What is the regulatory pathway for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

Q: Who is the manufacturer of Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

Circa Scientific, LLC filed the 510(k) submission for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (K200943).

Q: What is the FDA product code for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

K200943 · Circa Scientific, LLC · FLL · Dec 17, 2021 · General Hospital

Device Facts

Record ID	K200943
Device Name	Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
Applicant	Circa Scientific, LLC
Product Code	FLL · General Hospital
Decision Date	Dec 17, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2

Intended 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 °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.

Device Story

System consists of touch-screen monitor, interconnect cables, and 10Fr esophageal probe; probe features 12 NTC thermistor sensors along s-curve for continuous temperature measurement. Probe includes 4 electrode sensors for visualization within 3D cardiac mapping systems (EnSite NavX, CARTO 3). Monitor displays 12 sensor readings, min/max values, and provides user-selectable audible/visual alarms. Data stored internally and exportable via USB to PC. Used in ORs and EP labs by clinicians. Provides real-time temperature data to assist in monitoring esophageal thermal status during procedures; helps clinicians visualize probe position via 3D mapping integration.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1), sterility (ISO 11135), software (IEC 62304), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance (ISO 80601-2-56). In vivo animal study evaluated 3D mapping visualization accuracy: 2.0 ± 1.2mm (CARTO 3) and 7.4 ± 5.3mm (EnSite NavX).

Technological Characteristics

Materials: Polyether, Polyamide (PEBAX), Tecothane Urethane, Gold electrode bands. Sensing: 12 NTC thermistors. Connectivity: USB data export, Mapping Interconnect Cable for 3D systems. Power: 100-240 Vac. Sterilization: ETO. Class I Medical Electrical Equipment, Type CF Applied Part, Defibrillation-Proof.

Indications for Use

Indicated for continuous detection, measurement, and visualization of esophageal temperature in operating rooms and interventional electrophysiology rooms.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K192210)

Reference Devices

S-Cath Esophageal Temperature Probe and Temperature Monitoring Probe (K112376)

Related Devices

K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System · Circa Scientific, Inc. · May 25, 2023
K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System · Fiab Spa · Oct 10, 2019
K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System · Fiab Spa · Nov 8, 2018
K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM · Circa Scientific, LLC · Aug 31, 2011
K123361 — ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM · Fiab Spa · Feb 27, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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. {4}------------------------------------------------ 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 OF COMPARISON | SUBJECT DEVICE: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System | PREDICATE DEVICE: K192210 FIAB-ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | COMMENTS | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Thermometer type | Esophageal | Esophageal | Same | | Product Code | FLL, IKD | FLL, IKD | Same | | Regulation | 880.2910 Clinical Electronic Thermometer 890.1175 Cable, Electrode | 880.2910 Clinical Electronic Thermometer 890.1175 Cable, Electrode | Same | | ELEMENT OF COMPARISON | SUBJECT DEVICE: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System | PREDICATE DEVICE: K192210 FIAB-ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | COMMENTS | | 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. | The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI 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 ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI 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 ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated. | Same (except for the trade name) | | Components | Temperature probe, Patient cable, Monitor. The package includes an external power supply and hospital-grade power cord. Optional component: Mapping Interconnect Cable | Temperature probe, Patient cable, Monitor. The package includes an external power supply and an equipotential cable. Optional component: ESOTEST MULTI ADAPTER CABLE | Similar, predicate device includes additional equipotential cable. Equipotential cable is not required per IEC 60601-1; it is an accessory provided by predicate manufacturer. | | ELEMENT OF COMPARISON | SUBJECT DEVICE: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System | PREDICATE DEVICE: K192210 FIAB-ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | COMMENTS | | Temperature measurement range (°C) | 0 - 45 | 0 - 75 | Rated output range is lower for the subject device. Consensus standard ISO 80601- 2-56 states in section 201.12.1.101: The output temperature of clinical thermometers should cover the minimum rated output range from 34,0 °C to 43,0 °C. | | Number of temperature sensors | 12 | 5 or 7 | Subject device has more sensors allowing additional coverage within the esophageal area. | | Temperature sensor type | NTC Thermistor (system accuracy ± 0.3ºC) | T-type thermocouple (system accuracy ± 0.3°C) | Similar, a thermistor is a temperature- sensitive resistor, whilst a thermocouple generates a voltage proportional to the temperature. The same accuracy is ensured by the respective signal process and display. | | Measurement presentation / User Interface | LCD monitor Touch screen monitor | LCD monitor Touch screen monitor | Same | | Alarm temperature range (°C) | Upper threshold (Alarm and Warning High) Lower Threshold (Alarm and Warning Low) Low threshhold cannot be set higher than upper threshold. | 37-41 upper threshold (Tmax) 12-24 lower threshold (Tmin) | Similar, subject device allows user to select values within the same ranges. | | Alarm signal | Visual (flashing yellow or red on the LCD display) Audible (intermittent sound) | Visual (flashing red circles on the LCD display) Audible (intermittent sound) | Similar, subject device includes yellow visual for warning level and red for alarm level. | | Power requirements | 100 - 240 Vac | 100 - 240 Vac | Same | | ELEMENT OF COMPARISON | SUBJECT DEVICE: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System | PREDICATE DEVICE: K192210 FIAB-ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | COMMENTS | | Monitor classification | Class I Medical Electrical Equipment Type CF Applied Part, Defibrillation-Proof | Class I Medical Electrical Equipment Type CF Applied Part. Defibrillation-Proof | Same | | Dimensions (cm) | Monitor: 26W x 19H x 9D Patient cable length: 460 Temperature Probe: 65L; 10Fr | Monitor: 34W x 25H x 6.5D Patient cable length: 290 Temperature probe: 83L; 7Fr body, 11Fr sensors | Similar in size, minor differences that do not affect device placement or use. | | Introduction | Esophageal (nose / throat) | Esophageal (nose / throat) | Same | | Signal processing and display: | Actual temperature is a function of the thermistor resistance. Temperature displayed in 0.1℃ increments. 1 input (single probe) available. 12 sensors per probe measurements and user- selected alarm limits are displayed on LCD monitor. | Actual temperature is a function of the thermocouple voltage. Temperature displayed in 0.1℃ increments. 1 input (single probe) available. 5/7 sensors per probe measurements and user- selected alarm limits are displayed on LCD monitor. | Similar, temperature sensor technology (thermocouple and thermistor) are standard for temperature measurement. The same accuracy is ensured. Subject device has 5 more sensors per probe and therefore displays 12 temperatures. | | Patient contacting materials | Flexible Polyether and Rigid Polyamide PEBAX® Tecothane® Urethane and Gold Electrode Bands | Polyurethane and Stainless Steel (SST) AISI 304 | Similar, both use thermoplastics and metals commonly used for medical device applications. To bridge the difference, subject device was tested under ISO 10993-1. | | Operating conditions | 0°C to 40°C Non-condensed relative humidity: 30% to 75% | +10°C to +40°C Non-condensed relative humidity: 30% to 75% | Similar, subject monitor has a lower limit; devices are used in the same hospital setting. | | Accuracy | 0.3℃ within rated output range (ISO 80601-2-56 requirements for clinical thermometers) | 0.3℃ within rated output range (ISO 80601-2-56 requirements for clinical thermometers) | Same | | Precision and repeatability (°C) | 0.1 | 0.1 | Same | | ELEMENT OF COMPARISON | SUBJECT DEVICE: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System | PREDICATE DEVICE: K192210 FIAB-ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | COMMENTS | | Response time | Heating transient response time is approximately six seconds and cooling transient response time is approximately eight and a half seconds. Response time is for probe plunged from reference water bath to a water bath with a 2°C differential, ISO 80601- 2-56 requirements for clinical thermometers. | Both heating and cooling response time are approximately 1 second. Response time is defined as the mean value of the measured time intervals associated to temperature increase (tr) or to temperature difference (tf) necessary to cover 63.3% of the total temperature excursion. | Response time testing between FIAB ESOTEST and CIRCA S-CATH M using the same test methodology was conducted. The actual testing showed substantial equivalence, with the predicate device heating transient response time an average of only 2 seconds faster and also cooling transient response time an average of 2 seconds faster. | | Probe sterilization | ETO Sterilized | ETO Sterilized | Same | | Biocompatibility of the patient contacting 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 | | Performance bench testing | Compliance to ISO 80601-2- 56 | Compliance to ISO 80601-2- 56 | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Substantial Equivalence Discussion: Esophageal temperature monitoring using st…