(56 days)
The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.
The Digital Clinical Thermometers, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) -- controlled circuit, which is considered the hard-wire control instead of programmable control. Basically WL-3305 and WL-3306 have the same intended use and operation function except for the different measuring range caused by some small different design in IC circuit.
From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, it was designed and verified according to the US standard ASTM E1112-98.
Acceptance Criteria and Study Details for Innovatech Digital Clinical Thermometer
The Innovatech Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, was designed and verified according to the US standard ASTM E1112-98. The submission also states compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements. The primary basis of clearance is substantial equivalence to the predicate device, Actherm model ACT 2020 and ACT 2020+.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM E1112-98 Compliance | Designed and verified according to ASTM E1112-98. |
| EN 60601-1 Compliance | Compliance stated. |
| EN 60601-1-1 Compliance | Compliance stated. |
| EN 60601-1-2 Compliance | Compliance stated. |
| Substantial Equivalence to Predicate Device (Actherm ACT 2020/ACT 2020+) | Verification tests demonstrate the submitted models maintain the same safety and effectiveness as the cleared predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a specific test set. The evaluation is primarily based on compliance with existing standards (ASTM E1112-98, EN 60601 series) and substantiating substantial equivalence to a predicate device.
The data provenance is not explicitly stated as retrospective or prospective clinical data. The document refers to "verification tests" and compliance with standards. Given the nature of a 510(k) for a clinical thermometer, these tests would typically involve laboratory validation, potentially including in-vitro or in-vivo performance testing against a reference standard in a controlled environment. No information on the country of origin of testing data is provided beyond the manufacturer's location in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The evaluation is based on compliance with established performance standards for clinical thermometers, which prescribe methods for determining accuracy and other performance characteristics. It does not appear to involve expert consensus for ground truth as would be common in diagnostic imaging or clinical decision support AI devices.
4. Adjudication Method for the Test Set
An adjudication method is not applicable and therefore not described in this document. The assessment relies on objective measurements against established technical standards for thermometer performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this is a standalone device (clinical thermometer) and not an AI-assisted diagnostic tool requiring human interpretation comparison.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone performance evaluation was done in the sense that the device's accuracy was verified against the requirements of ASTM E1112-98. This standard dictates the methods for determining the accuracy of electronic thermometers, and the device's performance was measured independently of human interpretation of the readings. The "verification tests" demonstrating "the same safety and effectiveness" as the predicate device are indicative of standalone performance assessment.
7. Type of Ground Truth Used
The ground truth for performance evaluation would be established by reference temperature standards as defined by ASTM E1112-98, which specifies the requirements for electronic thermometers for intermittent determination of patient temperature. This standard outlines procedures for testing accuracy against known, highly precise temperature sources.
8. Sample Size for the Training Set
This question is not applicable as the device is a hardware-based electronic clinical thermometer controlled by an ASIC (Application Specific IC) and does not involve AI or machine learning algorithms that require a training set. The "ASIC-controlled circuit" is described as "hard-wire control instead of programmable control."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device does not employ machine learning or AI and therefore does not have a "training set."
§ 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.