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    K Number
    K991938
    Device Name
    CAPHOSOL ARTIFICIAL SALIVA
    Manufacturer
    INPHARMA A.S.
    Date Cleared
    1999-08-10

    (62 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K874106
    Why did this record match?
    Device Name :

    CAPHOSOL ARTIFICIAL SALIVA

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

    Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent.

    Caphosol is indicated for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety, obstruction of the salivary ducts, Sjögren's syndrome; and Bell's Palsy.

    Caphosol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.

    It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.

    Device Description

    Caphosol™ Artificial Saliva Consisting of a mixture of two solutions Caphosol™ A -- 15 mL Phosphate Solution and Caphosol™ B - 15 mL Calcium Solution

    AI/ML Overview

    Based on the provided text, there is no information available to answer the specific questions about the acceptance criteria and the study that proves the device meets them.

    The document is a 510(k) summary for "Caphosol™ Artificial Saliva," which primarily focuses on establishing substantial equivalence to a predicate device (GLANDOSANE (SALIVART®)). It outlines the device's name, classification, predicate device, and indications for use.

    The document does not contain:

    • Any specific acceptance criteria for the device's performance.
    • Details of a study conducted to demonstrate that the device meets such criteria.
    • Information regarding sample sizes, data provenance, expert involvement, adjudication methods, or MRMC studies.
    • Results of a standalone algorithm performance study (as this is an artificial saliva, not an AI/algorithm-driven device).
    • Details about the ground truth for training or testing sets.

    Therefore, I cannot provide the requested table or answer the specific questions based on the provided text.

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