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510(k) Data Aggregation

    K Number
    K991653
    Device Name
    INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Date Cleared
    1999-06-24

    (42 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K973167
    Why did this record match?
    Device Name :

    INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM

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

    The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

    Device Description

    The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.

    However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance CriteriaReported Performance (RyMed InVision-Plus™)
    Fluid reflux
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