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    K Number
    K130851
    Device Name
    CASCADE HEMODIALYSIS/APHERESIS CATHETER
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2014-01-09

    (288 days)

    Product Code
    MSD,REG
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K113487
    Predicate For
    K241581
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CASCADE™ Hemodialysis/Apheresis Catheter is intended for use in attaining long-term vascular access for Hemodialysis therapy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein, as required.

    Indications For Use:

    • The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining . Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis.
    • It may be inserted percutaneously and is primarily placed in the internal jugular vein ● of an adult patient.
    • Alternate insertion sites include subclavian vein as required. .
    • Catheters greater than 40 cm are intended for femoral vein insertion. .
    • . The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.
    Device Description

    The CASCADE™ Hemodialysis/Apheresis Catheter is a family of percutaneously inserted catheters designed to perform Hemodialysis therapy and Apheresis. The catheters are manufactured from medical grade radiopaque silicone material, which provides increased patient comfort while offering excellent biocompatibility. The CASCADE™ Hemodialysis/Apheresis Catheter Kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

    The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for dwell times greater than 30 days. The CASCADE™ Hemodialysis/Apheresis Catheter product line has catheters in 12.5 Fr dual lumen sizes. Catheters range from approximately 13 - 55 cm long and are offered in straight or curved catheter configurations with cuffs for long-term implantation. The catheters are attached to an injection-molded silicone hub that has a suture wing and extension legs with Luer lock fittings for access attachment.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the CASCADE™ Hemodialysis/Apheresis Catheter. This document focuses on demonstrating substantial equivalence to a predicate device for this medical device. It does not contain information about an AI/algorithm-driven device, nor does it detail a study proving the device meets acceptance criteria related to AI performance, human reader improvement with AI, or standalone AI performance.

    Therefore, I cannot fulfill most of your request regarding AI-specific criteria and studies.

    However, I can extract information related to the device itself and its regulatory approval process, which includes mentions of acceptance criteria as they relate to the substantial equivalence determination for a medical device.

    Here's what I can provide based on the given text:

    Acceptance Criteria and Device Performance (as related to substantial equivalence for a medical device, not AI):

    Acceptance Criteria (General)Reported Device Performance
    Safety and Effectiveness for Intended Use"The CASCADE™ Hemodialysis/Apheresis Catheter met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is safe and effective for its intended use..." (Page 4)
    Substantial Equivalence to Predicate Device (Medcomp Hemo-Cath® K113487)"Performance data gathered in design verification testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is substantially equivalent to the noted predicate device." (Page 4) "The CASCADE™ Hemodialysis/Apheresis Catheter met all established acceptance criteria... and based on FDA's decision tree is substantially equivalent to the following predicate device: Medcomp Hemo-Cath (K113487)." (Page 4)
    Compliance with FDA Draft Guidance (Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis)"The FDA's Draft Guidance... was used as a guide to determine the appropriate methods for evaluating the device's performance characteristics." (Page 4) "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards." (Page 4)
    Sterilization Requirements (ISO 11135:2007)Met by the device (Page 4)
    Biocompatibility Requirements (ISO-10993, Part 1)"Test profiles for externally communicating, circulating blood, permanent contact devices will be met." (Page 4)

    The following points cannot be addressed as the provided text is for a physical medical device (catheter) and does not involve AI or algorithms:

    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    • Adjudication method for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
    • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    • The sample size for the training set
    • How the ground truth for the training set was established
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