The VDT985US Vicks® SmartTemp™ 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.

Device Description

The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VDT985US Vicks® SmartTemp™ Thermometer, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (VDT985US Vicks® SmartTemp™ Thermometer)
Accuracy	±0.2° F (±0.1 ° C) within measurement range 95.9-107.6° F and ±0.4° F outside this range
Operating environment	Complies with ASTM E1112:2006 Standard
Clinical Accuracy (clinical bias with uncertainty and repeatability)	Per ASTM E 1965-09 Clinical Requirements
Limit of agreement (clinical)	Per ASTM E 1965-09 Clinical Requirements
Clinical Repeatability	Statistically and clinically acceptable (less than 0.3 °C or 0.58°F)
Biocompatibility	Complies with ISO 10993-5 (cytotoxicity), 10993-10 (irritation/sensitization), and FDA memo G95-1

Study Details

2. Sample Size and Data Provenance

The document states that a comparison study and clinical repeatability testing were performed on four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older. However, the exact sample size for the test set is not explicitly provided in the furnished text.

The data provenance is implied to be prospective clinical data since it refers to a "clinical comparison study" and "clinical repeatability testing" performed in accordance with ASTM E1112-00(2006) and ASTM E1965. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study in the provided text. The study described is a comparison study between the test device, a predicate device, and a gold standard reference thermometer.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the VDT985US Vicks® SmartTemp™ Thermometer (test thermometer) was compared directly to a "gold standard" device (Welch Allyn SureTemp® Plus in monitoring mode) and a predicate device (Vicks V966 Thermometer) to assess its clinical accuracy and repeatability. The results reported are for the device's performance itself.

7. Type of Ground Truth Used

The ground truth used was established by a reference device: the Welch Allyn SureTemp® Plus in the monitoring mode (K030580), which is referred to as the "gold standard."

8. Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The study described appears to be a validation/testing study rather than a development study involving specific training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not available in the provided text.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 23, 2016

KAZ USA Inc., A Helen Of Troy Company Mr. Raj Kasbekar Global Vice President, Regulatory Affairs 250 Turnpike Road Southborough, Massachusetts 01772

Re: K152975

Trade/Device Name: VDT985US Vicks® SmartTemp™ Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 8, 2016 Received: February 10, 2016

Dear Mr. Kasbekar:

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. 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.

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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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Erin I. Keith, M.S. 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) K152975

Device Name

VDT985US Vicks® SmartTemp™ Thermometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Kaz USA, Inc., a Helen of Troy Company Donald Lynch Boulevard · Marlborough, MA 01752

510(k) Summary K152975

1. Preparation Date:

March 15, 2016

2. Submitted By:

KAZ USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752

Primary Contact Person/Prepared by:

Raj S. Kasbekar, Global VP, Regulatory & Clinical Affairs KAZ USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 Phone: 508-490-7280 Email: rkasbekar@kaz.com

3. Device Identification:

3.1 Trade Name

VDT985US Vicks® SmartTemp™ Thermometer

3.2 Common Name

Oral, rectal and axillary digital electronic thermometer

3.3 Classification Name

21CFR 880.2910: Thermometer, Clinical, Electronic Class II, Product code: FLL

4. Predicate Device:

Predicate	Manufacturer	510(k)Number
MT18I1 (V966) Instant Digital ElectronicThermometer	Microlife Corporation	K043110
WT701 Wireless Thermometer	Raiing MedicalCompany	K132761

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5. Device Description:

Overview: The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.

Bluetooth Smart Radio and MCU: The Bluetooth Radio is part of a system on chip (SoC) by Texas Instruments. The CC2541 is comprised of a Bluetooth Smart radio and 8051 MCU. The unit defaults to sleep mode, in which the radio is off and the MCU is in time keeping low current mode. The thermometer measures temperature through a thermistor located in the tip of the device, which is measured using a resistor divider sampled by an onboard Analog to Digital Converter (ADC). When the thermometer is activated via a momentary contact switch, the unit enters normal operation mode. In normal operation mode, the radio is active and connects with the user's SmartTemp app on their device. The temperature measurement is then communicated to the SmartTemp app.

6. Indications for Use:

7. Validation Results:

Clinical Study to show substantial equivalence:_A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older in accordance with ASTM E1112-00(2006) and Clinical section (Appendix A) of ASTM E1965 to compare the VDT985US Vicks® SmartTemp™ Thermometer (test thermometer) with the predicate device, the Vicks V966 Thermometer (K043110). The reference or the qold standard used was the Welch Allyn SureTemp® Plus in the monitoring mode (K030580). This clinical comparison study demonstrated that the VDT985US Vicks® SmartTemp™ Thermometer is as good as (non-inferior or substantially equivalent to) the previously approved Vicks V966 Thermometer (K043110) in all age groups with respect to the bias and standard deviation in comparison to the reference Welch Allyn SureTemp® Plus in the monitoring mode (K030580). The temperatures obtained with the test Thermometer were highly related when compared to the predicate device. The clinical bias with stated uncertainty and clinical repeatability as defined in the ASTM E1112 standard were within clinical acceptability limits in accordance with the protocol (bias less than predicate device when compared to reference). The clinical repeatability of the test thermometer was statistically and clinically acceptable (less than 0.3 °C or 0.58°F).

8. Similarities/Differences of the proposed candidate device when compared to the predicate:

8.1 Intended Use

The predicate device, the Microlife MT18l1 Thermometer (K043110) is also intended for the intermittent determination of the human's body temperature for people of all ages. The intended use and indications for use of the MT18I1 Thermometer (predicate) and the VDT985US Vicks® SmartTemp™ Thermometer are similar. In addition, the WT1701

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Raiing Company Wireless Thermometer (K132761) uses the wireless feature that is similar to the VDT985US Vicks® SmartTemp™ Thermometer Bluetooth wireless feature. The predicate device MT18l1 as well as the KAZ VDT985US Vicks® SmartTemp™ Thermometer uses the oral, axillary and rectal as the measurement site.

8.2 Materials

Materials used in the manufacture of the VDT985US Vicks® SmartTemp™ Thermometer are similar (derived from similar resins) to the predicate device. All skin contacting materials used in the new thermometer have been tested successfully for biocompatibility (cytotoxicity in accordance with ISO 10993-5 as well as irritation and sensitization in accordance with ISO 10993-10) and FDA Blue book memo G 95-1 for both thermometers.

8.3 Design

The industrial design of the VDT985US Vicks® SmartTemp™ Thermometer is similar to the predicate device, the Microlife MT1811 Thermometer (K043110), except for a new outer shell.

8.4 Operational Principles

The VDT985US Vicks® SmartTemp™ Thermometer is a handheld device, containing an On/Off switch, sensor area, microcontroller to control the device and take measurements. The operating principle is based on conduction of heat to a thermistor based sensor and use of predictive algorithms to estimate the body temperature.

8.5 Technology

The technology of the VDT985US Vicks® SmartTemp™ Thermometer is identical to the predicate device MT18I1. The bluetooth feature is an additional feature similar to the predicate WT701.

8.6 Comparison Table between Subject Device and Predicates

ELEMENT OFCOMPARISON	VDT985US Vicks® SmartTemp™Thermometer	Predicate Device:MT18I1	Predicate Device:WT701
Manufacturer	KAZ USA, Inc.	Microlife: MT18I1	Raiing MedicalCompany: WT701
Classification	21CFR 880.2910	21CFR 880.2910	21CFR 880.2910
Product Code	FLL	FLL	FLL
Class	II	II	II
Thermometertype	Predictive Digital	Predictive Digital	Predictive Digital
Intended use	The VDT985US Vicks®SmartTemp™ Thermometer isindicated for the intermittentmeasurement and monitoring ofhuman body temperature orally,rectally or under the arm. It can beused on people of all ages exceptpreterm babies or very small (forgestational age). Thisthermometer is intended to beused with Apple and Androidmobile devices. It is intended forhousehold use only.	Microlife MT1811 is usedfor the intermittentmeasurement andmonitoring of humanbody temperature orally,rectally and under thearm. The device is forthe adult and pediatricpopulation.	The WT701 Wirelessthermometer is a batteryoperated electronicdevice with intended useof measuring andmonitoring human armpittemperature continuouslyvia wireless signaltransmission of themeasuring result. Thissystem is reusable andintended for armpittemperature monitoringfor persons over twoyears old.
Operation	Handheld device containingan On/Off switch, sensorhead, microcontroller, anddisplay on the smartphone.	Handheld devicecontaining an On/Offswitch, sensor head,microcontroller, anddisplay	Handheld devicecontaining an On/Offswitch, sensor head,microcontroller, andwireless capability
Sensor	Thermistor based	Thermistor based	Thermistor based
Signalprocessingand display	Internal software and displayon smartphone	MT1811: Internalsoftware and display	MT1811: Internalsoftware and display aswell as wireless display
Powerrequirements	Battery powered (3V)	Battery powered (1.55V)	Battery powered (3V)
Battery Duration	More than 100 measurementsor approximately 2 years ifused every week	More than 200 hours ofcontinuous operation or2 years if used 10 minper day	Similar
Materials	Impact Resistant Casingand Sealed Sensor.Biocompatible metals andresins.	Impact Resistant Casingand Sealed Sensor.Biocompatible metalsand resins.	Impact Resistant Casingand Sealed Sensor.Biocompatible metals andresins.
Scale	Degree F /Degree C	same	same
Measurementlocations	Oral, Axillary and Rectal	Oral, Axillary and Rectal	Oral, Axillary and Rectal
Measurement range	89.6° F to 109.2° F(32°C to 42.9 °C)	89.6° F to 109.2° F(32°C to 42.9 °C)	25-45 °C
Operationenvironment	50.0° F to 104.0° F (10°C to40 °C) Humidity: 15 -95%(non condensing)	Similar	Similar
Storageenvironment	-13° F to 131° F(-25°C to 55 °C) Humidity:15 -95% (non condensing)	Similar	Similar
Accuracy	±0.2° F (±0.1 ° C)within measurement range95.9-107.6° F and ±0.4° Foutside this range	±0.2°F(±0.1 ° C) withinmeasurement range 96-107° F	±0.05 ° C (35 to 38.5 °C)±0.1 ° C (25 to 35.99° Cand 38.51 -45° C)
Operatingenvironment	Complies with ASTME1112:2006 Standard	Complies with ASTME1112:2006 Standard	Complies with ASTME1112:2006Standard
Clinical Accuracy:clinical bias with itsuncertainty andrepeatability	Per ASTM E 1965-09Clinical Requirements	Similar	Similar
Limit of agreement(clinical)	Per ASTM E 1965-09Clinical Requirements	Similar	not known
Response time	6 sec (up to 20 sec foraxillary/rectal)	Similar	Similar
ASTM E1112-2006Standard forintermittentdetermination ofpatient temperature	Complies with ASTME1112-2006 Standard	Complies with ASTME1112-2006 Standard	Complies with ASTME1112:2006Standard
IEC/ISO/EN 60601-1-2 MedicalElectrical Equipment-Part 1 GeneralRequirements forSafety,ElectromagneticCompatibility-Requirements andTests	Complies with IEC 60601-1-2:2006 Standard	Complies with IEC 60601-1-2:2006 Standard	Complies IEC 60601-1-2:2006 Standard
IEC/ISO/EN 60601-1Medical ElectricalEquipment- Part 1GeneralRequirements forElectrical Safety,Requirements andTests	Complies with IEC 60601-1:2005 Standard	Complies with IEC 60601-1:2005Standard	Complies with IEC60601-1:2005Standard
Biocompatibility- ISO10993-1	Complies with ISO 10993-5standard for cytotoxicity,10993- 10 standard forirritation as well assensitization onbiocompatibility for surfacecontact less than 24 hoursand FDA memo G95-1through tests done in acertified laboratory	Complies with ISO 10993-5standard forcytotoxicity,10993-10standard for irritation aswell as sensitization on bio-compatibility for surfacecontact less than 24 hours	Not known

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9. Conclusion:

Based on the testing and compliance with acceptable voluntary standards, we believe that the VDT985US Vicks® SmartTemp™ Thermometer (K152975) is substantially equivalent to its predicate devices cited above and is as safe and as effective as these predicate devices.

Regulation Number and Section

§ 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.