(182 days)
Not Found
No
The summary describes a standard infrared thermometer that measures thermal radiation. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on accuracy, repeatability, and equivalence to a predicate device, not on algorithmic performance metrics typically associated with AI/ML.
No
The device is an infrared thermometer used for measuring body temperature, not for treating or preventing a disease or condition.
No
Explanation: The device is an infrared thermometer intended for "intermittent measurement of human body temperature." While temperature can be an indicator of health conditions, the device's stated "Intended Use" is solely for measurement, not for diagnosing a specific disease or condition. Diagnostic devices typically help identify the nature or cause of a disease.
No
The device description explicitly states it is a "hand-held and battery-operated" device that uses an "exclusive optic aiming system" to measure infrared thermal radiation. This indicates it is a hardware device, not software only.
No, 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 series measures human body temperature by detecting infrared thermal radiation emitted from the skin. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
Therefore, based on the provided information, the Thermofocus series is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The Thermofocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (mainly middle of the forehead, potentially navel 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
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)
Non-clinical Performance Testing:
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Pag. 8 of 10
+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
Image /page/0/Picture/9 description: The image shows two logos related to quality management systems. The first logo on the left is "CSQ 9120 LATA". The second logo on the right is the "IQNet" logo with the text "IT-13181" below it. The text above the logos reads "UNI EN ISO 9002 for Medical Devices".
1
| Device Description: | 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. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Thermofocus 0800, 0900, 01500, 0700 series
are infrared thermometers intended for the
intermittent measurement of human body
temperature in people of all ages. |
| Characteristics: | The Thermofocus thermometers and the
predicate device are used to measure the
temperature of human body by means of a
thermopile sensor.
To show the temperature in the LCD display,
both devices make a mathematical
adjustment. Thermopile and thermistor
sensors generate two signals that are
necessary to make the mathematical
adjustment.
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.
SensorTouch is a skin surface contact
thermometer, while Thermofocus is a non-
contact thermometer detecting body
temperature at an established distance that is
indicated by a led aiming system.
Sensor Touch can only display the familiar
rectal temperature, while Thermofocus can |
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wings.
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.
4
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
5
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
Over-the-Counter
Prescription
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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: