(209 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Vicks® VDT972 RapidRead™ Digital Thermometer
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vicks® VDT972 RapidRead™ Digital Thermometer are primarily based on demonstrating substantial equivalence to its predicate devices, especially regarding performance standards like accuracy, and compliance with relevant international standards. The study aimed to show non-inferiority in clinical performance compared to the predicate device and the "Gold Standard" reference device.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Vicks® VDT972 RapidRead™) | How Performance Meets Criteria |
|---|---|---|---|
| Accuracy (Technical) | ± 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 (Predicate V966) | ± 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 | Identical to predicate. |
| Accuracy (Clinical) | Clinical Bias < ± 0.20℃ (< ± 0.36°F) | For all age groups combined: 0.2°C (Test) vs. -0.34°C (Predicate). For febrile subjects: 0.09°C (Test) vs. -0.70°C (Predicate). Overall Clinical Bias was < ± 0.20℃. | The clinical bias of the test device was demonstrably within the acceptance criteria and equivalent to the predicate. |
| Clinical Repeatability | Clinical Repeatability < ± 0.3°C (< ± 0.54°F) | Overall Clinical Repeatability was < ± 0.3°C (< ± 0.54°F). | The clinical repeatability of the test device was demonstrably within the acceptance criteria and equivalent to the predicate. |
| Performance Standard (Bench) | Meets ASTM E1112-00:2011 | Meets ASTM E1112-00:2011 | Device meets the specified standard. |
| Performance Standard (Clinical) | Meets ISO 80601-2-56:2017 | Meets ISO 80601-2-56:2017 | Device meets the specified standard. |
| 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 | Test reports for materials of construction showed compliance with Cytotoxicity, Irritation, and Sensitization. | Device meets the specified standards. |
| Electromagnetic Compatibility | Meets IEC 60601-1-2:2014 | Resulted in full compliance with IEC 60601-1-2-2014. | Device meets the specified standard. |
| Basic Safety & Essential Performance | Meets applicable portions of EN 60601-1:2014 and IEC 60601-1-11:2015 | Resulted in full compliance with applicable portions of EN 60601-1:2014 and IEC 60601-1-11:2015. | Device meets the specified standards. |
| Software Verification & Validation | Adheres to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304:2006. | Software verification and validation testing was conducted, and documentation was provided as recommended by FDA guidance and IEC 62304:2006. | Documentation was provided, and the software was considered "Moderate Level of Concern". Implies compliance. |
| Safety (Clinical) | No reports of Adverse Events, Serious Adverse Events, or discomfort. | No adverse events, serious adverse events, or complaints of discomfort were reported. | Device demonstrated a favorable safety profile. |
| Overall Equivalence | Non-inferiority and substantial equivalence to predicate device. | Found to be non-inferior and substantially equivalent to the predicate thermometer with a similar safety and effectiveness profile. | The study met its primary and secondary endpoints. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 165 subjects.
- Breakdown by age group and measurement site:
- 0 to 3 months: 13 (Axillary), 16 (Rectal), 0 (Oral) = 29 total
-
3 to 12 months: 14 (Axillary), 14 (Rectal), 0 (Oral) = 28 total
-
12 months to 5 years: 30 (Axillary), 28 (Rectal), 0 (Oral) = 58 total
-
5 to 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total
-
18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total
- Breakdown by age group and measurement site:
- Data Provenance: The document does not explicitly state the country of origin. It describes a "multicenter" clinical investigation, implying data collected from multiple locations, likely within the same country given the FDA submission.
- Retrospective or Prospective: The study was a prospective clinical investigation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by a "Gold Standard" reference device, the Welch Allyn SureTemp® Plus 690 Thermometer. The study methodology describes readings taken with this device. It does not mention human experts directly establishing ground truth for individual temperature readings. The accuracy of the reference device itself is presumed to be established through its own regulatory clearances and accepted metrological standards.
4. Adjudication Method for the Test Set
The document does not detail an adjudication method for disagreements between human readers, as the primary comparison was between devices. Instead, it describes:
- For afebrile subjects and febrile subjects ≥ 5 years of age: 1 reading with the reference thermometer, followed by 3 consecutive readings with the test thermometer, and 3 consecutive readings with the predicate thermometer, at one-minute intervals.
- For febrile subjects < 5 years of age: 1 reading with each of the reference, test, and predicate thermometers, at one-minute intervals.
- The use order of test and predicate thermometers was randomized.
- Test and predicate devices were randomized to eliminate bias.
This approach focuses on direct comparison and statistical analysis of device output rather than clinical adjudication of individual readings by multiple human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is for a digital thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the core of the evaluation is a standalone performance assessment of the Vicks® VDT972 RapidRead™ Digital Thermometer. The predictive algorithm within the thermometer itself generates the temperature reading. The clinical study directly evaluated the accuracy and repeatability of this device's readings compared to a reference standard and a predicate device, without human intervention in the temperature measurement and display process.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established using an accepted "Gold Standard" reference device: the Welch Allyn SureTemp® Plus 690 Thermometer (510(k) # K030580). This reference device itself has established accuracy specifications, making its measurements the de facto ground truth for this particular study.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the clinical study. For a digital thermometer using a predictive algorithm, the "training" for the algorithm itself would likely occur during its development and calibration by the manufacturer, using a variety of temperature profiles and physiological data. This information is typically proprietary and not included in a 510(k) summary focused on clinical validation. The clinical study described here is primarily a validation study for the finished device.
9. How the Ground Truth for the Training Set was Established
As noted in point 8, the document does not provide details on a specific training set or how its ground truth was established. The "predictive algorithm" in the thermometer is mentioned, implying internal development and calibration, but the methodology for establishing ground truth for that specific algorithm's training is not detailed in this regulatory submission.
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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
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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
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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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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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE(S) VI.
| Substantial Equivalence Comparison Table - Vicks® V966 ComfortFlex® Digital Thermometer | ||
|---|---|---|
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks® V966ComfortFlex® DigitalThermometer | Comparison |
|---|---|---|---|
| Manufacturer(Legal) | Kaz USA, Inc., a Helen of TroyCompany | Kaz USA, Inc., a Helen of TroyCompany | |
| ContractManufacturer | Microlife Corporation | Microlife Corporation | |
| ThermometerType | Axillary / Oral / Rectal, PredictiveDigital Thermometer | Axillary / Oral / Rectal, PredictiveDigital Thermometer | SubstantiallyEquivalent |
| Models | Vicks® VDT972 RapidRead™Digital Thermometer | V966 Vicks® ComfortFlex® DigitalThermometer (Microlife InstantDigital Thermometer, ModelMT18L1) | |
| 510(k) Number | K180131 | K043110 | |
| Intended Use | The Vicks® VDT972 RapidRead™Digital Thermometer is a handheld,battery-powered, predictive, digitalstick thermometer intended for theintermittent determination of humanbody temperature orally, rectally, orunder the arm, in a home-useenvironment for people of all ages(infants, children, and adults). It isintended to be used with a single-use, disposable probe cover for allmeasurements. | V966 Vicks® ComfortFlex® DigitalThermometer (Microlife InstantDigital Thermometer, ModelMT18L1) is used for the intermittentmeasurement and monitoring ofhuman body temperature, orally,rectally and under the arm. Thedevice is for the adult & pediatricpopulation. | SubstantiallyEquivalent |
| User Population | Infants, children, and adults | Adult and pediatric | SubstantiallyEquivalent |
| Labeling | Instructions for use, package / box,and rating label | Instructions for use, package / box,and rating label | SubstantiallyEquivalent |
| Components | On / Off Button, Site SelectionButton, sensor head, protectivecover, microcontroller, & LCD | On / Off Button, sensor head,protective cover, microcontroller, &LCD | SubstantiallyEquivalent |
| Sensor | Thermistor | Thermistor | SubstantiallyEquivalent |
| Principles ofOperation | The thermometer uses a negativetemperature coefficient thermistorembedded in a measurement tip thatis in contact with the measurementsite. As the thermistor changestemperature, the resistance of thethermistor also changes, which ismeasured by the thermometer andconverted to a measurement of thetemperature of the tip of thethermometer. This temperature,following the use of the predictivealgorithm, is then displayed to the enduser. Because the thermometerdisplays the measurement for thephysiological site at which it is used, itdoes not need to convert thistemperature via clinical offset. | The thermometer uses a negativetemperature coefficient thermistorembedded in a measurement tip thatis in contact with the measurementsite. As the thermistor changestemperature, the resistance of thethermistor also changes, which ismeasured by the thermometer andconverted to a measurement of thetemperature of the tip of thethermometer. This temperature,following the use of the predictivealgorithm, is then displayed to the enduser. Because the thermometerdisplays the measurement for thephysiological site at which it is used, itdoes not need to convert thistemperature via clinical offset. | SubstantiallyEquivalent |
| MeasurementRange | 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) | SubstantiallyEquivalent |
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks® V966ComfortFlex® DigitalThermometer | Comparison |
| Accuracy | ± 0.1°C / 0.2°F withinmeasurement range(34.0°C to 43.0°C /93.2°F to 109.4°F) at roomtemperature of 71°F | ± 0.1°C / 0.2°F withinmeasurement range(35.6°C to 41.7°C /(96.0°F to 107.0°F) at roomtemperature of 71°F | SubstantiallyEquivalent |
| Resolution ofDisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | SubstantiallyEquivalent |
| Response Time | 2 to 8 seconds | 8 to 15 seconds | SubstantiallyEquivalent |
| MCU | The Sonix SN8F5907 is an 8-bitarchitecture microcontroller which iscompatible with MCS-51 instructionset. It includes an enhanced 8051microcontroller, up to 32 MHzflexible CPU frequency, hardwaremultiplication / division Unit, 256bytes internal RAM (IRAM), 2 KBexternal RAM (XRAM), 64 KB non-volatile flash memory (IROM), in-system program support, 10 interruptsources with priority control, 2external interrupts: INT0, INT1, 3 set16-bit timer/counter with auto reload,PWM output function, 1 set 8-bitbase timer for RTC, 1 set buzzerfunction output pin, one comparatorfor low battery detect 2.2V | The Holtek HT47C20 is an 8-bithigh performance RISC-likemicrocontroller. It includes a2.4V~3.6V operating voltage, eightbidirectional I/O lines, four inputlines, one interrupt input, one 16-bitprogrammable timer / event counterwith PFD (programmable frequencydivider) function, on-chip crystal andRC oscillator for system clock, one32.768kHz crystal oscillator for realtime clock, Watchdog Timer, 2K16program memory ROM, 648 datamemory RAM, one Real Time Clock(RTC), one 8-bit prescaler for RTC,one buzzer output, HALT functionand wake-up feature to reducepower consumption, LCD bias Ctype, one LCD driver with 203 or194 segments, one 38kHz or 40kHzIR carrier output (455kHz or 480kHzsystem clock only), two channelsRC type A/D converter, four-levelsubroutine nesting, bit manipulationinstruction, 16-bit table readinstruction, up to 8.3s instructioncycle with 480kHz system clock, allinstructions in one or two machinecycles, 63 powerful instructions, 64-pin QFP package G | SubstantiallyEquivalent |
| Signal Output andDisplay | LCD, Buzzer | LCD, Buzzer | SubstantiallyEquivalent |
| OperatingEnvironment | 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 | SubstantiallyEquivalent |
| StorageEnvironment | -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 | SubstantiallyEquivalent |
| Power Supply | One (1), 3V, CR2032 battery | One (1), 3V, CR1225 battery | SubstantiallyEquivalent |
| Battery Life | More than 400 measurements orapproximately 2 years if usedevery other day. | More than 300 measurements orapproximately 2 years if used everyother day. | SubstantiallyEquivalent |
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks® V966ComfortFlex® DigitalThermometer | Comparison |
| Materials | User contacting materials includeABS (sensor head, battery doorand On / Off Button), TPR (probeand Site Selection Button), PMMA(LCD lens and protective cover),and stainless steel (sensor tip) | User contacting materials includeABS (sensor head and batterydoor), TPR (probe, LCD lenscasing, On / Off Button, and sensorhead seam strip), PMMA (LCDlens and protective cover), andstainless steel (sensor tip) | SubstantiallyEquivalent |
| Performance | Meets ASTM E1112-00:2011 andISO 80601-2-56:2017 | Meets ASTM E1112 | SubstantiallyEquivalent |
| Biocompatibility | Meets ISO 10993-1:2009, 10993-5:2009, 10993-10:2010, and FDAGuidance Document, "Use ofInternational Standard ISO 10993-1" – June 16, 2016 | Meets ISO 10993-1, 10993-5, and10993-10, and FDA Bluebookmemo G95-1 | SubstantiallyEquivalent |
| Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | SubstantiallyEquivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2 | SubstantiallyEquivalent |
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Substantial Equivalence Comparison Table - Vicks® VDT985 SmartTemp™ Wireless Thermometer
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks®VDT985 SmartTemp™Wireless Thermometer | Comparison |
|---|---|---|---|
| Manufacturer(Legal) | Kaz USA, Inc., a Helen of TroyCompany | Kaz USA, Inc., a Helen of TroyCompany | |
| ContractManufacturer | Microlife Corporation | Microlife Corporation | |
| ThermometerType | Axillary / Oral / Rectal, PredictiveDigital Thermometer | Axillary / Oral / Rectal, PredictiveDigital Thermometer | SubstantiallyEquivalent |
| 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. | SubstantiallyEquivalent |
| User Population | Infants, children, and adults | People of all ages except preterm babies or very small (forgestational age) | SubstantiallyEquivalent |
| Labeling | Instructions for use, package / box, and rating label | Instructions for use, package / box, and rating label | SubstantiallyEquivalent |
| Components | On / Off Button, Site Selection Button, sensor head, protective cover, microcontroller, & LCD | On / Off Button, sensor head, microcontroller, LED status indicator, & protective cover | SubstantiallyEquivalent |
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks®VDT985 SmartTemp™Wireless Thermometer | Comparison |
| Sensor | Thermistor | Thermistor | SubstantiallyEquivalent |
| Principles ofOperation | The thermometer uses a negativetemperature coefficient thermistorembedded in a measurement tip thatis in contact with the measurementsite. As the thermistor changestemperature, the resistance of thethermistor also changes, which ismeasured by the thermometer andconverted to a measurement of thetemperature of the tip of thethermometer. This temperature,following the use of the predictivealgorithm, is then displayed to the enduser. Because the thermometerdisplays the measurement for thephysiological site at which it is used, itdoes not need to convert thistemperature via clinical offset. | The thermometer uses a negativetemperature coefficient thermistorembedded in a measurement tip thatis in contact with the measurementsite. As the thermistor changestemperature, the resistance of thethermistor also changes, which ismeasured by the thermometer andconverted to a measurement of thetemperature of the tip of thethermometer. This temperature,following the use of the predictivealgorithm, is then displayed to the enduser on their smartphone viaBluetooth communication using theVicks® SmartTemp™ Thermometerapp. Because the thermometerdisplays the measurement for thephysiological site at which it is used, itdoes not need to convert thistemperature via clinical offset. | SubstantiallyEquivalent |
| MeasurementRange | 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) | SubstantiallyEquivalent |
| Accuracy | ± 0.1°C / 0.2°F withinmeasurement range(34.0°C to 43.0°C /93.2°F to 109.4°F) at roomtemperature of 71°F | ± 0.1°C / 0.2°F withinmeasurement range(35.5°C to 42.0°C /(95.9°F to 107.6°F) at roomtemperature of 71°F | SubstantiallyEquivalent |
| Resolution ofDisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | SubstantiallyEquivalent |
| Response Time | 2 to 8 seconds | 8 to 15 seconds | SubstantiallyEquivalent |
| Signal Output andDisplay | LCD, Buzzer | LCD, Buzzer | SubstantiallyEquivalent |
| OperatingEnvironment | 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 | SubstantiallyEquivalent |
| StorageEnvironment | -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 | SubstantiallyEquivalent |
| Power Supply | One (1), 3V, CR2032 battery | One (1), 3V, CR2032 battery | SubstantiallyEquivalent |
| Battery Life | More than 400 measurements orapproximately 2 years if usedevery other day. | More than 100 measurements orapproximately 2 years if used everyweek. | SubstantiallyEquivalent |
| Element ofComparison | Test Device: Vicks® VDT972RapidRead™ DigitalThermometer | Predicate Device: Vicks®VDT985 SmartTemp™Wireless Thermometer | Comparison |
| MCU | The Sonix SN8F5907 is an 8-bitarchitecture microcontroller which iscompatible with MCS-51 instructionset. It includes an enhanced 8051microcontroller, up to 32 MHzflexible CPU frequency, hardwaremultiplication / division Unit, 256bytes internal RAM (IRAM), 2 KBexternal RAM (XRAM), 64 KB non-volatile flash memory (IROM), in-system program support, 10 interruptsources with priority control, 2external interrupts: INT0, INT1, 3 set16-bit timer/counter with auto reload,PWM output function, 1 set 8-bitbase timer for RTC, 1 set buzzerfunction output pin, one comparatorfor low battery detect 2.2V | The Sonix SN8F5909 is an 8-bitarchitecture microcontroller which iscompatible with MCS-51 instructionset. It includes an enhanced 8051microcontroller, up to 32 MHz flexibleCPU frequency, hardwaremultiplication / division Unit, 256bytes internal RAM (IRAM), 2 KBexternal RAM (XRAM), 64 KB non-volatile flash memory (IROM), in-system program support, 10 interruptsources with priority control, 2external interrupts: INT0, INT1, 3 set16-bit timer/counter with auto reload,PWM output function, 1 set 8-bitbase timer for RTC, 1 set buzzerfunction output pin, one comparatorfor low battery detect 2.2V | SubstantiallyEquivalent |
| Materials | User contacting materials includeABS (sensor head, battery doorand On / Off Button), TPR (probeand Site Selection Button), PMMA(LCD lens and protective cover),and stainless steel (sensor tip) | User contacting materials includeABS (sensor head and batterydoor), TPR (probe and On / OffButton), PMMA (face panel andprotective cover), and stainlesssteel (sensor tip) | SubstantiallyEquivalent |
| Performance | Meets ASTM E1112-00:2011 andISO 80601-2-56:2017 | Meets ASTM E1112 and ISO80601-2-56 | SubstantiallyEquivalent |
| Biocompatibility | Meets ISO 10993-1:2009, 10993-5:2009, 10993-10:2010, and FDAGuidance Document, "Use ofInternational Standard ISO 10993-1" – June 16, 2016 | Meets ISO 10993-1, 10993-5, and10993-10, and FDA Bluebookmemo G95-1 | SubstantiallyEquivalent |
| Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | SubstantiallyEquivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2 | SubstantiallyEquivalent |
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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 .
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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 | AxillaryMeasurement | RectalMeasurement | OralMeasurement | 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 < ± 0.20℃ (< ± 0.36°F) and the Clinical Repeatability was < ± 0.3°C (< ± 0.54°F).
Effectiveness:
The endpoints for the Vicks® VDT972 RapidRead™ Digital Thermometer pivotal clinical study focused on Clinical Accuracy, which is specified by two characteristics: Clinical Bias, with its Standard Deviation or Limits of Agreement, and Clinical Repeatability. The study results demonstrated that the Vicks® VDT972 RapidRead™ Digital Thermometer was equivalent to the predicate thermometer for Clinical Accuracy for all age groups combines, for each age group individually, and for febrile subjects. Hence,
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the study met its endpoints with the required 95% confidence level. Therefore, the effectiveness of the Vicks® VDT972 RapidRead™ Digital Thermometer at accurately measuring human body temperature in a home-use environment is similar to the effectiveness reported for the predicate device.
Safety:
There were no reports of Adverse Events. Serious Adverse Events, or complaints of discomfort while using the Vicks® VDT972 RapidRead™ Digital Thermometer during the pivotal clinical study.
Summary:
Based on the clinical performance as documented in the pivotal clinical study, the Vicks® VDT972 RapidRead™ Digital Thermometer was found to be non-inferior, substantially equivalent to the predicate thermometer, having a safety and effectiveness profile that is similar.
VIII. CONCLUSION
The non-clinical data verify the accuracy of the device and software verification and validation demonstrate that the Vicks® VDT972 RapidRead™ Digital Thermometer should perform as intended in the specified use conditions. The clinical data validates that the Vicks® VDT972 RapidRead™ Digital Thermometer performs comparably to the predicate device, the V966 Vicks® ComfortFlex® Digital Thermometer (Microlife Instant Digital Thermometer, Model MT18L1), a digital stick thermometer that gives a reading in 8 seconds (510K # K043110), which was cleared for marketing in the US in December 2004. For comparison of user population, it has the same intended use as the predicate device, the Vicks® VDT985 SmartTemp™ Wireless Thermometer, a digital stick thermometer that works with a smartphone app via Bluetooth (510(k) # K152975), which was cleared for marketing in the US in March 2016. Therefore, the Vicks® VDT972 RapidRead™ Digital Thermometer is substantially equivalent to the predicate devices.
§ 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.