UGFT3; FHT7

{0}------------------------------------------------ Kr3155 # SECTION 5 - 510(k) SUMMARY UGFT3 Date prepared: 20th of April, 2013 1. Submitter information: Medisim Ltd. r 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** {1}------------------------------------------------ #### 4. Description of the new device: 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 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 {2}------------------------------------------------ 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<br>Characteristics | | Forehead/Underarm<br>Thermometer cleared<br>under K051422 | Gentle Touch<br>Thermometer<br>cleared under<br>K103839 | K090386 | | Product Code /<br>Class | FLL / II | FLL / II | FLL / II | FLL / II | | Indications | A non-sterile, reusable<br>clinical thermometer<br>intended for the<br>determination of<br>human's body<br>temperature using the<br>forehead and/or axilla<br>and/or behind the ear<br>sites as measurement<br>sites. | A non-sterile, reusable<br>clinical thermometer<br>intended for the<br>determination of<br>human's body<br>temperature using the<br>forehead and/or axilla as<br>measurement sites. | A non-sterile,<br>reusable clinical<br>thermometer<br>intended for the<br>determination of<br>human's body<br>temperature using<br>behind the ear as<br>measurement site. | The NIR is non<br>sterile non-invasive<br>infrared<br>thermometer<br>intended for the<br>intermittent<br>calculation of<br>human body<br>temperature of<br>people of all ages<br>for home and<br>professional<br>use. | | Population | All age groups | All age groups | All age groups | All age groups | | Operational Modes<br>(Measurement<br>Sites) | Forehead<br>Axilla<br>Behind the ear- above<br>the PAA (posterior<br>auricular artery). | Forehead<br>Axilla | Behind the ear | Forehead | | Thermometer Type | Clinical Electronic | Clinical Electronic | Clinical Electronic | Clinical Electronic | | Intended Use and<br>Technological<br>Characteristics | UGFT3 | Dual Mode Up Grade<br>Forehead/Underarm<br>Thermometer cleared<br>under K051422 | Vicks Behind Ear<br>Gentle Touch<br>Thermometer<br>cleared under<br>K103839 | NIR Thermometer<br>K090386 | | Principle of<br>Operation | Thermometer<br>Predictive<br>Thermometer | Thermometer<br>Predictive Thermometer | Thermometer<br>Predictive<br>Thermometer | Thermometer<br>Infra Red<br>Thermometer | | Labeling | Instructions For Use | Instructions For Use | Instructions For<br>Use | Instructions For Use | | Major Components | Main (Control &<br>Processing) Unit<br>including display, and<br>Probe Tip | Main (Control &<br>Processing) Unit,<br>including display, and<br>Probe Tip | Main (Control &<br>Processing) Unit,<br>including display,<br>and Probe Tip | Main (Control &<br>Processing) Unit<br>including display,<br>and Probe housing | | Sensor | Thermistor | Thermistor | Thermistor | Thermopile | | Display | LCD (20 mm x 19.6<br>mm) | LCD (20 mm x 19.6<br>mm) | LCD (20.4mm x<br>20.4 mm) | LCD (20 mm x 19.6<br>mm) | | Power<br>Requirements | 2 x 1.5V AAA<br>Batteries | 2 x 1.5V AAA Batteries | 1 x CR2032 (3V<br>lithium battery) | 3x1.5V AAA<br>Batteries | | Patient Contact<br>Materials | Case - ABS Plastic<br>Probe Tip - Stainless<br>Steel , ABS plastic<br>and silicon rubber | Case - ABS Plastic<br>Probe Tip - Stainless<br>Steel , ABS plastic and<br>silicon rubber | Case - ABS<br>Plastic, rubber | ABS plastics | | Clinical<br>Measurement<br>Display | Temperature | Temperature | Temperature | Temperature | | Units of<br>Measurement | °C, °F | °C, °F | °C, °F | °C, °F | | Clinical<br>Measurement<br>Range | 35.0°C to 42.0°C<br>95.5°F to 107.6°F | 35.0°C to 42.0°C<br>95.5°F to 107.6°F | 35.5°C to 42.0°C<br>95.9°F to 107.6°F | 22.0°C to 40.0<br>°C (71.6°F to<br>104.0°F) | | Ambient<br>Temperature for<br>measurement | 16°C to 40°C<br>60.8°F to 104.0°F | 16°C to 40°C<br>60.8°F to 104.0°F | 10°C to 40°C<br>50°F to 104.0°F | 16.0°C to 40.0°C<br>(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<br>Technological<br>Characteristics | UGFT3 | Dual Mode Up Grade<br>Forehead/Underarm<br>Thermometer cleared<br>under K051422 | Vicks Behind Ear<br>Gentle Touch<br>Thermometer<br>cleared under<br>K103839 | NIR Thermometer<br>K090386 | | | condensing | condensing | non-condensing | non-condensing | | Medication Timer<br>Reminder with<br>alert (MTR) | Timer to alert the<br>patient when to take<br>next dosage | None | None | Timer to alert the<br>patient when to take<br>next dosage | | Technical<br>Accuracy | ASTM E1112-00 | ASTM E1112-00 | ASTM E1112-00<br>ASTM E1965-98 | ASTM E1112-00<br>ASTM E1965-98 | | Response Time | 6-8 seconds | 6-8 seconds | 1 second | 2 seconds | | Activation | Automatic body<br>detection | Automatic body<br>detection | Manually | Automatic body<br>detection | | Dimensions | Length: 10.0cm (3.9")<br>Width: 5.2cm (2.05")<br>Depth: 3.2cm (1.25") | Length: 10.0cm (3.9")<br>Width: 5.2cm (2.05")<br>Depth: 3.2cm (1.25") | Length: 14.4cm<br>(6")<br>Width: 4.2cm<br>(1.65")<br>Depth: 2.4cm<br>(0.95") | Length: 10.5cm<br>(4.1")<br>Width: 4.5 cm<br>(1.77")<br>Depth: 3.5 cm<br>(1.37") | | Weight (including<br>batteries) | 44gr | 44gr | 76gr | 70gr | ## 6. Comparison to the predicate devices: {3}------------------------------------------------ {4}------------------------------------------------ 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; . {5}------------------------------------------------ # 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 2. 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 {6}------------------------------------------------ - · 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. {7}------------------------------------------------ #### 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: 1. 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. 2. The dual mode upgrade forehead thermometer is referred to as UGFT2/FHT2/FHT5. {8}------------------------------------------------ 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. {9}------------------------------------------------ #### 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 {10}------------------------------------------------ 510(k) Number: K131155 Device Name : Up-grade forehead/underarm/behind ear thermometer (UGFT3) 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. 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) : : . ' · Page 1 of 1 Richard C. Chapman 2013.08.28 11:55:47 · -04'00'