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510(k) Data Aggregation

    K Number
    K971124
    Device Name
    TM MICRO-CATHETERS
    Manufacturer
    XOMED, INC.
    Date Cleared
    1997-05-16

    (50 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K820453,K810461,K844061
    Why did this record match?
    Reference Devices :

    K820453, K810461

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

    The TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.

    Device Description

    The TM Micro-Catheters are formed of silicone elastomer tubing. Connected to the tubing at the proximal end is an injection port. The TM Micro-Catheter w/ Flange (In-dwelling style) has a small distal flange end for retention in the eardrum. The TM Micro-Catheter w/o Flange has a distal end with a bevel.

    AI/ML Overview

    This document describes a medical device, the "TM Micro-Catheter," and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a performance study or AI/ML model.

    This 510(k) summary is for a traditional medical device, not a software or AI/ML-driven device. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. Therefore, the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this document.

    The document primarily discusses:

    • Device Name: TM Micro-Catheter
    • Device Description: Formed of silicone elastomer tubing with an injection port. Two styles: with flange (for retention) and without flange (with a bevel).
    • Intended Use:
      • With Flange: Temporary (less than 29 days) indwelling catheter for fluid delivery in ear disorder treatment.
      • Without Flange: Immediate (up to 4 hours) fluid delivery into the middle ear for ear disorder treatment.
    • Substantial Equivalence: Claims equivalence to the Microtek Irrigation system (K844061) for intended use, and to tympanostomy tubes and butterfly catheters (K820453 or K810461) for technological characteristics, stating no new safety or effectiveness issues are raised.

    To answer your prompt with the provided input, I would have to state that the information you're asking for is not present in the given text.

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