LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082670
    Device Name
    MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
    Manufacturer
    MEDTRONIC INC.
    Date Cleared
    2008-12-04

    (80 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K031211,K032622
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

    Device Description

    The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm Steerable catheter, one guidewire, one Y-connector with valve, one extension set, 3-way stopcock, one guidewire clip and two guidewire torque tools.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided 510(k) summary for the Medtronic Attain Prevail™ 6228CTH80 Steerable Catheter Set:

    This submission is for a medical device (catheter), not an AI/ML-driven diagnostic or image analysis system. Therefore, many of the typical acceptance criteria and study components related to ML models (like statistical performance metrics, ground truth experts, MRMC studies, or training/test sets) are not applicable in this context. The evaluation focuses on device integrity, biocompatibility, and sterility as compared to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: The provided document does not contain specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device. Instead, acceptance is based on meeting design and performance requirements through various engineering and biological tests, demonstrating substantial equivalence to a predicate device.

    Acceptance Criterion (Type of Test)Reported Device Performance
    Bench TestingThe Attain Prevail™ 6228CTH80 Steerable Catheter Set met all specified design and performance requirements. (Details on specific tests and their outcomes are not provided in this summary but were part of the full 510(k) submission).
    Sterilization ValidationThe device will continue to be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
    Biocompatibility EvaluationThe device is verified to be biocompatible, consistent with ISO 10993-1:2003 ("Biological Evaluation of Medical devices- Part 1: Evaluation and Testing"). Classified as an external communicating device with
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1