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510(k) Data Aggregation

    K Number
    K133023
    Device Name
    JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2014-08-27

    (335 days)

    Product Code
    MCW,QEW
    Regulation Number
    870.4875
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K122916,K120242,K111229,K110626,K101334,K101221,K093456,K092332,K091509,K082186,K081328,K130637
    Why did this record match?
    Reference Devices :

    K122916, K120242, K111229, K110626, K101334, K101221, K093456, K092332, K091509, K082186, K081328

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

    The JETSTREAM System is intended for use in atherectomy of the the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotic, iliac or renal vasculature.

    Device Description

    The JETSTREAM Systems are rotational atherectomy catheter systems designed with either a fixed (JETSTREAM SC 1.85, JETSTREAM SC 1.6) or an expandable (JETSTREAM XC 2.4/3.4, JETSTREAM XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

    The JETSTREAM Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

    • . JETSTREAM Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the identical JETSTREAM Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
    • PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

    The purpose of this 510(k) is to add atherectomy lubricant as an optional procedure supply listed within the Instructions for Use (IFU). This modification applies to the entire family of JETSTREAM Systems.

    AI/ML Overview

    The provided text is a 510(k) summary for the JETSTREAM Systems (various models of atherectomy catheters). It describes the device, its intended use, and comparative testing to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that uses acceptance criteria for an AI/ML device.

    The document makes no mention of AI or machine learning. It describes a medical device (atherectomy catheter) and the engineering and biocompatibility tests performed on it.

    Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving an AI/ML device meets them, as this information is not present in the provided text.

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