Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250329
    Manufacturer
    Date Cleared
    2025-06-25

    (140 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K030774,K160136,K222025,K182681

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

    Collymer Self-Assembling Scaffold is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

    Device Description

    Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.

    AI/ML Overview

    The provided FDA 510(k) Clearance Letter for the GeniPhys Collymer Self-Assembling Scaffold (K250329) does not include information about any clinical studies or the performance of a device based on acceptance criteria.

    The clearance letter explicitly states:
    "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Collymer Self-Assembling Scaffold to the predicate device."

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such clinical study data is presented in this document.

    The document focuses on demonstrating substantial equivalence through:

    • Comparison of Indications for Use and Technological Characteristics to a predicate device (Integra Flowable Wound Matrix, K072113) and several reference devices.
    • Non-Clinical Testing: Biocompatibility assessments, viral inactivation studies, sterility assessments, shipping studies, and stability evaluations. For these non-clinical tests, it is stated that "All results met the acceptance criteria" or "The acceptance criteria were met," but the specific numerical acceptance criteria themselves are not detailed, nor are the specific performance results beyond a qualitative statement of meeting the criteria.

    To directly answer your specific points based on the provided document:

    1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document for any clinical performance. For non-clinical tests, only a qualitative statement that acceptance criteria were met is given.
    2. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described. For non-clinical tests, sample sizes are not specified.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
    4. Adjudication method for the test set: Not applicable as no clinical test set is described.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document states clinical testing was not necessary.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (wound scaffold), not a software algorithm.
    7. The type of ground truth used: Not applicable as no clinical study or test set with a "ground truth" (in the context of AI/diagnostic device performance) is described.
    8. The sample size for the training set: Not applicable, as the document refers to a physical device and not a machine learning model that would have a training set.
    9. How the ground truth for the training set was established: Not applicable, as no training set is described.

    In summary, this 510(k) clearance relied on substantial equivalence to a predicate device and extensive non-clinical testing, rather than a clinical study demonstrating performance against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    K Number
    K230980
    Manufacturer
    Date Cleared
    2023-09-22

    (170 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K160136, K072113

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

    MicroMatrix® Flex is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use.

    Device Description

    The MicroMatrix® Flex device is a dual-syringe system for the mixing and delivery of a paste for the management of wounds. The particulate component of the device is composed of porcine-derived extracellular matrix known as urinary bladder matrix. The particulate component is identical to that particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of

    AI/ML Overview

    The provided FDA 510(k) summary for the MicroMatrix® Flex device does not describe specific acceptance criteria in the typical sense of a diagnostic device (e.g., sensitivity, specificity, AUC). Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MicroMatrix® UBM Particulate) by showing that the new device has identical intended use, similar technological characteristics, and similar principles of operation, with minor differences not raising new safety or effectiveness issues.

    The "acceptance criteria" here are therefore related to demonstrating that the new device performs equivalently to the predicate in various aspects.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Material CompositionIdentical material (porcine-derived extracellular matrix from urinary bladder matrix) and particle size to predicate.The particulate component is composed of porcine-derived extracellular matrix (urinary bladder matrix) and is identical to the particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1