ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.

Device Description

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts: Monitor, Interconnect Cable, Esophageal Probe. Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm. Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System:

The document focuses on demonstrating substantial equivalence to a predicate device (S-Cath - Esophageal Temperature Probe and Temperature Monitoring System, K112376) through non-clinical performance testing. It does not describe a study involving human subjects or AI.

Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ESOTEST requirement)	Reported Device Performance
Accuracy of the device	±0.3°C	±0.3°C
Precision in condition of repeatability	0.1°C	0.1°C
Response Time	1s (limit established: 1.6s)	Approximately 1s

Study Details for the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System

This summary does not contain information about studies involving human subjects, AI/algorithm performance, or extensive clinical trials. The "study" referenced is a set of non-clinical, bench-top performance tests.

Sample size used for the test set and the data provenance:
- Accuracy Test: 3 ESOTEST Monitors with 3 Probes (meaning 9 independent thermometers were tested, as each monitor has 3 thermometers).
- Repeatability Test: 5 ESOTEST Monitors with Probes (meaning 15 independent thermometers were tested).
- Response Time Test: 6 ESOTEST Monitors and probes.
- Data Provenance: The tests were non-clinical, performed in a laboratory setting by FIAB SpA. The data is prospective, generated specifically for this 510(k) submission. No country of origin for patients or retrospective data is applicable as it's a bench test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for these non-clinical tests was established by a reference thermometer (Pt100) and a reference thermometer, both calibrated, conforming to standards (ISO 80601-2-56:2009 and NIST Technical Note 1297: 1994 Edition). No human experts were involved in establishing the "ground truth" for the device's technical specifications in these bench tests.
Adjudication method for the test set:
- Not applicable. This was not a human interpretation study. The "adjudication" was a direct comparison of the ESOTEST device's readings against a calibrated reference instrument.
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:
- No MRMC comparative effectiveness study was done. This device is a temperature monitoring system and does not involve human readers interpreting images or data that AI would assist with.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI. The device itself is a standalone measurement system (without human-in-the-loop performance in terms of interpretation, though human intervention is required for placement and alarm setting). Its performance was tested as a standalone physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Calibrated Reference Standard: The ground truth for all performance tests (accuracy, repeatability, response time) was established using highly accurate, calibrated reference thermometers and controlled laboratory conditions (thermostatic baths). This is a physical, objective standard.
The sample size for the training set:
- Not applicable. This device is a hardware product with embedded firmware, not an AI model requiring a training set in the typical sense. Performance was evaluated through hardware testing.
How the ground truth for the training set was established:
- Not applicable, as there is no AI training set for this device.

Summary

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K 123361

FEB 2 7 2013

510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification – Section 05

Section 05 510(k) Summary

This document was prepared on 2012/11/07 and reviewed on 2013/02/21
Section 05		1
510(k) Summary		1
1.	Submitter	1
2.	Device name and classification	1
3.	Predicates	2
4.	Device description	2
5.	Indications for use	3
6.	Comparison to predicate	4
7.	Non-clinical performance data	6
8.	Conclusion	7

Submitter 1.

Fiab SpA Via Costoli, 4 50039 Vicchio Florence - Italy Tel : (39) 055 849 79 216 Fax: (39) 055 849 79 87 Contact: Silvia Calabrò, Official Correspondent Email: silvia@fiab.it; regulatory(@fiab.it

Device name and classification 2.

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System. Regulation description: Clinical electronic thermometer, Product code: FLL, Regulation number: 880.2910,

Device class: II,

There were no prior submissions addressed to FDA related to device in object of present submission. -

11	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10-4000 AL-4000 - A 4010-46-44	THE COLLECTION	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification - Section 05

3. Predicates

Lawfully marketed device to which is claimed equivalence:

S-Cath - Esophageal Temperature Probe and Temperature Monitoring System, K112376

4. Device description

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts (on parenthesis is reported FIAB model and reference):

Monitor (ESOTEST PLUS 7717, 30110),
Interconnect Cable (F5406/TER),
Esophageal Probe (26155S/US).

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification – Section 05

Image /page/2/Figure/1 description: The image shows four different parts of an ESOTEST system. The first part is the monitor, which is shown from the front and back. The other parts are the temperature probe and the interconnect cable.

Fig.1: ESOTEST parts.

Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm.

Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable.

ર. Indications for use

ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification - Section 05

Comparison to predicate 6.

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System have the same intended use as the predicate and do not imply new technological characteristics. Bench testing contained in this submission demonstrate that any differences in their technological characteristics and performance specifications do not raise any new questions of safety or effectiveness.

Thus FIAB ESOTEST is substantially equivalent to the predicate device S-Cath.

Feature	Device under submisisonFIAB - ESOTEST	PredicateS-Cath
Thermometer type	esophageal	esophageal
Intended Uses	continuous temperature monitoring ofpatient's esophagus	continuous patient temperaturemonitoring, designed for insertion intoesophagus
Labelling	Package label: includes productidentification, lot number.Instructions for use: established.Temperature probe: labelled for single use	Package label: includes productidentification, lot number.Instructions for use: established.Temperature probe: labelled for single use
Components	temperature probeinterconnect cablemonitor	temperature probeinterconnect cablemonitor
Temperaturemeasurementrange [°C]	25-45	25-45
Number oftemperaturesensors	3	12
Temperaturesensor type	high accuracy thermocouple T type(accuracy ±0,3°C)	NTC thermistor (accuracy ±0,2°C)
Measurementpresentation	3 led display	LCD monitor
Displayspecification	5 digit, 7-segment, 14 mm LED	n.a.
Alarmtemperature range[°C]	36-41	0-90
Alarm signal	visual (flashing red led)audible (intermittent buzzer)	visual and audible
Control interface	UP and DOWNon/offvolume knob	touch screen monitor
Powerrequirements	100-120/230 Vac	100-240 Vac

Sec.05 - 4/8

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification - Section 05

Feature	Device under submisisonFIAB - ESOTEST	PredicateS-Cath
Monitorclassification	I, CF, defib protected	I,BF, defib protected
Dimensions [cm]	monitor: 36,7x24,9x11,0interconnect cable (length): 250temperature probe (length anddiameter): 95; Ø7Fr	monitor: 26x20x8,2interconnect cable (length): 305temperature probe (length and diameter):77,5; Ø10Fr
Introduction	esophageal (nose/throat)	esophageal
Signal processingand display	Actual temperature is a function of thethermocouple voltage.Temperature displayed in 0,1°Cincrements.1 input (single probe) available3 sensors per probe measurements anduser-selected alarm limit are displayedon LED Displays.	Actual temperature is a function of thethermistor resistance.Temperature displayed in 0,1°Cincrements.1 input (single probe) available12 sensors per probe displayed LCDDisplay includes user-selected alarmlimits.
Materials (patientcontacting)	Polyurethane and Stainless Steel(SST) AISI 304	Flexible Polyether and Rigid Polyamide(PEBAX)
Ambienttemperatureenvironment	no special ambient temperature rangeis specified for the device	no special ambient temperature range isspecified for the device
Accuracy [°C]	within rated output range in normaluse is not greater than 0,3°C (ISO80601-2-56:2009 requirements forclinical thermometers)	within rated output range in normal use isnot greater than 0,3°C (ISO 80601-2-56:2009 requirements for clinicalthermometers)
Precision andrepeatibility [°C]	0,1	0,1
Response time	Both heating transient response timeand cooling transient response time areapproximately 1"; time is for probeplunged from reference bath to a waterbath with a 2°C differential.	Heating transient response time is 7" andcooling transient response time isapproximately 4.5" (time is for probeplunged from reference bath to a waterbath with a 2°C differential)
Other capabilities	Device fully complies with UL andIEC (electrical, EMC):UL60601-1:2006IEC60601-1-2: 2007UL listing:FIAB SPA:Medical equipment PIDF (UL File #E324758)	Device fully complies with IEC(electrical, EMC):IEC60601-1:1998+A1+A2;IEC60601-1-2:2007

Tab.1: Comparison table.

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification – Section 05

7. Non-clinical performance data

In order to support Substantial Equivalence and performance characteristics of ESOTEST, non-clinical test were performed; the detailed description is reported on Section 18.

Following it is reported a brief description of the tests, including purpose, measurement protocols and layouts, and the acceptance criteria for each parameter under test; the materials and the instruments used; the measurements results; the values of the parameters attributed to the devices as confirmed by the compliance to the specified criteria.

Performance characteristics that are evaluated were obtained from FDA guidance: "Guidance on the content of premarket notification [510(K)] submission for clinical electronic thermometers" [March 1993] and performed according to FIAB internal protocol developed by following the guidelines of the technical standards:

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
NIST Technical Note 1297: 1994 Edition Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results.

Characteristic	ESOTESTrequirement	Reference
Accuracy of the device	±0,3℃	ISO 80601-2-56 – 201.101.2Laboratory accuracy
Precision in condition of repeatability	0,1℃	NIST TN 1296 - Appendix D
Response Time	1s	ISO 80601-2-56 – 201.101.3 Timeresponse for a continuous clinicalthermometer

Performance characteristics that were evaluated are in the following table:

Thermometric chain of the devices under test

The esophageal temperature measurement process is realized through a thermometric chain resulting by 3 elements: ESOTEST Probe, interconnect cable for the connection of probe to the monitor and the ESOTEST Monitor itself. Since the ESOTEST system has 3 independent thermometers and independent connection to the sensor in the probe for each device there are 3 independent thermometric chain that work at the same time.

Tests performed

Accuracy: ESOTEST's accuracy was verified comparing temperature measurements performed by each of three thermometers present in the device with temperature measured by a reference thermometer. A reference thermometric chain, consisting in a reference probe (Pt100) and a reference thermometer, both calibrated, was used as

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510(k) Summary		FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification – Section 05

comparison instrument in order to evaluate the difference between the values of the same temperature, measured by the two chains. Explored temperature range is 25-45°C.

The measurements was performed in order to verify that thermometric chain realized with ESOTEST System (connecting cable, connectors and internal wiring employed for the assembly of ESOTEST System), ensure the accuracy requirements of the reference standard, as well as the predicate device's performances (±0.3℃).

For the tests were used 3 ESOTEST Monitor with 3 Probes, a thermostatic bath and a reference thermometer with probe. Based on a considerable number of measurements, the results were that for each tested thermometers for each monitor for a total of 9 tested thermometers) none of the difference between reference and measured temperature exceed the device's accuracy. Then it was possible to conclude that the device ESOTEST Monitor with his ESOTEST Probe and their connecting cable is characterized by an accuracy of ±0,3℃ in the whole measurement range 25-45℃.

Repeatibility: The purpose of this test is to measure, in condition of repeatability, the precision of the thermometric chain previously described and verify that it do not exceeds the displays resolution (0,1℃). For the tests were used 5 ESOTEST Monitor with Probe a thermostatic bath and a reference thermometer with probe. Under repeatibility conditions were performed 14 measurements for each thermometer (for a total of 15 independent thermometers) and results obtained confirmed that precision is in the specified limit (0,1℃).

Response time: the purpose of this test is measure rise and fall times of the values displayed by ESOTEST Monitor in reply to temperature variations sensed by ESOTEST Probe, and verify that these response times do not exceed the limits established (1,6s). For the test were used 6 ESOTEST Monitor and probe, 1 thermostatic bath, 1 adiabatic bottle, 2 reference thermometers, 1 video camera. Following procedure was followed: a bath is at a certain temperature (T) and the other one is maintained at a greater temperature (T+2°C). For the rise time: after thermal stabilization in the thermostatic baths at lower temperature probe was plunged in the thermostatic bath at upper temperature. Rise time is obtained measuring elapsed time from plunging of probe in the upper bath to the achievement of final temperature. For the fall time it was repeated same procedure from upper to lower bath. Rise and fall times were evaluated through a statistically significant and independent number of measurements (18 for each evaluation). Results confirmed that rise and fall times are in the expected range.

Conclusion 8.

The following data have been considered from devices comparison (ESOTEST Esophageal Temperature Probe and Temperature Monitoring System vs S-Cath - Esophageal Temperature Probe and Temperature Monitoring System) and from performance testing, in order to demonstrate Substantial Equivalence:

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510(k) Summary	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2013/02/21	510(k) notification - Section 05

the same intended use and site application (temperature monitoring of patient's esophagus);
the same components of monitoring system (probe, interconnect cable, monitor); -

similarity of technical/physical features (in terms of procedure of use); -

the same temperature measurement range (25-45 ℃); -

the same accuracy of measurement (±0,3℃ in the whole measurement range); ﺖ

the same precision and repeatibility (0.1℃); -

a faster response time (1" for both heating and cooling transient response time). -

According to these data we can finally conclude that the temperature measurement system composed of ESOTEST Monitor, ESOTEST Probe and their connecting cable, is substantially equivalent to the predicate device in terms of performances, usage characteristics, safety of use.

The differences with the predicate device do not affect substantial equivalence of performances and do not raise any new safety concern.

Sec.05 - 8/8

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

February 27, 2013

Ms. Silvia Calabrò FIAB SpA Official Correspondent Via P. Costoli, 4 50039 Vicchio Florence Italy

Re: K123361

Trade/Device Name: Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic thermometer Regulatory Class: II Product Code: FLL Dated: January 10, 2013 Received: January 18, 2013

Dear Ms. Calabrò:

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 - Ms. Calabrò

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/ucm115809.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,

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Anthony D. Watson, B.S., M.S., M.B.A. 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	Image: FIAB logo	FIAB spa Vicchio, ITALY
ESOTEST EsophagealTemperature Probe andTemperature Monitoring System	2012/10/15	510(k) notification - Section 04

Section 04 Indications for Use

510(k) Number (if known): - 11/23 צל 1

Device Name:

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System

Indications For Use:

ESOTEST Probe

Esotest probe is intended for continuous esophageal temperature monitomig.

ESOTEST Monitor

Esotest monitor is intended for display continuous temperature measurement (°C) from 3 sensors temperature probe.

Prescription Use __ X_________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	413361
----------------	--------

	Sec.04 - 1/1
--	--------------

Kathleen	Digitally signed by Kathleen E. Fitzgerald DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0010093027, cn=Kathleen E. Fitzgerald Date: 2013.02.26 11:40:17 -05'00'
Fitzgerald

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.