(406 days)
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Attachment | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Software | A1.1 | IEC 62304 | Safety and effectiveness of software meet the device's indications for use. | PASS |
| Electrical Safety & Performance | A1.2 | IEC 60601-1 | Basic safety and essential performance of medical electrical equipment and systems. | PASS |
| A1.3 | IEC 60601-1-11 | Basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | PASS | |
| A1.4 | IEC 60601-1-2 | Maintain Essential Performance and Basic Safety of EMC requirements when exposed to electromagnetic disturbances. | PASS | |
| Risk Management | A2.1 | ISO 14971 | Acceptable level of risk established against risk criteria. | Overall the risks are acceptable. |
| General Performance - Accuracy | A1.5 | ISO 80601-2-56 | Storage Test: Greatest calculated error (δ) should not be > 0.09°F (0.05°C) between 95.00°F to 100.40°F (35.00°C to 38.00°C), and not > 0.18°F (0.10°C) between 68.00°F to 94.98°F (20.00°C to 34.99°C) and 100.42°F to 113.00°F (38.01°C to 45.00°C). | When error δ |
§ 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.