(6 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
The Microlife Digital Infrared Ear Thermometer, consists mainly of the five parts:
- IR Thermopile Sensor a)
- ASIC b)
- E2 PROM IC C)
- LCD and Blacklight d)
- Kev "2. Buzzer" 1 e)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1:
Key Finding: This 510(k) submission does not contain any clinical study data for the IR1DE1 model. It relies on the substantial equivalence to a previously cleared device (IR1DA1) and states that clinical studies were already conducted for the original, unmodified device. Therefore, a complete table of acceptance criteria and reported device performance directly from this document, as well as several other requested details, cannot be provided.
Acceptance Criteria and Study Details for Microlife Digital Infrared Ear Thermometer, Model IR1DE1
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, specific numerical acceptance criteria and reported device performance from a new study for the specific model IR1DE1 are not available. The submission states that compliance to various standards was performed, but it does not detail specific performance thresholds or results.
However, the document indicates compliance with the following:
| Acceptance Criteria Category | Reported Device Performance (as implied by submission) |
|---|---|
| Standards Compliance | Compliant with ASTM E1112, ASTM E1104, ASTM E-1965-98, IEC 60601-1, and IEC 60601-1-2 requirements. |
| Functional Equivalence | Identical in functionality and performance to the predicate device (Model IR1DA1). |
| Algorithm and Software | Temperature measurement algorithm and software codes remain unchanged from the predicate device. |
| Safety and Effectiveness | Verification and validation tests demonstrate that modified portions maintained original safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No new clinical human testing was conducted for this specific modified device (IR1DE1).
- Data Provenance: Not applicable for new clinical data. The submission refers to "clinical studies/low power testing were conducted for the original unmodified device," but details of those prior studies are not provided in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. No new clinical studies requiring expert ground truth establishment for a test set were conducted for this device according to the document.
4. Adjudication Method for the Test Set:
- Not applicable. No new clinical studies were conducted for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done for the modified device (IR1DE1). Clinical studies were explicitly not conducted for this modified device.
6. Standalone Performance Study:
- No, a standalone (algorithm only without human-in-the-loop) performance study was not done specifically for the modified device (IR1DE1) as a new clinical study. The submission states that "Accuracy performance, reliability and EMC testing is only applicable," suggesting engineering and bench testing, but no specific in-depth performance study results are detailed in this document.
7. Type of Ground Truth Used:
- Not applicable for new clinical data. The ground truth for the original device's clinical studies (referenced but not detailed here) would likely have been reference thermometer readings or medical consensus, but this is speculative given the lack of detail.
8. Sample Size for the Training Set:
- Not applicable. The device's temperature measurement algorithm and software codes "remain unchanged" from the predicate device. Therefore, no new training set was used for the IR1DE1 model. The document does not provide details on the training set (if any, as an infrared thermometer might not 'train' in the AI sense) used for the original algorithm development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no new training set was described for the IR1DE1 model. Details on the ground truth establishment for the original algorithm are not provided in this document.
Summary of the Submission's Approach:
The submission for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1, is a 510(k) for a modified device. The core argument for substantial equivalence relies on:
- The device having the same intended use as the predicate device (Model IR1DA1).
- The temperature measurement algorithm and software codes remaining unchanged.
- The fundamental scientific technology remaining the same.
- Modifications being limited to "ergonomics of the user interface, dimensional specifications and environmental specifications," and PCB layout, which are considered to not affect the intended use or alter the fundamental scientific technology.
- Compliance with applicable voluntary standards and guidance documents.
Therefore, the submission explicitly states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged." This means no new primary clinical data for the IR1DE1 model is presented in this document.
§ 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.