LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021700
    Device Name
    ANIMUS EZSERTER INFUSION SET INSERTER
    Manufacturer
    ANIMAS CORP.
    Date Cleared
    2002-06-04

    (12 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANIMUS EZSERTER INFUSION SET INSERTER

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

    The Animas ezSerter™ Infusion Set Inserter is intended to aid in the insertion of the Animas ezSet™ infusion sets. This device is intended for home use and is a prescription device.

    Device Description

    The Animas ezSerter™ Infusion Set Inserter is a simple device for automatically inserting the cannula of the Animas ezSef™ angled infusion sets subcutaneously. The inserter is composed of several molded plastic pieces and stainless steel springs. An elongated molded plastic housing acts as a handle and a quide for an internally mounted spring-loaded carrier. An opening in the proximal end of the carrier accepts and retains the handle of the introducer needle hub.

    AI/ML Overview

    This document, K021700, is a 510(k) summary for the Animas ezSerter™ Infusion Set Inserter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-read ground truth.

    Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment is not available in this document.

    The 510(k) summary describes:

    • Device Name: Animas ezSerter™ Infusion Set Inserter
    • Intended Use: To aid in the insertion of Animas ezSet™ infusion sets.
    • Predicate Device: MiniMed Sil-Serter™ Infusion Set Insertion System
    • Comparison of Technical Features: Both are spring-loaded devices where the user loads the infusion set, compresses a spring, and activates the device. The 510(k) states that "The differences between the new device and the predicate devices do not affect the safety or effectiveness of the device." This statement implies that the device's performance is considered to be on par with the predicate, but specific performance data or acceptance criteria are not detailed in this summary.

    In summary, this document is a regulatory submission for substantial equivalence and does not contain the kind of detailed performance study results, acceptance criteria, or ground truth methodology typically found in clinical validation reports for AI/diagnostic devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1