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510(k) Data Aggregation

    K Number
    K241278
    Device Name
    ASEPT® Glide Peritoneal Drainage System
    Manufacturer
    PFM Medical, Inc.
    Date Cleared
    2025-01-14

    (253 days)

    Product Code
    PNG
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K221779
    Why did this record match?
    Device Name :

    ASEPT**®** Glide Peritoneal Drainage System

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

    The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.

    The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

    Device Description

    The ASEPT Glide Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Glide Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital. The device is provided sterile.

    The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.

    AI/ML Overview

    The provided text is a 510(k) summary for the ASEPT® Glide Peritoneal Drainage System, a medical device for draining ascites. It focuses on demonstrating substantial equivalence to a predicate device through bench testing and technical comparisons.

    Crucially, this document does not describe a study involving an AI/software device that generates performance metrics (like accuracy, sensitivity, specificity) against acceptance criteria established with expert consensus or ground truth.

    Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance data for an AI/software device. The document explicitly states:

    • "No clinical tests were required to confirm the safety and effectiveness of the subject device." (Page 7, Section IX)
    • The performance data section (Page 7, Section VIII) refers to "Bench testing" for the catheter and valve, and "Biocompatibility" and "sterilization process" validation, not AI model performance.

    The device is a physical medical device (Peritoneal Drainage System), not an AI/software as a medical device (SaMD).

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