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    K Number
    DEN230021
    Device Name
    ensoETM
    Manufacturer
    Advanced Cooling Therapy, Inc. d/b/a Attune Medical
    Date Cleared
    2023-09-13

    (167 days)

    Product Code
    QXV
    Regulation Number
    870.5720
    Type
    Direct
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K170009
    Why did this record match?
    Product Code :

    QXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ECD01 model of ensoETM™ is indicated as follows:

    The ensoETM™ is a thermal regulating device, intended to:

      1. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature.
      1. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
      1. provide gastric decompression and suctioning.
        The ECD02 model of ensoETM™ is indicated as follows:

    The ensoETM™ is a thermal regulating device, intended to:

      1. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature.
      1. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia Systemto reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
      1. provide gastric decompression and suctioning.
    Device Description

    The ensoETM is a multi-lumen silicone tube that is placed in the esophagus in a manner similar to a standard orogastric tube. The primary function of the ensoETM™ is to connect to an external heat exchanger to either (1) cool or warm a patient or (2) cool the esophagus to reduce the likelihood of thermal injurv after radiofrequency (RF) cardiac ablation procedures.

    The external heat exchanger circulates warmed or chilled water through the two outer lumens of the ensoETMTM. One outer lumen serves as the water inflow, while the other serves as the water outflow. The distal end of the ensoETM™ contains an opening between the two outer lumens, allowing the water to circulate back to the external heat exchanger without contacting the patient.

    The central lumen of the ensoETM™ is open to the stomach to allow for gastric decompression and suction.

    The ensoETM™ is primarily composed of standard medical-grade silicone. The ensoETMIM is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the studies performed for the ensoETM™ device, based on the provided text:

    Acceptance Criteria and Device Performance for ensoETM™

    Note: The provided text details performance criteria for various non-clinical tests and outcomes of clinical studies. It doesn't explicitly state "acceptance criteria" in a singular, consolidated table for the overall device's effectiveness. Instead, the "acceptance criteria" are embedded within the description of each test or study objective. For the purpose of this response, I will synthesize these into a comprehensive table, drawing from the study descriptions.

    The primary clinical acceptance criterion for the device's new indication (reducing ablation-related esophageal injury) is implied by the clinical trial results showing a reduction in esophageal lesions, although statistical significance was not always met in individual RCTs and the pooled analysis showed a non-significant reduction.

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/Study TypeAcceptance Criteria (from text)Reported Device Performance (from text)
    Biocompatibility/MaterialsNon-cytotoxic (ISO 10993-5)Test articles found non-cytotoxic.
    Non-sensitizing (ISO 10993-10)Test articles found non-sensitizing.
    Non-irritating (ISO 10993-10)Test articles found non-irritating.
    Shelf Life/SterilityNon-sterile device acceptable based on RWD evaluation and complaint data.Device provided non-sterile (acceptable).
    Device and packaging functionality over 3 years (accelerated aging).Performance testing on devices which had completed 3-year accelerated aging demonstrated that the device and packaging materials did not experience significant degradation.
    MR Compatibility (Model ECD02)Magnetically induced displacement angle and torque do not pose significant risk in 1.5 T or 3.0 T MR environments.Results indicate effects do not pose significant risk.
    Maximum temperature rise ≤ 2.61 ℃ in 1.5 T or 3.0 T MR system at 2.0 W/kg SAR for 15 minutes.Maximum temperature rise was 2.61 ℃.
    Bench Performance - Tensile TestBond strength of ≥15 N.All tests met the specified acceptance criteria.
    Bench Performance - Burst Strength Test>15 psi.All tests met the specified acceptance criteria.
    Bench Performance - Ultimate Material Strength Test≥ 5 Mpa.All tests met the specified acceptance criteria.
    Bench Performance - Leakage TestNo visible evidence of leaks.All tests met the specified acceptance criteria.
    Bench Performance - Vacuum Resistance TestDevice does not collapse under 200 mmHg of negative pressure.All tests met the specified acceptance criteria.
    Bench Performance - End Cap Axial Deflection TestRequired force to bend is less than that needed for NeoMed enteral feeding connector.All tests met the specified acceptance criteria.
    Bench Performance - Dimensional TestingAccurate dimensions for Extruded Tube, Extension Tube, Proximal End Cap, Distal End Cap.All tests met the specified acceptance criteria.
    Bench Performance - Compatibility Testing (Flow Rate)> 31 L/hr.All tests met the specified acceptance criteria.
    Bench Performance - Compatibility Testing (Temperature Accuracy)Within ± 1.0 ℃.All tests met the specified acceptance criteria.
    Bench Performance - Compatibility Testing (Alarm Trigger)Alarms at ≤ 29 ℃ and ≥ 45 ℃ and when flow occluded.All tests met the specified acceptance criteria.
    Bench Performance - Compatibility Testing (System Pressures under Occlusive situation)
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