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The Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomag Magseed Pro Magnetic Marker is intended for use as a soft tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The Magseed Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system. The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue. Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.

The Sentimag Magnetic Localization System when used with the Magseed® marker is indicated to assist in localizing soft tissue lesions. The Endomag Sentimag System is the only non-imaging guidance system intended for use with the Magsed® magnetic marker.

The Sentimag Gen 3 System is the 3d generation of Sentimag detector, intended for the nonimaging detection and localization of Magseed® magnetic marker that has been implanted in a lumpectomy site intended for surgical removal. It consists of a base unit and a probe. This generation of the device has two modes: - a) Counts Mode: This mode is the exact equivalent of the current generation of the Sentimag detector (Sentimag Gen 2 - described in K153044). In this mode Magseed (K173587) and is detectable based on a counts signal displayed on the base unit of Sentimag device. - b) Measure Mode: Please note that this mode has a different graphic display and is currently dormant in Sentimag Gen 3 The Sentimag Gen 3 System comprises of a mains-powered base unit, a detachable hand-held probe available in 2 sizes (Standard Probe and Thinner Probe) that is connected to the base unit with a flexible cable, and a detachable electronic footswitch that is connected to the base unit with a flexible cable. A single use sterile sheath is required to be placed over the probe prior to the procedure, this is to be supplied by the hospital. The hand-held probe which emits an alternating magnetic field that detects the magnetic response of the marker. When the marker is exposed to a magnetic field it becomes magnetic, and this magnetism can then be detected using the probe which gives an audible and visual signal of the level of magnetism. In count mode this is in the format of a numerical reading.

The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomaq Maqseed® Magnetic Marker is intended for use as a tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The Magseed Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site that is for example intended for surgical removal. The Magseed Magnetic Marker is subsequently localized by using imaging quidance (such as ultrasound or radiography) or aided by non-imaging quidance (Endomag Sentimag® System, K153044 and K163541). The marker can be detected up to 3cm from the Sentimag® probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

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.