K Number

Device Name

UGFT3; FHT7

Manufacturer

MEDISIM LTD.

Date Cleared

2013-08-28

(126 days)

Product Code

FLL

Regulation Number

880.2910

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K051422, K103839, K090386

Reference Devices

K051422, K103839

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on heat conduction principles and proprietary software algorithms for temperature calculation, with no mention of AI or ML.

Therapeutic

No.
The device is described as a clinical thermometer intended for determining body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

A clinical thermometer that determines body temperature is not considered a diagnostic device. Diagnostic devices are used to identify the nature of a disease or other condition. While a fever can be a symptom of a disease, the thermometer itself only measures temperature and does not diagnose the underlying condition.

SaMD (Software as a Medical Device)

The device description explicitly states it has hardware components, including a thermistor sensor, electronic processing unit, buttons, and an LCD screen, and is made of ABS plastic and silicone rubber. While it mentions modified software algorithms, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 UGFT3 is a clinical thermometer that measures body temperature by sensing heat from the skin surface. It does not analyze samples taken from the body.
Intended Use: The intended use is for the "determination of human's body temperature," which is a direct measurement of a physiological parameter, not an analysis of a biological sample.
Device Description: The description details the technology used to measure heat flow from the skin, not the analysis of biological components.

Therefore, the UGFT3 falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FLL

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

forehead, underarm (axilla), behind the ear (above the PAA (posterior auricular artery))

Indicated Patient Age Range

All age groups

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

Clinical study for behind the ear temperature measurement accuracy validation:

Sample Size: 239 subjects (138 males, 101 females)
Age Range: 0-91 years
Data Source: Clinical study comparing UGFT3 measurements to the Vicks behind ear Thermometer.
Annotation Protocol: Not explicitly stated, but the study evaluated clinical accuracy by comparing to temperature measurements taken using the Vicks behind ear Thermometer to validate the compliance of the behind the ear site. Also tested 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A. Software Validation Tests:

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.
Includes Hardware architecture diagram, General software flowchart, Summary of system requirement specification (SRS), Summary of system test plan (STP), and Device Hazard Analysis.
Key Results: The device software was validated successfully and changes in software are implemented successfully as device is fully functional.

B. Performance testing:

Bench testing according to ASTM E-1112-00:
- Performed on the UGTF3 device.
- Tests performed: Display Temperature Range Test, Lab Accuracy Test, Operating Environment Test, Storage Environment Test, Drop Test.
- Key Results: The device passed all bench tests successfully as it withstands acceptance criteria for each and every bench test performed.
Clinical testing behind the ear temperature measurement accuracy validation through a clinical study according to ISO80601-2-56:
- Study Type: Clinical study.
- Sample Size: Total subjects were 239 (138 males and 101 females), within ages range of 0-91 years. Subjects with and without fever were included.
- Primary Objective: To demonstrate the effectiveness of the new device UGFT3 for measurements behind the ear by comparing to temperature measurements taken using the Vicks behind ear Thermometer.
- Secondary Objective: 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.
- Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051422, K103839, K090386

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

4. Description of the new device:

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

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
Technological
Characteristics		Forehead/Underarm
Thermometer cleared
under K051422	Gentle Touch
Thermometer
cleared under
K103839	K090386
Product Code /
Class	FLL / II	FLL / II	FLL / II	FLL / II
Indications	A non-sterile, reusable
clinical thermometer
intended for the
determination of
human's body
temperature using the
forehead and/or axilla
and/or behind the ear
sites as measurement
sites.	A non-sterile, reusable
clinical thermometer
intended for the
determination of
human's body
temperature using the
forehead and/or axilla as
measurement sites.	A non-sterile,
reusable clinical
thermometer
intended for the
determination of
human's body
temperature using
behind the ear as
measurement site.	The NIR is non
sterile non-invasive
infrared
thermometer
intended for the
intermittent
calculation of
human body
temperature of
people of all ages
for home and
professional
use.
Population	All age groups	All age groups	All age groups	All age groups
Operational Modes
(Measurement
Sites)	Forehead
Axilla
Behind the ear- above
the PAA (posterior
auricular artery).	Forehead
Axilla	Behind the ear	Forehead
Thermometer Type	Clinical Electronic	Clinical Electronic	Clinical Electronic	Clinical Electronic
Intended Use and
Technological
Characteristics	UGFT3	Dual Mode Up Grade
Forehead/Underarm
Thermometer cleared
under K051422	Vicks Behind Ear
Gentle Touch
Thermometer
cleared under
K103839	NIR Thermometer
K090386
Principle of
Operation	Thermometer
Predictive
Thermometer	Thermometer
Predictive Thermometer	Thermometer
Predictive
Thermometer	Thermometer
Infra Red
Thermometer
Labeling	Instructions For Use	Instructions For Use	Instructions For
Use	Instructions For Use
Major Components	Main (Control &
Processing) Unit
including display, and
Probe Tip	Main (Control &
Processing) Unit,
including display, and
Probe Tip	Main (Control &
Processing) Unit,
including display,
and Probe Tip	Main (Control &
Processing) Unit
including display,
and Probe housing
Sensor	Thermistor	Thermistor	Thermistor	Thermopile
Display	LCD (20 mm x 19.6
mm)	LCD (20 mm x 19.6
mm)	LCD (20.4mm x
20.4 mm)	LCD (20 mm x 19.6
mm)
Power
Requirements	2 x 1.5V AAA
Batteries	2 x 1.5V AAA Batteries	1 x CR2032 (3V
lithium battery)	3x1.5V AAA
Batteries
Patient Contact
Materials	Case - ABS Plastic
Probe Tip - Stainless
Steel , ABS plastic
and silicon rubber	Case - ABS Plastic
Probe Tip - Stainless
Steel , ABS plastic and
silicon rubber	Case - ABS
Plastic, rubber	ABS plastics
Clinical
Measurement
Display	Temperature	Temperature	Temperature	Temperature
Units of
Measurement	°C, °F	°C, °F	°C, °F	°C, °F
Clinical
Measurement
Range	35.0°C to 42.0°C
95.5°F to 107.6°F	35.0°C to 42.0°C
95.5°F to 107.6°F	35.5°C to 42.0°C
95.9°F to 107.6°F	22.0°C to 40.0
°C (71.6°F to
104.0°F)
Ambient
Temperature for
measurement	16°C to 40°C
60.8°F to 104.0°F	16°C to 40°C
60.8°F to 104.0°F	10°C to 40°C
50°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 and
Technological
Characteristics	UGFT3	Dual Mode Up Grade
Forehead/Underarm
Thermometer cleared
under K051422	Vicks Behind Ear
Gentle Touch
Thermometer
cleared under
K103839	NIR Thermometer
K090386
	condensing	condensing	non-condensing	non-condensing
Medication Timer
Reminder with
alert (MTR)	Timer to alert the
patient when to take
next dosage	None	None	Timer to alert the
patient when to take
next dosage
Technical
Accuracy	ASTM E1112-00	ASTM E1112-00	ASTM E1112-00
ASTM E1965-98	ASTM E1112-00
ASTM E1965-98
Response Time	6-8 seconds	6-8 seconds	1 second	2 seconds
Activation	Automatic body
detection	Automatic body
detection	Manually	Automatic body
detection
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 (including
batteries)	44gr	44gr	76gr	70gr

6. Comparison to the predicate devices:

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; .

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

· 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.

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.

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is 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 its wings spread. The eagle is facing to the right.

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.

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

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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