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The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuciide sources into the body, and for aspirating, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner). The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone, vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits. They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for: - . Microscopic, histologic, diagnostic, evaluation - Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, . MRI (magnetic resonance imaging), and/or direct visualization - . Guiding biopsy needles to the target lesion - Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital structures (e.g., blood vessels, nerves) - Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or . complete removal of the imaged abnormality - Aspirating, draining, or injecting various fluids or contents in soft tissues, including . introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding - Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection . or aspiration of fluids - Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve . block/anesthesia, and amniocentesis - Manual application of a radionuclide source into or on the body for radiation therapy . - Including, but not limited to, the following anatomical locations and lesions; . - Pleural cavity - Lung - Lymph nodes - Thyroid - Adrenals - Soft tissue organs of the abdomen and thorax - Abdominal cavity/ abdominal soft tissue masses - Kidney - Liver - Spleen - Pancreas - Prostate - Tumors - Cysts - Fluid spaces - Soft tissue lesions or tissue spaces - Breast: - The PneumRx Family of Biopsy Needles and Kits is indicated to provide breast . tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality; - The extent of a histologic 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 histologic 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 PneumRx Family of Biopsy Needles and Kits are comprised of the following main components: - Standard and steerable biopsy needles in a range of sizes; - Standard straight and steering stylets compatible with a range of steerable and . standard biopsy needles; - . Remote Control Steering Handle accessory: - Procedure accessories including drapes, gauze sponges, syringes, scalpels, depth . markers, and prep tray.