VDT985US Vicks SmartTemp Thermometer

K152975 · Kaz USA, Inc., A Helen of Troy Company · FLL · Mar 23, 2016 · General Hospital

Device Facts

• Record ID: K152975
• Device Name: VDT985US Vicks SmartTemp Thermometer
• Applicant: Kaz USA, Inc., A Helen of Troy Company
• Product Code: FLL · General Hospital
• Decision Date: Mar 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Handheld digital thermometer; measures human body temperature via thermistor tip; uses predictive algorithms to estimate temperature. Input: thermal signals from oral, rectal, or axillary sites. Processing: onboard 8051 MCU samples thermistor via ADC; transmits data via Bluetooth Smart to user's smartphone. Output: temperature reading displayed on Kaz SmartTemp app. Used in home environment by patients or caregivers. Healthcare providers use app-displayed data to monitor temperature trends and support clinical decisions. Benefits: convenient, wireless tracking of temperature over time.

Clinical Evidence

Clinical comparison and repeatability study conducted across four age groups (0-12 months to 18+ years) per ASTM E1112-00(2006) and ASTM E1965. Compared VDT985US to predicate V966 using Welch Allyn SureTemp® Plus (monitoring mode) as reference. Results showed clinical bias and repeatability within acceptable limits (repeatability < 0.3°C/0.58°F). Device demonstrated substantial equivalence to predicate in all age groups.

Technological Characteristics

Thermistor-based sensor; 8051 MCU; Bluetooth Smart (TI CC2541 SoC); 3V battery powered. Form factor: handheld. Connectivity: Bluetooth to mobile app. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Standards: ASTM E1112-2006, IEC 60601-1:2005, IEC 60601-1-2:2006.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature (oral, rectal, axillary) in all ages, excluding preterm or small-for-gestational-age infants. Intended for household use with Apple/Android mobile devices.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• MT18I1 (V966) Instant Digital Electronic Thermometer (K043110)
• WT701 Wireless Thermometer (K132761)

Reference Devices

• Welch Allyn SureTemp® Plus (K030580)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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: [phone] Email: [e-mail]

#### 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)<br>Number |
|---------------------------------------------------------|---------------------------|------------------|
| MT18I1 (V966) Instant Digital Electronic<br>Thermometer | Microlife Corporation | K043110 |
| WT701 Wireless Thermometer | Raiing Medical<br>Company | 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:

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.

#### 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 OF<br>COMPARISON | VDT985US Vicks® SmartTemp™<br>Thermometer | Predicate Device:<br>MT18I1 | Predicate Device:<br>WT701 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | KAZ USA, Inc. | Microlife: MT18I1 | Raiing Medical<br>Company: WT701 |
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 |
| Product Code | FLL | FLL | FLL |
| Class | II | II | II |
| Thermometer<br>type | Predictive Digital | Predictive Digital | Predictive Digital |
| Intended use | The VDT985US Vicks®<br>SmartTemp™ Thermometer is<br>indicated for the intermittent<br>measurement and monitoring of<br>human body temperature orally,<br>rectally or under the arm. It can be<br>used on people of all ages except<br>preterm babies or very small (for<br>gestational age). This<br>thermometer is intended to be<br>used with Apple and Android<br>mobile devices. It is intended for<br>household use only. | Microlife MT1811 is used<br>for the intermittent<br>measurement and<br>monitoring of human<br>body temperature orally,<br>rectally and under the<br>arm. The device is for<br>the adult and pediatric<br>population. | The WT701 Wireless<br>thermometer is a battery<br>operated electronic<br>device with intended use<br>of measuring and<br>monitoring human armpit<br>temperature continuously<br>via wireless signal<br>transmission of the<br>measuring result. This<br>system is reusable and<br>intended for armpit<br>temperature monitoring<br>for persons over two<br>years old. |
| Operation | Handheld device containing<br>an On/Off switch, sensor<br>head, microcontroller, and<br>display on the smartphone. | Handheld device<br>containing an On/Off<br>switch, sensor head,<br>microcontroller, and<br>display | Handheld device<br>containing an On/Off<br>switch, sensor head,<br>microcontroller, and<br>wireless capability |
| Sensor | Thermistor based | Thermistor based | Thermistor based |
| Signal<br>processing<br>and display | Internal software and display<br>on smartphone | MT1811: Internal<br>software and display | MT1811: Internal<br>software and display as<br>well as wireless display |
| Power<br>requirements | Battery powered (3V) | Battery powered (1.55V) | Battery powered (3V) |
| Battery Duration | More than 100 measurements<br>or approximately 2 years if<br>used every week | More than 200 hours of<br>continuous operation or<br>2 years if used 10 min<br>per day | Similar |
| Materials | Impact Resistant Casing<br>and Sealed Sensor.<br>Biocompatible metals and<br>resins. | Impact Resistant Casing<br>and Sealed Sensor.<br>Biocompatible metals<br>and resins. | Impact Resistant Casing<br>and Sealed Sensor.<br>Biocompatible metals and<br>resins. |
| Scale | Degree F /Degree C | same | same |
| Measurement<br>locations | Oral, Axillary and Rectal | Oral, Axillary and Rectal | Oral, Axillary and Rectal |
| Measurement range | 89.6° F to 109.2° F<br>(32°C to 42.9 °C) | 89.6° F to 109.2° F<br>(32°C to 42.9 °C) | 25-45 °C |
| Operation<br>environment | 50.0° F to 104.0° F (10°C to<br>40 °C) Humidity: 15 -95%<br>(non condensing) | Similar | Similar |
| Storage<br>environment | -13° F to 131° F<br>(-25°C to 55 °C) Humidity:<br>15 -95% (non condensing) | Similar | Similar |
| Accuracy | ±0.2° F (±0.1 ° C)<br>within measurement range<br>95.9-107.6° F and ±0.4° F<br>outside this range | ±0.2°F(±0.1 ° C) within<br>measurement range 96-<br>107° F | ±0.05 ° C (35 to 38.5 °C)<br>±0.1 ° C (25 to 35.99° C<br>and 38.51 -45° C) |
| Operating<br>environment | Complies with ASTM<br>E1112:2006 Standard | Complies with ASTM<br>E1112:2006 Standard | Complies with ASTM<br>E1112:2006<br>Standard |
| Clinical Accuracy:<br>clinical bias with its<br>uncertainty and<br>repeatability | Per ASTM E 1965-09<br>Clinical Requirements | Similar | Similar |
| Limit of agreement<br>(clinical) | Per ASTM E 1965-09<br>Clinical Requirements | Similar | not known |
| Response time | 6 sec (up to 20 sec for<br>axillary/rectal) | Similar | Similar |
| ASTM E1112-2006<br>Standard for<br>intermittent<br>determination of<br>patient temperature | Complies with ASTM<br>E1112-2006 Standard | Complies with ASTM<br>E1112-2006 Standard | Complies with ASTM<br>E1112:2006<br>Standard |
| IEC/ISO/EN 60601-<br>1-2 Medical<br>Electrical Equipment-<br>Part 1 General<br>Requirements for<br>Safety,<br>Electromagnetic<br>Compatibility-<br>Requirements and<br>Tests | Complies with IEC 60601-1-<br>2:2006 Standard | Complies with IEC 60601-1-<br>2:2006 Standard | Complies IEC 60601-<br>1-2:2006 Standard |
| IEC/ISO/EN 60601-1<br>Medical Electrical<br>Equipment- Part 1<br>General<br>Requirements for<br>Electrical Safety,<br>Requirements and<br>Tests | Complies with IEC 60601-1:<br>2005 Standard | Complies with IEC 60601-1:<br>2005Standard | Complies with IEC<br>60601-1:2005<br>Standard |
| Biocompatibility- ISO<br>10993-1 | Complies with ISO 10993-5<br>standard for cytotoxicity,<br>10993- 10 standard for<br>irritation as well as<br>sensitization on<br>biocompatibility for surface<br>contact less than 24 hours<br>and FDA memo G95-1<br>through tests done in a<br>certified laboratory | Complies with ISO 10993-5<br>standard for<br>cytotoxicity,10993-10<br>standard for irritation as<br>well as sensitization on bio-<br>compatibility for surface<br>contact 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.