Vicks RapidRead Digital Thermometer

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August 14, 2018 Kaz USA, Inc., A Helen of Troy Company Matt Baun Associate Director of Clinical & Regulatory Affairs 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 Re: K180131 Trade/Device Name: Vicks RapidRead Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 9, 2018 Received: July 9, 2018 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. 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. 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180131 Device Name Vicks® VDT972 RapidRead™ Digital Thermometer #### Indications for Use (Describe) The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) | |---------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart G) | _ | 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}------------------------------------------------ #### 510(k) Summary Section 5: K180131 #### SUBMITTER l. KAZ USA, Inc., A Helen of Troy Company 400 Donald Lynch 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: 8-November-2017 #### DEVICE = Name of Device: Vicks® VDT972 RapidRead™ Digital Thermometer Common or Usual Name: Axillary / Oral / Rectal, Predictive Digital Thermometer Classification Name: Thermometer, Clinical, Electronic (21CFR 880.2910) Regulatory Class: II Product Code: FLL #### III. PREDICATE DEVICE(S) - o V966 Vicks® ComfortFlex® Digital Thermometer (Microlife Instant Digital Thermometer, Model MT18L1) - 510(k) # K043110 - Vicks® VDT985 SmartTemp™ Wireless Thermometer 510(k) # K152975 ● #### DEVICE DESCRIPTION IV. The Vicks® VDT972 RapidRead™ Digital Thermometer is a predictive, thermistor-based, stick thermometer capable of measuring oral, axillary, or rectal temperature in 2 to 8 seconds. It is equipped with a site selection button that requires the operator to select the desired measurement site before taking a temperature. For each measurement, it must be used with a commercially-available, single-use, disposable probe cover. The Vicks® VDT972 RapidRead™ Digital Thermometer is a contact thermometer, using a negative temperature coefficient (NTC) thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes. This change in resistance is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user. The Vicks® VDT972 RapidRead™ Digital Thermometer does not use a clinical offset algorithm. clinical offset algorithms are typically used to perform a measurement on one physiological site (i.e. the forehead. temple, or ear) and represent what the equivalent measurement would be at a different physiological site (i.e. oral), had the measurement been performed at that site instead. Typically, these formulas account for ambient temperature, at a minimum, in calculating the appropriate offset. Because the Vicks® VDT972 RapidRead™ Digital Thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via the use of a clinical offset. #### V. INDICATIONS FOR USE The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, rectally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements. {4}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE(S) VI. | Substantial Equivalence Comparison Table - Vicks® V966 ComfortFlex® Digital Thermometer | | | |-----------------------------------------------------------------------------------------|--|--| | | | | | Element of<br>Comparison | Test Device: Vicks® VDT972<br>RapidRead™ Digital<br>Thermometer | Predicate Device: Vicks® V966<br>ComfortFlex® Digital<br>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 | Microlife Corporation | Microlife Corporation | | | Thermometer<br>Type | Axillary / Oral / Rectal, Predictive<br>Digital Thermometer | Axillary / Oral / Rectal, Predictive<br>Digital Thermometer | Substantially<br>Equivalent | | Models | Vicks® VDT972 RapidRead™<br>Digital Thermometer | V966 Vicks® ComfortFlex® Digital<br>Thermometer (Microlife Instant<br>Digital Thermometer, Model<br>MT18L1) | | | 510(k) Number | K180131 | K043110 | | | Intended Use | The Vicks® VDT972 RapidRead™<br>Digital Thermometer is a handheld,<br>battery-powered, predictive, digital<br>stick thermometer intended for the<br>intermittent determination of human<br>body temperature orally, rectally, or<br>under the arm, in a home-use<br>environment for people of all ages<br>(infants, children, and adults). It is<br>intended to be used with a single-<br>use, disposable probe cover for all<br>measurements. | V966 Vicks® ComfortFlex® Digital<br>Thermometer (Microlife Instant<br>Digital Thermometer, Model<br>MT18L1) is used for the intermittent<br>measurement and monitoring of<br>human body temperature, orally,<br>rectally and under the arm. The<br>device is for the adult & pediatric<br>population. | Substantially<br>Equivalent | | User Population | Infants, children, and adults | Adult and pediatric | Substantially<br>Equivalent | | Labeling | Instructions for use, package / box,<br>and rating label | Instructions for use, package / box,<br>and rating label | Substantially<br>Equivalent | | Components | On / Off Button, Site Selection<br>Button, sensor head, protective<br>cover, microcontroller, & LCD | On / Off Button, sensor head,<br>protective cover, microcontroller, &<br>LCD | Substantially<br>Equivalent | | Sensor | Thermistor | Thermistor | Substantially<br>Equivalent | | Principles of<br>Operation | The thermometer uses a negative<br>temperature coefficient thermistor<br>embedded in a measurement tip that<br>is in contact with the measurement<br>site. As the thermistor changes<br>temperature, the resistance of the<br>thermistor also changes, which is<br>measured by the thermometer and<br>converted to a measurement of the<br>temperature of the tip of the<br>thermometer. This temperature,<br>following the use of the predictive<br>algorithm, is then displayed to the end<br>user. Because the thermometer<br>displays the measurement for the<br>physiological site at which it is used, it<br>does not need to convert this<br>temperature via clinical offset. | The thermometer uses a negative<br>temperature coefficient thermistor<br>embedded in a measurement tip that<br>is in contact with the measurement<br>site. As the thermistor changes<br>temperature, the resistance of the<br>thermistor also changes, which is<br>measured by the thermometer and<br>converted to a measurement of the<br>temperature of the tip of the<br>thermometer. This temperature,<br>following the use of the predictive<br>algorithm, is then displayed to the end<br>user. Because the thermometer<br>displays the measurement for the<br>physiological site at which it is used, it<br>does not need to convert this<br>temperature via clinical offset. | Substantially<br>Equivalent | | Measurement<br>Range | 34.0°C to 43.0°C<br>(93.2°F to 109.4°F) | 32.0°C to 42.9°C<br>(89.6°F to 109.2°F) | Substantially<br>Equivalent | | Element of<br>Comparison | Test Device: Vicks® VDT972<br>RapidRead™ Digital<br>Thermometer | Predicate Device: Vicks® V966<br>ComfortFlex® Digital<br>Thermometer | Comparison | | Accuracy | ± 0.1°C / 0.2°F within<br>measurement range<br>(34.0°C to 43.0°C /<br>93.2°F to 109.4°F) at room<br>temperature of 71°F | ± 0.1°C / 0.2°F within<br>measurement range<br>(35.6°C to 41.7°C /<br>(96.0°F to 107.0°F) at room<br>temperature of 71°F | Substantially<br>Equivalent | | Resolution of<br>Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Substantially<br>Equivalent | | Response Time | 2 to 8 seconds | 8 to 15 seconds | Substantially<br>Equivalent | | MCU | The Sonix SN8F5907 is an 8-bit<br>architecture microcontroller which is<br>compatible with MCS-51 instruction<br>set. It includes an enhanced 8051<br>microcontroller, up to 32 MHz<br>flexible CPU frequency, hardware<br>multiplication / division Unit, 256<br>bytes internal RAM (IRAM), 2 KB<br>external RAM (XRAM), 64 KB non-<br>volatile flash memory (IROM), in-<br>system program support, 10 interrupt<br>sources with priority control, 2<br>external interrupts: INT0, INT1, 3 set<br>16-bit timer/counter with auto reload,<br>PWM output function, 1 set 8-bit<br>base timer for RTC, 1 set buzzer<br>function output pin, one comparator<br>for low battery detect 2.2V~3.6V<br>(0.2V/step), 1 set charge pump<br>regulator (AVDDR and ACM), 1 set<br>programmable gain instrument<br>amplifier (Gain:1x~128x), 24-bit<br>Delta Sigma ADC with 9 external<br>channels and 4 internal channels, 1<br>set operational amplifier, C-type LCD<br>driver up to 252 dot (4x44 or 6x42<br>dots), programmable watchdog and<br>software reset, SPI, UART, I2C<br>interface with SMBus support, on-<br>chip debug support (single-wire<br>debug interface), wide supply<br>voltage (1.8V to 5.5V), wide working<br>temperature (-40°C to 85°C). | The Holtek HT47C20 is an 8-bit<br>high performance RISC-like<br>microcontroller. It includes a<br>2.4V~3.6V operating voltage, eight<br>bidirectional I/O lines, four input<br>lines, one interrupt input, one 16-bit<br>programmable timer / event counter<br>with PFD (programmable frequency<br>divider) function, on-chip crystal and<br>RC oscillator for system clock, one<br>32.768kHz crystal oscillator for real<br>time clock, Watchdog Timer, 2K16<br>program memory ROM, 648 data<br>memory RAM, one Real Time Clock<br>(RTC), one 8-bit prescaler for RTC,<br>one buzzer output, HALT function<br>and wake-up feature to reduce<br>power consumption, LCD bias C<br>type, one LCD driver with 203 or<br>194 segments, one 38kHz or 40kHz<br>IR carrier output (455kHz or 480kHz<br>system clock only), two channels<br>RC type A/D converter, four-level<br>subroutine nesting, bit manipulation<br>instruction, 16-bit table read<br>instruction, up to 8.3s instruction<br>cycle with 480kHz system clock, all<br>instructions in one or two machine<br>cycles, 63 powerful instructions, 64-<br>pin QFP package G | Substantially<br>Equivalent | | Signal Output and<br>Display | LCD, Buzzer | LCD, Buzzer | Substantially<br>Equivalent | | Operating<br>Environment | 15.0°C to 40.0°C /<br>59.0°F to 104.0°F;<br>≤ 95% Relative Humidity | 10°C to 40°C /<br>50°F to 104°F;<br>15-95% Relative Humidity | Substantially<br>Equivalent | | Storage<br>Environment | -25.0°C to 60.0°C /<br>-13.0°F to 140.0°F;<br>≤ 95% Relative Humidity | -25.0°C to 60.0°C /<br>-13.0°F to 140.0°F;<br>15-95% Relative Humidity | Substantially<br>Equivalent | | Power Supply | One (1), 3V, CR2032 battery | One (1), 3V, CR1225 battery | Substantially<br>Equivalent | | Battery Life | More than 400 measurements or<br>approximately 2 years if used<br>every other day. | More than 300 measurements or<br>approximately 2 years if used every<br>other day. | Substantially<br>Equivalent | | Element of<br>Comparison | Test Device: Vicks® VDT972<br>RapidRead™ Digital<br>Thermometer | Predicate Device: Vicks® V966<br>ComfortFlex® Digital<br>Thermometer | Comparison | | Materials | User contacting materials include<br>ABS (sensor head, battery door<br>and On / Off Button), TPR (probe<br>and Site Selection Button), PMMA<br>(LCD lens and protective cover),<br>and stainless steel (sensor tip) | User contacting materials include<br>ABS (sensor head and battery<br>door), TPR (probe, LCD lens<br>casing, On / Off Button, and sensor<br>head seam strip), PMMA (LCD<br>lens and protective cover), and<br>stainless steel (sensor tip) | Substantially<br>Equivalent | | Performance | Meets ASTM E1112-00:2011 and<br>ISO 80601-2-56:2017 | Meets ASTM E1112 | Substantially<br>Equivalent | | Biocompatibility | Meets ISO 10993-1:2009, 10993-<br>5:2009, 10993-10:2010, and FDA<br>Guidance Document, "Use of<br>International Standard ISO 10993-<br>1" – June 16, 2016 | Meets ISO 10993-1, 10993-5, and<br>10993-10, and FDA Bluebook<br>memo G95-1 | Substantially<br>Equivalent | | Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | Substantially<br>Equivalent | | EMC | Meets IEC 60601-1-2:2014…