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510(k) Data Aggregation

    K Number
    K021591
    Device Name
    PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Date Cleared
    2002-05-22

    (7 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K965181,K972518,K993266,K003925
    Predicate For
    K043538,K113289,K151638,K210838,K214025
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

    Device Description

    The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller for PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10 and 14, depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.

    AI/ML Overview

    The provided document describes a medical device, the PROWLER® SELECT™ Infusion Catheter, and its safety and effectiveness summary for a 510(k) submission. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

    The document discusses "Design verification testing" for the PROWLER® SELECT™ PLUS Infusion Catheters. This type of testing is standard for medical devices like catheters to ensure physical characteristics and performance align with design specifications. The tests listed are entirely related to the physical properties and functionality of the catheter itself, not to an algorithm's performance.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the provided text. The document is for a physical medical device, not an AI or algorithmic device.

    However, I can extract the information about the device verification testing that was performed for this specific catheter system:

    Summary of Device Verification Testing (Not AI-related Acceptance Criteria)

    Acceptance Criteria (Measured Performance)Reported Device Performance (as stated in document)
    Outer Diameter Dimension Inspection (pre-coating)Performed as intended
    Visual InspectionPerformed as intended
    Flexible Coil Length Inspection/Distal Zone Length InspectionPerformed as intended
    Lateral StiffnessPerformed as intended
    TrackabilityPerformed as intended
    Joint Pull TestPerformed as intended
    Static Burst TestingPerformed as intended
    BiocompatibilityAll materials used are biocompatible

    Regarding the other requested points (for an AI/algorithmic device):

    The provided text does not contain any of the following information because it pertains to a physical medical device (catheter) and not an AI or algorithmic system:

    • Sample size used for the test set and data provenance
    • Number of experts used to establish ground truth for the test set and their qualifications
    • Adjudication method for the test set
    • Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
    • Standalone (algorithm only) performance
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established
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