(157 days)
The Digital Thermometer is intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.
The digital thermometer DMT-4735b is hand held instruments which can measure human body's temperature orally, axillary (under the arm), and rectally The results can be displayed on LCD. And, the results measured by DMT-4735b can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for clinical or home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.
The provided text describes a 510(k) submission for a Digital Thermometer (Model: DMT-4735b). The document asserts substantial equivalence to a predicate device (K163518, Model: DMT-4735). The acceptance criteria for this device are largely derived from international standards and performance specifications rather than a comparative effectiveness study with human readers or clinical trials.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as compliance with international standards and specific performance ranges. The table below summarizes the key performance aspects where criteria are implied by the predicate device comparison and reported performance is stated.
| Acceptance Criteria (Implied from predicate comparison or stated standards) | Reported Device Performance (DMT-4735b) |
|---|---|
| Intended Use / Indication for Use: Measure human body temperature orally, rectally, or under the arm; reusable for clinical or home use on people of all ages. | Intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages. |
| Fundamental Technology & Operating Principle: Thermistor resistance changes with temperature, measured by MCU, displayed on LCD/APP. | A change of thermistor resistance, caused by changes of temperature. The resistance is measured by MCU, so changes of temperature will correspond to changes of resistance. Then display the measured temperature on the LCD or APP through BLE. |
| Measurement Range: Typically around 32.0°C-42.9°C (89.6°F-109.2°F) as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements) | 32.00°C-43.99°C (89.60°F-111.18°F). (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.") |
| Accuracy: Typically ± 0.2°F (± 0.1°C) during 95.9°F ~107.6°F (35.5°C ~42.0°C) as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements) | ± 0.05 °C ( ± 0.1 °F) during 35.00 °C ~38.00 °C (95.00 °F ~100.40°F); ± 0.1 °C ( ± 0.2 °F) during T38.00°C(100.40°F). (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.") |
| Response Time: ≤45s as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements) | ≤60s. (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.") |
| Resolution of Display: 0.1 °C / 0.1 °F as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements) | 0.01 °C / 0.01°F. (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.") |
| Electrical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment, and ISO 80601-2-56:2017. | Complied with IEC 60601-1 (stated in comparison table). Performance data section lists compliance with AAMI / ANSI ES60601-1:2005/(R)2012, A1:2012,C1:2009/(R)2012, A2:2010/(R)2012, and ISO 80601-2-56:2017. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014. | Complied with IEC 60601-1-2 (stated in comparison table). Performance data section lists compliance with IEC 60601-1-2:2014, EN300328, ETSI EN 301489-1, ETSI EN 301489-17. Also, Note 2 states "FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed." |
| Biocompatibility: Compliance with ISO 10993-5 and ISO 10993-10. | Comply with ISO 10993-5 and ISO 10993-10 (stated in comparison table). Performance data section lists compliance with ISO 10993-5:2009 and ISO10993-10:2010. |
| Software/Firmware Validation: In accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. | Software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. |
| Wireless Interface (BLE): Performance of Bluetooth Low Energy, compliance with wireless standards. (Implied by differences from predicate) | Bluetooth Low Energy (BLE). Note 2 states "FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed." |
| Home Healthcare Environment Requirements: Compliance with IEC 60601-1-11:2015. | Performance data section lists compliance with IEC 60601-1-11:2015. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical testing was not required to establish equivalency of the device." This implies that no specific test set involving human subjects with associated sample sizes was used for demonstrating the performance of the device against a clinical ground truth. The acceptance is based on compliance with international standards and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since "Clinical testing was not required," there would be no experts establishing ground truth for a clinical test set in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "Clinical testing was not required." Therefore, no MRMC study, or any study involving human readers, was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a digital thermometer, not an AI/algorithm-based diagnostic tool that would typically undergo "standalone" algorithm performance testing in the sense of image recognition or diagnostic algorithms. Its "performance" refers to its accuracy, response time, and compliance with technical standards, which were evaluated through bench testing and compliance with various engineering and safety standards (e.g., electrical safety, EMC, biocompatibility) rather than a standalone algorithm performance independent of a human operator interpreting its output. While the device does have software/firmware and can connect to a mobile app, its primary function as a thermometer relies on its sensor and internal processing, which is verified through the listed engineering standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by physical standards and measurement traceability in laboratories and testing facilities that verify compliance with standards like ISO 80601-2-56 for clinical thermometers. For accuracy, this would involve comparing the device's readings against calibrated reference thermometers under controlled environmental conditions. For other aspects like electrical safety, EMC, and biocompatibility, the ground truth is defined by the specific test methods and limits outlined in the relevant IEC/ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is a digital thermometer, not a machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.