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510(k) Data Aggregation

    K Number
    K030402
    Device Name
    ARTHROSCOPY PUMP, MODEL A107
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2003-04-17

    (70 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K990443,K954465
    Why did this record match?
    Device Name :

    ARTHROSCOPY PUMP, MODEL A107

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

    The Arthroscopy Pump A107 is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

    Device Description

    The Arthroscopy Pump A107 is a microprocessor controlled dual pump system designed to provide liquid distention and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. Both the irrigation and suction pump of the device function according to the peristaltic principle. The Arthroscopy Pump A107 consists of the following main components: a housing, power supply, two roller wheels, two pump heads, a pinch valve, various setting keys and display elements. The device is to be used with special designed irrigation and suction tubings and a remote control. A constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

    AI/ML Overview

    The provided document describes the 510(k) premarket notification for the Arthroscopy Pump A107. However, it does not contain information regarding acceptance criteria, device performance results from a study, sample sizes, expert qualifications, ground truth establishment, or details about comparative effectiveness studies for AI.

    This document is a regulatory submission for a medical device (an arthroscopy pump), not a study report for an AI/CADe device. The "Performance Data" section merely states compliance with general electrical safety and electromagnetic compatibility standards, and that the device bears the CE mark. It does not present specific performance metrics or a study designed to evaluate how well it meets certain criteria in a clinical context.

    Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and study details based on the provided text. The document is solely focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical efficacy metrics.

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