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510(k) Data Aggregation

    K Number
    K020083
    Device Name
    TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
    Manufacturer
    TUTA HEALTHCARE PTY LIMITED
    Date Cleared
    2002-02-12

    (33 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

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

    The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).

    Device Description

    The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.

    AI/ML Overview

    The provided text describes a 510(k) summary for Tuta's Arthroscopic Flushing Device. However, it does not contain information regarding a study, acceptance criteria, or device performance metrics.

    Therefore, I cannot fulfill the request to provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts or their qualifications for establishing ground truth.
    4. Adjudication method for the test set.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
    6. If a standalone performance study was done.
    7. The type of ground truth used.
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.

    The document is a 510(k) premarket notification for an Arthroscopy Flushing Set, focusing on establishing substantial equivalence to a legally marketed predicate device (Edwards Orthopedic Division, Baxter Healthcare Irrigation Set K883300). The 510(k) process primarily demonstrates that a new device is as safe and effective as a predicate device, often without requiring new clinical studies if the technology and intended use are similar. The information provided confirms the device name, manufacturer, intended use, and substantial equivalence to a predicate device, as well as the FDA's clearance letter.

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