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510(k) Data Aggregation

    K Number
    K050049
    Device Name
    DYNAFLO BYPASS GRAFT
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Date Cleared
    2005-01-31

    (21 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K983861
    Predicate For
    K083169
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dynaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

    Device Description

    The Dynaflo bypass graft has a pre-formed cuff at the distal end to promote good hemodynamic performance at the distal anastomosis. Dynaflo grafts are available in various lengths and diameters, with and without external support.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Dynaflo Bypass Graft. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device meets those criteria in a typical sense for AI/software-as-a-medical-device (SaMD).

    Instead, the "acceptance criteria" here are compliance with recognized standards and guidance documents for vascular prostheses, and the "study" is a series of non-clinical performance tests.

    Here's an interpretation based on the provided text:

    1. Table of Acceptance Criteria and the Reported Device Performance

    Acceptance Criteria (Guidance/Standard/Protocol)Reported Device Performance
    FDA Guidance Document for Vascular Prosthesis 510(k) Submissions, 11/01/2000Conformance was met.
    ANSI/AAMI VP20-1994, Cardiovascular Implants Vascular ProsthesisEvaluated based on this standard.
    ANSI/AAMI/ISO 7198: 1998/2001, Cardiovascular implants - Tubular vascular implantsEvaluated based on this standard.
    AAMI/ANSI/ISO 10993-1: 1997, Biological evaluation of medical devices -- Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test ProfileEvaluated based on this standard.
    AAMI/ANSI/ISO 10993-7: 1995, Biological evaluation of medical devices -- Part 1: Ethylene Oxide Sterilization ResidualsEvaluated based on this standard.
    AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide SterilizationEvaluated based on this standard.
    Predetermined performance criteria of design verification (as specified by applicable standards, guidance's, test protocols, and/or customer inputs)"All test results confirm the modified device to be substantially equivalent to the predicate device."
    "Dynaflo Bypass Grafts met all the predetermined performance criteria of design verification."

    2. Sample Size Used for the Test Set and the Data Provenance

    This document does not specify a "test set" in the context of data for an AI/SaMD. The evaluation for the Dynaflo Bypass Graft was based on non-clinical performance data (e.g., mechanical tests, biocompatibility tests), not a data set of patient images or outcomes.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    Not applicable. This device is a physical medical device (vascular graft), not an AI/SaMD that requires expert ground truth labeling of data.

    4. Adjudication Method for the Test Set

    Not applicable.

    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. This is a physical device, not an AI system.

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

    Not applicable. This is a physical device, not an AI algorithm.

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

    The "ground truth" for this medical device's performance would be derived from:

    • Compliance with established engineering and biocompatibility standards: This includes physical and mechanical properties, material safety, and sterilization effectiveness.
    • Comparison to the predicate device: The fundamental "ground truth" for a 510(k) is that the new device performs as safely and effectively as a legally marketed predicate device.

    8. The Sample Size for the Training Set

    Not applicable. This is a physical device undergoing a 510(k) submission, not an AI model requiring a training set of data.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable.

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