(57 days)
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 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 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.
The provided text describes the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization (subject device) and its substantial equivalence to a predicate device (K180047 – ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and performance specifications. The "acceptance criteria" can be inferred from the predicate device's established performance and relevant standards. The reported device performance is presented as being "Same" or compliant with the standards listed.
| Acceptance Criteria (Inferred from Predicate/Standards) | Subject Device Performance (Reported) |
|---|---|
| Accuracy: 0.3°C within rated output range (ISO 80601-2-56:2009 requirements for clinical thermometers) | Same / Meets requirements |
| Precision and Repeatability: 0.1°C | Same |
| Response Time: Approximately 1 second (both heating and cooling) | Same / Meets requirements |
| Temperature Measurement Range: 0-75°C | Same |
| Insulation Classification: I, CF, Defib protected | Same |
| Biocompatibility: Compliance to ISO 10993-1 | Compliance to ISO 10993-1 |
| Sterilization Requirements: Compliance to ISO 10993-7, ANSI/AAMI ST72:2011, FDA guidelines, USP <151>, ISO 11607 | Compliance to relevant standards and guidelines |
| Software: Compliance to EN 62304 | Compliance to EN 62304 |
| Electrical Safety: Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| EMC: Compliance to EN 60601-1-2 | Compliance to EN 60601-1-2 |
| EO and ECH Residuals: Below limit (ISO 10993-7) | EO < 0.1 mg/disp, ECH < 1 mg/disp |
| Endotoxin Concentration: Below limit (ANSI/AAMI ST72:2011, FDA guidelines) | Endotoxin concentration < 5 |
| Pyrogenicity: Pyrogen free (USP) | Meets USP requirements |
| Shelf-life: 4 years | Validated for 4 years |
| Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity: Compliant with ISO 10993-1 | Not cytotoxic, not sensitizing, meets intracutaneous reactivity, meets pyrogen absence |
| Adapter Cable Compliance: Compliance to ANSI/AAMI EC53:1995 | Guarantees compliance |
| Immunity to Disturbances / Compatibility with Mapping Systems: Not affected by noise sources, compatible with specified mapping systems | Not affected by noise sources; compatible with EnSite Precision and Carto 3 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state specific sample sizes for test sets used in each non-clinical test. The testing is described generally as "non-clinical testing" or "several clinical procedures" for the adapter cable validation.
The data provenance is industrial/laboratory testing to verify compliance with various international standards (e.g., ISO, IEC, EN, ANSI/AAMI, USP). It is not specified as country-of-origin, but given it's for FDA clearance, it's assumed to be conducted in a manner acceptable to the FDA. The tests are retrospective in the sense that they are conducted on the manufactured device to demonstrate its performance against predefined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical/diagnostic accuracy studies. The "ground truth" for the performance tests (e.g., accuracy, response time) is established by the specified international standards (e.g., ISO 80601-2-56:2009). For biocompatibility and sterilization, the ground truth refers to the limits and methodologies defined by the relevant ISO, ANSI/AAMI, and USP standards.
The phrase "verified during several clinical procedures" for the adapter cable to mapping systems does not specify the number or qualifications of clinicians involved, nor how "ground truth" (e.g., correct visualization) was formally established or assessed by experts.
4. Adjudication Method for the Test Set:
Not applicable in the context of the described technical and performance bench testing against standards. Such tests typically involve direct measurement and comparison to predefined thresholds or specifications, not expert adjudication of subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical compliance and performance testing, not on comparing reader performance with or without AI assistance. The device is a monitor and probe system, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this is not applicable. The device is an esophageal temperature monitoring system, which requires human interaction for placement and interpretation of displayed temperature values. It does not contain an AI algorithm for standalone diagnostic performance.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on:
- Established International Standards and Benchmarks: For accuracy, response time, electrical safety, EMC, software compliance, biocompatibility, and sterility, the ground truth is defined by the requirements and test methodologies outlined in standards such as ISO 80601-2-56:2009, IEC 60601-1, IEC 60601-1-2, EN 62304, ISO 10993 series, ANSI/AAMI ST72:2011, USP <151>, ISO 11607, and ANSI/AAMI EC53:1995.
- Direct Measurement and Comparison: The performance parameters (e.g., temperature values, response times, residual levels) are directly measured and compared against the specified limits and benchmarks derived from these standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a measurement and monitoring system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set is used for this device.
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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.
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
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| Indications for Use | FIAB spa Vicchio, ITALY | |
|---|---|---|
| ESOTEST MULTIEsophageal Temperature Probe andTemperature Monitoring Systemwith Visualization | 2018/12/18Revised 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. 0910-0120Expiration Date: 06/30/2020See 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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FORM FDA 3881 (7/17)
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PSC Publishing Services (301) 443-6740 EF
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ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization
510(k) Summary
| Submitter: | Fiab SpAVia Costoli, 450039 VicchioFlorence, Italy |
|---|---|
| Application Correspondent: | Mr. Francesco Batistini,Title: Official CorrespondentPhone: (39) 055 849 79 43Fax: (39) 055 849 79 87E-mail: regulatory@fiab.it |
| Preparation Date: | September 24, 2019 |
| Trade Name: | ESOTEST MULTIEsophageal Temperature Probe and TemperatureMonitoring 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 TemperatureProbe 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 ofcomparison | Subject Device:FIAB - ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System withVisualization | Predicate Device:K180047 FIAB - ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | Comments |
|---|---|---|---|
| Thermometertype | Esophageal | Same | |
| Product Code | FLLIKD | FLL | Product code IKD refersto the ESOTEST MULTIADAPTER CABLEaccessory, see thecomponents comparisonbelow |
| Regulation | 880.2910 Clinical ElectronicThermometer890.1175 Cable, Electrode | 880.2910Clinical ElectronicThermometer | Regulation 890.1175refers to the ESOTESTMULTI ADAPTERCABLE accessory, see thecomponents comparisonbelow |
| Element ofcomparison | Subject Device:FIAB - ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System withVisualization | Predicate Device:K180047 FIAB - ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | Comments |
| Indications foruse | The ESOTEST MULTITemperature MonitoringSystem is composed ofESOTEST MULTI Monitorand ESOTEST MULTI Probeand is intended for thecontinuous detection,measurement andvisualization (in $ ° C $ ) ofesophageal temperature. Theintended environments of useare operating rooms andinterventionalelectrophysiology rooms. TheESOTEST MULTI Monitormust be used in conjunctionwith the ESOTEST MULTIProbe.The role of esophagealtemperature monitoring usingthis device in reducing therisk of cardiac ablation-related esophageal injury hasnot been established. Theperformance of theESOTEST MULTI system indetecting esophagealtemperature changes as aresult of energy deliveryduring cardiac ablationprocedures has not beenevaluated. | The ESOTEST MULTITemperature MonitoringSystem is composed ofESOTEST MULTI Monitorand ESOTEST MULTI Probeand is intended for thecontinuous detection,measurement and visualization(in $ ° C $ ) of esophagealtemperature. The intendedenvironments of use areoperating rooms andinterventionalelectrophysiology rooms. TheESOTEST MULTI Monitormust be used in conjunctionwith the ESOTEST MULTIProbe. | Same, with the addition ofa remark about the lack ofan exhaustive evaluationregarding the employmentof the ESOTEST MULTIsystem during specificclinical procedures. Theremark applies both to thesubject and to thepredicate device, as theperformance of the systemis not affected by theaddition of the ESOTESTMULTI adapter cable. |
| Components | Temperature probe, Patientcable, Monitor. The packageof the monitor includes anexternal power supply and anequipotential cable.Optional component:ESOTEST MULTIADAPTER CABLE. | Temperature probe, Patientcable, Monitor. The package ofthe monitor includes anexternal power supply and anequipotential cable | Same, with the addition ofthe ESOTEST MULTIADAPTER CABLE, anoptional component soldseparately. Thetechnology is the sameadopted for thecommercially availableadapter cables typicallyused to connect diagnosticcatheters to mappingsystems. |
| Temperaturemeasurementrange [ $ ° C $ ] | 0 - 75 | Same | |
| Element ofcomparison | Subject Device:FIAB - ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System withVisualization | Predicate Device:K180047 FIAB - ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | Comments |
| Number oftemperaturesensors | 5 or 7 | Same | |
| Temperaturesensor type | T-type thermocouple(accuracy ±0.3°C) | Same | |
| Measurementpresentation/UserInterface | LCD monitorTouch screen monitor | Same | |
| Alarmtemperaturerange [°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 |
| Powerrequirements | 100 - 240 Vac | Same | |
| Monitorclassification | I, CF, defib protected | Same | |
| Dimensions [cm] | Monitor: 34(width) x25(height) x6.5 (depth)Patient cable (length): 290Temperature probe (length and diameter):83; 7Fr body, 11Fr sensors | Same | |
| Introduction | Esophageal (nose/throat) | Same | |
| Signal processingand display | Actual temperature is a function of the thermocouple voltage.Temperature displayed in 0.1°C increments.1 input (single probe) available5/7 sensors per probe measurements and user-selected alarmlimits 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 |
| Patientcontactingmaterials | Polyurethane and Stainless Steel (SST) AISI 304 | Polyurethane and Stainless Steel (SST) AISI 304 | Same |
| Operatingconditions | +10°C to +40°CNon condensed relative humidity:30% to 75% | +10°C to +40°CNon condensed relative humidity:30% to 75% | Same |
| Accuracy | 0.3°C within rated output range (ISO 80601-2-56:2009requirements for clinical thermometers) | 0.3°C within rated output range (ISO 80601-2-56:2009requirements for clinical thermometers) | Same |
| Precision andrepeatability [°C] | 0.1 | Same | |
| Response time(1) | Both heating and cooling response time are approximately 1second | Both heating and cooling response time are approximately 1second | Same |
| Requirements forprobesterilization | Compliance to standard ISO 10993-7Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.Pyrogenicity test as outlined in USP<151>.Shelf life procedure and protocol performed according tostandard ISO 11607 | Compliance to standard ISO 10993-7Compliance to ANSI/AAMI ST72:2011 and FDA guidelines.Pyrogenicity test as outlined in USP<151>.Shelf life procedure and protocol performed according tostandard ISO 11607 | Same |
| Element ofcomparison | Subject Device:FIAB - ESOTEST MULTIEsophageal TemperatureProbe and TemperatureMonitoring System withVisualization | Predicate Device:K180047 FIAB - ESOTESTMULTI EsophagealTemperature Probe andTemperature MonitoringSystem | Comments |
| Biocompatibilityof the patientcontacting 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 | |
| Performancebench 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 residualtesting | The residual levels must be below thelimit values prescribed by theISO 10993-7 standard | EO < 0.1 mg/dispECH < 1 mg/disp |
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| Test name | Endpoint | Result summary |
|---|---|---|
| LAL test | After the sterilization, the endotoxinconcentration must be below the limitprescribed by the ANSI/AAMIST72:2011 standard and FDA guidelines. | Endotoxin concentration <5 |
| Pyrogen test | The material used for the contact partmust be pyrogen free | According to USP, the tested product meets therequirement for the absence of pyrogens |
| Shelf life test | Validation of the declared shelf-life of thepackaged probe (4 years) according to thestandard ISO 11607 | Results of tests demonstrate that the packagingsystem ensures sterility of device for a claimedperiod of 4 years |
| In vitro cytotoxicitytest, sensitization test,intracutaneousreactivity test, acutesystemic toxicity test | Verifying the compliance of theesophageal probe to the requirements ofISO 10993-1 for the considered type andduration of contact | Results of tests demonstrate that the sample canbe considered not cytotoxic, not sensitizing,meets the requirements of intracutaenousreactivity and meets the requirement for theabsence of pyorogens |
| Software system tests | Verifying the correct implementation ofthe software requirements according tostandardEN 62304 | The residual anomalies found do not impact onthe safety or on the performance of the device |
| All the applicablesafety tests prescribedby theIEC 60601-1 standard | Verifying the compliance of the system totheIEC 60601-1 standard | The system passed all the applicable tests |
| All the applicableimmunity/emissionstests prescribed by theIEC 60601-1-2 standard | Verifying the compliance of the system totheEN 60601-1-2 standard | The system passed all the applicable tests |
| Accuracy and responsetime test | Verifying the compliance of the system totheISO 80601-2-56:2009 standard | The system accuracy and response time meetsthe requirements of the standard |
| Adapter cablevalidation | Verifying the compliance of the ESOTESTMULTI ADAPTER CABLE to the ANSI/AAMIEC53:1995 standard | The cable manufacturing process guarantees thecompliance to ANSI/AAMI EC53:1995 standard |
| Performance test in theworking environment | Verifying the immunity of the system tothe most common disturbance sources inthe working environment, verifying thecompatibility with mapping systems | The system is not affected by the noise sourcesin the working environment.The system is compatible with the followingmapping systems: EnSite Precision and Carto 3 |
Conclusion:
Based on the performance testing, comparison and analysis in the submission, the subject device is substantially equivalent to the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K180047).
§ 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.