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510(k) Data Aggregation

    K Number
    K984345
    Device Name
    AROMAPATCH
    Manufacturer
    ENVIS, INC.
    Date Cleared
    1999-03-19

    (105 days)

    Product Code
    LRD
    Regulation Number
    874.5220
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AROMAPATCH

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

    Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.

    Device Description

    Aromapatch™ nasal inhaler

    AI/ML Overview

    The provided documents are a Food and Drug Administration (FDA) 510(k) clearance letter and an "Indications for Use Statement" for the Aromapatch™ Nasal Inhaler.

    These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The FDA letter (K984345) confirms that the Aromapatch™ Nasal Inhaler has been found substantially equivalent to a legally marketed predicate device. This type of clearance (510(k)) generally focuses on demonstrating substantial equivalence to a device already on the market, rather than requiring detailed efficacy studies with acceptance criteria as might be seen for novel high-risk devices or those undergoing Premarket Approval (PMA).

    The "Indications for Use Statement" simply describes the intended use of the device: "Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil."

    Therefore, I cannot fulfill your request for the specific information about testing and acceptance criteria. The information requested is not present in these documents.

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