BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Sonometer

    PMA: P990035 · Supplement: S001 · Decision Jun 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    OMNISENSE 7000S ULTRASOUND BONE SONOMETER
    PMA Number
    P990035
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    MUA
    Generic Name
    Bone sonometer
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 21, 2001
    Date Received
    June 26, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF TWO NEW PROBES FOR USE ON TWO ADDITIONAL SKELETAL SITES, THE PROXIMAL THIRD PHALANX AND THE FIFTH METATARSAL. THE DEVICE, AS MODIFIED, IS INDICATED AS FOLLOWS: "A NONINVASIVE DEVICE THAT IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF THE SIGNAL VELOCITY OF ULTRASONIC WAVES ("SPEED OF SOUND" OR "SOS" IN M/SEC) PROPAGATING AT MULTIPLE SKELETAL SITES (I.E., THE DISTAL ONE-THIRD OF THE RADIUS, THE PROXIMAL THIRD PHALANX, AND THE FIFTH METATARSAL). SOS PROVIDES AN ESTIMATE OF SKELETAL FRAGILITY. THE OUTPUT IS ALSO EXPRESSED AS A T-SCORE AND A Z-SCORE, AND CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN THE DIAGNOSIS OF OSTEOPOROSIS AND OTHER MEDICAL CONDITIONS LEADING TO REDUCED BONE STRENGTH AND, ULTIMATELY , IN THE DETERMINATION OF FRACTURE RISK. MULTIPLE SKELETAL SITE TESTING PROVIDES CLINICIANS WITH ALTERNATIVES IF ONE SITE IS NOT ACCESSIBLE AND WITH ADDITIONAL SKELETAL INFORMATION (I.E., FROM BONES WITH DIFFERENT COMBINATIONS OF CORTICAL AND CANCELLOUS MATERIAL AND FROM WEIGHT BEARING AND NON-WEIGHT BEARING SITES) THAT ASSISTS IN DIAGNOSING OSTEOPOROSIS AND RISK FRACTURE. THE SOS MEASUREMENT BY OMNISENSE HAS A PRECISION ERROR LOW ENOUGH IN COMPARISON WITH THE EXPECTED ANNUAL CHANGE IN A PATIENT'S MEASUREMENT TO MAKE IT SUITABLE FOR MONITORING BONE CHANGES WHICH OCCUR IN THE EARLY YEARS FOLLOWING MENOPAUSE (I.E., AGE RANGE APPROXIMATELY 50-65 YEARS)."

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer