Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070431
    Manufacturer
    Date Cleared
    2007-05-24

    (100 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K052550

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

    Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

    Gowns provided as sterile and non-sterile.

    Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

    Device Description

    Not Found

    AI/ML Overview

    The Welmed, Inc. Surgical Gowns were evaluated for their performance based on a range of established standards and testing methods. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (IMC Surgical Gowns, K052550) through similarities in intended use, materials, design, and testing methodology.

    Here's an analysis of the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by the chosen standard test methods and the expectation that the Welmed Surgical Gowns perform comparably to, or in accordance with, these recognized standards for surgical gowns. The document reports that data was "Generated" in accordance with these standards, implying that the device demonstrated performance meeting the criteria outlined in each standard for its respective characteristic.

    Acceptance Criteria (Standard/Guidance Document)Reported Device Performance (Data Generated)
    AATCC Test Method 127-1998 Water Resistance: Hydrostatic Pressure TestHydrostatic Pressure - Water Resistance
    AATCC Test Method 42-2000 Water Resistance: Impact Penetration TestImpact Penetration - Water Resistance
    ASTM - D5034-95(2001) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)Tensile Strength
    ASTM - D5734-95(2001) Standard Test Method for Tearing Strength of Nonwoven Fabrics by Falling-Pendulum (Elmendorf) ApparatusElmendorf Tear
    ISO 9073-10:2003 - Textiles - Test methods for nonwovens -- Part 10: Lint and other particles generation in the dry stateGelbo Flex - Lint
    CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability of Clothing TextilesFlammability
    AAMI / ANSI / ISO 10993-1:2003(E). Biological evaluation of medical devices -- Part 1: Evaluation and testingBiocompatibility Testing Evaluation
    AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicityCytotoxicity
    AAMI / ANSI / ISO 10993-10:2002(E), Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitizationSkin Irritation, intra-cutaneous reactivity & sensitization

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

    The document does not explicitly state the specific sample sizes used for each of the performance tests. It only lists the test methods used to generate data. There is no information regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of these tests (material properties), they are typically conducted on new material samples.

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

    This information is not applicable to the evaluation of surgical gowns based on physical and biological performance standards. The "ground truth" for these tests is established by the well-defined methodologies and criteria within the internationally recognized standards themselves, not by expert consensus on individual cases.

    4. Adjudication Method for the Test Set

    This information is not applicable. The tests are objective measurements of material properties and biological responses, not subjective assessments requiring adjudication.

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

    No. This type of study is not relevant for the evaluation of surgical gowns. MRMC studies are typically used to assess the effectiveness of diagnostic or screening devices where human interpretation plays a significant role.

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

    No. This concept is not applicable as the device is a physical surgical gown, not an algorithm.

    7. The Type of Ground Truth Used

    The ground truth used for these performance tests is based on established scientific and engineering standards and their predefined pass/fail criteria. For example:

    • Physical Properties: The tensile strength, tear strength, hydrostatic pressure, and impact penetration are measured against the requirements specified in the respective ASTM and AATCC standards for surgical gowns to provide a barrier.
    • Flammability: Assessed against CPSC CS-191-53.
    • Lint Generation: Assessed against ISO 9073-10.
    • Biocompatibility: Evaluated based on the criteria set forth in the ISO 10993 series, which define acceptable levels of cytotoxicity, irritation, and sensitization.

    8. The Sample Size for the Training Set

    There is no "training set" in the context of this submission. The device is a physical product, and its performance is evaluated directly through standardized laboratory testing, not through machine learning or AI algorithms that require training data.

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

    Not applicable, as there is no training set.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1