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510(k) Data Aggregation

    K Number
    K992723
    Device Name
    ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
    Manufacturer
    TRANSFUSION TECHNOLOGIES CORP.
    Date Cleared
    1999-10-18

    (66 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSFUSION TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria: The patient is expected to lose sufficient blood in the perioperative period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion. Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion. Compatible allogeneic blood is not available. The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement. The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
    Device Description
    The OrthoPAT® system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused. The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifuge, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad. The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.
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    K Number
    K982660
    Device Name
    ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
    Manufacturer
    TRANSFUSION TECHNOLOGIES CORP.
    Date Cleared
    1999-03-30

    (243 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSFUSION TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. Autotransfusion is indicated for patients who meet at least one of the following criteria: - The patient is expected to lose sufficient blood in the perioperative period so as . to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion. - Religious beliefs cause the patient to refuse allogeneic transfusion, but accept . autologous transfusion. - . Compatible allogeneic blood is not available. - . The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement. - . The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
    Device Description
    The OrthoPAT™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused. The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifuge, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad. The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.
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    K Number
    K962475
    Device Name
    ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
    Manufacturer
    TRANSFUSION TECHNOLOGIES CORP.
    Date Cleared
    1997-02-20

    (240 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSFUSION TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPAT™ Orthopedic Perioperative Autotransfusion System is intended for use in major orthopedic surgical procedures, such as joint replacement or spinal fusion to salvage red blood cells lost during and after surgery. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.
    Device Description
    The OrthoPAT™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused. The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifige, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad. The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.
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