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The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.

The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ. The device is provided sterile for single use. The RedEx consists of a flexible specimen containment Baq, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision. The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed. After the Baq is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision. The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.

The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR 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 ContainOR device consists of two main components: - A laparoscopic multi-instrument port . - Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.

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.