The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead); and/or underarm (axilla); and/or behind the ear as measurement sites.

Device Description

The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and/or underarm and/or behind the ear as measurement sites. The UGFT3 is utilizing the Rapid Accurate Temperature Establishment (R.A.T.E.TM) technology, a technology based on the heat conduction principle, for determination of body temperature. Utilizing the R.A.T.E.TM technology, the device rapidly samples the heat flowing from the blood vessels to the skin surface. Then, based on the heat flow, the device calculates the blood vessel temperature, and then corrects this value to the body core temperature. User operation of the UGFT3 is identical to the operation of the Dual Mode Up Grade Forehead/Underarm Thermometer, cleared under K051422. The device allows user control by use of buttons located on the front panel of the device and the measured body temperature is displayed on an LCD screen, in Co or Fo units. The UGFT3 has an identical hardware as the UGFT2, as it uses the same thermistor sensor and electronic processing unit, however, the UGFT3 has a modified proprietary software algorithms. Device is made of ABS plastic and silicone rubber.

AI/ML Overview

The Medisim UGFT3 thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human body temperature using the forehead, underarm, and/or behind-the-ear as measurement sites. The device utilizes Rapid Accurate Temperature Establishment (R.A.T.E.TM) technology, which is based on the heat conduction principle, to determine body temperature by sampling heat flowing from blood vessels to the skin surface.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on technical accuracy according to ASTM standards and clinical validation for the new "behind the ear" measurement site.

Characteristic	Acceptance Criteria	Reported Device Performance
Technical Accuracy	ASTM E1112-00 (Bench Testing)	The device passed all bench tests successfully and "withstands acceptance criteria for each and every bench test performed" according to ASTM E1112-00. Specific performance metrics (e.g., accuracy range like +/- 0.1°C) are not explicitly detailed in the provided text for this general statement.
Clinical Accuracy (Behind the Ear)	Compliance with ISO80601-2-56 (Clinical Study - comparison to predicate)	The UGFT3 was evaluated in a clinical study against the Vicks Behind Ear Thermometer (predicate, K103839). The study concluded that the "UGFT-3 was found to be as reliable as Vicks Behind the Ear thermometer." No specific numerical accuracy or agreement metrics (e.g., mean difference, confidence intervals) are provided in the summary, but the conclusion implies it met equivalence criteria. Additionally, a secondary objective was to test the similarity between forehead and behind-the-ear measurements taken with the UGFT3. No specific performance results for this secondary objective are detailed.
Software Functionality	Full functionality of the device UGFT3	The software was validated successfully, and changes implemented allow the device to be fully functional.
Safety and Comfort	No discomfort or adverse effects during use.	The UGFT-3 was used safely without causing any discomfort to the patients. There were no observations or reports of adverse effects.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 239 subjects for the clinical study.
Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is implied to be prospective since it's a clinical study conducted for the validation of the new device.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth within the clinical study. The clinical study compares the UGFT3 to a predicate device (Vicks Behind Ear Thermometer), which likely serves as the reference standard. The "ground truth" seems to be generated by a legally marketed and cleared device rather than expert consensus on individual readings.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. Given that the clinical study compares the UGFT3's readings to those of a predicate device, it's implied that the predicate device's reading acts as the reference. There's no mention of multiple readers or an adjudication process for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The clinical study performed was a direct comparison of the UGFT3's temperature readings to those of a predicate thermometer for the behind-the-ear site. There is no mention of evaluating how human readers' performance improves with or without AI assistance, as this is a standalone device validation, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The clinical study was a standalone assessment of the UGFT3's performance (algorithm and hardware). The device takes a measurement and displays a temperature. While human interaction is required to operate the thermometer, the reported "accuracy" pertains to the device's ability to measure temperature correctly, independent of a human's interpretative skill. The study directly compares the UGFT3's output to that of another thermometer, which qualifies as a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison to a legally marketed and cleared predicate device, specifically the Vicks Behind Ear Thermometer cleared under K103839. This serves as a reference standard for clinical accuracy. Further, technical accuracy bench testing used ASTM E-1112-00 as the standard for performance.

8. The Sample Size for the Training Set

The document makes no mention of a "training set" in the context of machine learning or AI models. The UGFT3 uses "modified proprietary software algorithms" based on a heat conduction principle, but it's not described as a machine learning model that requires a labeled training set in the typical sense. The term "training set" is not applicable based on the provided information.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a training set as typically understood in machine learning/AI is not explicitly addressed. The device's "modified proprietary software algorithms" are based on a physical principle (heat conduction). It's likely that these algorithms were developed and refined through engineering, physics modeling, and potentially internal calibration data, rather than a publicly disclosed, labeled "training set" with ground truth in the context of expert annotations or pathology.

Summary

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Kr3155

SECTION 5 - 510(k) SUMMARY UGFT3

Date prepared: 20th of April, 2013

Submitter information:

Medisim Ltd.

G.G Communications Center

Neve Ilan

Israel 90850

Tel: 972-2-5791921

Fax: 972-2-5791926

Contact person: Moshe Yarden

Submission: 7.4.2013

2. Device information:

Trade Name: Up-Grade Forehead/ Underarm/Behind Ear Thermometer, UGFT3, FHT7**

Common name: Electronic Clinical Thermometer

Product code: FLL; Product class: II

Product classification: Clinical electronic thermometer, § 880.2910

Product Panel: 80 General hospital

3. Substantial equivalent:

a. Medisim's Dual Mode Up Grade Forehead/Underarm Thermometer, cleared under K051422

b. Vicks (KAZ) Behind Ear Thermometer, cleared under K103839

c. NIR Thermometer, cleared under K090386

AUG 2 8 2013

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4. Description of the new device:

User operation of the UGFT3 is identical to the operation of the Dual Mode Up Grade Forehead/Underarm Thermometer, cleared under K051422. The device allows user control by use of buttons located on the front panel of the device and the measured body temperature is displayed on an LCD screen, in Co or Fo units. The UGFT3 has an identical hardware as the UGFT2, as it uses the same thermistor sensor and electronic processing unit, however, the UGFT3 has a modified proprietary software algorithms.

Device is made of ABS plastic and silicone rubber

Image /page/1/Picture/4 description: The image shows a digital thermometer. The thermometer has a screen that displays the number 98.6. There are three buttons on the thermometer, one with a power symbol, one with the word "SET", and one with a clock symbol.

5. Intended use of the device

The device indication for use is:

The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead) and/or underarm (axilla) and/or behind the ear as measurement sites.

The UGFT3 is substantially equivalent regarding the intended use to the Dual Mode Up Grade Forehead/Underarm Thermometer cleared under K051422 and the Vicks Behind Ear

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Thermometer cleared under K103839. The UGFT3 and it's predicate devices are intended for use for determination of core -body temperature through measurements taken on the skin above a blood vessel.

The Dual Mode Up Grade Forehead/Underarm Thermometer is intended to measure using the forehead and underarm sites only; the Vicks Behind Ear Thermometer is intended to measure using the behind the ear site only; the new UGFT3 is intended to measure either in the underarm, and/or behind the ear and/or the forehead.

The UGFT3 is substantially equivalent to NIR Thermometer regarding the presence and function of MTR Feature (Medication Timer Reminder).

Intended Use and	UGFT3	Dual Mode Up Grade	Vicks Behind Ear	NIR Thermometer
TechnologicalCharacteristics		Forehead/UnderarmThermometer clearedunder K051422	Gentle TouchThermometercleared underK103839	K090386
Product Code /Class	FLL / II	FLL / II	FLL / II	FLL / II
Indications	A non-sterile, reusableclinical thermometerintended for thedetermination ofhuman's bodytemperature using theforehead and/or axillaand/or behind the earsites as measurementsites.	A non-sterile, reusableclinical thermometerintended for thedetermination ofhuman's bodytemperature using theforehead and/or axilla asmeasurement sites.	A non-sterile,reusable clinicalthermometerintended for thedetermination ofhuman's bodytemperature usingbehind the ear asmeasurement site.	The NIR is nonsterile non-invasiveinfraredthermometerintended for theintermittentcalculation ofhuman bodytemperature ofpeople of all agesfor home andprofessionaluse.
Population	All age groups	All age groups	All age groups	All age groups
Operational Modes(MeasurementSites)	ForeheadAxillaBehind the ear- abovethe PAA (posteriorauricular artery).	ForeheadAxilla	Behind the ear	Forehead
Thermometer Type	Clinical Electronic	Clinical Electronic	Clinical Electronic	Clinical Electronic
Intended Use andTechnologicalCharacteristics	UGFT3	Dual Mode Up GradeForehead/UnderarmThermometer clearedunder K051422	Vicks Behind EarGentle TouchThermometercleared underK103839	NIR ThermometerK090386
Principle ofOperation	ThermometerPredictiveThermometer	ThermometerPredictive Thermometer	ThermometerPredictiveThermometer	ThermometerInfra RedThermometer
Labeling	Instructions For Use	Instructions For Use	Instructions ForUse	Instructions For Use
Major Components	Main (Control &Processing) Unitincluding display, andProbe Tip	Main (Control &Processing) Unit,including display, andProbe Tip	Main (Control &Processing) Unit,including display,and Probe Tip	Main (Control &Processing) Unitincluding display,and Probe housing
Sensor	Thermistor	Thermistor	Thermistor	Thermopile
Display	LCD (20 mm x 19.6mm)	LCD (20 mm x 19.6mm)	LCD (20.4mm x20.4 mm)	LCD (20 mm x 19.6mm)
PowerRequirements	2 x 1.5V AAABatteries	2 x 1.5V AAA Batteries	1 x CR2032 (3Vlithium battery)	3x1.5V AAABatteries
Patient ContactMaterials	Case - ABS PlasticProbe Tip - StainlessSteel , ABS plasticand silicon rubber	Case - ABS PlasticProbe Tip - StainlessSteel , ABS plastic andsilicon rubber	Case - ABSPlastic, rubber	ABS plastics
ClinicalMeasurementDisplay	Temperature	Temperature	Temperature	Temperature
Units ofMeasurement	°C, °F	°C, °F	°C, °F	°C, °F
ClinicalMeasurementRange	35.0°C to 42.0°C95.5°F to 107.6°F	35.0°C to 42.0°C95.5°F to 107.6°F	35.5°C to 42.0°C95.9°F to 107.6°F	22.0°C to 40.0°C (71.6°F to104.0°F)
AmbientTemperature formeasurement	16°C to 40°C60.8°F to 104.0°F	16°C to 40°C60.8°F to 104.0°F	10°C to 40°C50°F to 104.0°F	16.0°C to 40.0°C(60.8 °F to 104 °F)
Environment	15% to 95% RH non-	15% to 95% RH non-	15% to 95% RH	15% to 95% RH
Intended Use andTechnologicalCharacteristics	UGFT3	Dual Mode Up GradeForehead/UnderarmThermometer clearedunder K051422	Vicks Behind EarGentle TouchThermometercleared underK103839	NIR ThermometerK090386
	condensing	condensing	non-condensing	non-condensing
Medication TimerReminder withalert (MTR)	Timer to alert thepatient when to takenext dosage	None	None	Timer to alert thepatient when to takenext dosage
TechnicalAccuracy	ASTM E1112-00	ASTM E1112-00	ASTM E1112-00ASTM E1965-98	ASTM E1112-00ASTM E1965-98
Response Time	6-8 seconds	6-8 seconds	1 second	2 seconds
Activation	Automatic bodydetection	Automatic bodydetection	Manually	Automatic bodydetection
Dimensions	Length: 10.0cm (3.9")Width: 5.2cm (2.05")Depth: 3.2cm (1.25")	Length: 10.0cm (3.9")Width: 5.2cm (2.05")Depth: 3.2cm (1.25")	Length: 14.4cm(6")Width: 4.2cm(1.65")Depth: 2.4cm(0.95")	Length: 10.5cm(4.1")Width: 4.5 cm(1.77")Depth: 3.5 cm(1.37")
Weight (includingbatteries)	44gr	44gr	76gr	70gr

6. Comparison to the predicate devices:

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The differences and similarity between UGTF3 Device and its predicates:

UGTF3 Vs Dual Mode Up Grade Forehead/Underarm:

The devices are similar in:

Similar principal of operation and user interface .
Measuring sites: Forehead/Under arm .

Devices are different:

Additional measurement location for UGFT3: Behind-ear; .

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UGTF3 Vs Vicks Gentle Touch device:

Devices are similar in:

. Measuring location: Behind Ear

Devices are different in:

. Technological principal of operation
. Additional measuring site of the UGFT3: Forehead /under arm

UGTF3 Vs NIR Thermometer:

Devices are similar in:

. MTR- Medication Reminder Timer feature
. Measuring location Forehead

Devices are different in:

Technological principal of operation .
Additional measuring site of the UGFT3: Forehead /under arm .

Essentially, the intended use between the two predicate thermometers, Upgrade dual mode and Vicks gentle touch. are due to the fact that the new UGFT3 device is the only device that is capable of measuring temperature in all three locations.

Comment: The predicate NIR thermometer is presented in this application to demonstrate similarity to the new UGFT3 device MTR (Medication Reminder Timer) feature only. The other characteristics of the NIR thermometer are is irrelevant to the comparison to the UGTF3 and it.

7. Device Testing (Software Validation, Bench and Clinical test)

The new device UGFT3 was tested in order to fully validate its performance under the following tests:

A. Software Validation Tests.
B. Performance testing:
1. Bench testing according to ASTM E-1112-00

Clinical testing behind the ear temperature measurement accuracy validation through a clinical study according to ISO80601-2-56.

A. Software Validation:

The software was validated to assure the full functionality of the device UGFT3.

The software validation protocol and relevant ECO report can be found in section 14 of this submission. The software validation information includes the following:

· Hardware architecture diagram of up-grade forehead thermometer
· General software flowchart of up-grade forehead thermometer

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· Summary of system requirement specification (SRS)
· Summary of system test plan (STP)
· Device Hazard Analysis

The device software was validated successfully and changes in software are implemented successfully as device is fully functional.

B. 1. Behind the ear temperature measurement accuracy validation through Performance of a clinical study:

The primary objective of the study was to demonstrate the effectiveness of the new device UGFT3 (also referred to in the clinical study report as FHT7) for measurements behind the ear. Clinical accuracy of the UGFT3 was evaluated by comparing to temperature measurements taken using the Vicks behind ear Thermometer to validate the compliance of the behind the ear site. The secondary objective was to test,the similarity between temperature measured on the forehead site (above the STA) compared to the temperature measured on the behind the ear site (above the PAA) using the UGFT3.

Total subjects were 239, Subjects were 138 males and 101 females, within ages range of 0-91 years (The full clinical study report is detailed in section 17).

Subjects with and without fever were included in the clinical study, Subjects from all groups were covered.

The UGFT-3 was used safely without causing any discomfort to the patients. There were no observations or reports of adverse effects. The UGFT-3 was found to be as reliable as Vicks Behind the Ear thermometer, cleared under K103839.

B. 2. Bench testing Bench testing was performed in accordance to ASTM E-1112-00 The following tests were performed on the UGTF3 device:

o Display Temperature Range Test

o Lab Accuracy Test

o Operating Environment Test
o Storage Environment Test

o Drop Test

The device passed all bench tests successfully as it withstands acceptance criteria for each and every bench test performed.

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8. Conclusions

The clinical and non-clinical testing, as well as the clinical research and previous testing done on the original device prove that the UGFT3 device is safe and effective as the cleared predicate devices.

The UGFT3 thermometer (K131155) is substantially equivalent to the UGFT2 thermometer , cleared under K051422, in the principal of operations and the measuring sites of forehead and underarm: the UGFT3 was found substantially equivalent to the Vicks thermometer, cleared under K103839 ,in regards of the measuring site - behind ear; and The UGFT3 thermometer is substantially equivalent to the NIR thermometer, cleared under K090386, in regards to the Medication Timer Reminder feature.

Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the UGFT3 Thermometer is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.

**Notes:

Throughout the submission the device is referred to as UGFT3 or FHT7 which is another trade name for the device, used in the device's labeling.
The dual mode upgrade forehead thermometer is referred to as UGFT2/FHT2/FHT5.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

August 28, 2013

Medisim, Limited Mr. Moshe Yarden Quality Assurance Manager G.G Communications Center Neve Ilan JERUSALEM IL 90850

Re: K131155

Trade/Device Name: Up-grade forehead/underarm/behind car thermometer (UGFT3) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 11, 2013 Received: July 18, 2013

Dear Mr. Yarden:

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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Yarden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/9/Picture/7 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The text is black against a white background. The letters are clear and legible, although there is some noise around the letters.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K131155

Device Name : Up-grade forehead/underarm/behind ear thermometer (UGFT3)

Indications For Use:

AND/OR Over-The-Counter Use_ V Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

: :

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Page 1 of 1

Richard C. Chapman 2013.08.28 11:55:47 · -04'00'

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.