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510(k) Data Aggregation

    K Number
    K221386
    Device Name
    PERF-GEN Pulsatile Perfusion Solution
    Manufacturer
    Institut Georges Lopez
    Date Cleared
    2022-06-14

    (32 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Institut Georges Lopez

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PERF-GEN Pulsatile Perfusion is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
    Device Description
    Institut Georges Lopez manufactures the PERF-GEN Pulsatile Perfusion Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer-MPS solution" used as kidney flushing and perfusion storage solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). The PERF-GEN Pulsatile Perfusion Solution is a clear to light yellow, sterile, non-pyrogenic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. PERF-GEN Pulsatile Perfusion Solution has an osmolality of 300 mOsm/kg, a total sodium concentration of 100 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter bags with a shelf life of 18 months. The PERF-GEN Pulsatile Perfusion Solution is used at hospital by health professionals. The PERF-GEN Pulsatile Perfusion Solution must be cooled to +2°C and +8°C (35.6-46.5°F) prior to use. The colution is used for the in-vitro flushing and temporary continuous perfusion of explanted kidneys.
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    K Number
    K221387
    Device Name
    BEL-GEN Cold Storage Solution
    Manufacturer
    Institut Georges Lopez
    Date Cleared
    2022-06-14

    (32 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Institut Georges Lopez

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEL-GEN Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
    Device Description
    Institut Georges Lopez manufactures the BEL-GEN Cold Storage Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer UW solution". The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). The BEL-GEN Cold Storage Solution is a clear to light yellow single use, sterile and non-pyrogenic solution. BEL-GEN Cold Storage Solution has an osmolality of 320 mOsm/kg, a total sodium concentration of 29 mmol/L, a total potassium concentration of 125 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter or 2-liter bags with a shelf life of 2 years. The BEL-GEN Cold Storage solution is used at hospital by health professionals. The BEL-GEN Cold Storage solution must be cooled to +2°C (36° and 43°F) prior to use The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation to cool the organ and lower its metabolic requirements.
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    K Number
    K211224
    Device Name
    RM4 Control Unit
    Manufacturer
    Institut Georges Lopez
    Date Cleared
    2021-10-15

    (175 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Institut Georges Lopez

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
    Device Description
    The RM4 Control Unit controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. The RM4 Control Unit is part of the RM4 Kidney Perfusion System (RM4), which is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient. The RM4 Control Unit is used with a sterile, disposable, singleuse, organ cassette intended to receive one or two kidneys from the same donor. The system is provided with a power cord and a USB flash drive that contains the instructions for use, and is intended to be used with an organ cassette and accessories including an insulation cover, and various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette.
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