Vicks VNT200 No Touch Forehead Thermometer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. April 28, 2020 Kaz USA, Inc., a Helen of Troy Company Matt J. Baun Associate Director of Clinical & Regulatory Affairs 400 Donald Lynch Boulevard Suite 300 Marlborough, Massachusetts 01752 Re: K193213 Trade/Device Name: Vicks® VNT200 No Touch Forehead Thermometer, Model VNT200US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 25, 2020 Received: March 27, 2020 Dear Matt Baun: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 does 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K193213 Device Name Vicks® VNT200 No Touch Forehead Thermometer (Model Number: VNT200US) #### Indications for Use (Describe) The Vicks® VNT200 No Touch Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a "no touch" mode, using the center of the forehead as the measurement site, on people of all ages, in a home use environment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### Section 5: 510(k) Summary K193213 #### SUBMITTER l. Kaz USA, Inc., a Helen of Troy Company 400 Donald Lvnch Blvd.. Suite 300 Marlborough, MA 01752 Phone: (508) 490-7240 Fax: (508) 251-1048 Contact Person: Matt J. Baun, Associate Director of Clinical & Regulatory Affairs Date Prepared: 10-April-2020 #### ll. DEVICE Name of Device: Vicks® VNT200 No Touch Forehead Thermometer Model Number: VNT200US Common or Usual Name: Infrared Skin Thermometer Regulation Medical Specialty / 510k Review Panel: General Hospital Classification Name: Thermometer, Clinical, Electronic (21 CFR 880.2910) Regulatory Class: II Product Code: FLL #### lll. PREDICATE DEVICE Braun No Touch + Forehead NTF3000 Thermometer - 510(k) # K163516 #### DEVICE DESCRIPTION IV. The Vicks® VNT200 No Touch Forehead Thermometer is a hand-held, battery-powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature. It is calibrated for non-contact use at a distance of up to 5 centimeters (2 inches) from the center of the forehead. It uses an infrared thermopile sensor with integrated thermistor mounted in the head of the thermometer for the target reading and ambient temperature reading. #### V. INDICATIONS FOR USE The Vicks® VNT200 No Touch Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a "no touch" mode, using the center of the forehead as the measurement site, on people of all ages, in a home use environment. {4}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. | Element of<br>Comparison | Subject Device: Vicks®<br>VNT200 No Touch Forehead<br>Thermometer | Predicate Device: Braun®<br>No Touch + Forehead<br>NTF3000 Thermometer | Comparison | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Manufacturer<br>(Legal) | Kaz USA, Inc., a Helen of Troy<br>Company | Kaz USA, Inc., a Helen of Troy<br>Company | - | | Contract<br>Manufacturer | HeTaiDa Corporation | AVITA Corporation | - | | Thermometer<br>Type | Infrared Forehead<br>Thermometer | Infrared Forehead<br>Thermometer | - | | Models<br>(Configuration) | Vicks® VNT200 No Touch<br>Forehead Thermometer | The Braun® No Touch +<br>Forehead NTF3000<br>Thermometer | - | | 510(k) Number | K193213 | K163516 | - | | Principles of<br>Operation | The device measures the<br>infrared energy emitted in the<br>area around the user's<br>forehead | The device measures the<br>infrared energy emitted in the<br>area around the user's<br>forehead | - | | Intended Use | The Vicks® VNT200 No<br>Touch Forehead Thermometer<br>is a non-sterile, reusable<br>clinical thermometer intended<br>for the intermittent<br>determination of human body<br>temperature in a "no touch"<br>mode, using the center of the<br>forehead as the measurement<br>site, on people of all ages, in a<br>home use environment. | The Braun No Touch +<br>Forehead NTF3000<br>Thermometer is a non-sterile,<br>reusable clinical thermometer<br>intended for the intermittent<br>determination of human body<br>temperature in a touch and no<br>touch mode on the center of the<br>forehead as the measurement<br>site on people of all ages. | Different | | Labeling | Instructions for use, quick start<br>guide, package, and rating<br>label | Instructions for use, quick start<br>guide, package, and rating<br>label | Different | | Features | Temperature guidance<br>feature, and memory feature | Temperature guidance feature | Different | | Components | Power / temperature<br>measurement button, Mode<br>button, Memory button,<br>scanner, microcontroller, & LCD | Power button, temperature<br>measurement button, scanner,<br>silent mode switch, protective<br>cap, microcontroller, & LCD | Different | | Element of<br>Comparison | Subject Device: Vicks®<br>VNT200 No Touch Forehead<br>Thermometer | Predicate Device: Braun®<br>No Touch + Forehead<br>NTF3000 Thermometer | Comparison | | Sensors | The thermometer uses an<br>infrared thermopile sensor with<br>integrated thermistor mounted<br>in the head of the thermometer<br>for the target reading and<br>ambient temperature reading. | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for the<br>target reading, a thermistor<br>mounted in the head of the<br>thermometer for ambient<br>temperature readings, a<br>parabolic mirror to help focus<br>the infrared energy emitted<br>from the forehead, and an<br>infrared proximity sensor for<br>detection of contact or non-<br>contact use and compensation<br>of the temperature reading. | Different | | Operating<br>Environment<br>(Specifications) | 15°C to 40°C (59°F to 104°F);<br>≤ 95% Relative Humidity;<br>700-1060 hPA (0.7-1.06 atm) | 15°C to 40°C (59°F to 104°F);<br>≤ 95% Relative Humidity;<br>700-1060 hPA (0.7-1.06 atm) | Identical | | Storage<br>Environment<br>(Specifications) | -25°C to 55°C (-13°F to 131°F);<br>≤ 95% Relative Humidity;<br>700-1060 hPA (0.7-1.06 atm) | -25°C to 60°C (-13°F to 140°F);<br>≤ 95% Relative Humidity;<br>700-1060 hPA (0.7-1.06 atm) | Different | | Measurement<br>Range<br>(Body Mode) | 34.0°C to 43.0°C<br>(93.2°F to 109.4°F) | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | Different | | Accuracy<br>(Body Mode) | ± 0.2°C (± 0.4°F)<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br>± 0.3°C (± 0.5°F)<br>34.0°C to 35.0°C<br>(93.2°F to 95.0°F);<br>± 0.3°C (± 0.5°F)<br>Above 42.0°C<br>(Above 107.6°F); | ± 0.2°C (± 0.4°F)<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br>± 0.3°C (± 0.5°F)<br>34.4°C to 35.0°C<br>(93.9°F to 95.0°F);<br>± 0.3°C (± 0.5°F)<br>Above 42.0°C<br>(Above 107.6°F); | Different | | Resolution of<br>Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Identical | | Signal Output<br>and Display | LCD, Buzzer | LCD, Buzzer | Identical | | Measurement<br>Distance | Up to 5 centimeters (2 inches)<br>from the center of the forehead | Up to 5 centimeters (2 inches)<br>from the center of the forehead | Identical | | Element of<br>Comparison | Subject Device: Vicks®<br>VNT200 No Touch Forehead<br>Thermometer | Predicate Device: Braun®<br>No Touch + Forehead<br>NTF3000 Thermometer | Comparison | | MCU | Sonix SN8P1929 - a high-<br>performance 8-bit micro-<br>controller with 4K-word OTP<br>ROM, 256 bytes of RAM, one 8-<br>bit basic timer (T0) with RTC<br>(Real Time Clock) function, two<br>8-bit timer counters (TC0, TC1) ,<br>a watchdog timer, five interrupt<br>sources (T0, TC0, TC1, INT0,<br>INT1), an in-system<br>programming ROM (ISP ROM)<br>register, a 16-bit ADC, a PGIA, a<br>charge pump/regulator, an<br>integrated LCD driver for 4-<br>common x 24 segment LCD<br>panel, an 8-level stack register,<br>and a dual-clock system (high-<br>speed clock generated from the<br>external oscillator circuit or on-<br>chip 16MHz high-speed RC<br>oscillator circuit (IHRC 16MHz),<br>low-speed clock generated from<br>LXIN / LXOUT by 32768 crystal<br>or RC oscillator circuit, and as a<br>clock source for slow mode,<br>real-time clock, & LCD function). | Weltrend WT5075F - A high-<br>speed, high-performance and<br>low power consumption 8-bit<br>micro-controller, including<br>Turbo 8052 CPU, 64K bytes<br>embedded Flash, 256-byte<br>direct-or-indirect-addressing<br>SRAM, 2K-byte indirect-<br>addressing-only SRAM,<br>40x4(max.) LCD driver, a Time-<br>Base Timer, 4 multi-function<br>timer/counters, 2-channel 12-bit<br>PWM, 1-channel divider output,<br>serial interface (UART and<br>SPI), 19-channel (15 external<br>and 4 internal) 12-bit AD<br>converter, 4 high-performance<br>OPs, analog switches and three<br>clock generators (32.768kHz<br>crystal oscillator, high-speed<br>crystal oscillator and high-<br>speed RC oscillator) on chip. | Different | | Power Supply | Two (2), AAA batteries | Two (2), AA batteries | Different | | Battery Life | At least 1000 measurements | At least 1000 measurements | Identical | | Materials | User contacting materials<br>include ABS (device housing /<br>handle, power / temperature<br>button, memory button, mode<br>button), & PMMA (LCD lens). | User contacting materials<br>include ABS (device housing /<br>handle and power button),<br>TPR (temperature button and<br>forehead touch bumper), and<br>PMMA (LCD lens and<br>protective scanner cap). | Different | | Biocompatibility | Meets ISO 10993-1:2009,<br>10993-5:2009, 10993-<br>10:2010, & FDA Guidance<br>Document, "Use of<br>International Standard ISO<br>10993-1" - June 16, 2016 | Meets ISO 10993-1, 10993-5,<br>and 10993-10, and FDA<br>Bluebook memo G95-1 | Substantially<br>Equivalent | | Performance | Meets ASTM E1965:2016 and<br>ISO 80601-2-56:2017 | Meets ASTM E1965 and<br>ISO 80601-2-56 | Substantially<br>Equivalent | | Element of<br>Comparison | Subject Device: Vicks®<br>VNT200 No Touch Forehead<br>Thermometer | Predicate Device: Braun®<br>No Touch + Forehead<br>NTF3000 Thermometer | Comparison | | Electrical<br>Safety | Meets ANSI / AAMI / IEC<br>60601-1:2012 | Meets ANSI / AAMI / IEC<br>60601-1:2012 | Substantially<br>Equivalent | | EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | Substantially<br>Equivalent | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### VII. DISCUSSION IDENTIFYING SIMILARITIES AND DIFFERENCES # Intended Use: The subject device has been validated and is specified for non-contact ("no touch") use, up to 5 centimeters (2 inches) from the center of the forehead, which is identical to the predicate device. The predicate device has also been validated for contact use. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E1965-98. Thus, this difference does not raise any new safety or performance questions. # Labeling: The labeling for the subject device contains additional directions describing the use of the memory feature. This does not change the safety or effectiveness of the subject device. ### Features: The memory feature of the subject device is implemented in software and hardware, whereby the most recent 10 temperature readings can be reviewed by the user by pressing the Memory button. The software was validated according to the FDA's software guidance. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E1965-98. Thus, this difference does not raise any new safety or performance questions. ### Components: Differences in components between the subject device are limited to accessibility to different features of the devices. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E1965-98. Thus, this difference does not raise any new safety or performance questions. ### Sensors: Unlike the predicate device, the subject device does not have a separate thermistor for ambient temperature measurement, a digital, infrared proximity sensor for detection of contact use and compensation of the temperature reading, or a parabolic mirror to help focus the infrared energy emitted from the forehead. However, both thermometers convert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature. The same level of performance was achieved using the single sensor. This was shown with laboratory and clinical accuracy testing, validated per ASTM E1965 and ISO 80601-2-5. Therefore, the differences in internal sensors used to achieve the same effect, does not change the safety or effectiveness of the subject device. {8}------------------------------------------------ # Storage Environment: Despite minor differences in the storage environment between the subject and predicate device, these are within the IEC 60601-1-11 and ASTM E1965 requirements, and therefore, meet these performance standards. ### Measurement Range: Despite minor differences in the measurement ranges between the subject and predicate device, these are within the ASTM E1965 requirements, and therefore, meet this performance standard. ### Accuracy: Despite minor differences in the temperature ranges over which the required accuracy is exhibited by the subject and predicate device, these are within the ASTM E1965 requirements, and therefore, meet this performance standard. # MCU: An alternate MCU, that achieved the same functionality as the MCU used in the predicate device, was used in the subject device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E1965-98. Thus, this difference does not raise any new safety or performance questions. ### Power Supply: The subject device uses the same voltage as the predicate device, achieved with different sized batteries. This does not change the safety or effectiveness of the device. ### Materials: The subject device contains ABS and PMMA for the same components but has no TPR in its construction. The biocompatibility testing shows that the subject device with standards ISO 10993-1. ISO 10993-5, and ISO 10993-10. Thus, this difference does not raise any new safety or performance questions. ### Other Elements of Comparison: All other "Elements of Comparison" in the Substantial Equivalence Comparison Table are identical. The changes described above have been addressed through testing to a known performance standard or by showing equivalency in terms of function. Therefore, these differences are not significant and do not change the safety or effectiveness of the subject device. {9}------------------------------------------------ #### VIII. NON-CLINICAL TESTING & PERFORMANCE DATA The following non-clinical testing and performance data for the Vicks® VNT200 No Touch Forehead Thermometer are provided in support of the substantial equivalence determination: | Test Name | Cited Standards | Acceptance Criteria | Result | |-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Accuracy in<br>Test Mode | 1. ASTM E1965-98:2016<br>2. Directive 93 / 42 EEC<br>3. ISO 80601-2-56:2017 | In test mode the thermometer shall be within ± 0.2°C for<br>34-43°C or ± 0.3°C for outside of the temperature range<br>for blackbody temperatures at 17.0, 23.0, 28.0, 29.0,<br>30.0, 31.0, 32.0, 33.0, 34.0, 35.0, 36.0, 37.0, 38.0, 39.0,<br>40.0, 41.0, & 42.0°C. | Pass | | Accuracy as a<br>Function of<br>Supply Voltage | | The thermometer shall have the same accuracy as<br>D004327 - Accuracy in Body and Surface Modes while<br>the thermometer is supplied 2.7V, 3.0V and 3.3V in a<br>37°C and 38.5°C blackbody and shall not be greater<br>than 0.2°C change between any voltage range on a<br>given unit | Pass | | Accuracy in<br>Range of<br>Environments<br>5E | ASTM E1965-98:2016<br>5.6.1 / 5.6.2<br>ISO 80601-2-56:2017 | 1. In each of the five environments listed below the device<br>shall be within 0.3°C of a blackbody at 22.5°C and<br>within 0.2°C of a blackbody at 35, 37, 41, and 42.5°C in<br>test mode.<br>- Environment 1: 15-16°C with 15-25% humidity<br>- Environment 2: 15-16°C with 85-95% humidity<br>- Environment 3: 24-26°C with 40-60% humidity<br>- Environment 4: 39-40°C with 15-25% humidity<br>- Environment 5: 39-40°C with 85-95% humidity<br>2. In operating mode, the displayed temperature should<br>be within permitted accuracy stated in the protocol<br>depending on blackbody temperature and ambient<br>temperature. | Pass | | Display-Out of<br>Range and<br>Response Time | 1. ASTM E1965-98:2016<br>2. Directive 93 / 42 EEC<br>3. ISO 80601-2-56:2017 | 1. In normal operating mode the thermometer shall<br>display 'Lo' if the temperature reading is below 34°C<br>and shall display 'Hi' if the temperature reading is<br>above 43°C.<br>2. The time between the user hitting the measure button<br>the reading being displayed on the screen is less than<br>2 seconds. | Pass | | Current Draw in<br>Use and Sleep<br>Modes | | The current draw shall not exceed:<br>- 3uA in sleep mode<br>- 15mA while the green backlight is displayed<br>- 40mA while the yellow backlight is displayed<br>- 30mA while the red backlight is displayed | Pass | | Battery Life | | The total calculated charge consumption of the<br>thermometer in 3 years of sleep condition & 1000<br>readings is less than the average usable battery capacity. | Pass | | Test Name | Cited Standards | Acceptance Criteria | Result | | Low Battery<br>Indication | 1. ASTM E1965-98:2016<br>2. ISO 80601-2-56:2017 | 1. Above 2.5V no low battery symbol shall be displayed | Pass | | | | 2. Between 2.3V and 2.5V a low battery symbol shall be<br>displayed on the bottom of the LCD | | | | | 3. Below 2.3V the thermometer shall not turn ON | | | | | 4. The thermometer shall still have the same accuracy as<br>D004327 - Accuracy in Body and Surface Modes while<br>the low battery indicator is present in a 37°C blackbody | | | Sound Level | | The beeper volume shall be between 50 dB and 85 dB<br>when measured at a distance of 2 inches from the<br>device, measured from the front center of the LCD. | Pass | | Backlight Check | | 1. The luminance of the backlight on the display shall be<br>greater than:<br>- 14cd/m2 while the green backlight is displayed<br>- 45cd/m2 while the yellow backlight is displayed<br>- 5cd/m2 while the red backlight is displayed | Pass | | | | 2. The display shall show the corresponding backlight<br>color during the following temperature readings:<br>- no backlight between 34.0-35.7°C<br>- green backlight between 35.8-37.4°C<br>- yellow backlight between 37.5-38.5°C<br>- red backlight between 38.6-43.0°C | | | LCD Display<br>Visibility and<br>Readability | | 1. The temperature display numerals shall be 7mm<br>high and 4mm wide | Pass | | | | 2. The temperature display shall be clearly visible from a<br>viewing angle between 5° above and 45° below the<br>disp…