Esophageal Temperature Probe: The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus. Temperature Monitor: Display continuous temperature measurement (°C) from 12-sensor temperature probe.

Device Description

The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels. The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.

AI/ML Overview

The information provided focuses on the non-clinical performance data for the CIRCA Scientific Temperature Monitoring System, specifically the S-Cath™ Esophageal Temperature Probe and Temperature Monitoring System.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (ISO 80601-2-56:2009 requirement for clinical thermometers)	The accuracy within the rated output range in normal use is not greater than 0.3°C. (Meets the predicate device's accuracy of not greater than 0.3°C and the ISO 80601-2-56:2009 requirement).
Precision and Repeatability	0.1°C. (The predicate device did not specify precision and repeatability, so the subject device meets or exceeds this aspect compared to the predicate).
Time Response (Heating transient)	Approximately 7 seconds. (The predicate device had a heating transient response time of approximately 29 seconds, indicating the subject device has a faster response time).
Time Response (Cooling transient)	Approximately 4.5 seconds. (The predicate device had a cooling transient response time of approximately 18 seconds, indicating the subject device has a faster response time).
Biocompatibility (ISO 10993-1)	Evaluated to ISO 10993-1 and meets biocompatibility requirements.
Electrical Safety (IEC 60601-1)	Fully complies with IEC 60601-1:1988 + A1:1991 + A2:1995.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Fully complies with IEC 60601-1-2:2007.
Programmable Electrical Medical Systems (IEC 60601-1-4)	Complies with IEC 60601-1-4 / 2000 Consol. Ed 1.1.
Risk Management (ISO 14971)	Complies with ISO 14971 / 2007.

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 primarily describes non-clinical performance testing. It does not provide specific sample sizes (e.g., number of probes tested) for the accuracy, precision, repeatability, and time response tests. It states these tests were performed per Standard ISO 80601-2-56 / First Edition 2009-10-01. The data provenance (country of origin, retrospective/prospective) is not specified for these tests, but they are typically laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The studies described are non-clinical performance tests for a temperature monitoring device, not studies requiring expert interpretation or ground truth establishment in a diagnostic context. Ground truth for temperature measurement would be established by reference standards in a controlled laboratory environment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of non-clinical performance tests described. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers.

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

This information is not applicable. The submission is for a temperature monitoring device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical temperature probe and monitor, not an algorithm, and its performance is inherently "standalone" in terms of its physical measurement capabilities. Its "performance" is its ability to accurately, precisely, and quickly measure temperature.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests (accuracy, precision, repeatability, time response), the ground truth would be established by reference temperature standards in a controlled laboratory environment, conforming to the requirements of ISO 80601-2-56. This standard outlines methods for testing clinical thermometers, ensuring traceability to national or international temperature standards.

8. The sample size for the training set

This information is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary

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510(k) SUMMARY
		AUG 3 1 2011	K112376
Submitter:	CIRCA Scientific, LLC14 Inverness Drive East, Suite H-240Englewood, CO 80112(303) 951-8767
Date Prepared:	July 28, 2011
Trade/Device Name:	S-Cath™ Esophageal Temperature Probe and TemperatureMonitoring System
Regulation Number:	880.2910
Regulation Name:	Clinical electronic thermometer
Regulatory Class:	Class II
Product Code:	FLL
Predicate Device:	Esophageal/Rectal Temperature Probe (510(k) K863646),Temperature Monitor (510(k) K913083)

DEVICE DESCRIPTION

The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe.

Image /page/0/Figure/4 description: The image shows four different diagrams of equipment. The first two diagrams show the front and back views of a monitor. The third diagram shows a temperature probe, and the fourth diagram shows an interconnect cable. The diagrams are labeled with text.

Page 1 of 5 510(k) ___

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The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels.

The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.

INDICATIONS FOR USE

Esophageal Temperature Probe:

The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus.

Temperature Monitor:

Display continuous temperature measurement (°C) from 12-sensor temperature probe.

TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

Legally Marketed Electronic Thermometer to Which Substantial Equivalence is Claimed: Smiths Medical Level 1® Esophageal/Rectal Temperature Probe (510(k) K863646), Smiths Medical Bi-Temp Temperature Monitor (510(k) K913083). The probe and monitor are originally listed under Respiratory Support Products, Inc. (RSP).

ELEMENT OF COMPARISON	SUBJECT DEVICE	CLAIMED SE DEVICE
Thermometer type	Esophageal	Esophageal / Rectal
Intended Uses	Continuous patient temperaturemonitoring, designed for insertioninto the esophagus.	Continuous patient temperaturemonitoring, designed for insertioninto the esophagus, nasopharynx,or rectum.
Labeling	Temperature Probe labeled forsingle-use.Package label includes productidentification, lot number.Instructions for use established.	Temperature Probe labeled forsingle-use.Package label includes productidentification, lot number.Instructions for use established.
Components	Temperature Probe(10Fr OD,30.5" total length);Interconnect Cable (10' Length);Monitor (10.2" W x 7.8" H x3.25" D).	Temperature Probe (9Fr and 12FrOD, 30.5" total length;Interconnect Cable (length notspecified);Monitor (6.1" W x 3.4" H x6.3" D).
Sensor	NTC Thermistor (accurate to ±0.2ºC within temperature range)	NTC Thermistor (accurate to ±0.2℃ within temperature range)

Signal processing and display	Actual temperature is a functionof the thermistor resistance.Temperature displayed in 0.1°Cincrements. 1 input (singleprobe) available. 12 sensors perprobe displayed.LCD Display includes user-selected alarm limits.	Actual temperature is a functionof the thermistor resistance.Temperature displayed in 0.1°Cincrements. 2 inputs (2 probes)available. 1 sensor per probedisplayed.LCD Display includes user-selected alarm limits.
Power requirements	100 – 240 Vac	Alkaline D (4 batteries)
Materials (Patient Contacting)	Flexible Polyether and RigidPolyamide PEBAX®	Polyvinyl Chloride (PVC)
Temperature Range	25°C to 45°C	5°C to 45°C
Ambient TemperatureEnvironment	No special ambient temperaturerange is specified for the device.	No special ambient temperaturerange is specified for the device.
Accuracy	The accuracy within the ratedoutput range in normal use is not-greater-than-0.3°C.(ISO 80601-2--56:2009 requirement for clinicalthermometers).	The accuracy within the ratedoutput range in normal use is notgreater-than-0.3°C.(ISO 80601-2--56:2009 requirement for clinicalthermometers).
Precision and Repeatability	0.1°C	Not specified
Response Time	Heating transient response time isapproximately 7 seconds andcooling transient response time isapproximately 4.5 seconds.(Note: time is for probe plungedfrom reference water bath to awater bath with a 2°Cdifferential.)	Heating transient response time isapproximately 29 seconds andcooling transient response time isapproximately 18 seconds.(Note: time is for probe plungedfrom reference water bath to awater bath with a 2°Cdifferential.)
Other Capabilities	Device fully complies with IEC60601-1:1988 + A1:1991 +A2:1995. Electromagneticcompatibility fully complies withIEC 60601-1-2:2007.	Electrical leakage current of thedevice (sensor and PVC tube)when used with Level 1 monitorand cable, comply with IEC 601-1/EN 60601-1.
Comparison Discussion	The S-Cath Esophageal Temperature Probe and Monitor issubstantially equivalent to the predicate Smiths MedicalEsophageal/Rectal Temperature Probe and Monitor for the followingelements:- Thermometer type;- Intended uses;- Labeling;- Components;- Sensor;- Signal process and display;- Temperature range;- Ambient temperature environment;

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The following differences are noted but do not affect substantialequivalence of safety and effectiveness:
- Power requirements: SE device uses batteries while S-Cathconnects to hospital mains supply (100 – 240 Vac). It hasbeen evaluated to IEC 60601-1 and meets electrical safetyrequirements.
- Materials (Patient Contacting): material of S-Cath PEBAXwas chosen for its flexibility and is used for other devicessuch as urology catheter. It has been evaluated to ISO 10993-1 and meets biocompatibility requirements.
- Response Time: S-Cath provides a faster response time thanpredicate device.

NON-CLINICAL PERFORMANCE DATA

The following performance testing was performed per Standard ISO 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 to establish and compare performance characteristics to the predicate device:

. Accuracy of the device.
. Precision and repeatability of the device.
. Time Response.

In addition, the device has been assessed against the standards below. The device has been tested and meets physical, operational, and biological specifications.

. ISO 10993-1 / 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
IEC 60601-1 / 1988 + Amendment 1 / 1991-11 + Amendment 2 / 1995 Medical electrical . equipment -- Part 1: General requirements for safety
. IEC 60601-1-2 / Edition 3:2007-03 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
1EC 60601-1-4 / 2000 Consol. Ed 1.1 Medical electrical equipment Part 1-4: General . requirements for safety - Collateral standard: Programmable electrical medical systems
1SO 15223-1 / First Edition:2007 Medical devices Symbols to be used with medical . device labels, labelling, and information to be supplied - Part 1: General requirements
ISO 14971 / 2007 Medical devices Application of risk management to medical devices .

CLINICAL PERFORMANCE DATA

No clinical studies were performed to demonstrate substantial equivalence.

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CONCLUSION OF SAFETY AND EFFECTIVENESS

The successful completion of:

· accuracy, precision and repeatability, and time response performance tests;
compliance to biological standard ISO 10993-1; and .
compliance to electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-4; .

demonstrate the safety and effectiveness of the CIRCA Scientific Esophageal Temperature Probe and Monitor when used for the defined indications for use, and demonstrate that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Circa Scientific, L.L.C C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313

AUG 3 1 2011

Re: K112376

Trade/Device Name: S-Cath™ Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: 11 Product Code: FLL Dated: August 16, 2011 Received: August 17, 2011

Dear Mr. Job:

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. 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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Page 2- Mr. Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112374

Indications for Use:

Esophageal Temperature Probe:

The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus.

Temperature Monitor:

Display continuous temperature measurement (°C) from 12-sensor temperature probe.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rly C. Chapman 8/31/4

Division Sign-Off) ୍ରvision of Anesthesiology, General Hospital ntection Control, Dental Devices

:10(k) Number: K112376

Page 1 of 1

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.