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510(k) Data Aggregation

    K Number
    K962218
    Device Name
    CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
    Manufacturer
    CARRINGTON LABORATORIES, INC.
    Date Cleared
    1996-09-12

    (94 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K915001,K925002,K944427,K902345
    Why did this record match?
    Device Name :

    CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG

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

    Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

    Device Description

    Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CARRINGTO device (Carrasyn® Hydrogel Wound Dressing):

    It's important to note that the provided text is a 510(k) Premarket Notification summary from 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) or for novel high-risk devices today. Therefore, the "studies" described are more akin to pilot or observational studies rather than rigorous, controlled clinical trials.

    Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state quantifiable acceptance criteria (e.g., "device must achieve 80% sensitivity for X condition" or "wound healing rate must be Y%"). Instead, it describes general findings regarding acceptability and effectiveness.

    Acceptance Criteria (Inferred)Reported Device Performance
    Biocompatibility: Minimal irritation (dermal/ocular)"Carrasyn® wound dressings are not primary dermal irritants or primary eye irritants." (Based on Primary Dermal Irritation testing and Primary Eye Irritation testing)
    Clinical Acceptability (Patient/Clinician): Well-received"These studies evaluated the acceptability of Carrasyn® Hydrogel Wound Dressing to both the patients and clinicians..." (Implicitly, the conclusion of "safe and effective" suggests good acceptability.)
    Effect on Wound/Skin Appearance: Positive impact"...to wound and skin appearance..." (Implicitly, the conclusion of "safe and effective" suggests a positive impact.)
    Effect on Wound Healing Environment: Favorable conditions"...and to the wound healing environment." (Implicitly, the conclusion of "safe and effective" suggests a favorable impact.)
    Overall Safety and Effectiveness for Intended Use:"These studies concluded that Carrasyn® wound dressings are safe and effective for their intended use." (This is the overarching conclusion, encompassing the above points for radiation dermatitis and diabetic ulcers.)

    Study Details

    Given the context of a 1998 510(k) for a wound dressing, the "studies" mentioned are quite limited compared to modern standards for AI/medical device performance evaluation.

    1. Sample size used for the test set and the data provenance:

      • Test Set Sample Size: 4 patients with radiation dermatitis and 30 patients with diabetic ulcers. (Total: 34 patients).
      • Data Provenance: The text does not specify the country of origin. It describes "clinical experience to date" and "these studies," implying they were conducted by or for Carrington Laboratories. It refers to these as "two studies." Given the context, these are prospective observational studies or case series, not randomized controlled trials.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The text does not specify the number of experts or their qualifications for establishing ground truth in clinical outcomes. It implies a clinical assessment was made, likely by the treating clinicians ("clinicians" are mentioned in evaluating acceptability).

    3. Adjudication method for the test set:

      • Not specified. The text does not describe any formal adjudication process for clinical outcomes.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

      • No. This type of study is entirely irrelevant for a hydrogel wound dressing undergoing a 510(k) submission in 1998. MRMC studies are typically for diagnostic imaging interpretation devices involving multiple readers.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • No. This is a physical wound dressing, not an AI algorithm.

    6. The type of ground truth used:

      • Clinical observation and assessment: For the clinical studies, the "ground truth" was based on clinical assessment of wound healing, skin appearance, wound environment, and patient/clinician acceptability over time by treating medical personnel. For the biocompatibility studies, the ground truth was based on the results of standardized animal model tests (e.g., observing for irritation).

    7. The sample size for the training set:

      • Not applicable. This device is a physical hydrogel wound dressing, not an AI model requiring a training set. The "clinical experience" described is a small pilot/observational evaluation rather than a dataset to train an algorithm.

    8. How the ground truth for the training set was established:

      • Not applicable. See point 7.
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