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To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Special 510(k) addresses the addition of a smaller size HydroMark Breast Biopsy Site Marker which will be provided in a smaller, rigid, sharp delivery system for use under ultrasound deployment either directly or though a commercially available 16 gauge x 9 cm coaxial needle. This Special 510(k) also describes minor modifications to the delivery system used for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices, and includes compatibility testing to allow the existing Mammotome MR Targeting Set to be labeled for use with other commercial MRI biopsy devices. Associated changes to the IFU and labels are also provided.

To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure. The Biopsy Sciences HydroMark Breast Biopsy Site Markers will have a change in vendor for the supplier of the hydrogel material. The change in the supplier of the hydrogel has no effect on the finished product specifications.

The Biopsy Sciences LLC., HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Breast Biopsy Site Markers are made of desiccated hydrogel embedded with either a stainless steel or titanium coil. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark Site Marker is currently provided pre-loaded in a sterile, disposable, flexible plastic syringe-like applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. Two modified applicators have been developed which are both 15 gauge stainless steel syringe-like applicators. One has cm markings and a beveled tip to aid in needle placement by direct puncture, or to fit inside a 13 gauge or larger coaxial needle. The distal tip of the applicator is etched to enhance its visibility under ultrasound guidance. An additional stainless steel applicator has been developed to be compatible with the Suros 12 gauge biopsy system. The hydrogel portion of the HydroMark Breast Biopsy Site Marker has a dimensional change to accommodate the 15 gauge applicators, which by design create smaller cavities. The titanium and stainless steel coils embedded in the hydrogel are identical to the original device.

The Biopsy Sciences, LLC. HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Breast Biospy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker and in the currently cleared HydroMark Breast Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark is available with either stainless steel or titanium coils, depending on physician preference. Both coils provide permanent visibility under x-ray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile. disposable applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.

The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible uneler ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Biospy Site Markers are made of The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.

The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Biopsy Sciences Lung Biopsy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, an FDA approved hydrogel used on the surgical site during lung surgery. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The Site Markers mark the site of the biopsy tissue sample, which provides accurate visualization during surgical resection of the tumor. Lung biopsy procedures are performed by fine needle aspiration through a coaxial needle. When the fine needle aspiration device is removed, the delivery system is mated to the coaxial needle. The plunger of the delivery system is depressed, which accurately places the Site Marker in the biopsy tract.

The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks. The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

The Bio-MARK biopsy site marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in the J&J Ethicon Mammotome 11 gauge biopsy probe. The Bio-MARK device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The Bio-MARK is sold in two styles: the Resorbable Bio-MARK is made of the copolymer only, the Permanent Bio-MARK is identical with the addition of a stainless steel component for permanent radiographic visibility. Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker.

The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate

The biopsy needle is a single lumen needle, identical in design to the predicate, from Sherwood Medical. The shaft of the needle has been modified to provide additional sampling sites approximately 0.40inches proximal to the needle tip. Once the needle is positioned at the site of interest, the stylet is removed and the needle is manually advanced to obtain a freehand needle biopsy of tissue, or aspirate, while suction is applied with a syringe. Then as the needle is withdrawn, the side-sampling site will also remove tissue, allowing the physician to collect at least twice the amount of tissue sample typically removed by a biopsy needle. The needle is made of ASTM type 304 stainless steel, as is the stylet.