Search Results

The Guardenia 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, Guardenia, 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. Guardenia consists of a flexible specimen containment/extraction Bag, with an integrated Opening Ring and Bag Tether with a separate Guard component to protect the Bag and incision during morcellation with a scalpel. 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 standard sized 12mm trocar cleared to market by the FDA may be used as an accessory for device deployment. A blue arrow on the Introducer provides the user with an indicator of the correct orientation during deployment in the abdominal cavity to ensure the Bag is correctly deployed. After the Bag is ejected from the Introducer into the abdominal cavity, the nitinol wire Opening Ring recovers its shape, opening the mouth of the Bag. This facilitates the encapsulation of the specimen. When the specimen is encapsulated, the Bag Tether, which extends externally through the trocar after deployment, is pulled, pulling the Opening Ring out through the trocar. This action also closes the mouth of the Bag inside the abdomen. The incision is then increased to the required size (2.5-6 cm) prior to removal of the trocar is removed, the mouth of the Bag is exteriorized, and then opened outside the abdomen. If the specimen is small enough, the Bag and specimen can be removed at this stage without the need for morcellation or the use of the Guard. If the specimen requires reduction, the Guard must be deployed first. To deploy the Guard, the free end of the end opposite to the blue Guard Ring) is inserted through the mouth of the Bag. The yellow Anchor Ring is then inserted through the center of 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 & Bag from damage due to inadvertent scalpel strikes or the traumatic graspers that are used to grasp and hold the tissue specimen at the incision. The physician then performs extracorporeal manual morcellation using a grasper and a scalpel. When the tissue specimen has been removed or sufficiently reduced, the surgeon flips 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 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 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 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.

The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform the following two functions. - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device. The QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device. Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity. - A retroctor component, which retracts an abdominal incision to allow the passage of ● laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical ● procedure. The QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.

The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions: - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device. The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components: - An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity. - A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical . procedure. The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows: - 1. Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration. - 2. The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient. The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device. The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.

The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic multi-instrument port which performs the following two functions. - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device. The ASC TriPort+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices. Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity. - A retractor component, which retracts an abdominal incision to allow the passage of laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical procedure. The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.

The ASC TriPort and QuadPort Laparoscopic Access Devices are intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The modified ASC TriPort Laparoscopic Access Device, like the parent TriPort cleared by the FDA under K073719, is still comprised of the following three components: - an introducer component which creates an abdominal incision (except in the case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity - a retractor component which retracts an abdominal incision to allow the passage of laparoscopic instruments - a valve component which maintains the pneumoperitoneum established for the surgical procedure The modified ASC TriPort Laparoscopic Access Device is still intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The modified ASC TriPort Laparoscopic Access Device is identical in function to the parent device, which has been cleared for marketing under K073719. The modifications made to the parent device labeling to produce the proposed TriPort Laparoscopic Access device informs users and patients that the device does not contain Natural Rubber Latex. Additionally the labelling has been revised to extend the shelf life from three months to three years as notified in the original 510(k) and to make the device safer and easier to use. The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device. The TriPort has additionally been modified resulting in the QuadPort device. The modifications to the TriPort comprise the following: - A fourth valve was added to accommodate an additional laparoscopic instrument. - The Boot is larger in diameter to accommodate the fourth instrument valve. - An Introducer and Retaining Clips are not required. - The Removal Ring is made from a different material (the same material as is used for the TriPort distal ring). The ASC TriPort and QuadPort Laparoscopic Access Devices are laparoscopic multiinstrument ports which perform the following two functions: - They retract a small abdominal incision to allow multiple laparoscopic instruments to pass through a small incision to the abdomen at the same time during laparoscopic surgery. - They ensure that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through them. The ASC TriPort and QuadPort Laparoscopic Access Devices apply radial force upon the incision creating an aperture though which the laparoscopic instruments pass. The ability to remove the boot, allows the clinician to deliver specimens without removing the entire port, and with the QuadPort, generally without the need to extend the incision. The physical design and performance of the modified TriPort is unchanged. Materials changes relate to substitution with materials already used for the TriPort. The physical properties of the QuadPort differ from the TriPort in that the diameter of the boot is increased, allowing space for the addition of a fourth port.

The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort Laparoscopic Access Device is a laparoscopic multi-instrument port which performs the following two functions: - t It retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery - . It ensures that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the TriPort The ASC TriPort Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort Laparoscopic Access Device performs the same function as other legally marketed port systems and standard trocars. Like the parent ASC R-Port II Laparoscopic Access Device, the proposed ASC TriPort Laparoscopic Access Device is comprised of the following three components: - an introducer component which creates an abdominal incision (except in the . case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity - a retractor component which retracts an abdominal incision to allow the . passage of laparoscopic instruments - . a valve component which maintains the pneumoperitoneum established for the surgical procedure The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort Laparoscopic Access Device is identical in function to the ASC R-Port II Laparoscopic Access Device, which has been cleared for marketing under K073170.