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510(k) Data Aggregation

    K Number
    K192625
    Device Name
    PG Pro Microcatheter
    Manufacturer
    MicroVention, Inc., A Terumo Group Company
    Date Cleared
    2019-11-21

    (59 days)

    Product Code
    DQY,KRA
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K101542,K142449
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroVention, Inc., A Terumo Group Company

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

    The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

    Device Description

    The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for the "PG Pro Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria for an AI/ML type of medical device through a clinical study.

    Therefore, the text does not contain the information requested regarding:

    1. A table of acceptance criteria and reported device performance for an AI/ML device.
    2. Sample size and data provenance for a test set.
    3. Number of experts and their qualifications for ground truth establishment.
    4. Adjudication method for a test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance of an algorithm.
    7. Type of ground truth used (expert consensus, pathology, outcomes data).
    8. Sample size for a training set.
    9. How ground truth for the training set was established.

    Instead, the document describes:

    • Device Description: The PG Pro Microcatheter is a single lumen catheter designed for introducing over a guidewire to access small, tortuous vasculature for infusing diagnostic and therapeutic agents in the peripheral vasculature.
    • Predicate Device: Headway 27 Microcatheter (K142449). A reference device (Headway 17 Microcatheter, K101542) is also listed.
    • Comparisons: The document includes a detailed "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" (Table 1) comparing the PG Pro Microcatheter to its predicate and reference devices across properties like Indications For Use, Principle of Operation, Material(s), Proximal ID/OD, Distal ID/OD, Number of Marker bands, Coating, Effective Length, Tip Configuration, Guidewire Compatibility, Method of Supply, and Accessories. The table highlights differences such as the PG Pro being intended only for peripheral vasculature, using a Tungsten coil vs. stainless steel, having a different range of effective lengths, being straight configuration only, being compatible with larger guidewires, and not including a shaping mandrel.
    • Performance Data (Non-Clinical):
      • Biocompatibility testing: Conducted according to ISO10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility, as it is considered a limited (
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