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510(k) Data Aggregation

    K Number
    K033317
    Device Name
    SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
    Manufacturer
    OPUS MEDICAL, INC.
    Date Cleared
    2003-12-30

    (76 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-

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

    The Opus SmartStitch M-Connector is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.
    The Opus SmartStitch Needle Cassette is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Opus Medical, Inc. regarding their Reuseable SmartStitch M-Connector and SmartStitch Needle Cassette. This document confirms the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory requirements.

    However, the document DOES NOT contain information regarding: acceptance criteria, device performance, details of any studies (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information from the given input.

    To answer your request, I would need a document that describes the design verification and validation testing performed for the device, including acceptance criteria and study results.

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