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510(k) Data Aggregation

    K Number
    K981323
    Device Name
    COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    1998-10-09

    (179 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K924308,K885339
    Why did this record match?
    Device Name :

    COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE

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

    The Novartis Nutrition COMPAT Mini-G Feeding Tube Kit provides for the delivery of enteral formula through an externally minimized feeding tube. This replacement tube is used when there exists an established, well healed and mature stoma tract communicating between the stomach and external body surface. Externally minimized or low profile feeding devices are used to minimize the exposure of the tube outside of the patient's body and to provide an improved body image to the patient by concealing the feeding device under the clothing.

    Device Description

    The Novartis Nutrition COMPAT MINI-G Replacement Gastrostomy Tube kit is a Class II medical device and is intended for use as an enteral feeding tube to deliver feeding formula and/or medications to the stomach, as well as providing the ability to decompress and drain the stomach.

    AI/ML Overview

    This document is a 510(k) summary for a medical device and does not contain information about a study with acceptance criteria and device performance data.

    The provided text outlines the device name, intended use, and a comparison of its technological characteristics to a legally marketed predicate device. The purpose of this 510(k) submission is to demonstrate substantial equivalence to an existing device, which is a regulatory pathway for certain medical devices in the US.

    Therefore, I cannot provide the requested information regarding:

    1. A table of acceptance criteria and the reported device performance: This type of data is typically found in performance studies or clinical trial reports, which are not present here.
    2. Sample size used for the test set and the data provenance: No test set is described.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment is mentioned.
    4. Adjudication method for the test set: No test set or adjudication process is mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is described.
    6. If a standalone performance (algorithm only) study was done: No such study is described.
    7. The type of ground truth used: No ground truth is described.
    8. The sample size for the training set: No training set is described.
    9. How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

    The document primarily focuses on establishing "substantial equivalence" of the new device (Novartis Nutrition COMPAT MINI-G Replacement Gastrostomy Tube Kit) to a predicate device (Novartis Nutrition (Sandoz Nutrition)/Superior Healthcare Flow-Thru Replacement Balloon Gastrostomy Tube Kits) based on technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and results.

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