(167 days)
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.
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.
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-
§ 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.