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    K Number
    K970866
    Device Name
    FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
    Manufacturer
    GEORGIA BIOMEDICAL, INC.
    Date Cleared
    1998-01-23

    (319 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K941438,K952508,K920205,K920986
    Why did this record match?
    Device Name :

    FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER

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

    The Georgia BioMedical Filter Heater/Hydrator Insufflation Gas Conditioner is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

    Device Description

    The Filter Heater/Hydrator Insufflation Gas Conditioner is a single use device which attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation. The device consists of a universal gas connector, a control module which houses the control and safety circuits for the system and a disposable filter heater/humidifier (FHH) tubing set.

    Gas from the insufflator is routed into the FHH tubing set via the control module. Within the filter heater/humidifier tubing set particles >0.3 um in size are filtered from the gas, the gas is heated to 35°C and the gas is hydrated to >80% relative humidity. The distal end of the filter heater/humidifier tubing set terminates in a Luer lock connection for attachment to a gas entrance port for the abdomen, pleural space, chest cavity, abdominal cavity or any other body cavity.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Georgia BioMedical, Inc. Filter Heater/Hydrator Insufflation Gas Conditioner, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Heating TimeDevice reaches 35°C (body temperature) rapidly after activation.Operates at 36°C within 100 seconds of activation.
    Humidity (Flow Rate)Maintains >80% relative humidity at varying flow rates.>80% relative humidity maintained at flow rates up to 8 liters/minute.
    Pressure DropInsignificant reduction in gas pressure.Only a very slight reduction in gas pressure, which increases with flow rate; humidification of FHH cassette does not increase pressure drop.
    Sustained HumidityCapacity adequate to humidify 180 liters of gas over usage conditions.Under worst-case conditions (high flow rate, under-humidification), results suggest adequate capacity with 8cc water charge and moderate flow rates.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state a "sample size" in terms of number of devices or experimental replicates for the performance tests. The descriptions are general (e.g., "Testing was performed").

    • Test Set Sample Size: Not explicitly stated. The descriptions imply multiple measurements were taken for each test condition (e.g., "This procedure was repeated for flow rates of 3,5,6 and 8 liters/minute").
    • Data Provenance: The studies were conducted by Georgia BioMedical, Inc. or their consultants for regulatory submission. The origin (e.g., country) is the USA, based on the submission to the FDA. The nature of the studies is prospective as they are performance tests conducted to demonstrate the device meets design specifications.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    This information is not applicable as the described tests are laboratory performance evaluations of physical parameters (temperature, humidity, pressure), not diagnostic or interpretative tasks requiring human expert ground truth.

    4. Adjudication Method for the Test Set

    This information is not applicable for the same reason as point 3.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance testing of the device's physical functions (heating, humidification, pressure), not a study comparing human reader performance with and without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This question is not applicable as the device is a physical medical accessory with no AI algorithms. The performance testing described is "standalone" in the sense that it measures the device's inherent physical performance, but it's not applicable to the context of "algorithm only" performance.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance criteria was established by measurement against engineering specifications and industry standards/expectations for medical gas conditioning. For example:

    • Temperature: Measured by a thermometer/sensor.
    • Relative Humidity: Measured by a hygrometer/sensor.
    • Gas Pressure: Measured by a pressure gauge/sensor.

    These measurements were then compared against the target performance values (e.g., 35°C, >80% relative humidity, slight pressure reduction).

    8. The Sample Size for the Training Set

    This information is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set" in the context of machine learning.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable for the same reason as point 8.

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