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510(k) Data Aggregation

    K Number
    K050654
    Device Name
    AMSINO I.V. START KIT
    Manufacturer
    AMSINO INTERNATIONAL, INC.
    Date Cleared
    2005-05-02

    (49 days)

    Product Code
    LRS
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMSINO I.V. START KIT

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

    The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the AMSINO® I.V. Start Kit. This letter does not contain information about acceptance criteria or a study proving device performance against such criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specified acceptance criteria as might be seen for novel devices or those undergoing a PMA (Premarket Approval) process.

    Therefore, I cannot extract the requested information from this document.

    Specific reasons why the requested information is not available in the document:

    1. Acceptance Criteria and Reported Device Performance: This document is an FDA clearance letter, not a study report or a summary of performance data. It states that the device is "substantially equivalent" to a predicate device, which is the regulatory standard for 510(k) clearance. It does not list specific performance metrics or acceptance criteria.
    2. Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: All these items pertain to the design and results of a clinical or performance study. The provided document does not contain any details about studies of this nature. It primarily focuses on the regulatory decision of substantial equivalence.
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