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.

Device Description

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.

AI/ML Overview

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.

Summary

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May 25, 2023

CIRCA Scientific, Inc. Fred Piazza Quality Assurance Manager 14 Inverness Drive East, Suite H-136 Englewood, Colorado 80112

Re: K222311

Trade/Device Name: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880,2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL, IDK Dated: April 26, 2023 Received: April 27, 2023

Dear Fred Piazza:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222311

Device Name

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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I. SUBMITTER

CIRCA Scientific, Inc. 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 Phone: (303) 951-8767 Contact: Fred Piazza Date Prepared: April 26, 2023

II. DEVICE INFORMATION

Name of Device: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Common or Usual Name: Clinical electronic thermometer

Classification Name: Clinical electronic thermometer (21 CFR 880.2910)

Regulatory Class: II

Product Code(s): FLL, IKD

Predicate Device: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring Probe, K200943

III. DEVICE DESCRIPTION

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.

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

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Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for placement.

IV. INDICATIONS FOR USE

V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE
PREDICATE DEVICE

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510(k) SUMMARY

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510(k) SUMMARY

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510(k) SUMMARY

Substantial Equivalence Discussion:

Esophageal temperature monitoring using standard temperature sensor technology (thermistor) is the technological principle for both the subject and predicate devices.

The subject device has the same intended use as the predicate device, which is legally marketed. The subject device (CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System) and the predicate device (CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System, K200943) are similar in the following areas:

Indications for use
Components
Temperature monitoring technology and monitor display ●
Number of temperature sensors
Route of administration .
Accuracy, precision and repeatibility

Both systems have been evaluated to FDA recognized consensus standards in the areas of biocompatibility, sterilization, software, electrical safety, EMC, and performance for clinical electronic thermometers.

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VI. NON-CLINICAL PERFORMANCE DATA

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. Performance, labeling, electrical, biocompatibility, and sterilization testing of the subject device was conducted based on the risk analysis and on the requirements of recognized standards and FDA guidance documents.

The device was subjected to the following non-clinical testing to demonstrate that it performs as intended to the predicate device:

TEST NAME	ENDPOINT	RESULT SUMMARY
In vitro cytotoxicity,sensitization, and irritation	Verifying the compliance of theesophageal probe to the requirementsof ISO 10993-1 for the consideredtype and duration of contact.	Results of tests demonstrate that thesample can be considered noncytotoxic, non sensitizer, and nonirritator for its intended use.
Sterility	Verifying the compliance of theesophageal probe to the requirementsof sterilization according to standardANSI/AAMI/ISO 11135.	Results of EO sterilization validationand tests demonstrate the devicemeets a Sterility Assurance Level(SAL) of 10-6.
Software system tests	Verifying the correct implementationof the software requirementsaccording to standard IEC 62304.	Following completion of all softwarelifecycle activities, the softwaredevice does not have any unresolvedanomalies (bugs or defects).
All the applicable safetytests prescribed by theIEC 60601-1 standard	Verifying the compliance of thesystem to the IEC 60601-1 standard.	The system passed all the applicabletests.
All the applicableimmunity and emissiontests prescribed by theIEC 60601-1-2 standard	Verifying the compliance of thesystem to the IEC 60601-1-2standard.	The system passed all the applicabletests.
Accuracy and responsetime test	Verifying the compliance of thesystem to the ISO 80601-2-56standard.	The system accuracy and responsetime meets the requirements of thestandard.
Mapping cable validation	Verifying the compliance of themapping cable to the ANSI/AAMIEC53:2013 standard.	The cable manufacturing processguarantees the compliance to thestandard.
Performance test in theworking environment,electrode positionverification	Verifying the immunity of the systemto the most common disturbancessources in the working environment,verifying the compatibility with 3Dcardiac mapping systems.	The system is not affected by thenoise sources in the workingenvironment. The system iscompatible with the following 3Dcardiac mapping systems: EnSiteNavX and CARTO 3.

VII. CONCLUSIONS

Based on the performance testing, comparison and analysis in the submission, the subject device is substantially equivalent to the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System (K200943).

Regulation Number and Section

§ 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.

ELEMENT OFCOMPARISON	SUBJECT DEVICE:CIRCA MATRIX12 MEsophageal TemperatureProbe and TemperatureMonitoring System	PREDICATE DEVICE:K200943 CIRCA S-CATH MEsophageal TemperatureProbe and TemperatureMonitoring System	COMMENTS
Thermometertype	Esophageal	Esophageal	Same
Product Code	FLL, IKD	FLL, IKD	Same
Regulation	880.2910 Clinical ElectronicThermometer890.1175 Cable, Electrode	880.2910 Clinical ElectronicThermometer890.1175 Cable, Electrode	Same
ELEMENT OFCOMPARISON	SUBJECT DEVICE:CIRCA MATRIX12 MEsophageal TemperatureProbe and TemperatureMonitoring System	PREDICATE DEVICE:K200943 CIRCA S-CATH MEsophageal TemperatureProbe and TemperatureMonitoring System	COMMENTS
Indications forUse	The CIRCA TemperatureMonitoring System iscomposed of CIRCATemperature Monitor andCIRCA MATRIX12 M Probeand is intended for thecontinuous detection,measurement andvisualization (in ℃) ofesophageal temperature. Theintended environments of useare operating rooms andinterventionalelectrophysiology rooms. TheCIRCA Monitor must be usedin conjunction with theCIRCA MATRIX12 MProbe.The role of esophagealtemperature monitoring usingthis device in reducing therisk of cardiac ablation-related esophageal injury hasnot been established. Theperformance of the CIRCATemperature MonitoringSystem in detectingesophageal temperaturechanges as a result of energydelivery during cardiacablation procedures has notbeen evaluated	The CIRCA TemperatureMonitoring System iscomposed of CIRCATemperature Monitor andCIRCA S-CATH M Probeand is intended for thecontinuous detection.measurement andvisualization (in °C) ofesophageal temperature. Theintended environments of useare operating rooms andinterventionalelectrophysiology rooms. TheCIRCA Monitor must be usedin conjunction with theCIRCA S-CATH M Probe.The role of esophagealtemperature monitoring usingthis device in reducing therisk of cardiac ablation-related esophageal injury hasnot been established. Theperformance of the CIRCATemperature MonitoringSystem in detectingesophageal temperaturechanges as a result of energydelivery during cardiacablation procedures has notbeen evaluated	Same (except fortrade name)
Components	Temperature probe, Patientcable, Monitor. The packageincludes an external powersupply and hospital-gradepower cord. Optionalcomponent: MappingInterconnect Cable	Temperature probe, Patientcable, Monitor. The packageincludes an external powersupply and hospital-gradepower cord. Optionalcomponent: MappingInterconnect Cable	Same
ELEMENT OFCOMPARISON	SUBJECT DEVICE:CIRCA MATRIX12 MEsophageal TemperatureProbe and TemperatureMonitoring System	PREDICATE DEVICE:K200943 CIRCA S-CATH MEsophageal TemperatureProbe and TemperatureMonitoring System	COMMENTS
Temperaturemeasurementrange (°C)	0 - 55	0 - 45	Rated extendedoutput range is higherfor the subject device.Consensus standardISO 80601-2-56states in section201.12.1.101: Theoutput temperature ofclinical thermometersshould cover theminimum rated outputrange from 34,0 °C to43,0 °C.
Number oftemperaturesensors	12	12	Same
Temperaturesensor type	NTC Thermistor(system accuracy ±0.3℃)	NTC Thermistor(system accuracy ±0.3℃)	Same
Measurementpresentation /User Interface	LCD monitorTouch screen monitor	LCD monitorTouch screen monitor	Same
Alarmtemperaturerange (°C)	Upper threshold (Alarm andWarning High)Lower Threshold (Alarm andWarning Low)Low threshhold cannot be sethigher than upper threshold.	Upper threshold (Alarm andWarning High)Lower Threshold (Alarm andWarning Low)Low threshhold cannot be sethigher than upper threshold.	Same
Alarm signal	Visual (flashing yellow, blue,or red on the LCD display)Audible (intermittent sound)	Visual (flashing yellow, blue,or red on the LCD display)Audible (intermittent sound)	Same
Powerrequirements	100 - 240 Vac	100 - 240 Vac	Same
Monitorclassification	Class I Medical ElectricalEquipmentType CF Applied Part,Defibrillation-Proof	Class I Medical ElectricalEquipmentType CF Applied Part,Defibrillation-Proof	Same
Dimensions(cm)	Monitor: 26W x 19H x 9DPatient cable length: 460Temperature Probe: 63L;14Fr	Monitor: 26W x 19H x 9DPatient cable length: 460Temperature Probe: 65L;10Fr	Similar in size, minordifferences that donot affect deviceplacement or use.
Introduction	Esophageal (nose / throat)	Esophageal (nose / throat)	Same
ELEMENT OFCOMPARISON	SUBJECT DEVICE:CIRCA MATRIX12 MEsophageal TemperatureProbe and TemperatureMonitoring System	PREDICATE DEVICE:K200943 CIRCA S-CATH MEsophageal TemperatureProbe and TemperatureMonitoring System	COMMENTS
Signalprocessing anddisplay:	Actual temperature is afunction of the thermistorresistance.Temperature displayed in0.1℃ increments. 1 input(single probe) available.12 sensors per probemeasurements and user-selected alarm limits aredisplayed on LCD monitor.	Actual temperature is afunction of the thermistorresistance.Temperature displayed in0.1℃ increments. 1 input(single probe) available.12 sensors per probemeasurements and user-selected alarm limits aredisplayed on LCD monitor.	Same
Patientcontactingmaterials	Flexible Polyether and RigidPolyamide PEBAX®,Polyurethane Film and GoldElectrodes	Flexible Polyether and RigidPolyamide PEBAX®Tecothane® Urethane andGold Electrode Bands	Similar, both usethermoplastics andmetals commonlyused for medicaldevice applications.To bridge thedifference, subjectdevice was testedunder ISO 10993-1.
Operatingconditions	0°C to 40°CNon-condensed relativehumidity: 30% to 75%	0°C to 40°CNon-condensed relativehumidity: 30% to 75%	Same
Accuracy	0.3℃ within rated outputrange (ISO 80601-2-56requirements for clinicalthermometers)	0.3℃ within rated outputrange (ISO 80601-2-56requirements for clinicalthermometers)	Same
Precision andrepeatability(°C)	0.1	0.1	Same
Response time	Heating transient responsetime is approximately 1.7seconds and cooling transientresponse time isapproximately 1.4 seconds.Response time is for probeplunged from reference waterbath to a water bath with a2℃ differential, ISO 80601-2-56 requirements for clinicalthermometers.	Heating transient responsetime is approximately 6seconds and cooling transientresponse time isapproximately 8.5 seconds.Response time is for probeplunged from reference waterbath to a water bath with a2℃ differential, ISO 80601-2-56 requirements for clinicalthermometers.	While the subjectdevice achieves a afaster response time,the clinical benefitsof the faster responsetime have not beenestablished.
Probesterilization	ETO Sterilized.Probe is for single-use only.	ETO Sterilized.Probe is for single-use only.	Same
ELEMENT OFCOMPARISON	SUBJECT DEVICE:CIRCA MATRIX12 MEsophageal TemperatureProbe and TemperatureMonitoring System	PREDICATE DEVICE:K200943 CIRCA S-CATH MEsophageal TemperatureProbe and TemperatureMonitoring System	COMMENTS
Biocompatibilityof the patientcontacting part	Compliance to ISO 10993-1Categorization by nature ofbody contact: Surface-contacting device, mucosalmembrane.Categorization by duration ofcontact: Limited exposure(A) – device whosecumulative single, multiple orrepeated use or contact is upto 24 h.	Compliance to ISO 10993-1Categorization by nature ofbody contact: Surface-contacting device, mucosalmembrane.Categorization by duration ofcontact: Limited exposure(A) – device whosecumulative single, multiple orrepeated use or contact is upto 24 h.	Same
Software	Compliance to IEC 62304	Compliance to IEC 62304	Same
Electrical safety	Compliance to IEC 60601-1	Compliance to IEC 60601-1	Same
EMC	Compliance to IEC 60601-1-2	Compliance to IEC 60601-1-2	Same
Performancebench testing	Compliance to ISO 80601-2-56	Compliance to ISO 80601-2-56	Same