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510(k) Data Aggregation

    K Number
    K982688
    Device Name
    SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-10-13

    (71 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK

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

    The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.

    Device Description

    The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.

    AI/ML Overview

    This document is a 510(k) summary for the "Spectrum Designs Pre-Form Contour Silicone Carving Block Implant." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through clinical or performance studies in the way you've outlined. This document primarily details:

    • Submitter's Data: Company contact information.
    • Device Name, Classification: "Spectrum Designs Pre-Form Contour Silicone Carving Block," Class II, FDA Code MIB.
    • Substantially Equivalent Devices: Lists similar silicone block implants.
    • Device Description: Fabricated from solid silicone elastomer with a pre-formed, rounded shape.
    • Indications for Use: To be used where a shaped, cut-to-fit implant is desired for augmenting or reconstructing cartilaginous tissue, soft tissue, and bone.
    • Contraindications for Use: Presence of infection.
    • Warnings, Precautions: Potential complications such as displacement, errors in positioning, tissue necrosis, bone resorption, fibrous tissue encapsulation, infection, neural damage, hematoma, poor wound healing, and patient intolerance.

    The FDA's response letter (pages 1 and 2 of the provided text) confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information provided in the 510(k) submission, not on a performance study against specific acceptance criteria.

    Therefore, I cannot provide the requested table or information about acceptance criteria, sample sizes, ground truth, or MRMC studies because this document does not contain that type of information.

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