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510(k) Data Aggregation

    K Number
    K091488
    Device Name
    FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-14

    (118 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C

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

    This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.

    Device Description

    Peripherally Inserted Central Catheter

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter. It is not an AI/ML device, and therefore the requested information about acceptance criteria and study details related to AI/ML performance is not present in the document.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than meeting specific performance criteria demonstrated by a clinical study in the context of AI/ML.

    Therefore, I cannot provide the requested information.

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