The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

Device Description

The Securus InfraRed Thermographic System (IRTS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on a monitor for the user.

The InfraRed Thermographic System (IRTS) consists of three components:

A. Thermal Imaging Probe (TIP or Probe)
B. Patient Interface Unit (PIU)
C. Patient Monitoring Unit (PMU)

The Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. In addition, the IRTS incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The thermal data is presented on the Patient Monitoring Unit as a two-dimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the InfraRed Thermographic System (IRTS), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Requirement)	Reported Device Performance
Accuracy (ISO 80601-2-56)	$\pm$ 0.3° C
Response Time (ISO 80601-2-56)	Both heating and cooling transient response time are less than 2.5 seconds
Biocompatibility (ISO 10993-1:2009)	Meets requirements (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity)
Electrical Safety (AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-1:2005 +A1:2012)	Fully complies with the specified standards
Electromagnetic Compatibility (IEC 60601-1-2 Ed. 3:2007-03)	Fully complies with the specified standard
Software Verification and Validation	All activities show that the software meets product requirements documentation (based on FDA Guidance)
Mechanical Strength and Service Life	Meets pre-established design input requirements (simulated worst-case conditions)

2. Sample Size and Data Provenance for the Test Set

The document does not specify the sample size used for the performance tests (accuracy, response time, mechanical testing). It states "Finished devices were tested" and "Probes were tested."

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, the nature of the tests (biocompatibility, electrical safety, EMC, software V&V, performance testing, mechanical testing) suggests these were prospective, laboratory-based tests conducted on manufactured devices or components.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The performance tests described are primarily objective, quantitative measurements against international standards (e.g., ISO, IEC). There's no indication that human experts were used to establish a "ground truth" in the traditional sense for these technical performance metrics.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are interpreting data and their disagreements need resolution to establish a consensus ground truth. The tests described here are technical and objective (e.g., measuring temperature accuracy against a known standard, confirming compliance with electrical safety).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The document focuses on the technical performance and safety of the device itself, not on its comparative effectiveness with or without AI assistance for human readers/clinicians, nor on the impact of its thermal imaging feature on clinical outcomes.

6. Standalone (Algorithm Only) Performance

Partially applicable/implicitly yes. The core performance tests (accuracy, response time) for the thermocouple sensor are standalone performance metrics of the device's ability to measure temperature. The document explicitly states the "InfraRed Thermographic System (IRTS) was tested in accordance with the requirements of ISO 80601-2-56... Testing included accuracy and response time. All performance testing data shows that the IRTS system meets the requirements of ISO 80601-2-56." This describes the standalone performance of the temperature sensing component.

For the thermographic sensor (the "AI-like" component that displays a 2D color map), the document states: "The thermal data of the IRTS is not classified under the Clinical Thermometer designation of ISO 80601-2-56." It also mentions "The thermal image and peak temperature are offered as additional temperature monitoring features." While it describes the function of this feature, it does not provide standalone performance metrics (e.g., accuracy, sensitivity, specificity) specifically for the thermal imaging capability itself, nor does it specify a study proving its individual performance against a ground truth. It states "The performance testing supports substantial equivalence of the IRTS to the predicate," but the predicate did not have this feature.

7. Type of Ground Truth Used

For the thermocouple sensor's performance (i.e., temperature measurement):
The ground truth used for accuracy and response time testing was based on known, standardized reference values or conditions as dictated by ISO 80601-2-56. For example, temperature accuracy is typically measured against a highly accurate reference thermometer in a controlled bath with known temperatures.

For the thermal imaging feature:
The document does not specify a ground truth method or study for the thermal imaging feature's performance in terms of its ability to accurately represent esophageal temperature distribution. It only states its output as "additional temperature monitoring features" and the data "is not classified under the Clinical Thermometer designation."

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. The product description and performance data focus on the physical and electrical characteristics of a medical device (thermometer), not an AI algorithm that would typically require a training set. The "thermal imaging" component is described as passively collecting infrared radiation and presenting it as a map, which sounds more like signal processing and display rather than a machine learning model requiring training.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for a machine learning model, this question is not applicable.

Summary

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

March 4, 2016

Securus, Inc. Mr. William Gorman Director of Quality and Regulatory Affairs 100 Cummings Center, Suite 215f Beverly, Massachusetts 01915

Re: K152402

Trade/Device Name: InfraRed Thermographic System (IRTS) IRTS Thermal Imaging Probe (TIP), IRTS Patient Monitoring Unit (PMU), IRTS Patient Interface Unit (PIU) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometers Regulatory Class: II Product Code: FLL Dated: January 27, 2016 Received: February 2, 2016

Dear Mr. Gorman:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -5

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, 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) K152402

Device Name

Infrared Thermographic System (IRTS) IRTS Thermal Imaging Probe (TIP), IRTS Patient Monitoring Unit (PMU), IRTS Patient Interface Unit (PIU)

Indications for Use (Describe)

The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(K) SUMMARY K152402, INFRARED THERMOGRAPHIC SYSTEM (IRTS)

PREPARED: MARCH 3, 2016

1) Submitter

Securus Medical Group, Inc. 100 Cummings Center Suite 215F Beverly, MA 01915

Phone: 978-317-0836 Contact: William J. Gorman

2) Device

Trade name:	InfraRed Thermographic System (IRTS)
	IRTS Thermal Imaging Probe (TIP)
	IRTS Patient Monitoring Unit (PMU)
	IRTS Patient Interface Unit (PIU)

Clinical Electronic Thermometer Common name:

Classification Number/ Classification name/Product code:

Clinical Electronic Thermometers are Class II devices under 21 CFR § 880.2910 and are classified by the General Hospital Panel. Product code - FLL.

Special Controls:

Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers, March 1993

3) Predicate Device

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System, FIAB, (K123361)

4) Reference Device

S-Cath Esophageal Temperature Probe and Temperature Monitoring System, Circa Scientific, (K112376)

5) Device Description

The InfraRed Thermographic System (IRTS) consists of three components:

A. Thermal Imaging Probe (TIP or Probe)

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B. Patient Interface Unit (PIU)
C. Patient Monitoring Unit (PMU)

The Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. The Probe has been tested in compliance with ISO 80601-2-56:2009, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. In addition, the IRTS incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The thermal data is presented on the Patient Monitoring Unit as a twodimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features. The thermal data of the IRTS is not classified under the Clinical Thermometer designation of ISO 80601-2-56.

6) Indications for Use

The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit (PMU) with Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C') from the IRTS Thermal Imaging Probe.

7) Comparison to Predicate Device

The IRTS is substantially equivalent to the primary predicate device FIAB ESOTEST System (K123361). Both the subject device and the primary predicate device have the same intended use and indications for use as a continuous esophageal temperature monitor. Both use thermocouple sensors for temperature monitoring of the patients esophagus. The subject device also includes a thermographic sensor for displaying thermal images as an additional temperature monitoring feature. This feature does not raise different questions of safety or effectiveness as it provides additional information about the temperature in the patient's esophagus. Similar to reference device Circa Scientific, Esophageal Temperature Probe and Temperature Monitoring System (K112376), the subject device is provided non-sterile. Thus, the subject device has the same intended use and similar technological characteristics as the primary predicate device K123361. Any differences in technological characteristics do not raise different questions of safety or effectiveness. A summary comparison between the subject, primary predicate and reference devices is provided in the following table:

	Securus Medical Group,Inc.,IRTS SystemSubject Device	FIAB, ESOTESTEsophageal TemperatureProbe and TemperatureMonitoring SystemK123361Primary PredicateDevice	Circa Scientific,Esophageal RectalTemperature Probe andTemperature MonitoringSystemK 112376Reference Device	SE Discussion
Intended Use	Continuous temperaturemonitoring of thepatients esophagus	Continuous temperaturemonitoring of thepatients esophagus.	Continuous esophagealtemperature monitoring	Same intended use
	Securus Medical Group,Inc.,IRTS SystemSubject Device	FIAB, ESOTESTEsophageal TemperatureProbe and TemperatureMonitoring SystemK123361Primary PredicateDevice	Circa Scientific,Esophageal RectalTemperature Probe andTemperature MonitoringSystemK 112376Reference Device	SE Discussion
Indications forUse	The IRTS Probe isintended for continuousesophageal temperaturemonitoring.The IRTS Monitor isintended to displaycontinuous esophagealtemperaturemeasurements (°C) fromthe IRTS Probe.	The ESOTEST Probe isintended for continuousesophageal temperaturemonitoring.ESOTEST Monitor isintended to displaycontinuous temperaturemeasurement (°C) from3 sensors temperatureprobe.	The EsophagealTemperature Probe isintended for continuouspatient temperaturemonitoring. Theradiopaque probe isdesigned for placementin the esophagus.Temperature Monitor:Display continuoustemperaturemeasurement (°C) from12-sensor temperatureprobe.	Same indicationsas primarypredicate
SystemComponents	Temperature probePatient Interface UnitPatient Monitoring Unit	Temperature probeInterconnect cablePatient Monitor	Temperature probeInterconnect cableMonitor	Similarcomponents
Probe Sterility	Provided Non-sterile	Provided Sterile	Provided Non-sterile	Same as referencedevice
Probe Material(patient contact)	Polyethylene andplatinum iridium	Polyurethane andstainless steel	Flexible Polyester andRigid Pebax	Similar materials,tested forbiocompatibility
Probe size	9 Fr catheter with 9 Frsensor150 cm length	7 Fr catheter with 11 Frsensors95 cm length	10 Fr OD, 30.5" totallength.Interconnect Cable 10'long	Similar sizes
SystemTemperaturePrecision andResolution	0.1° C	0.1° C	0.2° C	Similar precisionand resolution.
TemperatureSensor	Type-T thermocouple	Type-T thermocouple	Thermistor	Similar sensor
TemperatureSensor Range	25° - 45° C	15°-75° C	25° - 45° C	Same range asreference device

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	Securus Medical Group,Inc.,IRTS SystemSubject Device	FIAB, ESOTESTEsophageal TemperatureProbe and TemperatureMonitoring SystemK123361Primary PredicateDevice	Circa Scientific,Esophageal RectalTemperature Probe andTemperature MonitoringSystemK 112376Reference Device	SE Discussion
TemperatureSensor Accuracy	$\pm$ 0.3° Ctested in accordance withISO 80601-2-56	$\pm$ 0.5° Ctested in accordance withISO 80601-2-56	$\pm$ 0.3° Ctested in accordance withISO 80601-2-56	Better accuracythan primarypredicate device
TransientResponse Timeof TemperatureSensor	Both heating transientresponse time andcooling transientresponse time are lessthan 2.5 seconds: timefor probe plunged fromreference bath to a waterbath with a 2° Cdifferential.	Both heating transientresponse time andcooling transientresponse time areapproximately 1 second:time for probe plungedfrom reference bath to awater bath with a 2° Cdifferential.	Heating transient 7seconds, coolingtransient 4.5 seconds	Insignificant timedifferential.
Power Supply	100-240 Vac AC adaptorpower supply 24 VDC	100-120/230 Vac	100-240 Vac	Compliant to USpower supply
Electrical SafetyandElectromagneticCompatibility	Fully complies with IEC60601-1:2005 +A1:2012IEC 60601-1-2:2007	Fully complies with IECUL 60601-1: 2006IEC 60601-1-2:2007	Fully complies with IEC60601-1:1998(applicable sections)	Same standards

8) Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility:

Probes were tested in accordance with ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included:

. Cytotoxicity
. Sensitization
. Irritation/Intracutaneous Reactivity

Test results show that the device meets the requirements of ISO 10993 for its intended use.

Electrical Safety and EMC:

The InfraRed Thermographic System (IRTS) was tested in accordance with:

AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and .

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a2:2010/(r)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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.
This testing demonstrates that the InfraRed Thermographic System (IRTS) meets the recognized standards for electrical safety and compatibility.

Software Verification and Validation:

Per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Securus has provided appropriate software documentation based on Level of Concern. A system level software verification and validation protocol was developed to test each requirement. This protocol includes a cross-reference matrix to map each requirement with a test activity and a pass/fail criteria. Results of each test are recorded and compared to the pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation.

Performance Testing:

The InfraRed Thermographic System (IRTS) was tested in accordance with the requirements of 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. Testing included accuracy and response time. All performance testing data shows that the IRTS system meets the requirements of ISO 80601-2-56.

Mechanical Testing:

Finished devices were tested in accordance with pre-approved protocols based on design input requirements for mechanical strength and service life (simulated use). This testing shows that the IRTS system meets pre-established design input requirements for mechanical strength and service life when tested in simulated worst case conditions.

Conclusions

The IRTS has the same intended use, indications for use and similar technological characteristics as the primary predicate device K123361. Any difference in technological characteristics does not raise different questions of safety or effectiveness. The thermal imaging feature of the IRTS provides additional temperature monitoring of the patient's esophagus. The performance testing supports substantial equivalence of the IRTS to the predicate.

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.