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510(k) Data Aggregation

    K Number
    K202330
    Device Name
    Impella XR Sheath Set
    Manufacturer
    Abiomed Inc.
    Date Cleared
    2020-12-07

    (112 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K780532,K180785
    Why did this record match?
    Device Name :

    Impella XR Sheath Set

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

    INTENDED USE:

    The Impella XR Sheath Set is intended to facilitate femoral access to the vascular system.

    INDICATIONS FOR USE:

    The Impella XR Sheath Set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.

    Device Description

    The Impella XR Sheath Set is a sterile, single-use, prescription device. The Impella XR Sheath Set consists of an introducer sheath (Impella XR Introducer Sheath) and a tapered sheath dilator (Impella XR Dilator) which is compatible with a 0.035" guidewire. The Impella XR Sheath Set is kitted with a 0.035" access quidewire and a supplemental dilator in the Impella XR Sheath Kit for convenience to help facilitate insertion.

    The Impella XR Introducer Sheath consists of a sheath hub with a three-way stop cock and flush port at its proximal end and an expandable sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stop cock and flush port, a butterfly (suture pad), and connects with the dilator hub. The sheath body has an insertion profile of 10 Fr and expands after removal of the dilator to allow the insertion of the Impella 2.5 catheter. The sheath body also features a hydrophobic coating to aid in the insertion of the introducer sheath.

    The Impella XR Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub.

    AI/ML Overview

    The provided document describes the Impella XR Sheath Set, a medical device for introducing catheters, and its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and study details typical of an AI/ML medical device submission. Specifically, it does not include:

    • A table of acceptance criteria with reported device performance for an AI/ML algorithm.
    • Sample sizes for test sets, data provenance, or details about ground truth establishment by experts for AI/ML performance evaluation.
    • Information on MRMC comparative effectiveness studies or standalone AI algorithm performance.
    • Details regarding training set size or how ground truth was established for a training set (which are relevant to AI/ML devices).

    The document is for a traditional catheter introducer device, and the performance testing mentioned (Visual Inspection, Dimensional Verification, Packaging, Sterilization, Shelf Life, Biocompatibility, and a GLP animal study) relates to the physical and biological characteristics of this type of hardware, not to an AI/ML algorithm's diagnostic or predictive performance.

    Therefore, I cannot provide the requested information for an AI/ML device based on the given text.

    If this were an AI/ML device submission, the requested information would typically be found in dedicated sections describing the clinical validation study, often including sensitivity, specificity, AUC, and other performance metrics against established acceptance criteria, along with detailed methodologies for data collection, expert review, and ground truth generation.

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