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510(k) Data Aggregation

    K Number
    K040683
    Device Name
    BIODERM SCIENCES WOUND DRESSING
    Manufacturer
    BIODERM SCIENCES, INC.
    Date Cleared
    2004-06-04

    (80 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K993969,K972185,K941999
    Why did this record match?
    Device Name :

    BIODERM SCIENCES WOUND DRESSING

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

    BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and fullthickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

    BioDerm Wound Solution can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.

    Device Description

    Bio Derm Wound Solution is an acidic zinc-saline wet dressing for external wound management. It provides an acidic, moist environment that aids the body in the healing process. The non-toxic nature of the solution allow it to be used in the mouth, eyes and on mucous membranes as well as on the skin.

    BioDerm Wound Solution is supplied sterile in 50 ml injection bottles with Teflon septums. The solution is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tab which must be removed to get the syringe through the septum. The pull-tab supplies whether the bottle has been opened or not. The contents must be used within five days after opening.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary for the BioDerm Wound Solution, focusing on acceptance criteria and supporting studies:

    Acceptance Criteria and Device Performance for BioDerm Wound Solution

    Based on the provided K040683 510(k) summary, the device is a wound cleanser and wet dressing. The acceptance criteria are primarily focused on the compositional range compared to legally marketed predicate devices, and its performance as an aid to wound healing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    P-Value (chemical composition): Within the range of essential chemical components of predicate devices (acidic saline solutions with a pH ≤ 7, potentially with metallic salts or other additives). Predicate devices identified: Saljet Single Dose Sterile Saline Topical Solution (K993969), 20 ml Normal Saline Topical Solution, 0.9% w/v Sodium Chloride (K972185), Hypertonic saline wet dressing - sterile (K941999)."BioDerm Wound Solution is within the range of essential chemical components of the predicate devices." (See Table 1 - Note: Table 1 itself is not included in the provided text, but the statement confirms compliance). This implies the device's composition (acidic zinc-saline) falls within the accepted range of other cleared saline-based wound dressings.
    Performance (clinical efficacy/safety): Safe and effective as a wound cleanser and wet dressing when used as directed, aiding in the healing of incision, grafts, burns, partial and full-thickness wounds."A study of various formulations... performed at the University of Miami... using a porcine model evaluated BioDerm Wound Solution as an aid to healing of incision, grafts, burns, partial and full-thickness wounds." The conclusion states: "When used as directed, BioDerm Wound Solution is safe and effective as a wound cleanser or wet dressing." (Appendices B-E are referenced but not provided).
    Sterility: Supplied sterile."BioDerm Wound Solution is supplied sterile."
    Intended Use: To cleanse, irrigate, and externally manage dermal lesions (lacerations, post-operative wounds, grafts, partial and full-thickness wounds, burns, ulcers) in conjunction with a sterile dressing.The "Indications for Use" section explicitly states this intended use.

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

    • Sample Size: The document mentions "a porcine model" for performance testing. However, it does not specify the sample size (number of animals or wounds) used in this study.
    • Data Provenance: The study was conducted at the "University of Miami (Department of Dermatology & Cutaneous Surgery)." The data provenance is pre-clinical (animal model) rather than human clinical data. It is prospective in nature, as it describes a planned evaluation of various formulations. The country of origin is the USA.

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

    • The document does not specify the number of experts or their qualifications.
    • Given it's a porcine model, the "ground truth" would likely be established by veterinarians, histopathologists, or dermatologists experienced in animal models of wound healing, who would assess wound progression, histological changes, and healing metrics. However, this information is not provided.

    4. Adjudication Method for the Test Set

    • The document does not describe any adjudication method for the test set. For animal studies, this is less common than for human clinical trials or image-based diagnostic studies. Outcomes would typically be assessed by the research team involved in the study.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

    • No, an MRMC comparative effectiveness study was not done. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No, a standalone algorithm performance study was not done. This device is a physical product (liquid solution), not an algorithm.

    7. The Type of Ground Truth Used

    • The type of ground truth used for the performance study was based on observations and measurements of wound healing in a porcine model. This would likely include:
      • Clinical assessment: Visual inspection of wound size reduction, re-epithelialization, inflammation, etc.
      • Histopathology: Microscopic examination of tissue samples from the wounds to assess new tissue formation, collagen deposition, cellular infiltration, and other healing markers.
      • Potentially other objective measurements: Such as wound tensile strength or biochemical markers, although not explicitly stated.

    8. The Sample Size for the Training Set

    • Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "various formulations" evaluated in the study could be considered analogous to different experimental groups, but not a training set for an algorithm.

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

    • Not applicable. As stated above, there is no training set for this type of device.
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