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510(k) Data Aggregation

    K Number
    K192921
    Device Name
    Zeos Aqua Vision Pump and tube
    Manufacturer
    Hemodia SAS
    Date Cleared
    2020-10-09

    (359 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130169
    Why did this record match?
    Device Name :

    Zeos Aqua Vision Pump and tube

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

    The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.

    Device Description

    The ZEOS AQUA VISION pump is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.

    Test CategoryAcceptance Criteria (Implied)Reported Device Performance
    Electrical safety and electromagnetic compatibility (EMC)Compliance with IEC 60601-1 and IEC 60601-1-2 standardsEvaluation and testing demonstrated substantial equivalence to the predicate device.
    Biocompatibility testingCompliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11.Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests were performed and demonstrated substantial equivalence to the predicate device.
    Software Verification and Validation TestingCompliance with FDA guidance "General Principles of Software Validation" and IEC 62304Evaluation and testing demonstrated substantially equivalent performance to the identified predicate device.
    Sterilization ValidationCompliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7 for sterilization and residuals.Validation demonstrated substantial equivalence to the identified predicate devices. Residual ethylene oxide (EO)
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