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510(k) Data Aggregation

    K Number
    K062689
    Device Name
    SIDESTREAM PLUS
    Manufacturer
    RESPIRONICS LTD.
    Date Cleared
    2007-02-16

    (158 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K933535,K963924,K935540
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS LTD.

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

    The Sidestream Plus is a handheld nebulizer designed to aerosolize medication approved for nebulization and prescribed by a physician. The Sidestream Plus is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

    Device Description

    Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification. The Sidestream Plus is a breath-enhanced nebulizer and works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540).

    AI/ML Overview

    The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets those criteria, as typically found in comprehensive medical device studies. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical or performance study with specific acceptance criteria and outcome metrics.

    The document states that the "Sidestream Plus is a Class II device. It is a breath-enhanced reusable nebulizer to be used with a compressor that is capable of providing appropriate air pressure and flow to operate the device according to specification." It also mentions that it "works utilizing the same operating principles as the Ventstream (K933535), the Pari LC Star (K963924) and the Pari LC + (K935540)."

    Without a dedicated section detailing performance criteria and a study to meet them, I cannot populate the requested tables and information. The 510(k) process primarily relies on demonstrating equivalence through design, operating principles, and intended use as compared to legally marketed predicate devices, along with some basic performance testing, which is generally not detailed in the summary itself.

    Therefore, many of the requested fields cannot be filled based on the provided text.

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