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510(k) Data Aggregation

    K Number
    K192210
    Device Name
    ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    Manufacturer
    Fiab SpA
    Date Cleared
    2019-10-10

    (57 days)

    Product Code
    FLL, IKD
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fiab SpA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
    Device 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 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.
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    K Number
    K180047
    Device Name
    ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    Manufacturer
    Fiab SpA
    Date Cleared
    2018-11-08

    (304 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fiab SpA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.
    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.
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    K Number
    K123361
    Device Name
    ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
    Manufacturer
    FIAB SPA
    Date Cleared
    2013-02-27

    (119 days)

    Product Code
    FLL, REG
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIAB SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.
    Device Description
    ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts: Monitor, Interconnect Cable, Esophageal Probe. Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm. Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable.
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    K Number
    K100333
    Device Name
    FIAB SPA, MODELS F7244, F7233, F7234, F7277
    Manufacturer
    FIAB SPA
    Date Cleared
    2010-06-21

    (136 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIAB SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required.
    Device Description
    Self-powered devices for the cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.
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    K Number
    K083428
    Device Name
    F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
    Manufacturer
    FIAB SPA
    Date Cleared
    2009-09-01

    (286 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIAB SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.
    Device Description
    Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.
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    K Number
    K091163
    Device Name
    PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST
    Manufacturer
    FIAB SPA
    Date Cleared
    2009-07-22

    (91 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIAB SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.
    Device Description
    PG47xW SERIES are disposable adhesive electrodes with solid conductive gel. They consist of a conductive pad made of three primary layers: a non-woven fabric top, a carbon filled film and a solid hydrogel adhesive layer. Between the conductive film and the insulating top a 10 cm long cable is attached, terminated with 2 mm touch proof socket for the connection with electro-stimulating devices. Multiple shapes and sizes are available to accommodate placement on various location on the body. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient's skin. The electrodes are non-sterile and for single patient use only.
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