(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
CIRCA Scientific, Inc. Fred Piazza Quality Assurance Manager 14 Inverness Drive East. Suite H-136 Englewood, Colorado 80112
Re: K200943
Trade/Device Name: Circa S-Cath 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, IKD Dated: November 18, 2021 Received: November 19, 2021
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.
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
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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 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) K200943
Device Name
CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System
Indications for Use (Describe)
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 esophaged 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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: November 18, 2021
II. DEVICE INFORMATION
Name of Device: CIRCA S-CATH 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: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, K192210
Reference Device: S-Cath Esophageal Temperature Probe and Temperature Monitoring Probe, K112376
III. 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 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.
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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.
IV. INDICATIONS FOR USE
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 ℃) 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.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| ELEMENT OFCOMPARISON | SUBJECT DEVICE: CIRCAS-CATH M EsophagealTemperature Probe andTemperature MonitoringSystem | PREDICATE DEVICE:K192210 FIAB-ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | 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: CIRCAS-CATH M EsophagealTemperature Probe andTemperature MonitoringSystem | PREDICATE DEVICE:K192210 FIAB-ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | COMMENTS |
| Indications forUse | The CIRCA TemperatureMonitoring System iscomposed of CIRCATemperature Monitor andCIRCA S-CATH M Probeand is intended for thecontinuous detection,measurement andvisualization (in ℃) ofesophageal temperature. Theintended environments of useare operating rooms andinterventionalelectrophysiology rooms.The CIRCA Monitor must beused in 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. | The ESOTEST MULTITemperature MonitoringSystem is composed ofESOTEST MULTI Monitorand ESOTEST MULTI Probeand is intended for thecontinuous detection,measurement andvisualization (in °C) ofesophageal temperature. Theintended environments of useare operating rooms andinterventionalelectrophysiology rooms. TheESOTEST MULTI Monitormust be used in conjunctionwith the ESOTEST MULTIProbe.The role of esophagealtemperature monitoring usingthis device in reducing therisk of cardiac ablation-related esophageal injury hasnot been established. Theperformance of the ESOTESTMULTI system in detectingesophageal temperaturechanges as a result of energydelivery during cardiacablation procedures has notbeen evaluated. | Same (except for thetrade 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 an equipotentialcable. Optional component:ESOTEST MULTIADAPTER CABLE | Similar, predicatedevice includesadditionalequipotential cable.Equipotential cable isnot required per IEC60601-1; it is anaccessory providedby predicatemanufacturer. |
| ELEMENT OFCOMPARISON | SUBJECT DEVICE: CIRCAS-CATH M EsophagealTemperature Probe andTemperature MonitoringSystem | PREDICATE DEVICE:K192210 FIAB-ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | COMMENTS |
| Temperaturemeasurementrange (°C) | 0 - 45 | 0 - 75 | Rated output range islower for the subjectdevice. Consensusstandard ISO 80601-2-56 states in section201.12.1.101: Theoutput temperature ofclinical thermometersshould cover theminimum rated outputrange from 34,0 °C to43,0 °C. |
| Number oftemperaturesensors | 12 | 5 or 7 | Subject device hasmore sensorsallowing additionalcoverage within theesophageal area. |
| Temperaturesensor type | NTC Thermistor(system accuracy ± 0.3ºC) | T-type thermocouple (systemaccuracy ± 0.3°C) | Similar, a thermistoris a temperature-sensitive resistor,whilst a thermocouplegenerates a voltageproportional to thetemperature. Thesame accuracy isensured by therespective signalprocess and display. |
| 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. | 37-41 upper threshold (Tmax)12-24 lower threshold (Tmin) | Similar, subjectdevice allows user toselect values withinthe same ranges. |
| Alarm signal | Visual (flashing yellow or redon the LCD display)Audible (intermittent sound) | Visual (flashing red circles onthe LCD display)Audible (intermittent sound) | Similar, subjectdevice includesyellow visual forwarning level and redfor alarm level. |
| Powerrequirements | 100 - 240 Vac | 100 - 240 Vac | Same |
| ELEMENT OFCOMPARISON | SUBJECT DEVICE: CIRCAS-CATH M EsophagealTemperature Probe andTemperature MonitoringSystem | PREDICATE DEVICE:K192210 FIAB-ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | COMMENTS |
| 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: 65L;10Fr | Monitor: 34W x 25H x 6.5DPatient cable length: 290Temperature probe: 83L; 7Frbody, 11Fr sensors | Similar in size, minordifferences that donot affect deviceplacement or use. |
| Introduction | Esophageal (nose / throat) | Esophageal (nose / throat) | Same |
| 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 thermocouplevoltage.Temperature displayed in0.1℃ increments. 1 input(single probe) available.5/7sensors per probemeasurements and user-selected alarm limits aredisplayed on LCD monitor. | Similar, temperaturesensor technology(thermocouple andthermistor) arestandard fortemperaturemeasurement. Thesame accuracy isensured.Subject device has 5more sensors perprobe and thereforedisplays 12temperatures. |
| Patientcontactingmaterials | Flexible Polyether and RigidPolyamide PEBAX®Tecothane® Urethane andGold Electrode Bands | Polyurethane and StainlessSteel (SST) AISI 304 | 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% | +10°C to +40°CNon-condensed relativehumidity: 30% to 75% | Similar, subjectmonitor has a lowerlimit; devices areused in the samehospital setting. |
| 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 |
| ELEMENT OFCOMPARISON | SUBJECT DEVICE: CIRCAS-CATH M EsophagealTemperature Probe andTemperature MonitoringSystem | PREDICATE DEVICE:K192210 FIAB-ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | COMMENTS |
| Response time | Heating transient responsetime is approximately sixseconds and cooling transientresponse time isapproximately eight and ahalf seconds.Response time is for probeplunged from reference waterbath to a water bath with a2°C differential, ISO 80601-2-56 requirements for clinicalthermometers. | Both heating and coolingresponse time areapproximately 1 second.Response time is defined asthe mean value of themeasured time intervalsassociated to temperatureincrease (tr) or to temperaturedifference (tf) necessary tocover 63.3% of the totaltemperature excursion. | Response time testingbetween FIABESOTEST andCIRCA S-CATH Musing the same testmethodology wasconducted. Theactual testing showedsubstantialequivalence, with thepredicate deviceheating transientresponse time anaverage of only 2seconds faster andalso cooling transientresponse time anaverage of 2 secondsfaster. |
| Probesterilization | ETO Sterilized | ETO Sterilized | Same |
| Biocompatibilityof the patientcontacting part | Compliance to ISO 10993-1 | Compliance to ISO 10993-1 | 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 |
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Substantial Equivalence Discussion:
Esophageal temperature monitoring using standard temperature sensor technology (thermocouple or 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 S-CATH M Esophageal Temperature Probe and Temperature Monitoring System) and the predicate device (ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, K192210) are similar in the following areas:
- Indications for use ●
- Components
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- Temperature monitoring technology and monitor display
- . Probe diameter and rout 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.
Due to the difference in shape of the subject device compared to the predicate device, Circa is using a reference device (S-Cath Esophageal Temperature Probe and Temperature Monitoring System (K112376)) to address the safety and effectiveness of the new technological characteristic when compared to the predicate device.
The s-curve shape of the subject device has been reviewed and cleared in a similar device, S-Cath Esophageal Temperature Probe and Temperature Monitoring System (K112376). The S-Cath Esophageal Temperature Probe and Temperature Monitoring System is intended for continuous temperature monitoring and is designed for placement in the esophagus. The Probe evaluated the impact the s-curve shape had on performance time, accuracy, precision, and repeatibility. Performance testing was conducted per Standard 80601-2-56 / First Edition 2009-10-01 Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Results for the reference device and its predicate device showed that the s-curve shape provided a faster response time.
Because more sensors are placed along the s-curve shape of the device to cover the geometry, the distance between each sensor is closer for the subject device than for the predicate device. The number of sensors are much like that for the reference device. Therefore, the s-curve shape is as safe and effective and does not raise different questions of safety and effectiveness.
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, andintracutaneous reactivity | Verifying the compliance of theesophageal probe to therequirements of ISO 10993-1 for theconsidered type and duration ofcontact. | Results of tests demonstrate that thesample can be considered noncytotoxic, not sensitizing, and meetsthe requirements of intracutatneousreactivity. |
| TEST NAME | ENDPOINT | RESULT SUMMARY |
| Sterility | Verifying the compliance of theesophageal probe to therequirements of sterilizationaccording 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 correctimplementation of the softwarerequirements according to standardIEC 62304. | Following completion of all softwarelifecycle activities, the softwaredevice does not have any unresolvedanomalies (bugs or defects). |
| All the applicable safetytests prescribed by the IEC60601-1 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 the IEC60601-1-2 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 | Verifying the immunity of thesystem to the most commondisturbances sources in the workingenvironment, verifying thecompatibility with 3D cardiacmapping 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 |
| Performance test in vivo(animal) setting | Evaluate precision and accuracy ofthe electrode position detected bythe 3D cardiac mapping system bymeasuring the distances betweenelectrodes and control catheter tip onfluoroscopy and 3D cardiac mappingsystem. | Data confirmed S-CATH M probe isvisible on 3D cardiac mappingsystem with a determined precisionand accuracy of 2.0 ± 1.2mm onCARTO 3 and 7.4 ± 5.3mm onEnSite NavX. |
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VII. CONCLUSIONS
Based on the performance testing, comparison and analysis in the submission, the subject device is substantially equivalent to the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K192210).
§ 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.