Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K073180
    Device Name
    SMARTSPONGE PLUS SYSTEM
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Date Cleared
    2007-11-19

    (6 days)

    Product Code
    LWH
    Regulation Number
    880.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARCOUNT MEDICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCount Medical Solutions SmartSponge™ PLUS System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures, as well as for providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.
    Device Description
    The SmartSponge™ PLUS System includes surgical sponges, laparatomy pads and surgical towels, each of which contains a unique radio frequency identification (RFID) tag permanently attached to the gauze or fabric. The tags allow the sponges and towels to be individually recognized by an RFID reader. The SmartBucket is a specially designed cart containing a microcontroller unit with specialized software designed for mobile data collection. Integrated RFID technology allows capture of the information coded on the unique RFID tag on the sponges, pads and towels. The microcontroller unit counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original. By providing a count of the items entered into surgery, and a count of those discarded and removed permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient. A Detection Wand is an additional antenna that is tethered by a cable to the SmartBucket. It is powered and controlled by the SmartBucket. The antenna functions as an additional RFID antenna to the system, functioning in an identical manner to the internal SmartBucket antennas. By using a keypad the user may select activate the Detection Wand antenna. When in Detection Wand mode, the system uses the Wand antenna to recognize RFID-tagged items that may be inside the surgical site. A Detection Mat is a disposable or reusable element with multiple RFID tags embedded inside, along with several passive printed circuit traces. Like the RFID-tagged sponges, the Detection Mat tags contain unique identifying numbers and are distinguishable by the system software. The Detection Mat is placed on the operating room table before the patient is brought into the room and is covered by the standard sheets or drapes used in surgery, thus not making contact with the patient. The RFID tags in the Matt provide feedback to the user that the Detection Wand is being held close enough to the patient to ensure proper reading. The tags in the Detection Mat also ensure that the Detection Wand scan has covered the appropriate areas of the patient. The passive circuit traces help to enhance the readability of the RFID tags in the Detection Mat.
    Ask a Question
    K Number
    K071355
    Device Name
    SMARTSPONGE SYSTEM
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Date Cleared
    2007-05-24

    (9 days)

    Product Code
    LWH, GDY
    Regulation Number
    880.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARCOUNT MEDICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCount Medical Solutions SmartSponge™ System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures.
    Device Description
    The SmartSponge™ System includes surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique radio frequency identification (RFID) tag permanently attached to the gauze or fabric. The tags allow the sponges and towels to be individually recognized by an RFID reader. The SmartBucket is a specially designed cart containing a microcontroller unit with specialized software designed for mobile data collection. Integrated RFID technology allows capture of the information coded on the unique RFID tag on the sponges, pads and towels. The microcontroller unit counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original. By providing a count of the items entered into surgery, and a count of those discarded and removed permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient.
    Ask a Question

    Page 1 of 1