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.

Device Description

The ESOTEST MULTI Temperature Monitoring System is composed of the following device components:

Monitor ESOTEST MULTI MONITOR
Esophageal probe ESOTEST MULTI PROBE
Patient cable ESOTEST MULTI PATIENT CABLE

The LCD display of ESOTEST MULTI monitor shows the temperatures detected by the thermocouple sensors located in the probe, which is measuring the temperature of the patient's esophagus. Temperatures are displayed as numeric values and as scrolling plots. The user is able to set the value of an upper alarm threshold and that of a lower alarm threshold. If any measured temperature exceeds the upper alarm threshold or falls below the lower alarm threshold, ESOTEST MULTI monitor immediately emits visual and audible alarm signals.

The ESOTEST MULTI esophageal probe has a 7 French body equipped with 11 French sensors and is intended for the detection of esophageal temperature at multiple locations. The probe is connected to the monitor by ESOTEST MULTI patient cable.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. This is not an AI/ML powered device, therefore the information requested about the number of experts used to establish ground truth, the adjudication method, MRMC studies, or training set details are not applicable as these pertain to performance studies of AI/ML algorithms.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ESOTEST MULTI system are based on established international standards for clinical thermometers and medical device safety/performance.

Parameter	Acceptance Criteria (ESOTEST requirement)	Reported Device Performance
Accuracy of the device	±0.3°C in the rated range +10 to +45°C	Met (implied by "In all testing, the pre-determined acceptance criteria were met.")
Precision in condition of repeatability	0.1°C	Met (implied by "In all testing, the pre-determined acceptance criteria were met.")
Response Time	1 s (temperature step +27 to +43 °C)	Met (implied by "In all testing, the pre-determined acceptance criteria were met.")
Alarm Threshold	Auditory and visual alarm is triggered when outside threshold	Validated through performance testing and software verification/validation. Met (implied by "In all testing, the pre-determined acceptance criteria were met.")
Electrical Safety	Compliance with IEC 60601-1:2005	Verified by testing, criteria met.
EMC	Compliance with IEC 60601-1-2:2014	Verified by testing, criteria met.
Sterilization Process	Validation according to ISO 11135-1:2007 (EO gas)	Validated and routinely controlled, criteria met.
Biocompatibility	Compliance with ISO 10993-1:2009	Tested for cytotoxicity, sensitization, and intracutaneous reactivity (ISO 10993-5:2009, ISO 10993-10:2010), criteria met.
Risk Analysis	Compliance with ISO 14971:2007	Conducted, criteria met.

Study Details

The studies performed are non-clinical bench and lab tests, not clinical studies involving human subjects or AI/ML algorithm evaluation.

Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes for each non-clinical test (e.g., how many probes were tested for accuracy, or how many sterilization cycles were validated).
- The data provenance is from non-clinical laboratory testing performed by the manufacturer, Fiab SpA, in Italy. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a direct measurement medical thermometer, not an AI/ML algorithm requiring expert interpretation of complex data for ground truth establishment. Ground truth for the device's accuracy and performance parameters (e.g., temperature values, alarm functionality) is established by calibration against known standards and physical measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as it pertains to the resolution of discrepancies in expert interpretations, typically for AI/ML performance studies, which is not relevant for this device.
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 is not applicable. The device is an esophageal temperature monitoring system, not an imaging device or an AI-assisted diagnostic tool where human readers would be involved in interpreting data with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as there is no AI/ML algorithm in this device. The device performs direct physical measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For temperature accuracy, the ground truth is established by calibrated reference standards (e.g., precision temperature baths and reference thermometers) that meet the requirements of relevant international standards (e.g., ISO 80601-2-56).
- For other aspects like electrical safety, EMC, sterilization, and biocompatibility, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., IEC 60601-1, ISO 11135-1, ISO 10993-1).
The sample size for the training set:
- This is not applicable as there is no AI/ML algorithm requiring a training set for this device.
How the ground truth for the training set was established:
- This is not applicable as there is no AI/ML algorithm requiring a training set for this device.

Summary

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November 8, 2018

Fiab SpA Francesco Batistini Responsible for regulatory affairs Via Costoli, 4 Vicchio, 50039 It

Re: K180047

Trade/Device Name: ESOTEST MULTI 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 Dated: August 9, 2018 Received: October 9, 2018

Dear Francesco Batistini:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Alan M.
Stevens -S

Tina Kiang, Ph.D. for Acting 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) K180047

Device Name

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Indications for Use (Describe)

The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI 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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K180047 510(k) Summary

Submitter:	Fiab SpAVia Costoli, 450039 VicchioFlorence, Italy
Application Correspondent:	Silvia Calabrò.Title: Official CorrespondentPhone: (39) 055 849 79 216Fax: (39) 055 849 79 87E-mail: regulatory@fiab.it
Preparation Date:	November 7, 2018
Trade Name:	ESOTEST MULTI Esophageal Temperature Probeand Temperature Monitoring System
Common or Usual Name:	Thermometer, Electronic, Clinical
Regulation Name:	Clinical Electronic Thermometer.
Regulation Number:	21 CFR 880.2910
Product Code:	FLL
Device Class:	Class II
Predicate Device:	K123361 – ESOTEST Esophageal TemperatureProbe and Temperature Monitoring System

Device Indications for Use:

The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.

Device Description:

The ESOTEST MULTI Temperature Monitoring System is composed of the following device components:

Monitor ESOTEST MULTI MONITOR
Esophageal probe ESOTEST MULTI PROBE

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- Patient cable ESOTEST MULTI PATIENT CABLE

Element ofcomparison	Subject Device: K180047FIAB- ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System	Primary Predicate: K123361 -ESOTEST EsophagealTemperature Probe andTemperature MonitoringSystem	Comparison(Same/Different)
Thermometer type	Esophageal	Esophageal	Same
Indications for use	The ESOTEST MULTITemperature Monitoring Systemis composed of ESOTESTMULTI Monitor and ESOTESTMULTI Probe and is intendedfor the continuous detection,measurement and visualization(in °C) of esophagealtemperature. The intendedenvironments of use areoperating rooms andinterventional electrophysiologyrooms.	ESOTEST Probe is intended forcontinuous esophagealtemperature monitoring.ESOTEST Monitor is intendedfor display continuoustemperature measurement (°C)from 3 sensors temperatureprobe.	Same(both devices areintended for the sameuse as temperaturemonitoring systems, butthe indications for useof ESOTEST MULTIare more detailed))
Components	Temperature probe, Patientcable, Monitor. The package ofthe monitor includes an externalpower supply and anequipotential cable	Temperature probe, Interconnectcable, Monitor. The package ofthe monitor includes anequipotential cable	Different(the main difference isthat ESOTEST MULTIis powered by anexternal power supply)
Temperaturemeasurement	0 - 75	25 - 45	Different
Element ofcomparison	Subject Device: K180047FIAB- ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System	Primary Predicate: K123361 -ESOTEST EsophagealTemperature Probe andTemperature MonitoringSystem	Comparison(Same/Different)
range [°C]
Number oftemperaturesensors	5 or 7	3	Different
Temperaturesensor type	Thermocouple T type(accuracy±0.3°C)	Thermocouple T type (accuracy±0.3°C)	Same
Measurementpresentation/UserInterface	LCD monitorTouch screen monitor	LED displayUp and down buttons	Different
Alarmtemperature range[°C]	37-41 upper threshold (Tmax)12-24 lower threshold (Tmin)	36-41 upper threshold	Different
Alarm signal	Visual (flashing red circles onthe LCD display)Audible (intermittent sound)	Visual (flashing red LEDs)Audible (intermittent sound)	Same
Powerrequirements	100 - 240 Vac	100-120/230 Vac	Different
Monitorclassification	I, CF, defib protected	I, CF, defib protected	Same
Dimensions [cm]	Monitor: 34(width) x25(height)x6.5 (depth)Patient cable (length): 290Temperature probe (length anddiameter): 83; 7Fr body, 11Frsensors	Monitor: 36.7x24.9x11.0Interconnect cable (length): 250Temperature probe (length anddiameter): 95; 7Fr body, 11Frsensors	Different
Introduction	Esophageal (nose/throat)	Esophageal (nose/throat)	Same
Signal processingand display	Actual temperature is a functionof the thermocouple voltage.Temperature displayed in 0.1°Cincrements.	Actual temperature is a functionof the thermocouple voltage.Temperature displayed in 0.1°Cincrements.	Different
Element ofcomparison	Subject Device: K180047FIAB- ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System	Primary Predicate: K123361 -ESOTEST EsophagealTemperature Probe andTemperature MonitoringSystem	Comparison(Same/Different)
	1 input (single probe) available5/7 sensors per probemeasurements and user-selectedalarm limits are displayed onLCD monitor.	1 input (single probe) available3 sensors per probemeasurements and user-selectedalarm limit are displayed onLED displays.
Materials (patientcontacting)	Polyurethane and Stainless Steel(SST) AISI 304	Polyurethane and Stainless Steel(SST) AISI 304	Same
Ambienttemperature	+10°C to +40°CNon condensed relativehumidity:30% to 75%	+10°C to +40°CNon condensed relativehumidity:30% to 75%	Same
Accuracy	0.3°C within rated output range(ISO 80601-2-56:2009requirements for clinicalthermometers)	0.3°C within rated output range(ISO 80601-2-56:2009requirements for clinicalthermometers )	Same
Precision andrepeatability [°C]	0.1	0.1	Same
Response time(1)	Both heating and coolingresponse time are approximately1 second	Both heating and coolingresponse time are approximately1 second	Same

Technological Characteristics and Substantial Equivalence:

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Substantial Equivalence Discussion

The ESOTEST MULTI Temperature Monitoring System is intended for the same use as the predicate device. The differences between the ESOTEST MULTI Temperature Monitoring System and the predicate device are listed and discussed in the table below:.

Difference	Impact on safety and effectiveness
ESOTEST MULTI makes use of an external power supply (included in the package of ESOTEST	The adoption of a medical grade external power supply and of a custom locking connector does not introduce new
Difference	Impact on safety and effectiveness
MULTI monitor)	questions of safety and effectiveness. It has been verified bytesting the power supply system together with the deviceaccording to the requirements of the applicable ElectricalSafety standards,
ESOTEST MULTI has a larger measurement range	The larger measurement range does not introduce newquestions of safety and effectiveness. It has been verifiedthough performance accuracy testing.
ESOTEST MULTI probe has 5 to 7 sensors insteadof 3 as the probe of the predicate device	The greater number of sensors allows the device to monitora longer portion of esophagus temperature and does notintroduce new questions of safety and effectiveness. Theprobes were verified through performance testing.
ESOTEST MULTI makes use of a touch screenuser interface instead of employing LED displaysand physical buttons as the predicate device	The adoption of an LCD display with adequate size andbrightness, along with the capacitive touch screen. Thisdoes not introduce new questions of safety andeffectiveness.
ESOTEST MULTI has a lower alarm threshold inaddition to the upper alarm threshold of thepredicate device	The presence of a second alarm threshold allows the user toemploy the alarm both during heating and coolingtreatments. This does not introduce new questions of safetyand effectiveness. The alarm thresholds were validatedthrough performance testing and the software wasverified/validated.
ESOTEST MULTI can tolerate a slightly largermains supply voltage range	This does not introduce new questions of safety andeffectiveness. It has been verified by testing the device inthe mains supply rated voltage range, according torequirements of applicable Electrical Safety standards
The main unit of ESOTEST MULTI is smaller andlighter and the interconnection cables are longerthan the corresponding components of the predicatedevice	The fact that the main unit is smaller and lighter does notintroduce new questions of safety and effectiveness.
ESOTEST MULTI measures and displays thetemperature detected by 5 to 7 sensors instead of 3as the predicate device	The LCD display of the greater number of sensors does notintroduce new questions of safety and effectiveness.

l Response time is defined as the mean value of the measured time intervals associated to temperature increase (tr) or to temperature decrease (tf) necessary to cover the 63.3% of the total temperature excursion.

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Non-Clinical Testing Summary:

Non-clinical tests were conducted to verify and validate that the proposed device meets requirement specifications and is substantially equivalent (SE) to the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System. The device was subjected to the following non-clinical testing to demonstrate that it performs as intended:

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ISO 80601-2-56:2009 Medical electrical equipment. Part 2-56: Particular requirements for . basic safety and essential performance of clinical thermometers for body temperature measurement. Performance parameters that were evaluated are listed in the following table:

Parameter	ESOTEST requirement
Accuracy of the device	±0.3°Cin the rated range +10 to +45°C
Precision in condition ofrepeatability	0.1°C
Response Time	1 stemperature step +27 to +43 °C
Alarm Threshold	Auditory and visual alarm is triggeredwhen outside threshold

Software documentation including verification & validation was provided in accordance with . FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a software with a moderate level of concern.
. Verification/validation was completed for Electrical Safety according to the standard IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, and for EMC according to the standard IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
The process for sterilizing ESOTEST MULTI probe is an EO gas cycle in sterilization chamber. . The process is validated according to the standard ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The product is released after each sterilization cycle only after having verified the sterility of the biological indicators (BIs) inserted in the load according to the validation protocol; BIs are tested according to the standard ISO 11737-2:2009 - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
The patient contact device, ESOTEST MULTI probe, has been tested according to the ● requirements of the standard ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Based on the contact categorization as "mucosal membrane" for a "limited exposure" duration time, as requested by ISO 10993-1 the following tests were performed: in vitro cytotoxicity test according to ISO 10993- 5:2009; sensitization test and intracutaneous reactivity test according to ISO 10993-10:2010.
A risk analysis was conducted in accordance with ISO 14971: 2007 Medical devices -. Application of risk management to medical devices.

In all testing, the pre-determined acceptance criteria were met.

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Substantial Equivalence Conclusion

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is Substantially Equivalent (SE) to the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System, cleared under K123361.

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.