(296 days)
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
HT series infrared thermometers (includes model HT-101, HT-102, HT-103 and HT-104) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:
- The device is intended to be used by consumers in the household environments and by healthcare providers;
- The device is mainly composed of infrared sensor, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;
- It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer;
- Switching between Celsius and Fahrenheit;
- Multi-functional, can measure ear and forehead temperature;
- Automatic range selection; resolution is 0.1 Celsius (0.1 Fahrenheit);
- The latest 35 measurement data can be memorized and stored; the user can view the previous measurement results;
- High temperature alarm function, displayed in green, orange and red backlight;
- Switching between mute and un-mute mode;
- Low battery indication, and auto shut-down.
The document describes the acceptance criteria and the study conducted for the Infrared Thermometer (Models HT-101, HT-102, HT-103, HT-104).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Thermometer are primarily based on established medical device standards and comparison to a predicate device (K191570).
| Feature / Criterion | Acceptance Criteria (from predicate or standards) | Reported Device Performance (Subject Devices) | Comments |
|---|---|---|---|
| Product Code | FLL | FLL | Same |
| Regulation Number | 880.2910 | 880.2910 | Same |
| Indications for Use | Intermittent measurement of body temperature from auditory canal or central forehead skin surface on people of all ages; for consumers and healthcare providers. | Intermittent measurement of body temperature from auditory canal or central forehead skin surface on people of all ages; for consumers and healthcare providers. | Same |
| Thermometer type | Digital thermometer | Digital thermometer | Same |
| Sensor | Thermopile | Thermopile | Same |
| Operational Principle | Infrared radiation detection | Infrared radiation detection | Same |
| Display type | LCD | LCD | Same |
| Measurement site | Forehead and ear | Forehead and ear | Same |
| Measurement Range | Ear & Forehead: 32.0°C | Ear & Forehead: 32.0°C | Same |
| Measurement Accuracy | Predicate: ±0.4°F (0.2°C) within 95 | ||
| Standard: ISO80601-2-56 and ASTM E1965-98 requirements. | 34.0°C | ||
| 32.0 °C | Comparable (meets ISO80601-2-56 and ASTM E1965-98) | ||
| Display Resolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Power Supply | d.c. 3.0V (2pcs AAA batteries) | d.c. 3.0V (2pcs AAA batteries) | Same |
| Measurement Time | 1 second | 1 second | Same |
| Measurement data memories | 20 sets | 35 sets | Comparable (software verified, no safety/effectiveness issues) |
| Beeper setting | Yes | Yes | Same |
| Date and time setting | No | No | Same |
| Backlight | Yes | Yes | Same |
| Auto-off time | 30s | 15s±1s | Similar (meets IEC 60601-1:2005+AMD 1:2012, no safety/effectiveness issues) |
| Operation Condition (Temperature) | 10°C~40°C | 10°C~40°C | Same |
| Operation Condition (Relative Humidity) | ≤85% | ≤95% | Comparable (tested per IEC 60601-1-2 EMC, IEC 60601-1, ISO 80601-2-56 and ASTM E1965-98) |
| Operation Condition (Atmospheric Pressure) | 70kPa~106kPa | 70kPa~106kPa | Same |
| Storage & Transportation Temp. | -20°C~55°C | -20°C~50°C | Comparable (no safety/effectiveness issues) |
| Storage & Transportation Humidity | 15%~93% | ≤95% | Comparable (tested per IEC 60601-1-2 EMC, IEC 60601-1, ISO 80601-2-56 and ASTM E1965-98) |
| Storage & Transportation Pressure | 70kPa~106kPa | 70kPa~106kPa | Same |
| Protection against electric shock | Externally power supply, Type BF | Externally power supply, Type BF | Same |
| IP Class | IP22 | IP22 | Same |
| Mode of operation | Continuous Operation | Continuous Operation | Same |
| Materials of skin-contacting components | ABS | ABS/ PA757(+); PC/PC-110 | Comparable (tested per IEC 60601-1-2 EMC, IEC 60601-1, ISO 80601-2-56, ASTM E1965-98 and ISO 10993-1) |
| Physical Dimensions | Not available (for predicate) | HT-101: 1653850 mm; HT-102: 1563744mm; HT-103: 1555238 mm; HT-104: 1543950mm | Comparable (no new safety/effectiveness issues) |
| Weight | Not available (for predicate) | HT-101: 62.5g (Battery excluded); HT-102: 58g (Battery excluded); HT-103: 64.5g (Battery excluded); HT-104: 63g (Battery excluded) | Comparable (no new safety/effectiveness issues) |
| Electromagnetic Compatibility | Meets IEC 60601-1-2 requirements | Passed testing according to IEC 60601-1-2:2014, IEC 60601-1:2005+AMD 1:2012, IEC 60601-1-11:2015 | Compliance demonstrated |
| Electrical Safety | Meets IEC 60601-1 requirements | Passed testing according to IEC 60601-1:2005+AMD 1:2012 | Compliance demonstrated |
| Biocompatibility | Meets ISO 10993 requirements | Passed testing according to ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization) | Compliance demonstrated |
| Performance (Bench) | Meets ISO 80601-2-56 and ASTM E1965-98 requirements | Passed testing according to ISO 80601-2-56:2017+AMD2018 and ASTM E1965-98 (Reapproved 2016) | Compliance demonstrated |
| Software Verification & Validation | Moderate level of concern, all software requirements met, hazards mitigated to acceptable risk levels. | Software documentation consistent with moderate level of concern, system validation testing demonstrates all software requirement specifications met and all software hazards mitigated to acceptable risk levels. | Compliance demonstrated |
| Clinical Accuracy | Meet requirements for clinical bias and clinical repeatability per ASTM E1965-98 (Reapproved 2016) | Clinical accuracy validation test report demonstrates that the subject devices met the requirements for clinical bias and clinical repeatability per ASTM E1965-98(Reapproved 2016). | Compliance demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 150 subjects were included in the clinical accuracy validation test.
- Infants: 50 subjects (newborn to one year)
- Children: 50 subjects (greater than one to five years)
- Adults: 50 subjects (greater than five years old)
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is a clinical accuracy validation test, which implies prospective data collection for the purpose of validating the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications for establishing ground truth during the clinical accuracy validation. It only states that the clinical accuracy validation testing was conducted according to ASTM E1965-98 (Reapproved 2016), which implies standard clinical measurement procedures and potentially comparison to a reference thermometer.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1 or 3+1). The testing focused on comparing the device's readings against established clinical accuracy standards (ASTM E1965-98), which inherently define acceptable differences from a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of an infrared thermometer. The device itself is the standalone measurement tool. Its performance is evaluated both on the bench (bench testing) and in clinical settings (clinical accuracy validation), where it is operated by a human user to take a measurement. However, there is no separate "algorithm only" performance that needs to be assessed, as the device's function is direct temperature measurement.
7. The Type of Ground Truth Used
For the clinical accuracy validation, the ground truth was implied by the reference measurements taken in accordance with ASTM E1965-98 (Reapproved 2016). This standard typically defines the reference method for temperature measurement against which the test device's accuracy (bias and repeatability) is assessed. It's not expert consensus, pathology, or outcomes data in the traditional sense, but rather a standard measurement reference.
8. The Sample Size for the Training Set
The document does not mention a training set as this device is a hardware medical device (infrared thermometer), not an AI/machine learning algorithm that requires a training set.
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.