ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Device Facts
| Record ID | K192210 |
|---|---|
| Device Name | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
| Applicant | Fiab Spa |
| Product Code | FLL · General Hospital |
| Decision Date | Oct 10, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
Intended Use
The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
Device Story
System monitors esophageal temperature via sterile, single-use probe containing up to seven T-type thermocouple sensors soldered to spherical steel electrodes; patient cable converts analog thermocouple voltages to digital signals for monitor processing. Monitor displays temperature as numerical values, colored bars, and scrolling plots; features integrated alarm system for user-defined upper/lower thresholds (audible/visual alerts). Optional adapter cable enables visualization of probe sensors within 3D patient body models when connected to external mapping systems (e.g., EnSite Precision, Carto 3). Used in operating rooms and interventional electrophysiology rooms by clinicians. Data stored internally or exported via USB for later review. Benefits include continuous temperature tracking during heating/cooling procedures.
Clinical Evidence
Bench testing only. Performance verified via electrical safety (IEC 60601-1), EMC (EN 60601-1-2), accuracy/response time (ISO 80601-2-56), and biocompatibility (ISO 10993-1). Adapter cable validated for compatibility with mapping systems (EnSite Precision, Carto 3) and ANSI/AAMI EC53:1995 standards. Sterility and shelf-life (4 years) validated per ISO 11607.
Technological Characteristics
System uses T-type thermocouples (accuracy ±0.3°C, 1s response time). Patient-contact materials: Polyurethane and AISI 304 Stainless Steel. Monitor: LCD touch screen, 100-240 Vac power. Connectivity: USB data export, optional adapter cable for 3D mapping system integration. Sterilization: EO/ECH residual testing per ISO 10993-7. Software: EN 62304 compliant.
Indications for Use
Indicated for continuous detection, measurement, and visualization of esophageal temperature in patients undergoing procedures in operating rooms and interventional electrophysiology rooms.
Regulatory Classification
Identification
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
Special Controls
(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
Predicate Devices
- ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K180047)
Reference Devices
- St Jude Medical Supreme Diagnostic Cable, Model 401986
Related Devices
- K200943 — Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System · Circa Scientific, LLC · Dec 17, 2021
- K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System · Fiab Spa · Nov 8, 2018
- K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System · Circa Scientific, Inc. · May 25, 2023
- K123361 — ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM · Fiab Spa · Feb 27, 2013
- K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM · Circa Scientific, LLC · Aug 31, 2011
Submission Summary (Full Text)
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May 12, 2020
Fiab SpA Francesco Batistini Regulatory Affairs Manager Via Costoli, 4 Vicchio. Firenze 50039 Italy
Re: K192210
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, IKD
Dear Francesco Batistini:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 10, 2019. Specifically, FDA is updating this SE Letter to correct the Indications For Use statement for your device as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Tina Kiang, OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, 301-796-7030, tina.kiang@fda.hhs.gov
Sincerely,
# Sapana Patel -S
for Tina Kiang, Ph.D. Director Division of Drug Delivery and General Hospital and Human Factors Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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October 10, 2019
FIAB SpA Francesco Batistini Regulatory Affairs Manager Via Costoli, 4 Vicchio. Firenze, 50039 Italy
Re: K192210
Trade/Device Name: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring Svstem Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL, IKD Dated: August 7, 2019 Received: August 14, 2019
Dear Mr. Francesco Batistini:
We have reviewed vour 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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for Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | FIAB spa Vicchio, ITALY |
|----------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|
| ESOTEST MULTI<br>Esophageal Temperature Probe and<br>Temperature Monitoring System<br>with Visualization | 2018/12/18<br>Revised 2020/05/06 | 510(k) notification - Section 04 |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
**Indications for Use**
| | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|--------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K192210 |
| Device Name | ESOTEST MULTI |
#### Indications for Use (Describe)
The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophage. injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization
## 510(k) Summary
| Submitter: | Fiab SpA<br>Via Costoli, 4<br>50039 Vicchio<br>Florence, Italy |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Mr. Francesco Batistini,<br>Title: Official Correspondent<br>Phone: (39) 055 849 79 43<br>Fax: (39) 055 849 79 87<br>E-mail: regulatory@fiab.it |
| Preparation Date: | September 24, 2019 |
| Trade Name: | ESOTEST MULTI<br>Esophageal Temperature Probe and Temperature<br>Monitoring System |
| Common or Usual Name: | Thermometer, Electronic, Clinical |
| Regulation Name: | Clinical Electronic Thermometer |
| Regulation Number: | 21 CFR 880.2910 |
| Product Codes: | FLL, IKD |
| Device Class: | Class II |
| Predicate Device: | K180047 – ESOTEST MULTI Esophageal Temperature<br>Probe and Temperature Monitoring System |
#### Device Indications for Use:
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 ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
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### Device Description:
The device is composed of the following cleared (K180047) system components:
- Monitor ESOTEST MULTI MONITOR
- Esophageal probe ESOTEST MULTI PROBE
- Patient cable ESOTEST MULTI PATIENT CABLE
The Adapter cable ESOTEST MULTI ADAPTER CABLE has been added to the system.
The ESOTEST MULTI MONITOR is a device for measuring the esophageal temperature through a sterile, single-use probe. This component, called ESOTEST MULTI PROBE, contains up to seven independent thermal sensors, each one consisting in T-type thermocouple soldered to a spherical steel electrode. The ESOTEST MULTI PATIENT CABLE connects the main unit of the monitor to the temperature probe and continuously converts to digital signals the analog voltages generated by the thermocouples. ESOTEST MULTI MONITOR is able to keep track of the esophageal temperature during clinical procedures which involve heating or cooling processes, with an accuracy of 0.3℃ and a response time of 1s. The detected temperatures are visualized as numerical values, colored bars and scrolling plots. An integrated alarm system allows the operator to set 2 independent alarm thresholds, called "upper alarm threshold" and "lower alarm threshold". If any of the measured temperatures gets hotter than the upper threshold or colder than the lower threshold, ESOTEST MULTI MONITOR immediately emits sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions can be stored in the internal memory of the device and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). By connecting the ESOTEST MULTI to a mapping system through the optional component ESOTEST MULTI ADAPTER CABLE, the probe sensors can be visualized inside a 3D model of the patient's body for optimal placement.
| Element of<br>comparison | Subject Device:<br>FIAB - ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System with<br>Visualization | Predicate Device:<br>K180047 FIAB - ESOTEST<br>MULTI Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comments |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer<br>type | Esophageal | | Same |
| Product Code | FLL<br>IKD | FLL | Product code IKD refers<br>to the ESOTEST MULTI<br>ADAPTER CABLE<br>accessory, see the<br>components comparison<br>below |
| Regulation | 880.2910 Clinical Electronic<br>Thermometer<br>890.1175 Cable, Electrode | 880.2910<br>Clinical Electronic<br>Thermometer | Regulation 890.1175<br>refers to the ESOTEST<br>MULTI ADAPTER<br>CABLE accessory, see the<br>components comparison<br>below |
| Element of<br>comparison | Subject Device:<br>FIAB - ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System with<br>Visualization | Predicate Device:<br>K180047 FIAB - ESOTEST<br>MULTI Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comments |
| Indications for<br>use | The ESOTEST MULTI<br>Temperature Monitoring<br>System is composed of<br>ESOTEST MULTI Monitor<br>and ESOTEST MULTI Probe<br>and is intended for the<br>continuous detection,<br>measurement and<br>visualization (in $ ° C $ ) of<br>esophageal temperature. The<br>intended environments of use<br>are operating rooms and<br>interventional<br>electrophysiology rooms. The<br>ESOTEST MULTI Monitor<br>must be used in conjunction<br>with the ESOTEST MULTI<br>Probe.<br>The role of esophageal<br>temperature monitoring using<br>this device in reducing the<br>risk of cardiac ablation-<br>related esophageal injury has<br>not been established. The<br>performance of the<br>ESOTEST MULTI system in<br>detecting esophageal<br>temperature changes as a<br>result of energy delivery<br>during cardiac ablation<br>procedures has not been<br>evaluated. | The ESOTEST MULTI<br>Temperature Monitoring<br>System is composed of<br>ESOTEST MULTI Monitor<br>and ESOTEST MULTI Probe<br>and is intended for the<br>continuous detection,<br>measurement and visualization<br>(in $ ° C $ ) of esophageal<br>temperature. The intended<br>environments of use are<br>operating rooms and<br>interventional<br>electrophysiology rooms. The<br>ESOTEST MULTI Monitor<br>must be used in conjunction<br>with the ESOTEST MULTI<br>Probe. | Same, with the addition of<br>a remark about the lack of<br>an exhaustive evaluation<br>regarding the employment<br>of the ESOTEST MULTI<br>system during specific<br>clinical procedures. The<br>remark applies both to the<br>subject and to the<br>predicate device, as the<br>performance of the system<br>is not affected by the<br>addition of the ESOTEST<br>MULTI adapter cable. |
| Components | Temperature probe, Patient<br>cable, Monitor. The package<br>of the monitor includes an<br>external power supply and an<br>equipotential cable.<br>Optional component:<br>ESOTEST MULTI<br>ADAPTER CABLE. | Temperature probe, Patient<br>cable, Monitor. The package of<br>the monitor includes an<br>external power supply and an<br>equipotential cable | Same, with the addition of<br>the ESOTEST MULTI<br>ADAPTER CABLE, an<br>optional component sold<br>separately. The<br>technology is the same<br>adopted for the<br>commercially available<br>adapter cables typically<br>used to connect diagnostic<br>catheters to mapping<br>systems. |
| Temperature<br>measurement<br>range [ $ ° C $ ] | | 0 - 75 | Same |
| Element of<br>comparison | Subject Device:<br>FIAB - ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System with<br>Visualization | Predicate Device:<br>K180047 FIAB - ESOTEST<br>MULTI Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comments |
| Number of<br>temperature<br>sensors | 5 or 7 | | Same |
| Temperature<br>sensor type | T-type thermocouple<br>(accuracy ±0.3°C) | | Same |
| Measurement<br>presentation/User<br>Interface | LCD monitor<br>Touch screen monitor | | Same |
| Alarm<br>temperature<br>range [°C] | 37-41 upper threshold (Tmax)<br>12-24 lower threshold (Tmin) | | Same |
| Alarm signal | Visual (flashing red circles on the LCD display)<br>Audible (intermittent sound) | Visual (flashing red circles on the LCD display)<br>Audible (intermittent sound) | Same |
| Power<br>requirements | 100 - 240 Vac | | Same |
| Monitor<br>classification | I, CF, defib protected | | Same |
| Dimensions [cm] | Monitor: 34(width) x25(height) x6.5 (depth)<br>Patient cable (length): 290<br>Temperature probe (length and diameter):<br>83; 7Fr body, 11Fr sensors | | Same |
| Introduction | Esophageal (nose/throat) | | Same |
| Signal processing<br>and display | Actual temperature is a function of the thermocouple voltage.<br>Temperature displayed in 0.1°C increments.<br>1 input (single probe) available<br>5/7 sensors per probe measurements and user-selected alarm<br>limits are displayed on LCD monitor. | | Same |
| Software version | Esotest Multi Software Ver. 1.05 (Cod. 91000105) | Esotest Multi Software Ver. 1.05 (Cod. 91000105) | Same |
| Patient<br>contacting<br>materials | Polyurethane and Stainless Steel (SST) AISI 304 | Polyurethane and Stainless Steel (SST) AISI 304 | Same |
| Operating<br>conditions | +10°C to +40°C<br>Non condensed relative humidity:<br>30% to 75% | +10°C to +40°C<br>Non condensed relative humidity:<br>30% to 75% | Same |
| Accuracy | 0.3°C within rated output range (ISO 80601-2-56:2009<br>requirements for clinical thermometers) | 0.3°C within rated output range (ISO 80601-2-56:2009<br>requirements for clinical thermometers) | Same |
| Precision and<br>repeatability [°C] | 0.1 | | Same |
| Response time<br>(1) | Both heating and cooling response time are approximately 1<br>second | Both heating and cooling response time are approximately 1<br>second | Same |
| Requirements for<br>probe<br>sterilization | Compliance to standard ISO 10993-7<br>Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.<br>Pyrogenicity test as outlined in USP<151>.<br>Shelf life procedure and protocol performed according to<br>standard ISO 11607 | Compliance to standard ISO 10993-7<br>Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.<br>Pyrogenicity test as outlined in USP<151>.<br>Shelf life procedure and protocol performed according to<br>standard ISO 11607 | Same |
| Element of<br>comparison | Subject Device:<br>FIAB - ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System with<br>Visualization | Predicate Device:<br>K180047 FIAB - ESOTEST<br>MULTI Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comments |
| Biocompatibility<br>of the patient<br>contacting part | Compliance to ISO 10993-1 | | Same |
| Software | Compliance to EN 62304 | | Same |
| Electrical safety | Compliance to IEC 60601-1 | | Same |
| EMC | Compliance to EN 60601-1-2 | | Same |
| Performance<br>bench testing | Compliance to ISO 80601-2-56:2009 | | Same |
#### Technological Characteristics and Substantial Equivalence:
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(1) 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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#### Substantial Equivalence Discussion:
As shown in the table above, there is no significant difference in terms of design, materials, use or performance between the subject device and the predicate device. The indications for use of the subject device is same as the predicate device.
In fact, the adapter cable is an optional component intended exclusively to provide visualization of the location of the temperature probe. Such feature does not change the intended use of ESOTEST MULTI as a clinical thermometer for the esophageal temperature. Extensive non-clinical testing proves that the addition of the adapter cable to the system does not raise any new questions of safety or effectiveness.
The ESOTEST MULTI ADAPTER CABLE works in the identical way as a diagnostic cable for the purpose of electrode visualization. The ESOTEST MULTI ADAPTER CABLE is similar to the commercially available adapter cables typically used to connect diagnostic catheters to mapping systems, such as the St Jude Medical Supreme Diagnostic Cable, Model 401986.
#### Non-Clinical Testing Summary:
To ensure that the introduction of the adapter cable does not compromise in any way the safety and the performance of ESOTEST MULTI, the tests required by the IEC 60601-1 and IEC 60601-1-2 standards have been carried out with the adapter cable connected to the system. In addition, the performance of ESOTEST MULTI when connected to a mapping system and the sensors visualization feature have been verified during several clinical procedures. Such tests demonstrated that the presence of the adapter cable does not interfere with the temperature measurement and that the probe sensors are correctly visualized by the mapping system. All the non-clinical tests that have been performed on the ESOTEST MULTI system are listed in the table below.
| Test name | Endpoint | Result summary |
|--------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------|
| EO and ECH residual<br>testing | The residual levels must be below the<br>limit values prescribed by the<br>ISO 10993-7 standard | EO < 0.1 mg/disp<br>ECH < 1 mg/disp |
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| Test name…
