Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.

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.

AI/ML Overview

The provided text describes a 510(k) submission for new models of the Thermofocus infrared thermometer, which are updates to previously cleared devices. It states that "Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices." However, it does mention that "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." It also indicates that "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."

Based on the provided information, a full study (as commonly understood for AI/ML devices) demonstrating device performance against specific acceptance criteria is not detailed because the submission focuses on equivalence to a predicate device and adherence to a recognized standard.

Here's an attempt to fill in the requested information based on the provided text, with explicit notes about what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics from a dedicated study. Instead, it relies on conformance to the ASTM standard and equivalence to predicate devices.

Acceptance Criteria (Inferred from ASTM E1965-98)	Reported Device Performance
Conformance to ASTM E1965-98 Standard	Meets ASTM E1965-98 Standard (as far as applicable)
Device Safety and Effectiveness	Acceptable results from performance tests conducted as part of risk analysis

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not specified. The document states that "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," but the sample size for these tests is not mentioned.
Data Provenance: Not specified. The manufacturer is Tecnimed srl, Italy, which could imply European testing standards, but details are absent.
Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not specified. The device is a thermometer, and "ground truth" for temperature measurement typically refers to calibrated reference thermometers, not expert human assessment in the way it's used for diagnostic imaging.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus for a thermometer's performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study assesses how AI impacts human reader performance, which is not relevant for a standalone temperature measurement device.
Effect Size: Not applicable.

6. Standalone (Algorithm only without Human-in-the-loop performance) Study

Standalone Study Done: Yes, in principle. A thermometer's performance is inherently standalone. The document states, "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." and "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." These statements imply standalone performance evaluations against established standards.

7. Type of Ground Truth Used

Type of Ground Truth: For a thermometer, the "ground truth" would be established by a highly accurate and calibrated reference thermometer. The document implies adherence to the ASTM E1965-98 standard, which would define the methods and reference standards for temperature measurement accuracy. Specific details of the reference thermometer used are not provided in this excerpt.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is an infrared thermometer, not an AI/ML device that requires a "training set" in the computational sense. Its function is based on physical principles of infrared radiation, calibrated during manufacturing, rather than learned from a dataset.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI/ML context for this device. The device is calibrated during manufacturing against physical standards to ensure accurate temperature readings, which is a different process than establishing ground truth for machine learning.

Summary

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K072108

510(k) Summary

Administrative Information and Device Identification

Name and address of the manufacturer andsponsor of the 510(k) submission:	Tecnimed srl,12 P.le Cocchi,21040 Vedano Olona (VA) Italy
Official contact person for all correspondence:	Francesco BellifemineE-mail: info@tecnimed.it
Date Prepared:	July 17, 2007
Device Name:	Thermofocus 0700 series, Thermofocus0800 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 0700SERIESK033790

Description of Device:

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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 thedevice to be stabilized in a newenvironment.	The user can choose between three different calibrationoptions depending on the model to lessen the amount oftime for the stabilization of the thermometer.
Backlighting of the display wasnot available.	Backlighting of the display is now available.
No option to disable the homebutton.	In the hospital versions, it is possible to disable the "home"button.
Toggle between settings using 2buttons.	Toggle between settings using one button.
In the precedent versions, thedisplay of the model 0700 turnedoff after 20 seconds of no use.While in all the other models thedisplay remained on.	In the new models, it is possible to choose the displayalways on or always off when not in use.It is also possible to set models 0800, 0900 and 01500 sothat the display can turn off after 20 seconds.
Protective cap and memory buttonon 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.

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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)

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

Regulation Number and Section

§ 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.