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510(k) Data Aggregation

    K Number
    K122325
    Device Name
    SKINTEMP II
    Manufacturer
    HUMAN BIOSCIENCES, INC.
    Date Cleared
    2012-10-26

    (86 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K913023,K925545
    Why did this record match?
    Device Name :

    SKINTEMP II

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

    The device is intended for the management of burns, sores, blisters, scrapes, ulcers, and other wounds.

    Device Description

    Skin Temp. H. Dressing is a sterile, disposable, single use wound dressing. It is a hydrocolloid and hydrophillic dressing composed of fibrous type I bovine collagen. The device is to be provided in hydrated as well as dry form. The device is to be used for the management of burns, blisters, sores, scrapes, ulcers and other wounds. The Skin.Temp. II. Dressing will be available in 2"X2", 3"X4" and 8"X12" sizes and additional sizes may introduced at a later time.

    AI/ML Overview

    This submission details the SkinTemp II Dressing, a collagen-based wound dressing, as substantially equivalent to the predicate device, BioCore SkinTemp sheet. The core of the submission revolves around demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical testing.

    Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a formal table of "acceptance criteria" with quantitative performance metrics for the SkinTemp II Dressing. Instead, it relies on demonstrating substantial equivalence to a predicate device. The acceptance is implied by meeting or being analogous to the predicate device's characteristics and performance.

    However, based on the non-clinical testing and comparison to the predicate, we can infer some "performance criteria" that the SkinTemp II Dressing met:

    Accepted Performance Criteria CategoryTarget (Analogous to Predicate)SkinTemp II Dressing Performance
    Intended Use/IndicationsManagement of burns, sores, blisters, scrapes, ulcers, and other wounds.Identical: "The HBS SkinTemp II Dressing is indicated for the management of burns, sores, blisters, scrapes, ulcers, and other wounds." (Page 2, Table 7.1)
    Principles of UseCleanse wound, apply medication if needed, apply dressing, cover with non-adherent dressing, change as required.Identical: "Cleanse the wound. Apply medication if needed. Apply dressing and cover with non-adherent dressing. Change as required." (Page 2, Table 7.1)
    Scientific Technology100% type I bovine collagen as primary constituent.Identical: "The SkinTemp II Dressing uses 100% type I bovine collagen as its primary constituent." (Page 2, Table 7.1)
    Configuration / System ComponentsSterile, disposable, single use, collagen-based wound dressing with non-adherent backing. Hydrocolloid, absorbent, gel formation.Identical: "Sterile, disposable, single use, collagen based wound dressing with non adherent backing. Further properties include: a) Hydrocolloid b) Absorbent Dressing c) Gel formation" (Page 2, Table 7.1)
    Sterility MethodElectron Beam Sterilization.Identical: "Each dressing is sterilized using Electron Beam Sterilization." (Page 2, Table 7.1) Validated per AAMI TIR-27 and ISO 11137-1:2006. (Page 4-5)
    MaterialsType I Bovine Collagen, Distilled Water, Buffering Agent (Chemical Z).Identical: "Type I Bovine Collagen, Distilled Water, Buffering agent / Chemical Z (proprietary name)" (Page 2, Table 7.1). The inclusion of Chemical Z was the specific reason for this new 510(k) submission to formally document an ingredient that was previously used but not formally documented in the predicate's 510(k). (Page 5)
    BiocompatibilityMeet all biocompatibility testing requirements.Confirmed: "Testing has confirmed that SkinTemp II Dressing meets all biocompatibility testing requirements stated by FDA regulations and ISO 10993." (Page 4) Performed by North American Science Association, Inc. (NAmSA).
    Sterilization AssuranceValidated sterilization process.Confirmed: Sterilized per AAMI TIR-27, validated, and routine control created in accordance with ISO 11137-1:2006. (Page 4-5)
    Physical RequirementsGeneral Physical Requirements, Dimensional Analysis, Visual Inspections, Moisture Content testing, Package and Labeling requirements, Operational Environment Requirements.Confirmed: Design verification testing via functional testing detailed in Section 20.2 (not provided in the excerpt). This included General Physical Requirements, Dimensional Analysis (e.g., 2" ± 0.25" x 2" ± 0.25",
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