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510(k) Data Aggregation

    K Number
    K981150
    Device Name
    SOLOSITE GEL CONFORMABLE DRESSING
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    1998-06-22

    (83 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K935096,K962218,K933495
    Why did this record match?
    Reference Devices :

    K935096, K962218, K933495

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

    SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:

    • Minor burns
    • Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears
      Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:
    • Venous ulcers (leg ulcers)
    • Surgical incisions
    • Diabetic foot ulcers
    • Pressure ulcers (including stage IV).
      Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.
    Device Description

    SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.
    The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.
    Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called SoloSite® Gel Conformable Dressing. It focuses on demonstrating substantial equivalence to previously marketed devices and biocompatibility testing, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a comparative effectiveness study is not present in this document.

    However, I can extract the information that is available and clarify what is not.

    Acceptance Criteria and Study Information for SoloSite® Gel Conformable Dressing

    1. A table of acceptance criteria and the reported device performance

    No explicit acceptance criteria with numerical targets for clinical performance are presented in this 510(k) summary. The document primarily focuses on demonstrating the device's biocompatibility and substantial equivalence to predicate devices. The "performance" reported relates to the results of biocompatibility tests, indicating the device meets safety standards.

    Acceptance Criteria (Implied from testing)Reported Device Performance
    Biocompatibility:
    In vitro cytotoxicity (ISO 10993-5) – No significant cell lysis or toxicity."The test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic and passed this ISO study."
    Primary skin irritation (FHSA Regulations, 16 CFR 1500) – Not a primary irritant (Irritation Index
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