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510(k) Data Aggregation

    K Number
    K110479
    Device Name
    ACUITY WHISPER VIEW GUIDE WIRES
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2011-04-08

    (49 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061453,K090554
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Boston Scientific ACUITY WHISPER VIEW™ Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature.

    Device Description

    The ACUITY Whisper View guide wire family comprises three individual guide wires with different support profiles: Extra Support (ES), Distal Support (DS), and Extra Distal Support (EDS). The guide wires have a nominal diameter of 0.014 inches (0.36 mm) and a length of 190 centimeters, and are available with a straight distal tip that is shapeable or a preformed coronary sinus (CS) J-shaped tip. The guide wire is coated with a hydrophilic coating for increased lubricity.

    The ACUITY Whisper View guide wires are available in the following models, rail supports, and tip shapes:
    Model 4640, Extra Support (ES), Straight
    Model 4641, Extra Support (ES), CS-J
    Model 4642, Distal Support (DS), Straight
    Model 4643, Distal Support (DS), CS-J
    Model 4647, Extra Distal Support (EDS), Straight
    Model 4648, Extra Distal Support (EDS), CS-J

    AI/ML Overview

    Here's an analysis of the provided text regarding the ACUITY Whisper View™ Guide Wires, focusing on acceptance criteria and supporting studies:

    This document is a 510(k) Summary and the FDA's acceptance letter for the Boston Scientific ACUITY Whisper View™ Guide Wires. It outlines a comparison to predicate devices, and the testing conducted is primarily for demonstrating substantial equivalence rather than establishing formal acceptance criteria for a novel device. As such, the "acceptance criteria" here are implicitly related to meeting the performance characteristics of the predicate device.

    Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds. Instead, it describes the new device's performance in relation to its predicate device. The underlying acceptance criterion for a 510(k) submission is that the new device performs at least as well as, or equivalently to, the legally marketed predicate device for its intended use.

    Here's an interpretation of the performance criteria and how the device met them, based on the text:

    Acceptance Criteria (Implied from Predicate Comparison)Reported Device Performance (Summary)
    Intended Use: Facilitate LV lead placement.The ACUITY Whisper View guide wire has the same intended use as the predicate (Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature).
    Technological Characteristics:Inherently substantially equivalent to the predicate.
    - Stainless steel core wireUses a stainless steel core wire.
    - Same lengths, support, and shape optionsOffers the same lengths, guide wire support, and shape options (Extra Support (ES), Distal Support (DS), Extra Distal Support (EDS); Straight or CS-J tip).
    - Radiopaque distal end for fluoroscopyDistal end is radiopaque and can be seen under fluoroscopy for device placement.
    - Highly lubricious for smooth deliveryDescribed as "highly lubricious for smooth delivery of therapeutic devices."
    - Biocompatibility"Biocompatibility ... testing were also completed," implying satisfactory results.
    - Packaging/Shelf Life"packaging/shelf life ... testing were also completed," implying satisfactory results.
    - Sterility"sterility testing were also completed," implying satisfactory results.
    Mechanical Performance: (e.g., tensile strength,"Design verification testing, including mechanical bench testing... were conducted to verify that the performance of the ACUITY Whisper View guide wires are substantially equivalent to the predicate devices."
    "Test results confirm that Boston Scientific ACUITY Whisper View guide wires meet all of the minimum requirements and are adequate for their intended use." (This indicates performance was equivalent or better).
    torque, flexibility, etc. - implied tests )
    Animal Testing Performance: (to simulate in-vivo"design validation animal testing... were conducted to verify that the performance of the ACUITY Whisper View guide wires are substantially equivalent to the predicate devices."
    use)

    Study Information

    1. Sample Size Used for the Test Set and Data Provenance:

      • The document does not specify the exact sample sizes for the mechanical bench testing or animal testing. It only states that these tests were "conducted."
      • The data provenance is not mentioned (e.g., country of origin). The testing was "non-clinical," implying laboratory and animal studies, not human patient data.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

      • This is not applicable as the studies described are non-clinical (bench and animal testing). The "ground truth" for these types of tests would be established by engineering specifications, predicate device performance, and observed animal physiological responses, rather than expert interpretation of images or patient outcomes.

    3. Adjudication Method for the Test Set:

      • Not applicable for non-clinical bench and animal testing.

    4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

      • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Test Summary: Clinical evaluation was not required." This indicates that human reader performance or AI-assisted performance in a clinical setting was not assessed.

    5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • This is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system.

    6. The Type of Ground Truth Used:

      • For the mechanical bench testing, the ground truth would be based on engineering specifications, material properties, and the performance characteristics of the predicate device.
      • For the animal testing, the ground truth would be based on physiological observations, device navigability, and any tissue reactions within the animal model, compared to expected performance and predicate device behavior.

    7. Sample Size for the Training Set:

      • This is not applicable as the device is a physical medical device. There is no AI algorithm being trained.

    8. How the Ground Truth for the Training Set was Established:

      • Not applicable as there is no training set for an AI algorithm.
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