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510(k) Data Aggregation

    K Number
    K030824
    Device Name
    LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
    Manufacturer
    HAKKO MEDICAL CO., LTD.
    Date Cleared
    2003-06-04

    (82 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K010870,K020307
    Predicate For
    K070198
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological, gynecologic and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

    Device Description

    The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber membrane. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shapememory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.

    AI/ML Overview

    This submission, K030824, is for a medical device (LAP DISC Hand Access Device), not an AI/ML device. Therefore, the concepts of acceptance criteria, study data, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone algorithm) typically associated with AI/ML device evaluations are not applicable in this context.

    The 510(k) summary provided indicates that this submission is for a device identical in technological characteristics to a previously cleared predicate device (K010870 and K020307), with the only differences being an expanded intended use statement and the addition of a measuring tape accessory.

    The FDA's review for this type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. There is no mention of a study to prove acceptance criteria in the provided text because it is not relevant for this type of device submission.

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