LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122811
    Device Name
    CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
    Manufacturer
    MEDTRONIC INC.
    Date Cleared
    2012-10-12

    (29 days)

    Product Code
    DTL,PRO
    Regulation Number
    870.4290
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K113845
    Why did this record match?
    Device Name :

    CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE

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

    Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

    Device Description

    Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.

    AI/ML Overview

    This K122811 submission is for "Connector Components with Balance Biosurface" intended for use in extracorporeal cardiopulmonary perfusion bypass circuits. This device is a component, specifically tubing connectors, and not an AI/ML powered device. As such, the information requested in the prompt related to acceptance criteria, study details, expert involvement, and AI performance is not typically found in the documentation for such a device. This submission focuses on demonstrating substantial equivalence to a predicate device.

    However, I can extract the relevant information available from the provided document regarding substantial equivalence.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document implicitly uses "substantial equivalence" as the acceptance criterion. The performance is reported in terms of equivalence to the predicate device K113845.

    Acceptance Criteria (Implicit)Reported Device Performance (Comparison to Predicate K113845)
    Demonstrate substantial equivalence in design, test results, and indications for use to a legally marketed predicate device.The Medtronic Connector Components with Balance Biosurface have the same: Intended Use, Technological characteristics, Operating principle, Design features, Performance, Biological safety, Base materials prior to coating, Coating materials, Packaging materials and configurations, Method of sterilization and sterility assurance level, Shelf life.
    Fundamental scientific principle, labeling, and intended use are unchanged from the predicate device.The fundamental scientific principle, labeling and intended use are unchanged from the predicate device.

    2. Sample size used for the test set and the data provenance:

    • Not applicable for an AI/ML device. This document does not detail a "test set" in the context of AI/ML evaluation. The safety and effectiveness are established through comparative testing and material characterization against the predicate. The document doesn't specify the sample sizes for these comparative tests (e.g., for biological safety, material properties, or performance tests).

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable for an AI/ML device. This information is for AI/ML performance evaluation and is not relevant to this device's regulatory submission.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable for an AI/ML device. This is relevant for AI/ML performance evaluation and is not detailed for this type of device.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable for an AI/ML device. This is for AI/ML performance evaluation and is not relevant to this device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable for an AI/ML device. This is for AI/ML performance evaluation and is not relevant to this device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable for an AI/ML device. The "ground truth" for this device's submission is effectively the established performance and safety profile of the predicate device (K113845), as well as compliance with recognized standards for material properties and biological safety.

    8. The sample size for the training set:

    • Not applicable for an AI/ML device. This device does not involve a training set as it is not an AI/ML product.

    9. How the ground truth for the training set was established:

    • Not applicable for an AI/ML device. This device does not involve a training set.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1