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    K Number
    K162316
    Device Name
    Pirouette 014
    Manufacturer
    ArraVasc Ltd
    Date Cleared
    2016-11-22

    (96 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K093139,K151153
    Why did this record match?
    Device Name :

    Pirouette 014

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

    The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.

    Device Description

    The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.

    The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.

    The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.

    AI/ML Overview

    This document describes the Pirouette 014 PTA Catheter, a medical device for balloon dilation of arteries. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. Instead, it describes a conventional medical device (a catheter) and its non-clinical performance testing.

    Therefore, I cannot fulfill the request as it pertains to an AI/ML powered device, an acceptance criteria table, or a study demonstrating AI performance.

    The information given is about:

    • Device Name: Pirouette 014
    • Device Type: Percutaneous Transluminal Angioplasty (PTA) Catheter
    • Intended Use: Balloon dilation of the iliac, femoral, popliteal, infra-popliteal, and renal arteries.
    • Predicate Device: Pirouette 018 OTW PTA Catheter (K151153) and Bantam α PTA Catheter (K093139)
    • Performance Data: Non-clinical bench tests, biocompatibility tests, sterilization, shelf-life, and packaging validation were conducted. No clinical studies were performed. The results from these tests "showed that the Pirouette 014 met the pre-determined acceptance criteria," but the specific acceptance criteria or the reported performance values are not detailed in a quantitative table.

    To answer your prompt for an AI/ML powered device, I would need a different type of document specifically detailing the performance of an AI/ML algorithm.

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