(209 days)
No
The device uses a "predictive algorithm" based on a thermistor's resistance change, which is a standard method for digital thermometers and not indicative of AI/ML. The document explicitly states it does not use a clinical offset algorithm, which is a more complex calculation but still not necessarily AI/ML. There is no mention of AI, ML, or related terms.
No
The device is a digital thermometer used for measuring human body temperature. It is a diagnostic tool, not a therapeutic one that treats or prevents a condition.
Yes
The device is a digital thermometer, which measures body temperature. While it doesn't diagnose a specific disease, it provides a measurement that can be used by a healthcare professional (or an individual) to help determine if there is a fever, which is a symptom of many health conditions. Therefore, it provides information used in the diagnostic process.
No
The device description explicitly states it is a "handheld, battery-powered, predictive, digital stick thermometer" and uses a "thermistor-based" measurement tip, indicating it is a physical hardware device.
Based on the provided information, the Vicks® VDT972 RapidRead™ Digital Thermometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vicks® VDT972 RapidRead™ Digital Thermometer directly measures human body temperature through contact with the skin (oral, rectal, or axillary). It does not analyze a specimen taken from the body.
Therefore, while it's a medical device used for health monitoring, it falls under the category of a clinical thermometer rather than an IVD.
N/A
Intended Use / 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, 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.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally, or under the arm
Indicated Patient Age Range
people of all ages (infants, children, and adults)
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
Clinical Study:
Study Type: Prospective, multicenter, non-inferiority clinical investigation. Clinical testing focused on Clinical Accuracy, specified by Clinical Bias and Clinical Repeatability.
Sample Size: 165 subjects
Key Results:
Primary Endpoint: The Vicks® VDT972 RapidRead™ Digital Thermometer was found to be equivalent to the predicate device (Vicks® V966 ComfortFlex® Digital Thermometer) in terms of Clinical Bias for all age groups combined (0.2°C vs. -0.34°C), each age group individually, and for febrile subjects (0.09°C vs. -0.70°C).
Secondary Endpoint: The Vicks® VDT972 RapidRead™ Digital Thermometer was found to be equivalent to the predicate device, overall, in terms of Standard Deviation (Limits of Agreement) and Clinical Repeatability for all age groups and febrile subjects.
Overall Clinical Bias:
§ 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
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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)
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| 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)
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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
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks® V966
ComfortFlex® Digital
Thermometer | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer
(Legal) | Kaz USA, Inc., a Helen of Troy
Company | Kaz USA, Inc., a Helen of Troy
Company | |
| Contract
Manufacturer | Microlife Corporation | Microlife Corporation | |
| Thermometer
Type | Axillary / Oral / Rectal, Predictive
Digital Thermometer | Axillary / Oral / Rectal, Predictive
Digital Thermometer | Substantially
Equivalent |
| Models | Vicks® VDT972 RapidRead™
Digital Thermometer | V966 Vicks® ComfortFlex® Digital
Thermometer (Microlife Instant
Digital Thermometer, Model
MT18L1) | |
| 510(k) Number | K180131 | K043110 | |
| Intended 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. | V966 Vicks® ComfortFlex® Digital
Thermometer (Microlife Instant
Digital Thermometer, Model
MT18L1) is used for the intermittent
measurement and monitoring of
human body temperature, orally,
rectally and under the arm. The
device is for the adult & pediatric
population. | Substantially
Equivalent |
| User Population | Infants, children, and adults | Adult and pediatric | Substantially
Equivalent |
| Labeling | Instructions for use, package / box,
and rating label | Instructions for use, package / box,
and rating label | Substantially
Equivalent |
| Components | On / Off Button, Site Selection
Button, sensor head, protective
cover, microcontroller, & LCD | On / Off Button, sensor head,
protective cover, microcontroller, &
LCD | Substantially
Equivalent |
| Sensor | Thermistor | Thermistor | Substantially
Equivalent |
| Principles of
Operation | The thermometer uses a negative
temperature coefficient 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, which 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. Because the thermometer
displays the measurement for the
physiological site at which it is used, it
does not need to convert this
temperature via clinical offset. | The thermometer uses a negative
temperature coefficient 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, which 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. Because the thermometer
displays the measurement for the
physiological site at which it is used, it
does not need to convert this
temperature via clinical offset. | Substantially
Equivalent |
| Measurement
Range | 34.0°C to 43.0°C
(93.2°F to 109.4°F) | 32.0°C to 42.9°C
(89.6°F to 109.2°F) | Substantially
Equivalent |
| Element of
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks® V966
ComfortFlex® Digital
Thermometer | Comparison |
| Accuracy | ± 0.1°C / 0.2°F within
measurement range
(34.0°C to 43.0°C /
93.2°F to 109.4°F) at room
temperature of 71°F | ± 0.1°C / 0.2°F within
measurement range
(35.6°C to 41.7°C /
(96.0°F to 107.0°F) at room
temperature of 71°F | Substantially
Equivalent |
| Resolution of
Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Substantially
Equivalent |
| Response Time | 2 to 8 seconds | 8 to 15 seconds | Substantially
Equivalent |
| MCU | The Sonix SN8F5907 is an 8-bit
architecture microcontroller which is
compatible with MCS-51 instruction
set. It includes an enhanced 8051
microcontroller, up to 32 MHz
flexible CPU frequency, hardware
multiplication / division Unit, 256
bytes internal RAM (IRAM), 2 KB
external RAM (XRAM), 64 KB non-
volatile flash memory (IROM), in-
system program support, 10 interrupt
sources with priority control, 2
external interrupts: INT0, INT1, 3 set
16-bit timer/counter with auto reload,
PWM output function, 1 set 8-bit
base timer for RTC, 1 set buzzer
function output pin, one comparator
for low battery detect 2.2V3.6V128x), 24-bit
(0.2V/step), 1 set charge pump
regulator (AVDDR and ACM), 1 set
programmable gain instrument
amplifier (Gain:1x
Delta Sigma ADC with 9 external
channels and 4 internal channels, 1
set operational amplifier, C-type LCD
driver up to 252 dot (4x44 or 6x42
dots), programmable watchdog and
software reset, SPI, UART, I2C
interface with SMBus support, on-
chip debug support (single-wire
debug interface), wide supply
voltage (1.8V to 5.5V), wide working
temperature (-40°C to 85°C). | The Holtek HT47C20 is an 8-bit
high performance RISC-like
microcontroller. It includes a
2.4V~3.6V operating voltage, eight
bidirectional I/O lines, four input
lines, one interrupt input, one 16-bit
programmable timer / event counter
with PFD (programmable frequency
divider) function, on-chip crystal and
RC oscillator for system clock, one
32.768kHz crystal oscillator for real
time clock, Watchdog Timer, 2K16
program memory ROM, 648 data
memory RAM, one Real Time Clock
(RTC), one 8-bit prescaler for RTC,
one buzzer output, HALT function
and wake-up feature to reduce
power consumption, LCD bias C
type, one LCD driver with 203 or
194 segments, one 38kHz or 40kHz
IR carrier output (455kHz or 480kHz
system clock only), two channels
RC type A/D converter, four-level
subroutine nesting, bit manipulation
instruction, 16-bit table read
instruction, up to 8.3s instruction
cycle with 480kHz system clock, all
instructions in one or two machine
cycles, 63 powerful instructions, 64-
pin QFP package G | Substantially
Equivalent |
| Signal Output and
Display | LCD, Buzzer | LCD, Buzzer | Substantially
Equivalent |
| Operating
Environment | 15.0°C to 40.0°C /
59.0°F to 104.0°F;
≤ 95% Relative Humidity | 10°C to 40°C /
50°F to 104°F;
15-95% Relative Humidity | Substantially
Equivalent |
| Storage
Environment | -25.0°C to 60.0°C /
-13.0°F to 140.0°F;
≤ 95% Relative Humidity | -25.0°C to 60.0°C /
-13.0°F to 140.0°F;
15-95% Relative Humidity | Substantially
Equivalent |
| Power Supply | One (1), 3V, CR2032 battery | One (1), 3V, CR1225 battery | Substantially
Equivalent |
| Battery Life | More than 400 measurements or
approximately 2 years if used
every other day. | More than 300 measurements or
approximately 2 years if used every
other day. | Substantially
Equivalent |
| Element of
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks® V966
ComfortFlex® Digital
Thermometer | Comparison |
| Materials | User contacting materials include
ABS (sensor head, battery door
and On / Off Button), TPR (probe
and Site Selection Button), PMMA
(LCD lens and protective cover),
and stainless steel (sensor tip) | User contacting materials include
ABS (sensor head and battery
door), TPR (probe, LCD lens
casing, On / Off Button, and sensor
head seam strip), PMMA (LCD
lens and protective cover), and
stainless steel (sensor tip) | Substantially
Equivalent |
| Performance | Meets ASTM E1112-00:2011 and
ISO 80601-2-56:2017 | Meets ASTM E1112 | Substantially
Equivalent |
| Biocompatibility | Meets ISO 10993-1:2009, 10993-
5:2009, 10993-10:2010, and 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 |
| Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | Substantially
Equivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2 | Substantially
Equivalent |
5
6
Substantial Equivalence Comparison Table - Vicks® VDT985 SmartTemp™ Wireless Thermometer
| Element of
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks®
VDT985 SmartTemp™
Wireless Thermometer | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer
(Legal) | Kaz USA, Inc., a Helen of Troy
Company | Kaz USA, Inc., a Helen of Troy
Company | |
| Contract
Manufacturer | Microlife Corporation | Microlife Corporation | |
| Thermometer
Type | Axillary / Oral / Rectal, Predictive
Digital Thermometer | Axillary / Oral / Rectal, Predictive
Digital Thermometer | Substantially
Equivalent |
| Models | Vicks® VDT972 RapidRead™
Digital Thermometer | Vicks® VDT985 SmartTemp™
Wireless Thermometer | |
| 510(k) Number | K180131 | K152975 | |
| Intended 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. | Vicks® VDT985 SmartTemp™ Wireless Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally, or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only. | Substantially
Equivalent |
| User Population | Infants, children, and adults | People of all ages except preterm babies or very small (for
gestational age) | Substantially
Equivalent |
| Labeling | Instructions for use, package / box, and rating label | Instructions for use, package / box, and rating label | Substantially
Equivalent |
| Components | On / Off Button, Site Selection Button, sensor head, protective cover, microcontroller, & LCD | On / Off Button, sensor head, microcontroller, LED status indicator, & protective cover | Substantially
Equivalent |
| Element of
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks®
VDT985 SmartTemp™
Wireless Thermometer | Comparison |
| Sensor | Thermistor | Thermistor | Substantially
Equivalent |
| Principles of
Operation | The thermometer uses a negative
temperature coefficient 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, which 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. Because the thermometer
displays the measurement for the
physiological site at which it is used, it
does not need to convert this
temperature via clinical offset. | The thermometer uses a negative
temperature coefficient 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, which 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 on their smartphone via
Bluetooth communication using the
Vicks® SmartTemp™ Thermometer
app. Because the thermometer
displays the measurement for the
physiological site at which it is used, it
does not need to convert this
temperature via clinical offset. | Substantially
Equivalent |
| Measurement
Range | 34.0°C to 43.0°C
(93.2°F to 109.4°F) | 32.0°C to 42.9°C
(89.6°F to 109.2°F) | Substantially
Equivalent |
| Accuracy | ± 0.1°C / 0.2°F within
measurement range
(34.0°C to 43.0°C /
93.2°F to 109.4°F) at room
temperature of 71°F | ± 0.1°C / 0.2°F within
measurement range
(35.5°C to 42.0°C /
(95.9°F to 107.6°F) at room
temperature of 71°F | Substantially
Equivalent |
| Resolution of
Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Substantially
Equivalent |
| Response Time | 2 to 8 seconds | 8 to 15 seconds | Substantially
Equivalent |
| Signal Output and
Display | LCD, Buzzer | LCD, Buzzer | Substantially
Equivalent |
| Operating
Environment | 15.0°C to 40.0°C /
59.0°F to 104.0°F;
≤ 95% Relative Humidity | 10°C to 40°C /
50°F to 104°F:
15-95% Relative Humidity | Substantially
Equivalent |
| Storage
Environment | -25.0°C to 60.0°C /
-13.0°F to 140.0°F;
≤ 95% Relative Humidity | -25.0°C to 55.0°C /
-13.0°F to 131.0°F;
15-95% Relative Humidity | Substantially
Equivalent |
| Power Supply | One (1), 3V, CR2032 battery | One (1), 3V, CR2032 battery | Substantially
Equivalent |
| Battery Life | More than 400 measurements or
approximately 2 years if used
every other day. | More than 100 measurements or
approximately 2 years if used every
week. | Substantially
Equivalent |
| Element of
Comparison | Test Device: Vicks® VDT972
RapidRead™ Digital
Thermometer | Predicate Device: Vicks®
VDT985 SmartTemp™
Wireless Thermometer | Comparison |
| MCU | The Sonix SN8F5907 is an 8-bit
architecture microcontroller which is
compatible with MCS-51 instruction
set. It includes an enhanced 8051
microcontroller, up to 32 MHz
flexible CPU frequency, hardware
multiplication / division Unit, 256
bytes internal RAM (IRAM), 2 KB
external RAM (XRAM), 64 KB non-
volatile flash memory (IROM), in-
system program support, 10 interrupt
sources with priority control, 2
external interrupts: INT0, INT1, 3 set
16-bit timer/counter with auto reload,
PWM output function, 1 set 8-bit
base timer for RTC, 1 set buzzer
function output pin, one comparator
for low battery detect 2.2V3.6V128x), 24-bit
(0.2V/step), 1 set charge pump
regulator (AVDDR and ACM), 1 set
programmable gain instrument
amplifier (Gain:1x
Delta Sigma ADC with 9 external
channels and 4 internal channels, 1
set operational amplifier, C-type LCD
driver up to 252 dot (4x44 or 6x42
dots), programmable watchdog and
software reset, SPI, UART, I2C
interface with SMBus support, on-
chip debug support (single-wire
debug interface), wide supply
voltage (1.8V - 5.5V), wide working
temperature (-40°C to 85°C). | The Sonix SN8F5909 is an 8-bit
architecture microcontroller which is
compatible with MCS-51 instruction
set. It includes an enhanced 8051
microcontroller, up to 32 MHz flexible
CPU frequency, hardware
multiplication / division Unit, 256
bytes internal RAM (IRAM), 2 KB
external RAM (XRAM), 64 KB non-
volatile flash memory (IROM), in-
system program support, 10 interrupt
sources with priority control, 2
external interrupts: INT0, INT1, 3 set
16-bit timer/counter with auto reload,
PWM output function, 1 set 8-bit
base timer for RTC, 1 set buzzer
function output pin, one comparator
for low battery detect 2.2V3.6V128x), 24-bit
(0.2V/step), 1 set charge pump
regulator (AVDDR and ACM), 1 set
programmable gain instrument
amplifier (Gain:1x
Delta Sigma ADC with 9 external
channels and 4 internal channels, 1
set operational amplifier, C-type LCD
driver up to 252 dot (4x44 or 6x42
dots), programmable watchdog and
software reset, SPI, UART, I2C
interface with SMBus support, on-
chip debug support (single-wire
debug interface), wide supply
voltage (1.8V - 5.5V), wide working
temperature (-40°C to 85°C). | Substantially
Equivalent |
| Materials | User contacting materials include
ABS (sensor head, battery door
and On / Off Button), TPR (probe
and Site Selection Button), PMMA
(LCD lens and protective cover),
and stainless steel (sensor tip) | User contacting materials include
ABS (sensor head and battery
door), TPR (probe and On / Off
Button), PMMA (face panel and
protective cover), and stainless
steel (sensor tip) | Substantially
Equivalent |
| Performance | Meets ASTM E1112-00:2011 and
ISO 80601-2-56:2017 | Meets ASTM E1112 and ISO
80601-2-56 | Substantially
Equivalent |
| Biocompatibility | Meets ISO 10993-1:2009, 10993-
5:2009, 10993-10:2010, and 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 |
| Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | Substantially
Equivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2 | Substantially
Equivalent |
7
8
9
VII. PERFORMANCE DATA
The following performance data for the Vicks® VDT972 RapidRead™ Digital Thermometer are provided in support of the substantial equivalence determination:
BIOCOMPATIBILITY TESTING:
The biocompatibility evaluation for the Vicks® VDT972 RapidRead™ Digital 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 IS10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process," issued on June 16, 2016. The test reports for the materials of construction of the thermometer include the following:
- . Cytotoxicity
- Irritation .
- . Sensitization
ELECTROMAGNETIC COMPATIBILITY, BASIC SAFETY, AND ESSENTIAL PERFORMANCE:
An accredited laboratory (Shenzhen Huatongwei International Inspection Company, Ltd.) that was ISO 17025 certified, tested the Vicks® VDT972 RapidRead™ Digital Thermometer for electromagnetic compatibility per IEC 60601-1-2-2014 and for compliance to applicable portions of EN 60601-1:2014. A separate accredited laboratory (Washington Laboratories, Ltd.) that was ISO 17025 certified, tested the Vicks® VDT972 RapidRead™ Digital Thermometer 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 62304:2006 - Medical device software - Software lifecycle processes. The software for the Vicks® VDT972 RapidRead™ Digital 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.
FUNCTIONAL PERFORMANCE, RELIABILITY, PACKAGING, AND ENVIRONMENTAL TESTING:
- Performance throughout the environmental range ●
- . Low battery indication and accuracy as a function of supply voltage
- Power consumption, battery voltage, and life ●
- . Audio and visual feedback
- . Measurement time test
- Unit life ●
- Cleaning test, label rubbing, and product art rubbing
- Drop without packaging .
- . Packaging drop and vibration
- Packaging components check ●
- Storage ●
- Water ingress .
- Salt spray .
10
CLINICAL STUDY:
Clinical testing of the Vicks® VDT972 RapidRead™ Digital Thermometer included a pivotal study of 165 subjects, 59 (36%) of which were febrile and 74 (44%) of which were male. Substantial equivalence was based in part on the pivotal clinical study.
The investigation was a prospective, multicenter, non-inferiority clinical investigation. In order to test the Vicks® VDT972 RapidRead™ Digital Thermometer for non-inferiority (substantial equivalence) compared to the Vicks® V966 ComfortFlex® Digital Thermometer (510(k) # K043110), both thermometers were compared to the well-established, "Gold Standard" reference device, the Welch Allyn SureTemp® Plus 690 Thermometer (510(k) # K030580).
All readings were taken using calibrated thermometers in accordance with the respective manufacturer's instructions, and all readings were taken using FDA cleared, single-use, disposable probe covers (510(k) # K102508). For all afebrile subjects and febrile subjects greater than or equal to five (5) years of age, one (1) reading was taken with the reference thermometer, the Welch Allyn SureTemp® Plus 690 Thermometer, followed by three (3) consecutive readings with the test thermometer, the Vicks® VDT972 RapidRead™ Digital Thermometer, and three (3) consecutive readings with the predicate thermometer, the Vicks® V966 ComfortFlex® Digital Thermometer, at one-minute intervals. For all febrile subjects less than five (5) years of age, one (1) reading was taken with each the reference thermometer, the test thermometer, and the predicate thermometer, at one-minute intervals. The use order of the test and predicate thermometers for both single measurement and consecutive triplicate measurements was randomized, and the test and predicate devices used were randomized to eliminate any bias.
| Age Group | Axillary
Measurement | Rectal
Measurement | Oral
Measurement | TOTALS |
|------------------------|-------------------------|-----------------------|---------------------|--------|
| 0 to 3 months | 13 | 16 | 0 | 29 |
| > 3 to 12 months | 14 | 14 | 0 | 28 |
| > 12 months to 5 years | 30 | 28 | 0 | 58 |
| > 5 to 18 years | 0 | 0 | 25 | 25 |
| > 18 years | 0 | 0 | 25 | 25 |
| TOTALS | 57 | 58 | 50 | 165 |
The following table displays the number of subjects enrolled in the clinical study by age group and temperature measurement site:
Primary Endpoint:
The Vicks® VDT972 RapidRead™ Digital Thermometer was found to be equivalent to the predicate device, in terms of Clinical Bias, for all age groups combined (0.2°C vs. -0.34°C), each age group individually, and for febrile subjects (0.09°C vs. -0.70°C).
Secondary Endpoint:
The Vicks® VDT972 RapidRead™ Digital Thermometer was found to be equivalent to the predicate device, overall, in terms of Standard Deviation (Limits of Agreement) and Clinical Repeatability for all age groups and febrile subjects. The overall Clinical Bias was