THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

K033790 · Tecnimed S.R.L. · FLL · Jun 3, 2004 · General Hospital

Device Facts

• Record ID: K033790
• Device Name: THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
• Applicant: Tecnimed S.R.L.
• Product Code: FLL · General Hospital
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Hand-held, battery-operated infrared thermometers; measure natural thermal radiation emitted from human skin. Primary measurement site is middle of forehead; secondary sites include navel or underarm. Features exclusive optic aiming system for non-contact distance measurement. Device uses thermopile and thermistor sensors to generate signals; internal processor performs mathematical adjustments to calculate body temperature. Output displayed on LCD. Used in clinical or home settings by clinicians or patients. Non-contact operation eliminates need for physical contact with patient, reducing cross-contamination risk.

Clinical Evidence

Bench testing included accuracy, repeatability, °F/°C conversion, error messaging, display limits, DFU evaluation, current leakage, variable voltage, and EMC testing. Clinical performance was evaluated in hospital and clinic settings across various subjects and ambient temperatures. All tests passed, demonstrating substantial equivalence to the predicate.

Technological Characteristics

Hand-held, battery-operated infrared thermometer. Sensing principle: thermopile sensor detecting natural infrared thermal radiation. Includes thermistor for ambient compensation. Features LED-based optic aiming system for distance control. Conforms to ASTM E1965-98. Digital LCD display. No wireless connectivity mentioned.

Indications for Use

Indicated for intermittent measurement of human body temperature in patients of all ages.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• TemporalScanner thermometer (SensorTouch) (K011291)

Submission Summary (Full Text)

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K033790

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[e-mail]

: www.tecnimed.it

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### 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 [phone] Phone: Fax: [phone] 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,<br>0900, 01500, 0700 series are hand-held and<br>battery-operated, taking skin temperature<br>mainly in the middle of the forehead. In case<br>of difficult to take the temperature on this<br>area it is also possible to take the temperature<br>on the navel or under the armpit.<br>The Thermofocus devices use the principle<br>of surveying the natural emission of infrared<br>thermal radiation from all objects, including<br>the human body.<br>Thanks to an exclusive optic aiming system,<br>the peculiarity of Thermofocus thermometers<br>is to take the temperature at distance, without<br>any contact with the patient. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Thermofocus 0800, 0900, 01500, 0700 series<br>are infrared thermometers intended for the<br>intermittent measurement of human body<br>temperature in people of all ages. |
| Characteristics: | The Thermofocus thermometers and the<br>predicate device are used to measure the<br>temperature of human body by means of a<br>thermopile sensor.<br>To show the temperature in the LCD display,<br>both devices make a mathematical<br>adjustment. Thermopile and thermistor<br>sensors generate two signals that are<br>necessary to make the mathematical<br>adjustment.<br>Both devices meet the ASTM E1965-98<br>Standard for Infrared Thermometer for<br>Intermittent Determination of Patient<br>Temperature, as far as this standard applies<br>to them.<br>SensorTouch is a skin surface contact<br>thermometer, while Thermofocus is a non-<br>contact thermometer detecting body<br>temperature at an established distance that is<br>indicated by a led aiming system.<br>Sensor Touch can only display the familiar<br>rectal 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 [phone]. 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 [phone] or [phone] 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. [phone] Fax [phone]
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: