ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

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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. 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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) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------|-----------------------------------------------------------| |------------------------------------------------------------|-----------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K180047 510(k) Summary | Submitter: | Fiab SpA<br>Via Costoli, 4<br>50039 Vicchio<br>Florence, Italy | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Application Correspondent: | Silvia Calabrò.<br>Title: Official Correspondent<br>Phone: (39) 055 849 79 216<br>Fax: (39) 055 849 79 87<br>E-mail: regulatory@fiab.it | | Preparation Date: | November 7, 2018 | | Trade Name: | ESOTEST MULTI Esophageal Temperature Probe<br>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<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 °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 {4}------------------------------------------------ ## - 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<br>comparison | Subject Device: K180047FIAB<br>- ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System | Primary Predicate: K123361 -<br>ESOTEST Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comparison<br>(Same/Different) | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Thermometer type | Esophageal | Esophageal | Same | | Indications for use | The ESOTEST MULTI<br>Temperature Monitoring System<br>is composed of ESOTEST<br>MULTI Monitor and ESOTEST<br>MULTI Probe and is intended<br>for the 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 electrophysiology<br>rooms. | ESOTEST Probe is intended for<br>continuous esophageal<br>temperature monitoring.<br>ESOTEST Monitor is intended<br>for display continuous<br>temperature measurement (°C)<br>from 3 sensors temperature<br>probe. | Same<br>(both devices are<br>intended for the same<br>use as temperature<br>monitoring systems, but<br>the indications for use<br>of ESOTEST MULTI<br>are more detailed)) | | Components | Temperature probe, Patient<br>cable, Monitor. The package of<br>the monitor includes an external<br>power supply and an<br>equipotential cable | Temperature probe, Interconnect<br>cable, Monitor. The package of<br>the monitor includes an<br>equipotential cable | Different<br>(the main difference is<br>that ESOTEST MULTI<br>is powered by an<br>external power supply) | | Temperature<br>measurement | 0 - 75 | 25 - 45 | Different | | Element of<br>comparison | Subject Device: K180047FIAB<br>- ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System | Primary Predicate: K123361 -<br>ESOTEST Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comparison<br>(Same/Different) | | range [°C] | | | | | Number of<br>temperature<br>sensors | 5 or 7 | 3 | Different | | Temperature<br>sensor type | Thermocouple T type(accuracy<br>±0.3°C) | Thermocouple T type (accuracy<br>±0.3°C) | Same | | Measurement<br>presentation/User<br>Interface | LCD monitor<br>Touch screen monitor | LED display<br>Up and down buttons | Different | | Alarm<br>temperature range<br>[°C] | 37-41 upper threshold (Tmax)<br>12-24 lower threshold (Tmin) | 36-41 upper threshold | Different | | Alarm signal | Visual (flashing red circles on<br>the LCD display)<br>Audible (intermittent sound) | Visual (flashing red LEDs)<br>Audible (intermittent sound) | Same | | Power<br>requirements | 100 - 240 Vac | 100-120/230 Vac | Different | | Monitor<br>classification | I, CF, defib protected | I, CF, defib protected | Same | | Dimensions [cm] | Monitor: 34(width) x25(height)<br>x6.5 (depth)<br>Patient cable (length): 290<br>Temperature probe (length and<br>diameter): 83; 7Fr body, 11Fr<br>sensors | Monitor: 36.7x24.9x11.0<br>Interconnect cable (length): 250<br>Temperature probe (length and<br>diameter): 95; 7Fr body, 11Fr<br>sensors | Different | | Introduction | Esophageal (nose/throat) | Esophageal (nose/throat) | Same | | Signal processing<br>and display | Actual temperature is a function<br>of the thermocouple voltage.<br>Temperature displayed in 0.1°C<br>increments. | Actual temperature is a function<br>of the thermocouple voltage.<br>Temperature displayed in 0.1°C<br>increments. | Different | | Element of<br>comparison | Subject Device: K180047FIAB<br>- ESOTEST MULTI<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System | Primary Predicate: K123361 -<br>ESOTEST Esophageal<br>Temperature Probe and<br>Temperature Monitoring<br>System | Comparison<br>(Same/Different) | | | 1 input (single probe) available<br>5/7 sensors per probe<br>measurements and user-selected<br>alarm limits are displayed on<br>LCD monitor. | 1 input (single probe) available<br>3 sensors per probe<br>measurements and user-selected<br>alarm limit are displayed on<br>LED displays. | | | Materials (patient<br>contacting) | Polyurethane and Stainless Steel<br>(SST) AISI 304 | Polyurethane and Stainless Steel<br>(SST) AISI 304 | Same | | Ambient<br>temperature | +10°C to +40°C<br>Non condensed relative<br>humidity:<br>30% to 75% | +10°C to +40°C<br>Non condensed relative<br>humidity:<br>30% to 75% | Same | | Accuracy | 0.3°C within rated output range<br>(ISO 80601-2-56:2009<br>requirements for clinical<br>thermometers) | 0.3°C within rated output range<br>(ISO 80601-2-56:2009<br>requirements for clinical<br>thermometers ) | Same | | Precision and<br>repeatability [°C] | 0.1 | 0.1 | Same | | Response time(1) | Both heating and cooling<br>response time are approximately<br>1 second | Both heating and cooling<br>response time are approximately<br>1 second | Same | ## Technological Characteristics and Substantial Equivalence: {5}------------------------------------------------ {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<br>testing the power supply system together with the device<br>according to the requirements of the applicable Electrical<br>Safety standards, | | ESOTEST MULTI has a larger measurement range | The larger measurement range does not introduce new<br>questions of safety and effectiveness. It has been verified<br>though performance accuracy testing. | | ESOTEST MULTI probe has 5 to 7 sensors instead<br>of 3 as the probe of the predicate device | The greater number of sensors allows the device to monitor<br>a longer portion of esophagus temperature and does not<br>introduce new questions of safety and effectiveness. The<br>probes were verified through performance testing. | | ESOTEST MULTI makes use of a touch screen<br>user interface instead of employing LED displays<br>and physical buttons as the predicate device | The adoption of an LCD display with adequate size and<br>brightness, along with the capacitive touch screen. This<br>does not introduce new questions of safety and<br>effectiveness. | | ESOTEST MULTI has a lower alarm threshold in<br>addition to the upper alarm threshold of the<br>predicate device | The presence of a second alarm threshold allows the user to<br>employ the alarm both during heating and cooling<br>treatments. This does not introduce new questions of safety<br>and effectiveness. The alarm thresholds were validated<br>through performance testing and the software was<br>verified/validated. | | ESOTEST MULTI can tolerate a slightly larger<br>mains supply voltage range | This does not introduce new questions of safety and<br>effectiveness. It has been verified by testing the device in<br>the mains supply rated voltage range, according to<br>requirements of applicable Electrical Safety standards | | The main unit of ESOTEST MULTI is smaller and<br>lighter and the interconnection cables are longer<br>than the corresponding components of the predicate<br>device | The fact that the main unit is smaller and lighter does not<br>introduce new questions of safety and effectiveness. | | ESOTEST MULTI measures and displays the<br>temperature detected by 5 to 7 sensors instead of 3<br>as the predicate device | The LCD display of the greater number of sensors does not<br>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. {7}------------------------------------------------ # 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<br>in the rated range +10 to +45°C | | Precision in condition of<br>repeatability | 0.1°C | | Response Time | 1 s<br>temperature step +27 to +43 °C | | Alarm Threshold | Auditory and visual alarm is triggered<br>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. {9}------------------------------------------------ ### 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.