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510(k) Data Aggregation
(52 days)
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
The Wireless Body Temperature Monitor, model BTM-D1X series (model BTM-D1C, D, E, F, G and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two years old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, G and H, have only the function of ampit temperature monitoring.
The Wireless Body Temperature Monitor BTM-D1X series includes models BTM-DIC, D, E, F, G and H. This device is a battery-operated electronic device that is intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has the additional function of an ear thermometer.
The device is composed of two operational parts, the receiver and armband. An optional accessory may be included to assist in affixing the sensor of the armband more tightly. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit, and the main operation keys are included. The armband was designed and constructed with a thermo sensor and signal communication unit. For the monitoring operation, both the receiver and armband must be switched on. Soon after these two parts are switched on, the wireless signal communication will set up between the receiver and the armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of the receiver and will update every 12 seconds.
The device also has a high/low audible alarm, which will sound if the body temperature goes above the high alarm temperature or below the low alarm temperature set by the user.
In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on the receiver to take an ear temperature measurement at any time if needed. The reading on the LCD screen will return to the armpit temperature after 30 seconds.
This system uses a 3.0V DC battery for operation of the complete system. Whenever the battery is low, the MCU circuit will detect the low battery condition automatically, and will display "Low battery" on the LCD display. The BTM-D1X series was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.
The provided text describes a 510(k) premarket notification for a Wireless Body Temperature Monitor (BTM-D1X series) and references studies conducted for its predicate device (K081256) and an integrated component (K050463). The core of the submission revolves around demonstrating substantial equivalence, particularly concerning the addition of a high/low alarm function.
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1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate/Claimed) | Reported Device Performance (Modified Device) |
|---|---|---|
| Armpit Temperature Accuracy | ± 0.1 °C | Claimed to be the same as the predicate device, which met this criterion. No new studies were performed for armpit temperature accuracy for the modified device, implying it still meets ± 0.1 °C. |
| Ear Temperature Accuracy | ± 0.2 °C for 36 °C - 39 °C; ± 0.3 °C for others (for BTM-D1C only) | Ear temperature measuring function of the modified BTM-D1X series (BTM-D1C model only) is stated as "the same as the predicate BTM-D1X series (BTM-D1C model only) from K081256". This predicate device integrated a 510(k) cleared model (Taidoc/TD-1107, K050463) which itself met these accuracy specifications per ASTM E1965:2002. Therefore, the modified device is assumed to meet these same accuracy specs. |
| High Alarm Temperature Range | 36°C - 40°C (Manual setting) | The modified device adds this function with the specified range. Implicitly, the alarm will function correctly within this range, as this is a new feature for which direct performance against the range is the acceptance. |
| Low Alarm Temperature Range | 32°C - 35.5°C (Manual setting) | The modified device adds this function with the specified range. Implicitly, the alarm will function correctly within this range. |
| Electrical Safety | Compliance with EN 60601-1 | Compliance report included from Electronics Testing Center, Taiwan. |
| EMC/Wireless Performance | Compliance with EN 60601-1-2 / EN 300 440-2 / EN 3011489-17-3 | Compliance report included from Electronics Testing Center, Taiwan. |
| Biocompatibility | Cytotoxicity / Negative, Sensitization / Negative, Primary skin irritation / Negative (per ISO 10993) | Compliance report included from Taiwan National Chung-Hsing University Lab. |
| Continuous Monitoring Time | 24 hours | Stated as 24 hours for both predicate and modified devices, implying continued performance. |
| Temperature Range (Measurement) | 25 °C - 43 °C | Stated as 25 °C - 43 °C for both predicate and modified devices, implying continued performance. |
| Ambient Temperature (Operation) | 15 °C - 42 °C (with 95% RH humidity) | Stated as 15 °C - 42 °C (with 95% RH humidity) for both predicate and modified devices, implying continued performance. |
| Storage Condition | -20 °C - 50 °C (with 95% RH humidity) | Stated as -20 °C - 50 °C (with 95% RH humidity) for both predicate and modified devices, implying continued performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Armpit Temperature (ASTM E1112-00): The K100226 submission references the predicate K081256 for armpit temperature accuracy. K081256 would have conducted the ASTM E1112-00 test. The text does not specify the sample size for this test, nor the country of origin or whether it was retrospective or prospective. However, ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) outlines specific requirements for clinical testing, usually involving a defined number of subjects for accuracy verification.
- Ear Temperature (ASTM E1965-02): The K100226 submission specifically states that the ear temperature accuracy data comes from the 510(k) submission for Taidoc/TD-1107 (K050463) and was referenced in K081256.
- Sample Size: The text does not explicitly state the sample size for the ASTM E1965-02 clinical report from K050463. ASTM E1965-02 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) also mandates a specific number of subjects and measurements for clinical accuracy determination.
- Data Provenance: The original K050463 submission would contain this information. The current text does not specify the country of origin of the data or if it was retrospective or prospective. Given it's a clinical report for a device, it would typically be prospective clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for either the armpit or ear temperature accuracy studies. These details would typically be found in the original clinical study reports referenced (from K081256 and K050463). Clinical accuracy studies for thermometers generally rely on highly accurate reference thermometers (e.g., specific probe types, calibrated against NIST standards) and trained clinical personnel for proper measurement, rather than "experts" in the context of image interpretation.
4. Adjudication Method for the Test Set
The document does not provide information on an adjudication method. This concept is typically relevant for studies involving ambiguous interpretations (e.g., medical image diagnosis) where multiple readers review cases and disagreements need to be resolved. For thermometer accuracy studies, the ground truth is established by a reference measurement, not typically through adjudication of different interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are employed to evaluate the effectiveness of an AI system when used in conjunction with human readers, often for diagnostic tasks. This device is a measurement tool, and its evaluation focuses on accuracy compared to a reference standard, not its impact on human reader performance in a diagnostic workflow.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for accuracy. The "performance tests" listed, specifically "ASTM/ E 1112-00" for armpit temperature and "ASTM/ E 1965-02" for ear temperature, are standalone accuracy evaluations of the device itself against established reference measurement standards. The device's ability to measure temperature accurately is assessed independently of a diagnostic human-in-the-loop scenario. The primary modification in K100226, the high/low alarm, would also be tested standalone for its functionality (e.g., alarm triggers correctly at set temperatures).
The device is a direct measurement device; therefore, its performance is its standalone accuracy.
7. Type of Ground Truth Used
- Armpit Temperature: The ground truth for armpit temperature accuracy (evaluated by ASTM E1112-00) would be established using reference temperature measurements from highly accurate, calibrated thermometers, often in a controlled clinical setting, or by comparison to standard clinical methods (e.g., rectal temperature).
- Ear Temperature: The ground truth for ear temperature accuracy (evaluated by ASTM E1965-02, from K050463) would be established using reference temperature measurements from highly accurate, calibrated thermometers, typically tympanic temperature probes, or by comparison to standard clinical methods (e.g., rectal temperature).
- Other performance tests (electrical safety, EMC, biocompatibility): Ground truth for these is established by adherence to the respective international standards (e.g., EN 60601-1, ISO 10993) through laboratory testing.
8. Sample Size for the Training Set
This submission describes a medical device (thermometer), not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device's operation is based on fundamental principles of thermometry and wireless communication, not on learning from a dataset. Therefore, the concept of a "training set" as typically used for AI does not apply here.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device does not involve a "training set" in the AI/ML sense. Its operational parameters and calibration are established through engineering design, component specifications, and adherence to established performance standards.
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