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510(k) Data Aggregation

    K Number
    K961319
    Device Name
    EPIVIEW
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
    Date Cleared
    1996-07-08

    (94 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K811291
    Why did this record match?
    Device Name :

    EPIVIEW

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

    EpiVIEW Thin Film Dressing is indicated as a securement device and dressing for peripheral and central IV catheters. It may be used as a wound dressing on minor abrasions, superficial pressure ulcers, over eschar to facilitate debridement, skin graft donor sites, closed clean surgical wounds and first and second degree burns. EpiVIEW may also be used to prevent skin breakdown from chafing or from exposure to continuous moisture and friction .

    Device Description

    EpiVIEW Thin Film Dressing is similar in construction and design to Tegaderm; both dressings consist of a thin polyurethane film coated with an acrylic adhesive wound contact layer.

    AI/ML Overview

    EpiVIEW™ Thin Film Dressing

    The provided text describes a 510(k) Premarket Notification for the EpiVIEW Thin Film Dressing. This notification aims to demonstrate substantial equivalence to a predicate device, 3M's Tegaderm Transparent Dressing (K811291). The acceptance criteria and the study proving the device meets these criteria are primarily based on comparative performance to the predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (in comparison to 3M Tegaderm Transparent Dressing)Reported EpiVIEW™ Thin Film Dressing Performance
    Peel Adhesion (N/cm): Substantially equivalentShown to have the same peel adhesion (N/cm)
    Moisture Vapor Transmission Rate (MVTR): Substantially equivalentSubstantially equivalent MVTR profiles
    Elasticity: No significant differencesNo significant differences in elasticity
    Coefficient of Friction (COF): Lower than TegadermA lower coefficient of friction (COF) value
    Biocompatibility: Non-toxic, non-cytotoxic, non-hemolytic, negligible irritant, weak allergenic potentialConsidered to be non-toxic, non-cytotoxic, non-hemolytic, a negligible irritant and having a weak allergenic potential

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

    The provided text does not explicitly state the sample sizes used for the various tests (peel adhesion, MVTR, elasticity, COF, and biocompatibility). It only mentions that "both dressings have been tested."

    The data provenance is not specified. It is likely retrospective as these are laboratory tests performed on fabricated samples of the dressings, not clinical data from patients.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This type of device ($510(k)$ for a thin film dressing) and the tests described (physical and biocompatibility) do not typically involve "experts" in the sense of clinical specialists establishing a "ground truth" for a test set. The ground truth for these tests is established by standardized laboratory methods and measurements.

    For biocompatibility testing, the "ground truth" would be the scientific interpretation of the ISO 10993 results by experts in toxicology and material science, but the number and qualifications of these individuals are not specified here. The FDA guidance for biocompatibility (ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix) is the standard followed.

    4. Adjudication Method

    An adjudication method is not applicable to the types of tests described (peel adhesion, MVTR, elasticity, COF, biocompatibility). These are objective laboratory measurements, not subjective evaluations requiring expert consensus.

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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or screening devices where human readers interpret results, and the AI's impact on their performance is assessed. This is not applicable to a thin film dressing.

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

    No, a standalone "algorithm only" performance study was not done. This is also not applicable to a physical medical device like a thin film dressing. The "performance" here refers to the physical and biological characteristics of the dressing itself.

    7. The Type of Ground Truth Used

    The ground truth used for the performance evaluations is based on:

    • Standardized Laboratory Measurements: For peel adhesion, MVTR, elasticity, and COF, the "ground truth" is the objective measurement obtained through established engineering and materials testing protocols.
    • Biocompatibility Standards: For biocompatibility, the "ground truth" is determined by adherence to ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix, and the results are interpreted against established criteria for non-toxicity, non-cytotoxicity, etc.

    8. The Sample Size for the Training Set

    Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are used in machine learning or AI algorithm development.

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

    Not applicable. As there is no training set, there is no ground truth for it to be established.

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