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510(k) Data Aggregation

    K Number
    K970916
    Device Name
    H.V. PULSE LAVAGE (L31 SERIES)
    Manufacturer
    GLOBAL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-20

    (100 days)

    Product Code
    FQH,FOH
    Regulation Number
    880.5475
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K970916
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K970916

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

    Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.

    Device Description

    Tava Surgical Instruments' L31 H.V. Pulse Lavage is an ergonomically designed pneumatic instrument. The hatch of the cradle is raised in order to insert single-use sterile pump sets which isolates the sterile fluids from the instrument. Activation of the instrument causes engagement of the pump set and pulsates the sterile fluids into the surgical site to remove blood and debris.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device called the "Tava Surgical Instruments L31 H.V. Pulse Lavage." This document is a premarket notification to the FDA asserting substantial equivalence to a predicate device. It is not a detailed scientific study report demonstrating performance against specific acceptance criteria.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) cannot be found within this document.

    Explanation:

    The 510(k) submission process is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its independent safety and effectiveness through a comprehensive study with specific acceptance criteria. The document focuses on:

    • Device Description: What the device is and how it works.
    • Comparison to Predicate Device: How it is similar in design, materials, and intended use to an existing device (MicroAire® Hi Speed Pulse Lavage 4740).
    • Intended Use: The medical procedures for which it is designed.
    • Safety and Effectiveness Claim: A general statement that it is as safe and effective as the predicate device, implicitly relying on the predicate's established performance.

    There are no performance metrics, acceptance criteria, or details of a study with specific methodologies (like sample size, ground truth, expert review, or MRMC) presented in this 510(k) Summary.

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