(618 days)
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) 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 S-CATH 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 S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.
The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH 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 optimal placement.
The provided text describes a 510(k) premarket notification for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System. This is a medical device, and the submission aims to demonstrate its substantial equivalence to a legally marketed predicate device, not to showcase an AI algorithm.
Therefore, the requested information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, standalone algorithm performance, training sets, and ground truth establishment for training sets, is not present in the provided document. This document focuses on the equivalence of a physical medical device and its performance against established medical device standards.
However, I can extract information related to the device's functional performance testing and acceptance criteria as described for a physical medical device:
Device Performance and Acceptance Criteria (as described for a physical medical device)
The document outlines various non-clinical performance data for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System to demonstrate its compliance with recognized standards and its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| TEST NAME | ENDPOINT (Acceptance Criteria) | RESULT SUMMARY (Reported Device Performance) |
|---|---|---|
| In vitro cytotoxicity, sensitization, and intracutaneous reactivity | 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, not sensitizing, and meets the requirements of intracutatneous reactivity. |
| 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. | The system accuracy and response time meets the requirements of the standard |
| 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 | 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 |
| Performance test in vivo (animal) setting | Evaluate precision and accuracy of the electrode position detected by the 3D cardiac mapping system by measuring the distances between electrodes and control catheter tip on fluoroscopy and 3D cardiac mapping system. | Data confirmed S-CATH M probe is visible on 3D cardiac mapping system with a determined precision and accuracy of 2.0 ± 1.2mm on CARTO 3 and 7.4 ± 5.3mm on EnSite NavX. |
In addition, a key "acceptance criterion" for this type of submission is substantial equivalence to the predicate device. The comparison table (pages 5-6) and the "Substantial Equivalence Discussion" (pages 8-9) highlight this:
- Accuracy: The acceptance criterion for accuracy is ± 0.3°C within rated output range, as per ISO 80601-2-56 requirements. The device reported meeting this requirement.
- Response Time: The predicate device had a response time of approximately 1 second. The subject device's response time was deemed to show "substantial equivalence" despite being "an average of only 2 seconds faster" in heating and cooling transients when tested with the same methodology as the predicate.
- Temperature Measurement Range: Subject device: 0-45°C. Predicate device: 0-75°C. The subject device's range is lower but meets the consensus standard ISO 80601-2-56 requirement (34.0°C to 43.0°C).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for each non-clinical test. The tests are primarily laboratory-based and conducted on the device components or system. Data provenance is not specified beyond "non-clinical testing" and a "performance test in vivo (animal) setting." There is no mention of country of origin or whether the data is retrospective or prospective, as these are typically considerations for human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This filing describes the performance of a physical medical device against engineering standards (e.g., ISO, IEC) and internal testing protocols, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation or AI-assisted studies where inter-reader variability or differences in opinion need to be resolved. This document details physical device performance.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the measurement standards and specifications of the relevant international and national standards (e.g., ISO 10993-1 for biocompatibility, ANSI/AAMI/ISO 11135 for sterility, IEC 62304 for software, IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, ISO 80601-2-56 for accuracy and response time, ANSI/AAMI EC53:2013 for mapping cable). The in-vivo animal study likely used direct measurements (e.g., fluoroscopy) as the ground truth for assessing mapping system accuracy.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI 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.