(297 days)
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA MATRIX12 M Probe and is intended for the continuous detection, measurement and visualization (in ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA MATRIX12 M Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.
The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).
The MATRIX12 M Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadiusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located in a 3 x 4 sensor array. The sensors measure temperature by a thermistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 14Fr diameter probe is placed inside the esophagus.
The Probe is also equipped with 4 electrode sensors. By connecting the MATRIX12 M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for placement.
The provided text is a 510(k) summary for the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System. It describes the device, its intended use, and comparative testing against a predicate device (CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System, K200943).
However, the information provided does not describe a study involving an algorithm or AI that would require the in-depth data requested regarding sample sizes, expert ground truth, MRMC studies, or training/test sets. The device is a clinical electronic thermometer and sensing probe, and the testing described focuses on hardware performance, electrical safety, biocompatibility, and software system tests for an embedded system, not a diagnostic AI/algorithm.
Therefore, I cannot fully answer the request as the context of the input document is for a medical device that does not rely on an AI/algorithm based on the typical sense of machine learning models for diagnosis or prediction.
However, I can extract the acceptance criteria and performance data for the device itself from the provided tables, as well as information about the non-clinical testing.
Here's the information extracted concerning the device's acceptance criteria and proven performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Endpoint) | Reported Device Performance (Result Summary) |
|---|---|---|
| In vitro cytotoxicity, sensitization, and irritation | Verifying the compliance of the esophageal probe to the requirements of ISO 10993-1 for the considered type and duration of contact. | Results of tests demonstrate that the sample can be considered non cytotoxic, non sensitizer, and non irritator for its intended use. |
| Sterility | Verifying the compliance of the esophageal probe to the requirements of sterilization according to standard ANSI/AAMI/ISO 11135. | Results of EO sterilization validation and tests demonstrate the device meets a Sterility Assurance Level (SAL) of 10-6. |
| Software system tests | Verifying the correct implementation of the software requirements according to standard IEC 62304. | Following completion of all software lifecycle activities, the software device does not have any unresolved anomalies (bugs or defects). |
| All the applicable safety tests prescribed by the IEC 60601-1 standard | Verifying the compliance of the system to the IEC 60601-1 standard. | The system passed all the applicable tests. |
| All the applicable immunity and emission tests prescribed by the IEC 60601-1-2 standard | Verifying the compliance of the system to the IEC 60601-1-2 standard. | The system passed all the applicable tests. |
| Accuracy and response time test | Verifying the compliance of the system to the ISO 80601-2-56 standard (Accuracy: 0.3℃ within rated output range; Response time: Not explicitly stated as acceptance criteria, but predicate's response time was longer). | The system accuracy and response time meets the requirements of the standard. (Note: Subject device response time was ~1.7s heating, ~1.4s cooling, faster than predicate's ~6s heating, ~8.5s cooling). |
| Mapping cable validation | Verifying the compliance of the mapping cable to the ANSI/AAMI EC53:2013 standard. | The cable manufacturing process guarantees the compliance to the standard. |
| Performance test in the working environment, electrode position verification | Verifying the immunity of the system to the most common disturbances sources in the working environment, verifying the compatibility with 3D cardiac mapping systems. | The system is not affected by the noise sources in the working environment. The system is compatible with the following 3D cardiac mapping systems: EnSite NavX and CARTO 3. |
Additional Device Specifications (from Comparison Table, acting as implicit acceptance criteria):
- Temperature Measurement Range: 0 - 55 °C (subject device rated higher than predicate 0 - 45 °C, but still meets consensus standard ISO 80601-2-56 range of 34-43 °C).
- Number of Temperature Sensors: 12
- Temperature Sensor Type: NTC Thermistor (system accuracy ±0.3℃)
- Measurement Presentation / User Interface: LCD monitor, Touch screen monitor
- Alarm Temperature Range: Upper threshold (Alarm and Warning High), Lower Threshold (Alarm and Warning Low); Low threshold cannot be set higher than upper threshold.
- Alarm Signal: Visual (flashing yellow, blue, or red on LCD), Audible (intermittent sound).
- Power Requirements: 100 - 240 Vac
- Monitor Classification: Class I Medical Electrical Equipment, Type CF Applied Part, Defibrillation-Proof.
- Introduction: Esophageal (nose/throat)
- Signal Processing and Display: Actual temperature is a function of thermistor resistance; Temperature displayed in 0.1℃ increments; 1 input (single probe) available; 12 sensors per probe measurements and user-selected alarm limits displayed on LCD monitor.
- Operating Conditions: 0°C to 40°C; Non-condensed relative humidity: 30% to 75%.
- Precision and Repeatability: 0.1 °C
- Probe Sterilization: ETO Sterilized; Single-use only.
- Biocompatibility of Patient Contacting Part: Compliance to ISO 10993-1; Surface-contacting device, mucosal membrane; Limited exposure (A) – up to 24 h.
- Software: Compliance to IEC 62304.
- Electrical Safety: Compliance to IEC 60601-1.
- EMC: Compliance to IEC 60601-1-2.
- Performance Bench Testing: Compliance to ISO 80601-2-56.
Regarding points 2-9 (Sample sizes, experts, MRMC, training/test sets, ground truth):
These points are highly relevant to AI/ML software as a medical device (SaMD) clearances. However, the provided document describes a hardware medical device (a clinical electronic thermometer and probe). The "software system tests" mentioned refer to verification of embedded control software, not diagnostic AI algorithms. Therefore, the concepts of "test set," "training set," "experts for ground truth," "adjudication," and "MRMC comparative effectiveness studies" do not apply to the type of device and testing described in this 510(k) summary.
The non-clinical performance data provided focuses on:
- Biocompatibility
- Sterility
- Software (embedded system verification, not AI/ML)
- Electrical Safety and EMC
- Accuracy and Response Time (met standards for thermometers)
- Mapping Cable validation
- Performance in working environment (immunity to noise, compatibility with mapping systems)
There is no mention of any AI or machine learning component in the device's functionality, nor any clinical study involving human readers or comparative effectiveness in the way typically required for AI/ML SaMDs. This submission outlines a traditional medical device premarket notification based on substantial equivalence to a predicate 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.