(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 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
- 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
§ 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.