(123 days)
Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.
The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.
This document is a 510(k) Summary of Safety and Effectiveness for the Digital Thermometer, Models 1004 & 1005, manufactured by Biocare Asia Corporation Ltd. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily assessed against the standards ASTM E1112-00:2011 and EN 12470-3:2000+A1:2009.
| Acceptance Criteria (Standard) | Reported Device Performance | Verdict |
|---|---|---|
| Accuracy (ASTM E1112-00:2011) | ||
| ±0.3 °C at 33.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.2 °C at 36.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.1 °C at 38.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.2 °C at 40.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.3 °C at 42.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| Accuracy (EN 12470-3:2000+A1:2009 - Maximum permissible errors under reference conditions) | ||
| 0.1 °C within 35.5 - 42.0 °C (ambient 18 - 28°C) | Results in compliance with Subclause 6.2.3 | Pass |
| 0.2 °C outside 35.5 - 42.0 °C or ambient temperature range | Results in compliance with Subclause 6.2.3 | Pass |
| Drop Test (ASTM E1112-00:2011) | ||
| Max error within specified accuracy limits for 1m drop | Max calculated error: 0.1 °C at all tested temperatures (33.0-42.0 °C) | Pass |
| Operating Environment Test (ASTM E1112-00:2011) | ||
| Max errors within specified accuracy limits at various temp/humidity | Max calculated errors within acceptance criteria (0.1-0.2 °C) | Pass |
| Storage Environment Test (ASTM E1112-00:2011) | ||
| Max errors within specified accuracy limits after storage conditioning | Max calculated errors within acceptance criteria (0.1 °C) | Pass |
| Measuring Range (EN 12470-3:2000+A1:2009) | ||
| Cover minimum 35.5 - 42 °C (95.9 – 109.2 °F) | Test range covers 31.7 - 44.3 °C | Pass |
| Digital Increment (EN 12470-3:2000+A1:2009) | ||
| 0.1 °C (0.1 °F) | Inspected to be 0.1 °C (0.1 °F) | Pass |
| Time Response (EN 12470-3:2000+A1:2009) | ||
| Display correct temperature within 60 seconds | Results in compliance with Subclause 6.2.4 | Pass |
| Maximum energy dissipation (EN 12470-3:2000+A1:2009) | ||
| Max 2 mW on probe | Results in compliance with Subclause 6.2.5 | Pass |
| Long term stability (EN 12470-3:2000+A1:2009) | ||
| Comply with Subclause 6.2.3 after 288 hrs at 55±2 °C | Results in compliance with Subclause 6.2.6 | Pass |
| Environmental Requirements (EN 12470-3:2000+A1:2009) | ||
| Ambient operating range, effect of storage, thermal shock, humidity, EMC, mechanical shock, water resistance: Accuracy to comply with Subclause 6.2.3 | All results in compliance with relevant subclauses (6.3.1-6.3.7) | Pass |
| Voltage limit indication (EN 12470-3:2000+A1:2009) | ||
| Auto visual/auditory warning for out-of-spec voltage; meet 6.2.3 accuracy | Results in compliance with Subclause 6.4.1.1 | Pass |
| Indicating unit (EN 12470-3:2000+A1:2009) | ||
| Numerical values >= 4mm height; all segments activated for >= 1 sec on power-on | Numerical values > 4mm; all segments activated for >= 1 sec | Pass |
| Functional safety test (EN 12470-3:2000+A1:2009) | ||
| Self-testing routine with correct operation indicated | Results in compliance; refer to user manual for details | Pass |
| Material (EN 12470-3:2000+A1:2009) | ||
| Free from biological hazards | Results in compliance; refer to biocompatibility info in Section J | Pass |
| Construction (EN 12470-3:2000+A1:2009) | ||
| Smooth surface, tip dimensions, absence of sharp edges, water resistance | All results in compliance with relevant subclauses | Pass |
| Electrical safety (EN 12470-3:2000+A1:2009) | ||
| Compliance with EN 60601-1:1990 | Results in compliance with Subclause 6.5 | Pass |
| Mechanical safety (EN 12470-3:2000+A1:2009) | ||
| No sharp ends/angles; probe smoothly rounded | Results in compliance with Subclause 6.6.1 | Pass |
| Resistance to breakage (for glass housing) | Not applicable to subject device (no glass housing) | NA |
2. Sample size used for the test set and the data provenance
- Test Set (Clinical Accuracy & Repeatability): 120 samples.
- Test Set (Lab Accuracy, Drop, Operating Environment, Storage Environment tests): The document does not explicitly state the number of devices tested for each of these bench tests, but implies multiple devices were tested to report the "maximum calculated error".
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that Biocare Asia Corporation Ltd. is located in Jiangsu, China, it is likely the testing was conducted in China. The clinical accuracy tests, with "pooled clinical bias" and "pooled clinical repeatability," suggest a clinical study was performed, which would be prospective in nature. The other performance tests are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a digital thermometer, and the ground truth for temperature measurement is established by calibrated reference standards (e.g., water baths, and for clinical accuracy, potentially reference thermometers). Experts are not typically involved in establishing the "ground truth" for physical measurements like temperature in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a digital thermometer as ground truth is based on physical scientific measurements with calibrated equipment, not subjective expert assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a digital thermometer, not an AI-powered diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a standalone device in the sense that it provides a temperature reading without a human interpreting an algorithm's output. The "algorithm" here is the device's internal signal processing of the thermistor input. The performance tests (e.g., accuracy against reference temperatures) evaluate the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance tests (accuracy, repeatability, environmental robustness) is established by calibrated reference standards (e.g., water baths at precisely controlled temperatures) as defined by the mentioned international standards (ASTM E1112-00:2011, EN 12470-3:2000+A1:2009). For clinical accuracy, it would be a comparison to a highly accurate reference thermometer.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a training set. It is a traditional electronic device based on physical principles.
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.