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510(k) Data Aggregation

    K Number
    K223682
    Device Name
    Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    Manufacturer
    Sirius Medical Systems B.V.
    Date Cleared
    2023-11-09

    (336 days)

    Product Code
    PBY, NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirius Medical Systems B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended only for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
    Device Description
    The Sirius Pintuition Seed and Sirius Pintuition Detector (consisting of Base Unit and Probe) are part of the Sirius Pintuition Localization System. The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length variants). The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and quide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm). The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed.
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    K Number
    K222643
    Device Name
    Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    Manufacturer
    Sirius Medical Systems B.V.
    Date Cleared
    2022-10-19

    (48 days)

    Product Code
    PBY
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirius Medical Systems B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (<30 days) a lumpectomy site inteded for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed can be located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical removal.
    Device Description
    The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System. The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (<30 days) marking of a lumpectomy site intended for surgical removal. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length). The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during breast surgery to plan the surgical approach and guide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm). The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed.
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    K Number
    K200734
    Device Name
    Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    Manufacturer
    Sirius Medical Systems B.V.
    Date Cleared
    2021-02-24

    (341 days)

    Product Code
    PBY
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirius Medical Systems B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical removal.
    Device Description
    The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System. The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (<30 days) marking of a lumpectomy site intended for surgical removal. The device is supplied single-use, sterile and pre-loaded within its delivery needle (12cm or 20cm length). The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during breast surgery to plan the surgical approach and guide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm). The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed.
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