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510(k) Data Aggregation

    K Number
    K231614
    Device Name
    MiroTract Wound Matrix
    Manufacturer
    Reprise Biomedical, Inc.
    Date Cleared
    2023-12-13

    (194 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K223257
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MiroTract Wound Matrix is intended for the management of wounds including:

    · Partial and full thickness wounds

    • Pressure ulcers
    • Venous ulcers
    • · Chronic vascular ulcers
    • · Diabetic ulcers
    • · Tunneled, undermined wounds
    • · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
    • · Draining wounds

    · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

    Device Description

    The Reprise Biomedical MiroTract device consists of the MiroTract Wound Matrix and disposable delivery system. The MiroTract Wound Matrix is a sterile, single use, noncrosslinked acellular wound dressing that is derived from porcine liver tissue. The porcine liver is perfusion decellularized resulting in a collagen matrix that is dried, cut to size, and radially compressed onto the guidewire of the MiroTract delivery system. The delivery system includes a guidewire and tamp tube to manually push the MiroTract Wound Matrix off the guidewire into a wound. The MiroTract Wound Matrix porous scaffold provides a protective environment for wound healing. The MiroTract Wound Matrix is provided in two diameters (3 mm and 5 mm) and two lengths (5 cm and 9 cm). The MiroTract device is packaged dry in a plastic tray placed inside a foil pouch. The device is terminally sterilized in its packaging by e-beam irradiation. An optional Introducer Set accessory consisting of a tearaway sheath and dilator is provided in a separately packaged sterile pouch that is placed in a shelf box along with a MiroTract packaged device.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

    The document describes a 510(k) submission for a medical device called "MiroTract Wound Matrix". A 510(k) submission is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets new acceptance criteria through a clinical study.

    The "Performance Data" section (VIII) lists several types of testing performed:

    1. Biocompatibility Testing: This ensures the device is safe for biological contact.
    2. Bench Testing: This includes:
      • Package integrity
      • Package and product stability
      • Collagen denaturation (a material property)
      • Dimensional testing (ensuring it's within specified size tolerances)
      • MR testing (for MRI compatibility)
      • Deliverability assessment (how well the device can be delivered)

    These tests are primarily focused on the safety, material properties, and physical performance characteristics of the device, and ensuring it performs as intended from an engineering and safety perspective. They are not designed to determine clinical efficacy or diagnostic accuracy, which would typically involve human subject studies with specific clinical acceptance criteria.

    Therefore, I cannot provide the requested information for the following reasons:

    • No acceptance criteria for clinical performance: The document does not specify clinical acceptance criteria (e.g., wound healing rates, infection reduction percentages, diagnostic sensitivity/specificity).
    • No study proving clinical acceptance criteria met: The listed "performance data" is bench and biocompatibility testing, not a clinical study designed to measure effectiveness in human patients against predefined clinical endpoints.
    • No information on sample size for a test set (clinical): Since no clinical test set for efficacy is described, there's no sample size, data provenance, or details on expert adjudication for ground truth.
    • No MRMC study: A multi-reader multi-case study is not applicable as this is a wound matrix, not an imaging diagnostic device.
    • No standalone algorithm performance: This is a physical wound matrix, not a software algorithm.
    • No ground truth type for clinical efficacy: As above, no clinical efficacy study is detailed.
    • No sample size for training set (clinical/AI): Given it's not an AI/diagnostic device, this is not applicable.
    • No ground truth establishment for training set: As above, not applicable.

    In summary, the provided text describes the technical and material safety testing of a wound matrix device to demonstrate substantial equivalence, not its clinical efficacy against specific performance criteria derived from a human study.

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