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510(k) Data Aggregation

    K Number
    K120764
    Device Name
    EPIFLO(R)
    Manufacturer
    Date Cleared
    2012-04-27

    (45 days)

    Product Code
    Regulation Number
    878.5650
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

    Device Description

    EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

    AI/ML Overview

    The provided text describes the EPIFLO System, a transdermal continuous oxygen therapy device. However, it does not include a detailed study or specific acceptance criteria for device performance in the way typically expected for a medical device with measurable outcomes like accuracy or sensitivity/specificity.

    Instead, the performance testing section (Section 7) states: "Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation."

    This indicates that the acceptance criteria were related to the device's functional specifications (e.g., oxygen delivery rate, duration, safety features) rather than clinical efficacy or diagnostic accuracy, as this is an oxygen delivery system, not a diagnostic or screening tool.

    Given the information, I can only describe the reported device performance as it relates to its functional specifications, as specific metrics for clinical efficacy are not provided in this document.

    Here's the breakdown of what can be extracted and what is not available in the provided text:


    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Oxygen Delivery Rate per specification~3.0 ml/hour
    Oxygen Purity98 to 100 percent oxygen (near 100 percent pure oxygen)
    Labeled Durations (continuous oxygen delivery)Seven or fifteen days (depending on the model)
    EMC compatibility"EMC compatibility" testing was conducted and passed.
    Sterilization validation"Sterilization validation" testing was conducted and passed.
    Ambient Pressure OperationOperates at ambient pressure (typically 1 atmosphere)
    Disposable, Single Patient, Single UseDevice adheres to this specification.

    Note: The document only states that testing was conducted to validate performance "according to its specifications." Specific numerical acceptance thresholds (e.g., "oxygen delivery must be 3.0 +/- 0.1 ml/hour") are not explicitly stated, but the reported performance values are presented as meeting these underlying, implied specifications.

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

    This information is not provided in the document. The text mentions "Performance Testing" but does not detail the methodology, sample sizes, or nature of the test set (e.g., in-vitro, in-vivo, clinical subjects).

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

    This information is not provided. As this is a device for oxygen delivery, not a diagnostic system requiring expert interpretation of images or data, the concept of "ground truth" established by clinical experts in the traditional sense (e.g., radiologists for imaging) is not directly applicable to the functional performance testing described. Ground truth for functional tests would typically be established by calibrated measurement instruments.

    4. Adjudication Method for the Test Set

    This information is not provided.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. Such studies are typically for diagnostic or screening devices where human readers interpret data, often with and without AI assistance, to measure changes in diagnostic performance. The EPIFLO System is an oxygen delivery device, not a diagnostic tool requiring human interpretation.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    The described performance testing focuses on the device's functional operation (oxygen delivery rate, purity, duration, EMC, sterilization). This is inherently a "standalone" evaluation of the device's physical and operational characteristics without human intervention influencing its core function. However, it's not "algorithm-only" performance as the device's primary function is mechanical/chemical oxygen generation and delivery, not data processing.

    7. Type of Ground Truth Used

    For the functional performance testing described (oxygen delivery, EMC, sterilization), the ground truth would likely be established by:

    • Instrumental Measurement: Calibrated sensors and measurement tools for oxygen flow rate, purity, and duration.
    • Standardized Test Methods: Protocols for EMC (Electromagnetic Compatibility) and sterilization validation, which typically have defined pass/fail criteria.
      The document does not explicitly state the type of ground truth used, but these are the standard approaches for such device validations.

    8. Sample Size for the Training Set

    This information is not provided. As the EPIFLO System is a physical medical device (oxygen concentrator and cannula) and not an AI/ML algorithm requiring a training set, this question is not applicable in the context of this device.

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

    This information is not provided and is not applicable, as the device is not an AI/ML algorithm that requires a training set and corresponding ground truth.

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