(159 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) Summary for the Vicks® VNT200 No Touch Forehead Thermometer:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical testing section (Section VIII) of the 510(k) summary provides a comprehensive table of acceptance criteria and results. Below is a summarized version focusing on key performance aspects:
| Test Name | Cited Standards | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Accuracy (In Test Mode) | ASTM E1965-98:2016, Directive 93/42 EEC, ISO 80601-2-56:2017 | In test mode, the thermometer shall be within ± 0.2°C for 34-43°C or ± 0.3°C for outside of the temperature range for blackbody temperatures at specified points (17.0, 23.0, 28.0, 29.0, 30.0, 31.0, 32.0, 33.0, 34.0, 35.0, 36.0, 37.0, 38.0, 39.0, 40.0, 41.0, & 42.0°C). | Pass |
| Accuracy as a Function of Supply Voltage | N/A | The thermometer shall have the same accuracy as D004327 - Accuracy in Body and Surface Modes while supplied 2.7V, 3.0V, and 3.3V in a 37°C and 38.5°C blackbody, and shall not be greater than 0.2°C change between any voltage range on a given unit. | Pass |
| Accuracy in Range of Environments | ASTM E1965-98:2016, ISO 80601-2-56:2017 | 1. In each of five specified environments (varying temperature and humidity), the device shall be within 0.3°C of a blackbody at 22.5°C and within 0.2°C of a blackbody at 35, 37, 41, and 42.5°C in test mode. 2. In operating mode, the displayed temperature should be within permitted accuracy stated in the protocol depending on blackbody temperature and ambient temperature. | Pass |
| Display-Out of Range and Response Time | ASTM E1965-98:2016, Directive 93/42 EEC, ISO 80601-2-56:2017 | 1. In normal operating mode, the thermometer shall display 'Lo' if reading is below 34°C and 'Hi' if reading is above 43°C. 2. Time between user pressing measure button and reading being displayed is less than 2 seconds. | Pass |
| Battery Life | N/A | The total calculated charge consumption of the thermometer in 3 years of sleep condition & 1000 readings is less than the average usable battery capacity. | Pass |
| Low Battery Indication | ASTM E1965-98:2016, ISO 80601-2-56:2017 | 1. No low battery symbol above 2.5V. 2. Low battery symbol displayed between 2.3V and 2.5V. 3. Thermometer shall not turn ON below 2.3V. 4. Accuracy maintained when low battery indicator is present. | Pass |
| Backlight Check | N/A | 1. Luminance of backlight on display greater than specified values (14cd/m2 for green, 45cd/m2 for yellow, 5cd/m2 for red). 2. Display shows corresponding backlight color for specified temperature ranges. | Pass |
| LCD Display Visibility and Readability | N/A | 1. Numerals 7mm high and 4mm wide. 2. Clearly visible from 5° above to 45° below display. 3. Clearly visible throughout display angle range in low (15-16°C) and high (39-40°C) ambient temperatures. | Pass |
| Unit Life | N/A | The thermometer shall have the same accuracy as D004327 - Accuracy in Body and Surface Modes in a 38.5°C blackbody after 10,000 work cycles. | Pass |
| Electrical Safety | IEC 60601-1 | Compliance with IEC 60601-1:2005 + A1:2012 from a 3rd party lab. | Pass |
| Biocompatibility | ASTM E1112 4.6.2.2 and 5.3, ISO 10993-1:2009 | Compliance with ISO 10993-1:2009, ISO 10993-10:2010 (Irritation and Skin Sensitization), and ISO 10993-5:2009 (In Vitro Cytotoxicity) from a 3rd party lab. | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2:2015 | Compliance with IEC 60601-1-2:2015 from a 3rd party lab. | Pass |
| Software Verification and Validation | FDA Guidance, IEC 62304:2015 | "Software verification and validation testing was conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff... and the software lifecycle standard, IEC 62304:2015" | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: 208 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It refers to "a pivotal study." It is a prospective study as it involves enrolling subjects and conducting measurements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications (e.g., radiologists with 10 years of experience) used to establish ground truth for the clinical study. For a thermometer, "ground truth" for body temperature is typically established using a highly accurate reference thermometer measurement (e.g., rectal temperature for core body temperature, or a calibrated blackbody for laboratory accuracy testing) rather than expert subjective assessment of an image. The standards cited (ASTM E1965-98:2016 and ISO 80601-2-56:2017) lay out the methods for determining temperature accuracy against a reference.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved and multiple readers' opinions need to be reconciled for ground truth. For thermometer accuracy, the ground truth is often an objective measurement from a reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The study focuses on the device's accuracy in measuring temperature.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the majority of the "Non-Clinical Testing & Performance Data" (Section VIII) represents standalone performance of the device without human interpretation. This includes accuracy in test mode (against a blackbody), accuracy in various environments, response time, electrical safety, EMC, etc. The clinical testing evaluates its performance in actual human use, but the core measurement is automated "algorithm only."
7. The Type of Ground Truth Used
- Non-Clinical Testing: The ground truth for the non-clinical / laboratory testing (e.g., accuracy in test mode, accuracy as a function of supply voltage, accuracy in range of environments) was established using calibrated blackbody temperatures. A blackbody is a standardized thermal radiation source used to accurately calibrate and test infrared thermometers.
- Clinical Testing: For the clinical study, the ground truth for body temperature was established by comparing the device's measurements to a reference standard method for intermittent determination of patient temperature, as required by ASTM E1965-98:2016 and ISO 80601-2-56:2017. While the specific reference method isn't detailed, for clinical thermometers, this often involves simultaneous or nearly simultaneous measurements with a highly accurate rectal thermometer or other core body temperature measurement, or highly controlled environmental conditions with a known "true" temperature.
8. The Sample Size for the Training Set
This information is not provided. The document describes the "pivotal study" (clinical test set) and non-clinical testing. For a traditional medical device like a thermometer, there isn't typically a "training set" in the machine learning sense. The device is designed, calibrated, and validated based on physics and engineering principles, and then tested against established standards. If there were internal iterative design tests during development, those details are not part of this 510(k) summary. The software (MCU) was validated, but details on data used for its development are not disclosed.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" for an AI model in this context, this question is not fully applicable. However, for the development and calibration of the device (which broadly analogous to "training" in AI development):
- For the Device Hardware/Software: Ground truth would have been established through robust engineering principles, use of highly accurate reference temperature sources (e.g., blackbody simulators), and adherence to international standards for thermometer design and performance.
- For the Software: The software verification and validation (V&V) involved ensuring the software met its specifications and handled errors correctly, potentially using defined test cases with expected "ground truth" outputs. The document notes that the software was validated according to the FDA's software guidance and IEC 62304:2015.
In summary, the Vicks® VNT200 No Touch Forehead Thermometer demonstrates adherence to established performance standards for thermometers through a combination of rigorous non-clinical laboratory testing using objective calibrated sources and a clinical study with a sufficient sample size of human subjects. The acceptance criteria are based on recognized international and national standards for medical thermometers.
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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. 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
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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
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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)
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Section 5: 510(k) Summary
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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Element ofComparison | Subject Device: Vicks®VNT200 No Touch ForeheadThermometer | Predicate Device: Braun®No Touch + ForeheadNTF3000 Thermometer | Comparison |
|---|---|---|---|
| Manufacturer(Legal) | Kaz USA, Inc., a Helen of TroyCompany | Kaz USA, Inc., a Helen of TroyCompany | - |
| ContractManufacturer | HeTaiDa Corporation | AVITA Corporation | - |
| ThermometerType | Infrared ForeheadThermometer | Infrared ForeheadThermometer | - |
| Models(Configuration) | Vicks® VNT200 No TouchForehead Thermometer | The Braun® No Touch +Forehead NTF3000Thermometer | - |
| 510(k) Number | K193213 | K163516 | - |
| Principles ofOperation | The device measures theinfrared energy emitted in thearea around the user'sforehead | The device measures theinfrared energy emitted in thearea around the user'sforehead | - |
| Intended Use | The Vicks® VNT200 NoTouch Forehead Thermometeris a non-sterile, reusableclinical thermometer intendedfor the intermittentdetermination of human bodytemperature in a "no touch"mode, using the center of theforehead as the measurementsite, on people of all ages, in ahome use environment. | The Braun No Touch +Forehead NTF3000Thermometer is a non-sterile,reusable clinical thermometerintended for the intermittentdetermination of human bodytemperature in a touch and notouch mode on the center of theforehead as the measurementsite on people of all ages. | Different |
| Labeling | Instructions for use, quick startguide, package, and ratinglabel | Instructions for use, quick startguide, package, and ratinglabel | Different |
| Features | Temperature guidancefeature, and memory feature | Temperature guidance feature | Different |
| Components | Power / temperaturemeasurement button, Modebutton, Memory button,scanner, microcontroller, & LCD | Power button, temperaturemeasurement button, scanner,silent mode switch, protectivecap, microcontroller, & LCD | Different |
| Element ofComparison | Subject Device: Vicks®VNT200 No Touch ForeheadThermometer | Predicate Device: Braun®No Touch + ForeheadNTF3000 Thermometer | Comparison |
| Sensors | The thermometer uses aninfrared thermopile sensor withintegrated thermistor mountedin the head of the thermometerfor the target reading andambient temperature reading. | The thermometer uses athermopile sensor withintegrated thermistor for thetarget reading, a thermistormounted in the head of thethermometer for ambienttemperature readings, aparabolic mirror to help focusthe infrared energy emittedfrom the forehead, and aninfrared proximity sensor fordetection of contact or non-contact use and compensationof the temperature reading. | Different |
| OperatingEnvironment(Specifications) | 15°C to 40°C (59°F to 104°F);≤ 95% Relative Humidity;700-1060 hPA (0.7-1.06 atm) | 15°C to 40°C (59°F to 104°F);≤ 95% Relative Humidity;700-1060 hPA (0.7-1.06 atm) | Identical |
| StorageEnvironment(Specifications) | -25°C to 55°C (-13°F to 131°F);≤ 95% Relative Humidity;700-1060 hPA (0.7-1.06 atm) | -25°C to 60°C (-13°F to 140°F);≤ 95% Relative Humidity;700-1060 hPA (0.7-1.06 atm) | Different |
| MeasurementRange(Body Mode) | 34.0°C to 43.0°C(93.2°F to 109.4°F) | 34.4°C to 42.2°C(93.9°F to 108.0°F) | Different |
| Accuracy(Body Mode) | ± 0.2°C (± 0.4°F)35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C (± 0.5°F)34.0°C to 35.0°C(93.2°F to 95.0°F);± 0.3°C (± 0.5°F)Above 42.0°C(Above 107.6°F); | ± 0.2°C (± 0.4°F)35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C (± 0.5°F)34.4°C to 35.0°C(93.9°F to 95.0°F);± 0.3°C (± 0.5°F)Above 42.0°C(Above 107.6°F); | Different |
| Resolution ofDisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Identical |
| Signal Outputand Display | LCD, Buzzer | LCD, Buzzer | Identical |
| MeasurementDistance | Up to 5 centimeters (2 inches)from the center of the forehead | Up to 5 centimeters (2 inches)from the center of the forehead | Identical |
| Element ofComparison | Subject Device: Vicks®VNT200 No Touch ForeheadThermometer | Predicate Device: Braun®No Touch + ForeheadNTF3000 Thermometer | Comparison |
| MCU | Sonix SN8P1929 - a high-performance 8-bit micro-controller with 4K-word OTPROM, 256 bytes of RAM, one 8-bit basic timer (T0) with RTC(Real Time Clock) function, two8-bit timer counters (TC0, TC1) ,a watchdog timer, five interruptsources (T0, TC0, TC1, INT0,INT1), an in-systemprogramming ROM (ISP ROM)register, a 16-bit ADC, a PGIA, acharge pump/regulator, anintegrated LCD driver for 4-common x 24 segment LCDpanel, an 8-level stack register,and a dual-clock system (high-speed clock generated from theexternal oscillator circuit or on-chip 16MHz high-speed RCoscillator circuit (IHRC 16MHz),low-speed clock generated fromLXIN / LXOUT by 32768 crystalor RC oscillator circuit, and as aclock source for slow mode,real-time clock, & LCD function). | Weltrend WT5075F - A high-speed, high-performance andlow power consumption 8-bitmicro-controller, includingTurbo 8052 CPU, 64K bytesembedded Flash, 256-bytedirect-or-indirect-addressingSRAM, 2K-byte indirect-addressing-only SRAM,40x4(max.) LCD driver, a Time-Base Timer, 4 multi-functiontimer/counters, 2-channel 12-bitPWM, 1-channel divider output,serial interface (UART andSPI), 19-channel (15 externaland 4 internal) 12-bit ADconverter, 4 high-performanceOPs, analog switches and threeclock generators (32.768kHzcrystal oscillator, high-speedcrystal oscillator and high-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 materialsinclude ABS (device housing /handle, power / temperaturebutton, memory button, modebutton), & PMMA (LCD lens). | User contacting materialsinclude ABS (device housing /handle and power button),TPR (temperature button andforehead touch bumper), andPMMA (LCD lens andprotective scanner cap). | Different |
| Biocompatibility | Meets ISO 10993-1:2009,10993-5:2009, 10993-10:2010, & FDA GuidanceDocument, "Use ofInternational Standard ISO10993-1" - June 16, 2016 | Meets ISO 10993-1, 10993-5,and 10993-10, and FDABluebook memo G95-1 | SubstantiallyEquivalent |
| Performance | Meets ASTM E1965:2016 andISO 80601-2-56:2017 | Meets ASTM E1965 andISO 80601-2-56 | SubstantiallyEquivalent |
| Element ofComparison | Subject Device: Vicks®VNT200 No Touch ForeheadThermometer | Predicate Device: Braun®No Touch + ForeheadNTF3000 Thermometer | Comparison |
| ElectricalSafety | Meets ANSI / AAMI / IEC60601-1:2012 | Meets ANSI / AAMI / IEC60601-1:2012 | SubstantiallyEquivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | SubstantiallyEquivalent |
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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.
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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.
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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 inTest Mode | 1. ASTM E1965-98:20162. Directive 93 / 42 EEC3. ISO 80601-2-56:2017 | In test mode the thermometer shall be within ± 0.2°C for34-43°C or ± 0.3°C for outside of the temperature rangefor blackbody temperatures at 17.0, 23.0, 28.0, 29.0,30.0, 31.0, 32.0, 33.0, 34.0, 35.0, 36.0, 37.0, 38.0, 39.0,40.0, 41.0, & 42.0°C. | Pass |
| Accuracy as aFunction ofSupply Voltage | The thermometer shall have the same accuracy asD004327 - Accuracy in Body and Surface Modes whilethe thermometer is supplied 2.7V, 3.0V and 3.3V in a37°C and 38.5°C blackbody and shall not be greaterthan 0.2°C change between any voltage range on agiven unit | Pass | |
| Accuracy inRange ofEnvironments5E | ASTM E1965-98:20165.6.1 / 5.6.2ISO 80601-2-56:2017 | 1. In each of the five environments listed below the deviceshall be within 0.3°C of a blackbody at 22.5°C andwithin 0.2°C of a blackbody at 35, 37, 41, and 42.5°C intest mode.- Environment 1: 15-16°C with 15-25% humidity- Environment 2: 15-16°C with 85-95% humidity- Environment 3: 24-26°C with 40-60% humidity- Environment 4: 39-40°C with 15-25% humidity- Environment 5: 39-40°C with 85-95% humidity2. In operating mode, the displayed temperature shouldbe within permitted accuracy stated in the protocoldepending on blackbody temperature and ambienttemperature. | Pass |
| Display-Out ofRange andResponse Time | 1. ASTM E1965-98:20162. Directive 93 / 42 EEC3. ISO 80601-2-56:2017 | 1. In normal operating mode the thermometer shalldisplay 'Lo' if the temperature reading is below 34°Cand shall display 'Hi' if the temperature reading isabove 43°C.2. The time between the user hitting the measure buttonthe reading being displayed on the screen is less than2 seconds. | Pass |
| Current Draw inUse and SleepModes | The current draw shall not exceed:- 3uA in sleep mode- 15mA while the green backlight is displayed- 40mA while the yellow backlight is displayed- 30mA while the red backlight is displayed | Pass | |
| Battery Life | The total calculated charge consumption of thethermometer in 3 years of sleep condition & 1000readings is less than the average usable battery capacity. | Pass | |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| Low BatteryIndication | 1. ASTM E1965-98:20162. 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 bedisplayed 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 asD004327 - Accuracy in Body and Surface Modes whilethe low battery indicator is present in a 37°C blackbody | |||
| Sound Level | The beeper volume shall be between 50 dB and 85 dBwhen measured at a distance of 2 inches from thedevice, measured from the front center of the LCD. | Pass | |
| Backlight Check | 1. The luminance of the backlight on the display shall begreater than:- 14cd/m2 while the green backlight is displayed- 45cd/m2 while the yellow backlight is displayed- 5cd/m2 while the red backlight is displayed | Pass | |
| 2. The display shall show the corresponding backlightcolor during the following temperature readings:- no backlight between 34.0-35.7°C- green backlight between 35.8-37.4°C- yellow backlight between 37.5-38.5°C- red backlight between 38.6-43.0°C | |||
| LCD DisplayVisibility andReadability | 1. The temperature display numerals shall be 7mmhigh and 4mm wide | Pass | |
| 2. The temperature display shall be clearly visible from aviewing angle between 5° above and 45° below thedisplay | |||
| 3. The display shall be clearly visible throughout thedisplay angle range in low ambient temperatures (15-16°C) and high ambient temperatures (39-40°C) | |||
| Button ActuationForce & Life | 1. The actuation force for the On / Off button, Modebutton and Memory button shall be between 1-5N | Pass | |
| 2. The buttons shall withstand 10,000 actuations withoutfailure | |||
| Unit Life | The thermometer shall have the same accuracy asD004327 - Accuracy in Body and Surface Modes in a38.5°C blackbody after the unit has been through10,000 work cycles. A work cycle is defined as turningthe thermometer on, allowing the thermometer toperform a self-test, pressing the measurement buttonto display a temperature reading and allowing thethermometer to turn off automatically. | Pass | |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| Battery DoorReliability & Life | There shall be no loss of function or defects on thebattery door or device after 500 cycles of removing &snapping the battery door into place. | Pass | |
| Printing andSurfaceResistance toWiping,Cleaning andChemicals | ASTM-E1112 5.22 | The following standards shall be met after 1,000cleaning cycles of the thermometer housing using waterand 70% isopropyl alcohol:1. Accuracy defined in D004327 | |
| 2. All printing & labeling on device (including SN andLOT number) shall be clearly legible | Pass | ||
| 3. All printing & labeling shall remain intact afteradhesive tape is removed from the printed area at a30° angle | |||
| 4. All printing & labeling shall remain intact after beingscratched with a metal tip using 3-6 N of force. | |||
| Salt SprayStorage | There shall be no rust or degradation on the batterysprings, screws, PCBA or any other metal parts of thedevice after being in a salt spray chamber with 5%ionic concentration of salt solution for 48 hours. | Pass | |
| Drop TestwithoutPackaging | 1. ASTM E1965-98:20166.32. ISO 80601-2-56:20173. IEC 60601-1:2005 +A1:2012 | There shall be no evidence of damage on the visualappearance of the device or the internal components,& accuracy shall be met according to D004379Accuracy in Range of Environments 5E Test after a 1m free-fall drop over a hardwood board. The devicewill be dropped once with the IR sensor of the deviceparallel to the surface of the hardwood board & oncethrough the center of the mass of the device. | Pass |
| PackageVibration, Drop &Compress | ISTA 2A | Compliance with ISTA 2A shall be met with the device ina master pack. | Pass |
| Packaging andLabelling Check | 1. ASTM E1112 4.7.12. ASTM E1112 4.3.3.1 -4.3.3.43. ASTM E1112 4.7.34. ASTM E1112 4.7.45. ASTM E1112 4.7.56. ASTM E1112 4.7.6.1and 4.7.6.27. ASTM E1112 4.8.1 | 1. UDI barcode is grade C or higher2. Labeling is completely legible3. Artwork on the color box, Owner's Manual, & on thedevice shall match the approved artwork4. The Serial No. with date of manufacture symbolpresent on the device | Pass |
| Storage | ASTM E1965-98:20166.1.6 | The device shall be within 0.2°C on a 37°C blackbodyafter a 30-day storage. The devices shall be stored in lowtemperature storage, -25°C with <50% humidity, & will bestored in high temperature storage, 55°C with >85%humidity, for 30 days. | Pass |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| FunctionalSoftware | The user interface of the device shall match thespecifications outlined in D004247 User InterfaceSpecification | Pass | |
| FunctionalSoftware ErrorHandling | The error messages on the device shall match thespecifications outlined in D004247 User InterfaceSpecification for an incorrect button push, ambienttemperature outside of the specified limits, & targettemperature outside of the specified limits. | Pass | |
| User ErrorSafety | 1. There shall no permanent damage from inserting thebatteries with incorrect polarization2. There shall be no localized hot spots due to liquidbuildup within the device | Pass | |
| Electrical Safety | IEC 60601-1 | Compliance with IEC 60601-1:2005 + A1:2012 from a 3rdparty lab | Pass |
| Biocompatibility | ASTM E1112 4.6.2.2 and5.3ISO 10993-1:2009 | Compliance with ISO 10993-1:2009 from a 3rd party lab.Compliance with ISO 10993-10:2010 for Irritation andSkin Sensitization and ISO 10993-5:2009 for In VitroCytotoxicity. | Pass |
| ElectromagneticCompatibility | IEC 60601-1-2:2015 | Compliance with IEC 60601-2:2015 from a 3rd party lab | Pass |
| GeneralRequirementsfor Basic Safetyand EssentialPerformance | IEC 60601-1-11 2015 | Compliance with IEC 60601-1-11:2015 from a 3rd partylab | Pass |
| StandardSpecification forInfraredThermometersfor IntermittentDetermination ofPatientTemperature | ASTM E1965-98:2016 | Compliance with ASTM E1965-98:2016 from a third-party lab | Pass |
| Basic Safety andEssentialPerformance ofClinicalThermometersfor BodyTemperatureMeasurement | ISO 80601-2-56:2017 | Compliance with ISO 80601-2-56:2017 from a third-partylab | Pass |
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BIOCOMPATIBILITY TESTING:
The biocompatibility evaluation for the Vicks® VNT200 No Touch Forehead Thermometer was conducted in accordance with International Standards ISO 10993-1:2009. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization, as recognized by FDA, and per FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process," issued on June 16. 2016. The testing conducted included the following:
- . Cytotoxicity
- . Irritation
- Sensitization .
ELECTROMAGNETIC COMPATIBILITY, BASIC SAFETY, AND ESSENTIAL PERFORMANCE:
An accredited laboratory (SGS-CSTC Standards Technical Services Co., Ltd., Guangzhou Branch) that was ISO 17025 certified, tested the Vicks® VNT200 No Touch Forehead Thermometer for electromagnetic compatibility per IEC 60601-1-2-2014, for compliance to applicable portions of ANSI / AAMI / IEC 60601-1:2012, and for compliance to applicable portions of IEC 60601-1-11:2015.
Results show the thermometer is in full compliance with these requirements.
SOFTWARE VERIFICATION AND VALIDATION TESTING:
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005, and the software lifecycle standard, IEC 62304:2015 - Medical device - Software - Software lifecycle processes. The software for the Vicks® VNT200 No Touch Forehead Thermometer was considered as "Moderate Level of Concern", since a malfunction of, or a latent design flaw in, the thermometer could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
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IX. CLINICAL TESTING
Clinical testing of the Vicks® VNT200 No Touch Forehead Thermometer included a pivotal study of 208 subjects, 66 (32%) of which were febrile and 94 (45%) of which were male. The youngest subject enrolled was 3 days old, and the oldest subject enrolled was 69 years old.
The clinical study was conducted according to the requirements of the following standards for intermittent determination of patient temperature by electronic thermometers:
- . ASTM E1965-98:2016: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- . ISO 80601-2-56:2017 – Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
X. CONCLUSION
Based on the performance testing, comparison and analysis in this subject device, the Vicks® VNT200 No Touch Forehead Thermometer, is substantially equivalent to the predicate device, the Braun® No Touch + Forehead NTF3000 Thermometer – 510(k) # K163516.
§ 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.