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510(k) Data Aggregation

    K Number
    K060037
    Device Name
    FITPACK
    Manufacturer
    ASP PLASTICS PTY LTD.
    Date Cleared
    2006-07-25

    (200 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes.

    The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of 1 ml insulin hypodermic needles and syringes in health care arcas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml insulin hypodermic needles and syringes.

    The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain detailed information about the acceptance criteria for the ASP HealthCare FITPACK® PRODUCT LINE or a study proving its performance against these criteria. The document is a 510(k) premarket notification letter from the FDA, indicating that the device has been deemed substantially equivalent to a predicate device.

    The letter mentions:

    • Trade/Device Name: ASP HealthCare FITPACK® PRODUCT LINE
    • Regulation Number: 880.5570
    • Regulation Name: Hypodermic Single Lumen Needle
    • Regulatory Class: II
    • Product Code: MMK

    The "Indications for Use" section describes how the various Fitpack products are intended to be used (for collection, transportation, and disposal of hypodermic needles and syringes) but does not provide specific performance metrics, acceptance criteria, or details of a study with sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or adjudication methods based on the provided text.

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