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The Blunt Tip Trocar Port has applications for surgery in the legs for establishment of a port of entry for endoscopic instruments.

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The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula. The device is configured to accept a 5mm endoscope through the inner lumen of the cannula. The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.

has applications in open and endoscopic surgery. It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.

The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device

The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded ... .

This Origin Cardiac Stabilizer Occluder is a single use sterile device. It consists of a stabilizer foot, and occluders. The Origin Cardiac Stabilizer Occluder may be used by attaching the stabilizer foot to the Origin Cardiac Stabilizer Clamp; then this assembly is attached to a self retaining rib retractor or sternal retractor or other stationary platform. The Origin Cardiac Stabilizer Occluder may also be used by suturing the stabilizer foot to the desired area of the heart. The stabilizer foot rests against the epicardium. Forceps may be used to position the occluder over the desired vessel. Once in position the occluder may be advanced toward the vessel and locked in place; to cause the vessel to be temporarily occluded. Following completion of the surgical procedure , the Origin Cardiac Stabilizer Occluder is removed.

The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures. The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy. The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall.

The VasoView™ Balloon Dissection System is a single-use device which consist of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.

The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparoliff™ previously cleared under premarket notification k921103 September 9, 1993. The predicate device (Airlift™ Balloon Retraction System) has applications in laparoscopic surgery and is indicated and may be used as an alternative to insufflation for retracting organs and creating a working cavity for laparoscopic surgery. The predicate device is also used in conjunction with the Laparoliff™ . The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation. The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System k942678, same as (Lifting Distention Balloon System, the predicate device will be refered to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17).

The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments. During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar, The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm. The Origin Classic Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision cite. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

The 5mm Endoscope shares the same intended use as the predicate device. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.