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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.

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.

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.

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.

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.

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.

The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.

The RFID Localization System (RFLS) is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the tag. The RFLS is comprised of a Tag, Tag Applicator, Reader, and Surgical Probe. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.

The Endomag Magseed Magnetic Marker 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 (Endomag Sentimag® System) the Endomag Magseed Magnetic Marker is located and surgically removed with the target tissue. The Endomag Sentimag® System is intended for the non-imaging detection and localization of the "Endomag Magseed Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

The Magseed Magnetic Marker is identical to the Sentimark Magentic marker described in K153044. Only the trade name has changed. The Magseed Magnetic Marker is supplied to end users as a pre-packaged sterile, single-use delivery system. The system comprises an individual soft magnetic marker (magnetic seed) and a 18-gauge needle delivery system that is used to deliver the seed to the intended deployment location. This product is designed as a single use device that is supplied sterile in an individual sealed tyvek pouch. This Premarket Submission is solely concerned with a reduction in the length of the 18-gauge needle cannula that is used to introduce the Magseed Magnetic Marker. K153044 describes two device configurations, where: - REF: SM18-1-12 has a length of 12cm - REF: SM18-1-20 has a length of 20cm This submission solely considers a reduction in the needle canulla to a minimum length of 5cm. - REF: SM18-1-05 has a length of 5cm . - REF: SM18-1-07 has a length of 7cm . There is no revision to the implanted marker. The Sentimag Detector remains identical to that described in K153044 The Sentimag System is intended for the non-imaging detection and localization of the Magseed Magnetic Marker that has been implanted in a lumpectomy site intended for surgical removal. The Sentimag System and Magseed Magnetic Marker System are designed for use in an operating room environment by suitably trained physicians who are experienced in diagnosis and treatment of breast lesions. The Sentimag System aids the surgeon to detect surgically invasively magnetic marker material that has been placed for the purpose of detecting a non-palpable lesion, and to locate target excision sites. Prior to a lumpectomy procedure, the Magseed Magnetic Marker is placed percutaneously into the breast, using imaging quidance such as ultrasound or radiography, to temporarily mark a site intended for surgical removal. During a surqical procedure, the hand-held Sentimag probe emits an alternating maqnetic field that detects the magnetic response of the Magseed magnetic marker, this signal is converted by the base unit into a visual and audible response that is similar in use to the predicate device.

The Endomag Sentimark® Magnetic Marker 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 nonimaging guidance (Endomag Sentimag® System) the Endomag Sentimark® Magnetic Marker is located and surgically removed with the target tissue. The Endomag Sentimag® System is intended for the non-imaging detection and localization of the "Endomag Sentimark® Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

The Sentimag System is intended for the non-imaging detection and localization of the Sentimark Magnetic Marker that has been implanted in a lumpectomy site intended for surqical removal. The Sentimag System and Sentimark Magnetic Marker System are designed for use in an operating room environment by suitably trained physicians who are experienced in diagnosis and treatment of breast lesions. The Sentimag System aids the surgeon to detect surgically invasively magnetic marker material that has been placed for the purpose of detecting a non-palpable lesion, and to locate target excision sites. Prior to a lumpectomy procedure, the Sentimark Magnetic Marker is placed percutaneously into the breast, using imaging quidance such as ultrasound or radiography, to temporarily mark a site intended for surgical removal. During a surgical procedure, the hand-held Sentimaq probe emits an alternating magnetic field that detects the magnetic response of the Sentimark magnetic marker, this signal is converted by the base unit into a visual and audible response that is similar in use to the predicate device.

The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 30 days) mark a lumpectomy site intended for surgical removal. Using ultrasound or radiography imaging guidance, the Cianna Tissue Marker is located and surgically removed with the target tissue.

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.