LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101671
    Device Name
    SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2010-06-25

    (11 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K010007
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

    Device Description

    The Single-Site™ Flexible Bladeless Obturator is a sterile, single-use 5mm diameter X 304 mm length dilating obturator that is used in conjunction with a 5mm Curved Cannula. The Obturator has a cap at the proximal end that locks onto the Curved Cannula rim. The Curved Cannula is designed by Intuitive Surgical, Inc. (ISI) for use with their DaVinci SI robot model.

    AI/ML Overview

    This 510(k) summary (K101671) describes a medical device, the Single-Site™ Flexible Bladeless Obturator, but it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic or AI-driven aid would.

    This document is a premarket notification for a Class II surgical instrument, a device with a known mechanism of action that relies on mechanical performance rather than diagnostic accuracy. The "performance data" section is very brief and focuses on basic functional compatibility rather than a complex performance study with a test set, ground truth, or expert review.

    Therefore, the requested information elements related to diagnostic performance (e.g., sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable and not present in the provided text.

    Here's a breakdown of what is available and why other sections are not applicable:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not Explicitly Stated as Numerical CriteriaFunctional Compatibility: The proposed Single-Site™ Flexible Bladeless Obturator is inserted and removed from the Curved Cannula without any evidence of material degradation. (K. Performance Data)
    Overall Conclusion/OutcomeThe test results demonstrate the proposed Single-Site™ Flexible Bladeless Obturator is compatible with the ISI Curved Cannula. The changes made to the proposed Single-Site™ Flexible Bladeless Obturator do not introduce any new issues of safety and effectiveness. (L. Conclusion)

    Explanation: The document does not provide specific numerical acceptance criteria (e.g., >90% success rate,

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1