(61 days)
The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.
The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS Thermal Imaging Probe.
The Securus Aurora Thermographic System (ATS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on the Patient Interface Unit.
Aurora Thermographic System (ATS) consists of two components:
- A. ATS Thermal Imaging Probe
- B. ATS Patient Interface Unit
The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).
The ATS Thermal Imaging Probe and ATS Patient Interface Unit is a medical device intended for continuous esophageal temperature monitoring and displaying these temperature measurements. The product is a modification of the previously cleared InfraRed Thermographic System (IRTS). The modifications include combining two connectors into one handle, modifying the distal tip to include BaSO4 filler, changing the housing and circuit boards of the patient interface unit, and modifying the software.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification / Test Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ATS Thermal Imaging Probe Modifications | ||
| Accuracy (Thermocouple) | Accuracy ± 0.3° C across the rated output range. | All samples tested met the accuracy acceptance criteria of ± 0.3° C. |
| Response Time (Thermocouple) | Response time same as predicate, |
§ 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.