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    K Number
    K103641
    Device Name
    GUARDACARE
    Manufacturer
    HEMCON MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2011-06-16

    (185 days)

    Product Code
    QSY,FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K082703
    Why did this record match?
    Device Name :

    GUARDACARE

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

    HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

    Device Description

    The GuardaCare™XR dressing is composed of a radiopaque element attached to standard polyester/ravon blend non-woven medical gauze that is coated with chitosan. The product is produced in multiple sizes; e.q. two (2) inches by two (2) inches, eightply: four (4) inches by four (4) inches, eight-ply; and four (4) inches by two (2) yards (zfolded 4"x4"). All sizes are a single continuous length that is z-folded to the appropriate size. The products are double-pouched. The inner pouch is peelable foil and the outer pouch is clear peelable polvethylene terephthalate (PET). The pouched dressings are terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 °. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.

    AI/ML Overview

    This document describes the GuardaCare™XR hemostatic dressing, and its substantial equivalence (SE) to a predicate device, mRDH Bandage (K082703). The information provided is primarily focused on demonstrating this substantial equivalence through non-clinical performance data, rather than detailing a specific clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, and adjudication methods for a clinical study is not available in the provided text.

    However, I can extract the available information regarding the device's performance and the non-clinical studies conducted.

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: The document does not explicitly state "acceptance criteria" for each test in a quantitative manner as would typically be found in a clinical study report. Instead, it describes what each test demonstrated or determined in relation to the predicate device or a standard.

    Performance AttributeAcceptance Criteria (Implicit from Study Outcomes)Reported Device Performance
    BiocompatibilityDemonstrated per ISO 10993.Demonstrated.
    Hemostatic EfficacyControl bleeding at least as well as a competitive hemostatic dressing.Successfully controlled bleeding at least as well as the competitive product used as a reference.
    SterilityAchieve a sterility assurance level (SAL) of 10⁻⁶ per ISO 11137:2006.Achieved a 10⁻⁶ SAL using the VDmax method.
    RadiopacityEquivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 millimeter 99+% 1100 alloy aluminum sheet).Found to be equivalent to the ASTM Radiopacity Standard and therefore determined to be acceptable.

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

    The document describes in vivo efficacy studies in swine.

    • Sample Size: Not explicitly stated as a numerical value for each group, but refers to "a swine" in singular for each type of injury. This implies animal models were used.
    • Provenance: Animal study (swine model), likely prospective within the context of the study design. The country of origin is not specified but is implied to be where the studies were conducted for regulatory submission in the US.

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

    • Not applicable / Not provided. The studies described are non-clinical in vivo (animal model) and laboratory tests (biocompatibility, sterility, radiopacity), not human clinical trials requiring expert-established ground truth.

    4. Adjudication Method for the Test Set

    • Not applicable / Not provided. This information is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

    • No such study was mentioned. The document explicitly states: "Based upon the substantial equivalence determination for the predicate device, no clinical data is required for evaluation of this device."

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

    • Not applicable. This device is a physical wound dressing, not a software algorithm.

    7. Type of Ground Truth Used

    • For in vivo efficacy: Direct observation of bleeding control in a live animal model (swine). This is a functional outcome.
    • For biocompatibility: Laboratory test results against ISO 10993 standards.
    • For sterility: Laboratory validation following ISO 11137:2006 requirements.
    • For radiopacity: Laboratory testing in accordance with ASTM F640-07 Method C against a specified standard.

    8. Sample Size for the Training Set

    • Not applicable / Not provided. This concept of a "training set" is primarily relevant for machine learning algorithms. The studies described are traditional non-clinical performance evaluations.

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

    • Not applicable / Not provided. As mentioned above, there is no "training set" in the context of these device evaluations.
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