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510(k) Data Aggregation

    K Number
    K103535
    Device Name
    VACPLUS SUCTION UNIT
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2011-02-24

    (85 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K982304
    Why did this record match?
    Device Name :

    VACPLUS SUCTION UNIT

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

    The device is to be used to remove fluids from the treated tracheotomy patient airway.

    Device Description

    VacPlus is the portable AC/DC powered suction unit. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.

    AI/ML Overview

    The provided text describes the VacPlus device, an aspirator (powered suction pump), and its FDA 510(k) submission. However, it does not contain any information about a study involving AI, human readers, or image analysis for establishing acceptance criteria or assessing device performance in the context of AI.

    The document focuses on the mechanical and electrical performance of the VacPlus device as a medical suction pump, comparing it to a predicate device (DeVilbiss Suction Unit, Model 7305P). The "Performance Testing" section explicitly states:

    "Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in EN 60601-1, EN 60601-1-2 and EN/ISO 10079-1. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. Biocompatibility testing is not applicable since the proposed device has no direct patient contact."

    Therefore, based on the provided text, I cannot generate the requested information regarding AI acceptance criteria and related studies. The information you're asking for (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types) is relevant for AI/ML-based medical devices, which the VacPlus aspirator is not, as described in this document.

    To answer your prompt, I would need a different source document that details the development and validation of an AI-powered medical device.

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