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510(k) Data Aggregation

    K Number
    K002753
    Device Name
    SPARTAN A-10
    Manufacturer
    SPARTAN ULTRASONICS, INC.
    Date Cleared
    2000-12-04

    (90 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPARTAN ULTRASONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K991888
    Device Name
    MINIJECT
    Manufacturer
    SPARTAN ULTRASONICS, INC.
    Date Cleared
    1999-08-25

    (84 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K823536,K802483
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPARTAN ULTRASONICS, INC.

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

    This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.

    Device Description

    The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).

    AI/ML Overview

    The provided text is related to a 510(k) submission for a medical device called the "Miniject Syringe." However, it is a regulatory document focused on establishing substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and device performance based on the input provided. The document primarily identifies the device, its intended use, and its substantial equivalence to previously marketed devices (K823536 Intralig and K802483 Ligmaject). There is no mention of a clinical or performance study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

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