(167 days)
No
The summary describes a standard digital thermometer that communicates via Bluetooth to a smartphone app for display and potentially logging. There is no mention of AI, ML, or any complex algorithms beyond basic temperature measurement and transmission. The performance studies focus on clinical equivalence to predicate devices based on standard temperature measurement metrics.
No.
A therapeutic device is one that treats or prevents a disease or condition, whereas this device is for measurement and monitoring only.
No.
The device measures body temperature, which is a physiological parameter, but the information does not indicate that it is used to specifically diagnose a disease or condition. While temperature can be an indicator of illness, the device's intended use is for "intermittent measurement and monitoring of human body temperature," not for providing a diagnosis.
No
The device description explicitly states it is a "general purpose thermometer" and communicates with a smartphone via Bluetooth. This indicates the device includes hardware components for temperature measurement and communication, in addition to the software app.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vicks® SmartTemp™ Thermometer measures human body temperature directly, not by analyzing a sample taken from the body.
- Intended Use: The intended use clearly states "intermittent measurement and monitoring of human body temperature orally, rectally or under the arm." This is a direct measurement of a physiological parameter, not an in vitro test.
Therefore, based on the provided information, the Vicks® SmartTemp™ Thermometer is a medical device, but it falls under the category of a general purpose thermometer, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FLL
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.
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.
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 except preterm babies or very small (for gestational age)
Intended User / Care Setting
household use only.
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 to show substantial equivalence: A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months-
§ 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.
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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
2
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)
| 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 Electronic
Thermometer | Microlife Corporation | K043110 |
| WT701 Wireless Thermometer | Raiing Medical
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-