BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Optical Diagnostic Device For Melanoma Detection

    PMA: P090012 · Decision Nov 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Optical Diagnostic Device For Melanoma Detection
    Trade Name
    MELAFIND
    PMA Number
    P090012
    Device Class
    FDA Class 3
    Product Code
    OYD
    Generic Name
    Optical diagnostic device for melanoma detection
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 1, 2011
    Date Received
    June 3, 2009
    Expedited Review
    Y
    Docket Number
    12M-0074

    Advisory Committee Statement

    APPROVAL FOR THE MELAFIND DEVICE. MELAFIND IS INTENDED FOR USE ON CLINICALLY ATYPICAL CUTANEOUS PIGMENTED LESIONS WITH ONE OR MORE CLINICAL OR HISTORICAL CHARACTERISTICS OF MELANOMA, EXCLUDING THOSE WITH A CLINICAL DIAGNOSIS OF MELANOMA OR LIKELY MELANOMA. MELAFIND IS DESIGNED TO BE USED WHEN A DERMATOLOGIST CHOOSES TO OBTAIN ADDITIONAL INFORMATION FOR A DECISION TO BIOPSY. MELAFIND SHOULD NOT BE USED TO CONFIRM A CLINICAL DIAGNOSIS OF MELANOMA. MELAFIND IS ONLY FOR USE BY PHYSICIANS TRAINED IN THE CLINICAL DIAGNOSIS AND MANAGEMENT OF SKIN CANCER (I.E., DERMATOLOGISTS) WHO HAVE ALSO SUCCESSFULLY COMPLETED A TRAINING PROGRAM IN THE APPROPRIATE USE OF MELAFIND.THE MELAFIND RESULT IS ONE ELEMENT OF THE OVERALL CLINICAL ASSESSMENT. MELAFIND POSITIVE LESIONS (WHICH MAY INCLUDE MALIGNANT MELANOMA, MELANOMA IN SITU, HIGH GRADE DYSPLASTIC NEVI AND ATYPICAL MELANOCYTIC PROLIFERATION/HYPER-PLASIA) SHOULD BE CONSIDERED FOR BIOPSY; THE BIOPSYDECISION OF A MELAFIND NEGATIVE LESION SHOULD BE BASED ON THE REMAINDER OF THE ENTIRE CLINICAL CONTEXT. LESIONS THAT ARE "NON-EVALUABLE" BY MELAFIND SHOULD BE CAREFULLY RE-EVALUATED FOR BIOPSY.MELAFIND IS INDICATED ONLY FOR USE ON LESIONS WITH A DIAMETER BETWEEN 2 MM AND 22 MM, LESIONS THAT ARE ACCESSIBLE BY THE MELAFIND IMAGER, LESIONS THAT ARE SUFFICIENTLY PIGMENTED (I.E. NOT FOR USE ON NON-PIGMENTED OR SKIN-COLORED LESIONS), LESIONS THAT DO NOT CONTAIN A SCAR ORFIBROSIS CONSISTENT WITH PREVIOUS TRAUMA, LESIONS WHERE THE SKIN IS INTACT (LE., NON-ULCERATED OR NON-BLEEDING LESIONS), LESIONS GREATER THAN 1 CM AWAY FROM THE EYE, LESIONS WHICH DO NOT CONTAIN FOREIGN MATTER, AND LESIONS NOT ON SPECIAL ANATOMIC SITES (IE., NOT FOR USE ON ACRAL,PALMAR, PLANTAR, MUCOSAL, OR SUBUNGUAL AREAS). MELAFIND IS NOT DESIGNED TO DETECT PIGMENTED NON-MELANOMA SKIN CANCERS, SO THE DERMATOLOGIST SHOULD RELY ON CLINICAL EXPERIENCE TO DIAGNOSE SUCH LESIONS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OYD Optical Diagnostic Device For Melanoma Detection