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Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures

The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. This submission is for a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.

The Cassi Rotational Core Biopsy Device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone. The Cassi Device is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of a histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated CASSI biopsy handle, a valve block, battery, cryogen, a Cassi biopsy needle (CASSI biopsy needle comprised of a sticking needle and cutting cannula/piston assembly), and a sample collection tray. The sticking needle is operated by CASSI biopsy handle and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula is available in two sizes (10 and 12 gauge). The proposed CASSI biopsy handle are minor design evolution of the predicate CASSI II biopsy handle. The proposed CASSI II biopsy needle unit assembly remains unchanged from the predicate CASSI II biopsy needle unit assembly. The proposed CASSI II system uses one control unit handle and allows for multiple, single patient use, biopsy needle units to operate with the handle, in the very same manner as the predicate CASSI II device. The principles of operation for the proposed CASSI™ II Rotational Core Biopsy System and the predicate CASSI II system remain unchanged.

Beacon Tissue Marker (SE) is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future procedures.

The Beacon Tissue Marker (SE) consists of a radiographic soft tissue marker and the delivery system. The Beacon Tissue Marker (SE) includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. This submission is for an additional offering of a delivery system with radiused tip and increased rod length corresponding to the new radius tip. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a radius tip 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.