(159 days)
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components.
No.
A therapeutic device is used for treatment. This device is a thermometer used for diagnosis (measurement of body temperature), not treatment.
No.
The intended use of the device is for the intermittent determination of human body temperature, which is a measurement function, not a diagnostic one.
No
The device description explicitly states it is a "hand-held, battery-powered, infrared thermometer" and mentions hardware components like an "infrared thermopile sensor." This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vicks® VNT200 No Touch Forehead Thermometer measures body temperature by detecting infrared energy emitted from the forehead. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the "intermittent determination of human body temperature," which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, the Vicks® VNT200 No Touch Forehead Thermometer falls under the category of a clinical thermometer or a medical device for measuring body temperature, not an In Vitro Diagnostic device.
N/A
- Intended Use / 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.
- Product codes (comma separated list FDA assigned to the subject device): FLL
- Device Description: 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.
- Mentions image processing: Not Found
- Mentions AI, DNN, or ML: Not Found
- Input Imaging Modality: Not Found
- Anatomical Site: center of the forehead
- Indicated Patient Age Range: all ages
- Intended User / Care Setting: home use environment
- Description of the training set, sample size, data source, and annotation protocol: Not Found
- Description of the test set, sample size, data source, and annotation protocol: Not Found
- Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results):
- Clinical testing: 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.
- Non-clinical testing: accuracy in test mode, accuracy as a function of supply voltage, accuracy in range of environments, display-out of range and response time, current draw in use and sleep modes, battery life, low battery indication, sound level, backlight check, LCD display visibility and readability, button actuation force & life, unit life, battery door reliability & life, printing and surface resistance to wiping, cleaning and chemicals, salt spray storage, drop test without packaging, package vibration, drop & compress, packaging and labelling check, storage, functional software, functional software error handling, user error safety, electrical safety, biocompatibility, electromagnetic compatibility, general requirements for basic safety and essential performance, standard specification for infrared thermometers for intermittent determination of patient temperature, basic safety and essential performance of clinical thermometers for body temperature measurement.
- Results: All tests passed, indicating compliance with relevant standards (ASTM E1965-98:2016, ISO 80601-2-56:2017, IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010).
- Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.): Not Found
- Predicate Device(s): Braun No Touch + Forehead NTF3000 Thermometer - 510(k) # K163516
- Reference Device(s): Not Found
- Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc): Not Found
§ 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.
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. 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
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)
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3
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.
4
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Element of
Comparison | Subject Device: Vicks®
VNT200 No Touch Forehead
Thermometer | Predicate Device: Braun®
No Touch + Forehead
NTF3000 Thermometer | Comparison |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer
(Legal) | Kaz USA, Inc., a Helen of Troy
Company | Kaz USA, Inc., a Helen of Troy
Company | - |
| Contract
Manufacturer | HeTaiDa Corporation | AVITA Corporation | - |
| Thermometer
Type | Infrared Forehead
Thermometer | Infrared Forehead
Thermometer | - |
| Models
(Configuration) | Vicks® VNT200 No Touch
Forehead Thermometer | The Braun® No Touch +
Forehead NTF3000
Thermometer | - |
| 510(k) Number | K193213 | K163516 | - |
| Principles of
Operation | The device measures the
infrared energy emitted in the
area around the user's
forehead | The device measures the
infrared energy emitted in the
area around the user's
forehead | - |
| Intended 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. | The Braun No Touch +
Forehead NTF3000
Thermometer is a non-sterile,
reusable clinical thermometer
intended for the intermittent
determination of human body
temperature in a touch and no
touch mode on the center of the
forehead as the measurement
site on people of all ages. | Different |
| Labeling | Instructions for use, quick start
guide, package, and rating
label | Instructions for use, quick start
guide, package, and rating
label | Different |
| Features | Temperature guidance
feature, and memory feature | Temperature guidance feature | Different |
| Components | Power / temperature
measurement button, Mode
button, Memory button,
scanner, microcontroller, & LCD | Power button, temperature
measurement button, scanner,
silent mode switch, protective
cap, microcontroller, & LCD | Different |
| Element of
Comparison | Subject Device: Vicks®
VNT200 No Touch Forehead
Thermometer | Predicate Device: Braun®
No Touch + Forehead
NTF3000 Thermometer | Comparison |
| Sensors | The thermometer uses an
infrared thermopile sensor with
integrated thermistor mounted
in the head of the thermometer
for the target reading and
ambient temperature reading. | The thermometer uses a
thermopile sensor with
integrated thermistor for the
target reading, a thermistor
mounted in the head of the
thermometer for ambient
temperature readings, a
parabolic mirror to help focus
the infrared energy emitted
from the forehead, and an
infrared proximity sensor for
detection of contact or non-
contact use and compensation
of the temperature reading. | Different |
| Operating
Environment
(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 |
| Storage
Environment
(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 |
| Measurement
Range
(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 of
Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Identical |
| Signal Output
and Display | LCD, Buzzer | LCD, Buzzer | Identical |
| Measurement
Distance | 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 of
Comparison | Subject Device: Vicks®
VNT200 No Touch Forehead
Thermometer | Predicate Device: Braun®
No Touch + Forehead
NTF3000 Thermometer | Comparison |
| MCU | Sonix SN8P1929 - a high-
performance 8-bit micro-
controller with 4K-word OTP
ROM, 256 bytes of RAM, one 8-
bit basic timer (T0) with RTC
(Real Time Clock) function, two
8-bit timer counters (TC0, TC1) ,
a watchdog timer, five interrupt
sources (T0, TC0, TC1, INT0,
INT1), an in-system
programming ROM (ISP ROM)
register, a 16-bit ADC, a PGIA, a
charge pump/regulator, an
integrated LCD driver for 4-
common x 24 segment LCD
panel, an 8-level stack register,
and a dual-clock system (high-
speed clock generated from the
external oscillator circuit or on-
chip 16MHz high-speed RC
oscillator circuit (IHRC 16MHz),
low-speed clock generated from
LXIN / LXOUT by 32768 crystal
or RC oscillator circuit, and as a
clock source for slow mode,
real-time clock, & LCD function). | Weltrend WT5075F - A high-
speed, high-performance and
low power consumption 8-bit
micro-controller, including
Turbo 8052 CPU, 64K bytes
embedded Flash, 256-byte
direct-or-indirect-addressing
SRAM, 2K-byte indirect-
addressing-only SRAM,
40x4(max.) LCD driver, a Time-
Base Timer, 4 multi-function
timer/counters, 2-channel 12-bit
PWM, 1-channel divider output,
serial interface (UART and
SPI), 19-channel (15 external
and 4 internal) 12-bit AD
converter, 4 high-performance
OPs, analog switches and three
clock generators (32.768kHz
crystal oscillator, high-speed
crystal 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 materials
include ABS (device housing /
handle, power / temperature
button, memory button, mode
button), & PMMA (LCD lens). | User contacting materials
include ABS (device housing /
handle and power button),
TPR (temperature button and
forehead touch bumper), and
PMMA (LCD lens and
protective scanner cap). | Different |
| Biocompatibility | Meets ISO 10993-1:2009,
10993-5:2009, 10993-
10:2010, & FDA Guidance
Document, "Use of
International Standard ISO
10993-1" - June 16, 2016 | Meets ISO 10993-1, 10993-5,
and 10993-10, and FDA
Bluebook memo G95-1 | Substantially
Equivalent |
| Performance | Meets ASTM E1965:2016 and
ISO 80601-2-56:2017 | Meets ASTM E1965 and
ISO 80601-2-56 | Substantially
Equivalent |
| Element of
Comparison | Subject Device: Vicks®
VNT200 No Touch Forehead
Thermometer | Predicate Device: Braun®
No Touch + Forehead
NTF3000 Thermometer | Comparison |
| Electrical
Safety | Meets ANSI / AAMI / IEC
60601-1:2012 | Meets ANSI / AAMI / IEC
60601-1:2012 | Substantially
Equivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | Substantially
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 | |||
| Test Mode | 1. 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 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 | | The thermometer shall have the same accuracy as
D004327 - Accuracy in Body and Surface Modes while
the thermometer is 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
5E | ASTM E1965-98:2016
5.6.1 / 5.6.2
ISO 80601-2-56:2017 | 1. In each of the five environments listed below 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.
- 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% humidity
- 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 | 1. ASTM E1965-98:2016 - Directive 93 / 42 EEC
- ISO 80601-2-56:2017 | 1. In normal operating mode the thermometer shall
display 'Lo' if the temperature reading is below 34°C
and shall display 'Hi' if the temperature reading is
above 43°C. - The time between the user hitting the measure button
the reading being displayed on the screen is less than
2 seconds. | Pass |
| Current Draw in
Use and Sleep
Modes | | 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 the
thermometer in 3 years of sleep condition & 1000
readings is less than the average usable battery capacity. | Pass |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| Low Battery
Indication | 1. ASTM E1965-98:2016
- 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
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
D004327 - Accuracy in Body and Surface Modes while
the low battery indicator is present in a 37°C blackbody | |
| Sound Level | | The beeper volume shall be between 50 dB and 85 dB
when measured at a distance of 2 inches from the
device, measured from the front center of the LCD. | Pass |
| Backlight Check | | 1. The luminance of the backlight on the display shall be
greater 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 backlight
color 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 Display
Visibility and
Readability | | 1. The temperature display numerals shall be 7mm
high and 4mm wide | Pass |
| | | 2. The temperature display shall be clearly visible from a
viewing angle between 5° above and 45° below the
display | |
| | | 3. The display shall be clearly visible throughout the
display angle range in low ambient temperatures (15-
16°C) and high ambient temperatures (39-40°C) | |
| Button Actuation
Force & Life | | 1. The actuation force for the On / Off button, Mode
button and Memory button shall be between 1-5N | Pass |
| | | 2. The buttons shall withstand 10,000 actuations without
failure | |
| Unit Life | | The thermometer shall have the same accuracy as
D004327 - Accuracy in Body and Surface Modes in a
38.5°C blackbody after the unit has been through
10,000 work cycles. A work cycle is defined as turning
the thermometer on, allowing the thermometer to
perform a self-test, pressing the measurement button
to display a temperature reading and allowing the
thermometer to turn off automatically. | Pass |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| Battery Door
Reliability & Life | | There shall be no loss of function or defects on the
battery door or device after 500 cycles of removing &
snapping the battery door into place. | Pass |
| Printing and
Surface
Resistance to
Wiping,
Cleaning and
Chemicals | ASTM-E1112 5.22 | The following standards shall be met after 1,000
cleaning cycles of the thermometer housing using water
and 70% isopropyl alcohol:
- Accuracy defined in D004327 | |
| | | 2. All printing & labeling on device (including SN and
LOT number) shall be clearly legible | Pass |
| | | 3. All printing & labeling shall remain intact after
adhesive tape is removed from the printed area at a
30° angle | |
| | | 4. All printing & labeling shall remain intact after being
scratched with a metal tip using 3-6 N of force. | |
| Salt Spray
Storage | | There shall be no rust or degradation on the battery
springs, screws, PCBA or any other metal parts of the
device after being in a salt spray chamber with 5%
ionic concentration of salt solution for 48 hours. | Pass |
| Drop Test
without
Packaging | 1. ASTM E1965-98:2016
6.3 - ISO 80601-2-56:2017
- IEC 60601-1:2005 +
A1:2012 | There shall be no evidence of damage on the visual
appearance of the device or the internal components,
& accuracy shall be met according to D004379
Accuracy in Range of Environments 5E Test after a 1
m free-fall drop over a hardwood board. The device
will be dropped once with the IR sensor of the device
parallel to the surface of the hardwood board & once
through the center of the mass of the device. | Pass |
| Package
Vibration, Drop &
Compress | ISTA 2A | Compliance with ISTA 2A shall be met with the device in
a master pack. | Pass |
| Packaging and
Labelling Check | 1. ASTM E1112 4.7.1 - ASTM E1112 4.3.3.1 -
4.3.3.4 - ASTM E1112 4.7.3
- ASTM E1112 4.7.4
- ASTM E1112 4.7.5
- ASTM E1112 4.7.6.1
and 4.7.6.2 - ASTM E1112 4.8.1 | 1. UDI barcode is grade C or higher
- Labeling is completely legible
- Artwork on the color box, Owner's Manual, & on the
device shall match the approved artwork - The Serial No. with date of manufacture symbol
present on the device | Pass |
| Storage | ASTM E1965-98:2016
6.1.6 | The device shall be within 0.2°C on a 37°C blackbody
after a 30-day storage. The devices shall be stored in low
temperature storage, -25°C with 85%
humidity, for 30 days. | Pass |
| Test Name | Cited Standards | Acceptance Criteria | Result |
| Functional
Software | | The user interface of the device shall match the
specifications outlined in D004247 User Interface
Specification | Pass |
| Functional
Software Error
Handling | | The error messages on the device shall match the
specifications outlined in D004247 User Interface
Specification for an incorrect button push, ambient
temperature outside of the specified limits, & target
temperature outside of the specified limits. | Pass |
| User Error
Safety | | 1. There shall no permanent damage from inserting the
batteries with incorrect polarization - There shall be no localized hot spots due to liquid
buildup within the device | 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 from a 3rd party lab.
Compliance with ISO 10993-10:2010 for Irritation and
Skin Sensitization and ISO 10993-5:2009 for In Vitro
Cytotoxicity. | Pass |
| Electromagnetic
Compatibility | IEC 60601-1-2:2015 | Compliance with IEC 60601-2:2015 from a 3rd party lab | Pass |
| General
Requirements
for Basic Safety
and Essential
Performance | IEC 60601-1-11 2015 | Compliance with IEC 60601-1-11:2015 from a 3rd party
lab | Pass |
| Standard
Specification for
Infrared
Thermometers
for Intermittent
Determination of
Patient
Temperature | ASTM E1965-98:2016 | Compliance with ASTM E1965-98:2016 from a third-
party lab | Pass |
| Basic Safety and
Essential
Performance of
Clinical
Thermometers
for Body
Temperature
Measurement | ISO 80601-2-56:2017 | Compliance with ISO 80601-2-56:2017 from a third-party
lab | Pass |
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11
12
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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.