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510(k) Data Aggregation

    K Number
    K220317
    Device Name
    PuraPly Micronized Wound Matrix (PuraPly MZ)
    Manufacturer
    Organogenesis Inc.
    Date Cleared
    2022-07-01

    (148 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K172399,K011026
    Why did this record match?
    Device Name :

    PuraPly Micronized Wound Matrix (PuraPly MZ)

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

    PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include:

    • · Partial and full-thickness wounds
    • Pressure ulcers
    • Venous ulcers
    • · Diabetic ulcers
    • Chronic vascular ulcers
    • · Tunneled/undermined wounds
    • Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, Podiatric wound, and wound dehiscence).
    • · Trauma wounds (e.g., abrasions, lacerations, and skin tears)
    • Partial thickness burns
    • Draining wounds
      The device is intended for single patient use only.
    Device Description

    PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of ≤ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a wound matrix device (PuraPly® Micronized Wound Matrix) and focuses on demonstrating substantial equivalence to predicate devices, not on specific performance acceptance criteria or a study designed to meet them.

    The "Performance Data Non-Clinical Test" section mentions tests performed on the device (e.g., color, particle size, absorption capacity, endotoxin levels, pH) and biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, pyrogenicity, various systemic toxicities, genotoxicity, and a large animal wound healing study). However, it does not provide:

    • A table of acceptance criteria with corresponding reported device performance values.
    • Details on the study design, sample size, or data provenance for these tests.
    • Information about experts, ground truth, adjudication methods, or MRMC studies.
    • Specific details about the training set for any AI/ML model, as this device does not appear to be an AI-powered device.

    Therefore, I cannot fulfill your request based on the provided input.

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