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510(k) Data Aggregation

    K Number
    K041268
    Manufacturer
    Date Cleared
    2004-09-20

    (131 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

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

    Professional Indications (Prescription Use):

    Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites

    Device Description

    The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.

    The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.

    AI/ML Overview

    Please provide me with the specific section of the document that describes the acceptance criteria and study results. The provided text discusses the device description, intended use, comparison to predicate devices, and a general summary of preclinical performance studies and conclusions. However, it does not explicitly detail specific acceptance criteria values or present a table of device performance against these criteria as requested in your prompt.

    Without that specific information, I cannot complete the table or the detailed breakdown of the study you've requested.

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    K Number
    K011618
    Manufacturer
    Date Cleared
    2002-11-15

    (539 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

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

    Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites

    Device Description

    CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings). This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval letter, not a study report.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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    K Number
    K003134
    Manufacturer
    Date Cleared
    2000-12-22

    (77 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI/TECHNAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K000054
    Manufacturer
    Date Cleared
    2000-03-13

    (66 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K963656
    Manufacturer
    Date Cleared
    1996-11-12

    (61 days)

    Product Code
    Regulation Number
    880.5090
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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