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The LapBox Power Tissue Containment System is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The LapBox is compatible with electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. When used in women with fibroids, the LapBox Power Tissue Containment System is for women who are pre-menopausal and under age 50.

The LapBox Power Tissue Containment System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be morcellated using a power morcellator. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.

More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal. When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following: - A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm). - B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The ASC PneumoLiner is an inflated morcellation containment system that allows for containment of gynecological tissue, cells and fluids during power morcellation and removal. It is a sterile single use device and requires the surgeon to successfully complete a validated training program before use. The ASC PneumoLiner is for clinical use in a hospital or surgical center operating room. The device consists of the following components: the Retractor Introducer, Boot Assembly, the PneumoLiner Introducer and the PneumoLiner. The first three components (Retractor, Retractor Introducer and Boot Assembly) are used to retract an incision in the abdominal wall and to allow for the introduction of laparoscopic instruments and the PneumoLiner Bag while under pneumoperitoneum and with vision from a laparoscope. The PneumoLiner Bag is introduced via the PneumoLiner introducer and the large valve on the Boot Assembly. The PneumoLiner is intended for use in gynecological power morcellation. It is intended to form a complete containment barrier from the spillage of liquids, cells and tissue from the time the tissue or organ is excised and encapsulated in the PneumoLiner bag, throughout the morcellation procedure and withdrawal of the containment bag with accompanying liquids and debris.

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The PneumoLiner System consists of two main components: - A laparoscopic multi-instrument port - Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.