Tel. 0332.402350 Fax +39.0332.402347
www.tecnimed.com
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Aton b, h
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
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.