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510(k) Data Aggregation

    K Number
    K071783
    Device Name
    VERSAPOD (TM) INSTRUMENT TRAYS
    Manufacturer
    CONTAINMED, INC.
    Date Cleared
    2008-09-09

    (435 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K012105
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTAINMED, INC.

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

    ContainMed, Inc. VersaPod™ Instrument Trays organize, protect, and transport medical instruments during prevacuum steam sterilization and subsequent storage. They do not maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has not been validated for sterilization of instruments that are porous or have lumens.

    Prevacuum Steam Cycle Parameters: 132°C, 4 minutes Drying: 45 minutes

    Device Description

    ContainMed VersaPod™ Instrument Trays consist of an anodized aluminum base with handles and latches and an anodized aluminum cover. Bases have the following external dimensions: 510mm (length) x 250mm (width) x 40mm. 60mm, or 82mm (depth). An optional anodized aluminum insert trav is available for use with the 82mm deep base only. Bases, covers, and insert trays are highly perforated to facilitate steam sterilant penetration. Anodized aluminum placard, and silicone rubber mat and instrument holding accessories (with stainless steel mounting hardware), are available to identify, organize, and protect the contents during use.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (ContainMed, Inc. VersaPod™ Instrument Trays) and an FDA clearance letter. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML-based medical devices.

    The document is for a physical medical device (sterilization trays), not an AI/ML-driven diagnostic or analytical tool. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC study," "standalone performance," or "training set" as they relate to AI/ML device validation are not applicable to this submission.

    Thus, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or AI-related study details because this information is not present in the provided text.

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