(57 days)
No
The device description focuses on temperature measurement, visualization, and alarm functions based on fixed thresholds. There is no mention of AI/ML algorithms for data analysis, prediction, or decision support.
No.
The device is described as a monitoring system that detects, measures, and visualizes esophageal temperature. It does not provide any therapy or treatment.
No
The device is a temperature monitoring system that measures and visualizes esophageal temperature. It provides raw data (temperature readings) and offers alarm systems but does not interpret the data to diagnose a condition or disease.
No
The device description explicitly lists hardware components: Monitor, Esophageal probe, Patient cable, and Adapter cable. The software is part of a larger system that includes physical sensors and processing units.
Based on the provided information, the ESOTEST MULTI Temperature Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the continuous detection, measurement, and visualization of esophageal temperature within the body (in operating rooms and interventional electrophysiology rooms). IVD devices are intended for use on specimens derived from the human body (like blood, urine, tissue) outside the body to provide information about a physiological state, disease, or condition.
- Device Description: The device measures temperature directly within the esophagus using a probe. It does not analyze biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological specimens.
Therefore, the ESOTEST MULTI Temperature Monitoring System is a medical device used for physiological monitoring in vivo, not an in vitro diagnostic device.
N/A
Intended Use / 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 °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.
Product codes
FLL, IKD
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°C 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 a 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating rooms and interventional electrophysiology rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing Summary:
- EO and ECH residual testing: The residual levels must be below the limit values prescribed by the ISO 10993-7 standard. Result: EO
§ 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.
0
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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
1
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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
2
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.
Image /page/2/Picture/5 description: The image shows the name "Geeta K. Pamidimukkala -S" in a simple, sans-serif font. The text is stacked vertically, with "Geeta K." on the top line and "Pamidimukkala -S" on the second line. The background is plain and white, which makes the text stand out.
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
3
| Indications for Use | FIAB spa Vicchio, ITALY | |
|---|---|---|
| ESOTEST MULTI | ||
| Esophageal Temperature Probe and | ||
| Temperature Monitoring System | ||
| with Visualization | 2018/12/18 | |
| 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
Expiration Date: 06/30/2020
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
4
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization
510(k) Summary
| Submitter: | Fiab SpA
Via Costoli, 4
50039 Vicchio
Florence, Italy |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Mr. Francesco Batistini,
Title: Official Correspondent
Phone: (39) 055 849 79 43
Fax: (39) 055 849 79 87
E-mail: regulatory@fiab.it |
| Preparation Date: | September 24, 2019 |
| Trade Name: | ESOTEST MULTI
Esophageal Temperature Probe and Temperature
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
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.
5
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
comparison | Subject Device:
FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System with
Visualization | Predicate Device:
K180047 FIAB - ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | Comments |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer
type | Esophageal | | Same |
| Product Code | FLL
IKD | FLL | Product code IKD refers
to the ESOTEST MULTI
ADAPTER CABLE
accessory, see the
components comparison
below |
| Regulation | 880.2910 Clinical Electronic
Thermometer
890.1175 Cable, Electrode | 880.2910
Clinical Electronic
Thermometer | Regulation 890.1175
refers to the ESOTEST
MULTI ADAPTER
CABLE accessory, see the
components comparison
below |
| Element of
comparison | Subject Device:
FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System with
Visualization | Predicate Device:
K180047 FIAB - ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | Comments |
| 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 $ ° 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. | 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. | Same, with the addition of
a remark about the lack of
an exhaustive evaluation
regarding the employment
of the ESOTEST MULTI
system during specific
clinical procedures. The
remark applies both to the
subject and to the
predicate device, as the
performance of the system
is not affected by the
addition of the ESOTEST
MULTI adapter cable. |
| Components | Temperature probe, Patient
cable, Monitor. The package
of the monitor includes an
external power supply and an
equipotential cable.
Optional component:
ESOTEST MULTI
ADAPTER CABLE. | Temperature probe, Patient
cable, Monitor. The package of
the monitor includes an
external power supply and an
equipotential cable | Same, with the addition of
the ESOTEST MULTI
ADAPTER CABLE, an
optional component sold
separately. The
technology is the same
adopted for the
commercially available
adapter cables typically
used to connect diagnostic
catheters to mapping
systems. |
| Temperature
measurement
range [ $ ° C $ ] | | 0 - 75 | Same |
| Element of
comparison | Subject Device:
FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System with
Visualization | Predicate Device:
K180047 FIAB - ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | Comments |
| Number of
temperature
sensors | 5 or 7 | | Same |
| Temperature
sensor type | T-type thermocouple
(accuracy ±0.3°C) | | Same |
| Measurement
presentation/User
Interface | LCD monitor
Touch screen monitor | | Same |
| Alarm
temperature
range [°C] | 37-41 upper threshold (Tmax)
12-24 lower threshold (Tmin) | | Same |
| Alarm signal | Visual (flashing red circles on the LCD display)
Audible (intermittent sound) | Visual (flashing red circles on the LCD display)
Audible (intermittent sound) | Same |
| Power
requirements | 100 - 240 Vac | | Same |
| Monitor
classification | I, CF, defib protected | | Same |
| Dimensions [cm] | Monitor: 34(width) x25(height) x6.5 (depth)
Patient cable (length): 290
Temperature probe (length and diameter):
83; 7Fr body, 11Fr sensors | | Same |
| Introduction | Esophageal (nose/throat) | | Same |
| Signal processing
and display | Actual temperature is a function of the thermocouple voltage.
Temperature displayed in 0.1°C increments.
1 input (single probe) available
5/7 sensors per probe measurements and user-selected alarm
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
contacting
materials | Polyurethane and Stainless Steel (SST) AISI 304 | Polyurethane and Stainless Steel (SST) AISI 304 | Same |
| Operating
conditions | +10°C to +40°C
Non condensed relative humidity:
30% to 75% | +10°C to +40°C
Non condensed relative humidity:
30% to 75% | Same |
| Accuracy | 0.3°C within rated output range (ISO 80601-2-56:2009
requirements for clinical thermometers) | 0.3°C within rated output range (ISO 80601-2-56:2009
requirements for clinical thermometers) | Same |
| Precision and
repeatability [°C] | 0.1 | | Same |
| Response time
(1) | Both heating and cooling response time are approximately 1
second | Both heating and cooling response time are approximately 1
second | Same |
| Requirements for
probe
sterilization | Compliance to standard ISO 10993-7
Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.
Pyrogenicity test as outlined in USP.
Shelf life procedure and protocol performed according to
standard ISO 11607 | Compliance to standard ISO 10993-7
Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.
Pyrogenicity test as outlined in USP.
Shelf life procedure and protocol performed according to
standard ISO 11607 | Same |
| Element of
comparison | Subject Device:
FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System with
Visualization | Predicate Device:
K180047 FIAB - ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | Comments |
| Biocompatibility
of the patient
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
bench testing | Compliance to ISO 80601-2-56:2009 | | Same |
Technological Characteristics and Substantial Equivalence:
6
7
(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.
8
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 | ||
| testing | The residual levels must be below the | |
| limit values prescribed by the | ||
| ISO 10993-7 standard | EO |