(304 days)
K123361 – ESOTEST Esophageal Temperature Probe and Temperature Monitoring System
Not Found
No
The device description and performance studies focus on standard temperature measurement and alarm functions, with no mention of AI or ML technologies.
No.
The device is for monitoring and detecting esophageal temperature, not for therapeutic intervention or treatment.
Yes
The device is intended for the continuous detection, measurement, and visualization of esophageal temperature, and can emit alarm signals if temperatures fall outside of set thresholds. This continuous monitoring and alerting function by measuring a physiological parameter in a patient for the purpose of identifying potential medical conditions or changes aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components: a monitor, an esophageal probe, and a patient cable. The performance studies also include testing related to hardware, such as electrical safety, EMC, sterilization, and biological evaluation of the probe.
Based on the provided information, the ESOTEST MULTI Temperature Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- ESOTEST MULTI Function: The ESOTEST MULTI system directly measures the temperature of the patient's esophagus in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "continuous detection, measurement and visualization (in °C) of esophageal temperature," which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the ESOTEST MULTI Temperature Monitoring System falls under the category of a medical device that performs a direct physiological measurement, 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
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 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:
- 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°C in the rated range +10 to +45°C |
| Precision in condition of repeatability | 0.1°C |
| Response Time | 1 s temperature step +27 to +43 °C |
| Alarm Threshold | Auditory and visual alarm is triggered when 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of the device: ±0.3°C in the rated range +10 to +45°C
Precision in condition of repeatability: 0.1°C
Response Time: 1 s temperature step +27 to +43 °C
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123361 – ESOTEST Esophageal Temperature Probe and Temperature Monitoring System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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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
1
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
2
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 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.
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 SpA
Via Costoli, 4
50039 Vicchio
Florence, Italy |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Silvia Calabrò.
Title: Official Correspondent
Phone: (39) 055 849 79 216
Fax: (39) 055 849 79 87
E-mail: regulatory@fiab.it |
| Preparation Date: | November 7, 2018 |
| 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 Code: | FLL |
| Device Class: | Class II |
| Predicate Device: | K123361 – ESOTEST 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 °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
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- 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.
| Element of
comparison | Subject Device: K180047FIAB
- ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System | Primary Predicate: K123361 -
ESOTEST Esophageal
Temperature Probe and
Temperature Monitoring
System | Comparison
(Same/Different) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer type | Esophageal | Esophageal | Same |
| 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. | ESOTEST Probe is intended for
continuous esophageal
temperature monitoring.
ESOTEST Monitor is intended
for display continuous
temperature measurement (°C)
from 3 sensors temperature
probe. | Same
(both devices are
intended for the same
use as temperature
monitoring systems, but
the indications for use
of ESOTEST MULTI
are more detailed)) |
| Components | Temperature probe, Patient
cable, Monitor. The package of
the monitor includes an external
power supply and an
equipotential cable | Temperature probe, Interconnect
cable, Monitor. The package of
the monitor includes an
equipotential cable | Different
(the main difference is
that ESOTEST MULTI
is powered by an
external power supply) |
| Temperature
measurement | 0 - 75 | 25 - 45 | Different |
| Element of
comparison | Subject Device: K180047FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System | Primary Predicate: K123361 -
ESOTEST Esophageal
Temperature Probe and
Temperature Monitoring
System | Comparison
(Same/Different) |
| range [°C] | | | |
| Number of
temperature
sensors | 5 or 7 | 3 | Different |
| Temperature
sensor type | Thermocouple T type(accuracy
±0.3°C) | Thermocouple T type (accuracy
±0.3°C) | Same |
| Measurement
presentation/User
Interface | LCD monitor
Touch screen monitor | LED display
Up and down buttons | Different |
| Alarm
temperature range
[°C] | 37-41 upper threshold (Tmax)
12-24 lower threshold (Tmin) | 36-41 upper threshold | Different |
| Alarm signal | Visual (flashing red circles on
the LCD display)
Audible (intermittent sound) | Visual (flashing red LEDs)
Audible (intermittent sound) | Same |
| Power
requirements | 100 - 240 Vac | 100-120/230 Vac | Different |
| Monitor
classification | I, CF, defib protected | 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 | Monitor: 36.7x24.9x11.0
Interconnect cable (length): 250
Temperature probe (length and
diameter): 95; 7Fr body, 11Fr
sensors | Different |
| Introduction | Esophageal (nose/throat) | Esophageal (nose/throat) | Same |
| Signal processing
and display | Actual temperature is a function
of the thermocouple voltage.
Temperature displayed in 0.1°C
increments. | Actual temperature is a function
of the thermocouple voltage.
Temperature displayed in 0.1°C
increments. | Different |
| Element of
comparison | Subject Device: K180047FIAB - ESOTEST MULTI
Esophageal Temperature
Probe and Temperature
Monitoring System | Primary Predicate: K123361 -
ESOTEST Esophageal
Temperature Probe and
Temperature Monitoring
System | Comparison
(Same/Different) |
| | 1 input (single probe) available
5/7 sensors per probe
measurements and user-selected
alarm limits are displayed on
LCD monitor. | 1 input (single probe) available
3 sensors per probe
measurements and user-selected
alarm limit are displayed on
LED displays. | |
| Materials (patient
contacting) | Polyurethane and Stainless Steel
(SST) AISI 304 | Polyurethane and Stainless Steel
(SST) AISI 304 | Same |
| Ambient
temperature | +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 | 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 |
Technological Characteristics and Substantial Equivalence:
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6
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 by |
| testing the power supply system together with the device | |
| according to the requirements of the applicable Electrical | |
| Safety standards, | |
| ESOTEST MULTI has a larger measurement range | The larger measurement range does not introduce new |
| questions of safety and effectiveness. It has been verified | |
| though performance accuracy testing. | |
| ESOTEST MULTI probe has 5 to 7 sensors instead | |
| of 3 as the probe of the predicate device | The greater number of sensors allows the device to monitor |
| a longer portion of esophagus temperature and does not | |
| introduce new questions of safety and effectiveness. The | |
| probes were verified through performance testing. | |
| ESOTEST MULTI makes use of a touch screen | |
| user interface instead of employing LED displays | |
| and physical buttons as the predicate device | The adoption of an LCD display with adequate size and |
| brightness, along with the capacitive touch screen. This | |
| does not introduce new questions of safety and | |
| effectiveness. | |
| ESOTEST MULTI has a lower alarm threshold in | |
| addition to the upper alarm threshold of the | |
| predicate device | The presence of a second alarm threshold allows the user to |
| employ the alarm both during heating and cooling | |
| treatments. This does not introduce new questions of safety | |
| and effectiveness. The alarm thresholds were validated | |
| through performance testing and the software was | |
| verified/validated. | |
| ESOTEST MULTI can tolerate a slightly larger | |
| mains supply voltage range | This does not introduce new questions of safety and |
| effectiveness. It has been verified by testing the device in | |
| the mains supply rated voltage range, according to | |
| requirements of applicable Electrical Safety standards | |
| The main unit of ESOTEST MULTI is smaller and | |
| lighter and the interconnection cables are longer | |
| than the corresponding components of the predicate | |
| device | The fact that the main unit is smaller and lighter does not |
| introduce new questions of safety and effectiveness. | |
| ESOTEST MULTI measures and displays the | |
| temperature detected by 5 to 7 sensors instead of 3 | |
| as the predicate device | The LCD display of the greater number of sensors does not |
| introduce 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:
8
- 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°C |
| in the rated range +10 to +45°C | |
| Precision in condition of | |
| repeatability | 0.1°C |
| Response Time | 1 s |
| temperature step +27 to +43 °C | |
| Alarm Threshold | Auditory and visual alarm is triggered |
| when 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.