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The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood. The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.

The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System is a chest drainage system that incorporates features from the Thora-Klex Model 0077000, the Pleur-evac Model A-6000, and the Pleur-evac Plus Model A-9150 systems. It includes a dry one-way seal, negative pressure indicator, automatic high negative pressure relief valve, dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, and a patient drainage tube configuration. It also has a reinfusion port, reinfusion tube, and spike port for continuous reinfusion. The collection/reinfusion chamber is shorter and deeper than the Pleur-evac Plus Model A-9150 to increase capacity. The patient drainage tube components are latex-free. The system can be used with a Pleur-evac Sahara Model S-100 Autotransfusion Bag or a blood transfer bag for reinfusion. The Model S-100 Autotransfusion Bag is a flexible vinyl bag with a rigid top plate and a wire support frame, designed for collection and reinfusion of blood. It includes an Easy-Link Adaptor and tubing clamps.

The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery.

The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a CO2 tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient's abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.

The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems.

The device is a flexible PVC bag designed to evacuate and collect filtered blood from a thoracic drainage unit for reinfusion to the patient. The bag contains two spring-loaded plates which are latched together prior to device use. During use, the plates are unlatched and the spring acts against the plates to create a vacuum in the bag thereby drawing the blood into the bag from the Pleur-evac® unit.

The Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood. The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.

The Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System is a new chest drainage system that incorporates features from the Thora-Klex Model 0077000 Chest Drainage System, the Pleur-evac Model A-6000 Chest Drainage System, and the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. Key features transferred from predicate devices include the dry one-way seal, negative pressure indicator, automatic high negative pressure relief valve, dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, patient drainage tube configuration, reinfusion port, reinfusion tube, and spike port. Minor design changes were made to the collection/reinfusion chamber to increase its capacity. The patient drainage tube components (tube, snap lock connectors with injection site, and universal connector) are the same as the Pleur-evac Model A-6000 and A-9150, but the material for the tube and injection site has been changed to be latex free. A Pleur-evac Sahara Model S-100 Autotransfusion Bag or a blood transfer bag can be attached for bag reinfusion. The Model S-100 Autotransfusion Bag includes a rigid top plate assembled onto a flexible vinyl bag, mounted over a wire support frame. The frame is removed for reinfusion. The S-100 bag comes with an Easy-Link Adaptor, which is removed to attach the bag directly to the S-2150 unit using the metal frame and hooks. Tubing connectors are provided and are color coded. Tubing clamps are located on the bag ports. An injection site is on one set of connectors for adding anticoagulants or taking samples. A hanger strap is on the top of the unit for suspending the bag during reinfusion. The components, manufacturing processes, and specifications for the S-100 bag are the same as the A-1500 bag, except for the Easy-Link Adaptor and the latex-free materials for the patient drainage tube and injection site.

The Models S-1100, S-1200, S-2100, and S-2200 covered by this submission are sterile, single use devices, that are intended for postoperative chest drainage. The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, intended for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Chest Drainage,

Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2100, and S-2200 Deknatel DSP Worldwide, Inc. has recently acquired the Thora-Klex® Chest Drainage System product lines from Davol Inc., C.R. Bard, Inc. Deknatel DSP Worldwide, Inc. has incorporated certain features of the currently marketed Model 0077000 Thora-Klex Chest Drainage System with the features of the currently marketed Model A-6000 Pleur-evac Chest Drainage System into a new chest drainage system, the Pleur-evac Sahara Adult/Pediatric Chest Drainage System. Combining the proven technologies from the Thora-Klex and the Pleur-evac into one unit, creates a new, completely dry Pleur-evac Chest Drainage Unit. Features from the Thora-Klex and the Pleur-evac were transferred to the Pleur-evac Sahara unit without design changes. There are two basic Pleur-evac Sahara Chest Drainage models: the S-1100 Chest Drainage Unit which is shorter, wider and deeper than the standard Pleur-evac unit but more like the Thora-Klex Model 0077000 shape: and the S-2100 Chest Drainage Unit which carries the standard dimensions of the Pleur-evac Model A-6000 Chest Drainage unit. The S-1100 and S-2100 Chest Drainage Units are capable of autotransfusion option, by attaching a Pleur-evac Sahara Model S-100 Autotransfusion Bag. The Models S-1200 and the S-2200 are identical to the Models S-1100 and S-2100, but are provided with a Model S-100 Autotransfusion Bag attached. The Pleur-evac Sahara Chest Drainage are three bottle systems that include a means for integral suction control, a one way seal via a check valve, and a chamber for collecting fluids, Hangers are located on the right and left sides of the chest drainage unit to provide support for the chest drainage unit when it is suspended from a hospital bed rail. The Pleur-evac Sahara Models S-2100 and S-2200 are provided with an integral rotating floorstand. These units free stand when placed on a leveled surface with the floorstand in the open position. The floorstand rotates freely from the closed position to the open position. Once open, the floorstand requires the actuation of a lever to return to the closed position. The design of the Pleur-evac Sahara Models S-1100 and S-1200 does not require a rotating floorstand, since the base of the unit acts as a floorstand. Pleur-evac Sahara Model S-100 Autotransfusion Bag The Pleur-evac Sahara Autotransfusion Bag, includes an Autotransfusion Bag that contains a rigid top plate assembled onto a flexible vinyl bag. The Autotransfusion Bag is mounted over a wire support frame. The wire frame maintains the bag in an open position during the collection phase of operation. The frame is removed from the bag during the reinfusion phase to allow the bag to collapse and the reinfusion of the collected blood to occur. The Pleur-evac Sahara Autotransfusion Bag operates with either suction drainage or gravity drainage. During operation with suction drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is connected to a vacuum source. The patient vacuum is controlled by the Pleur-evac Sahara Chest Drainage System. During operation with gravity drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is not attached to a suction source. The Pleur-evac Sahara Autotransfusion Bag is connected to the Pleur-evac Sahara S-1100 Chest Drainage Unit by means of the Easy-Link Adaptor. The adaptor, which is attached to the Autotransfusion Bag, locks into the Easy-Link receptor on the Pleurevac Sahara Chest Drainage unit. For the Pleur-evac Sahara Model S-2100 Chest Drainage Unit, the Easy-Link Adaptor is removed from the Model S-100 Autotransfusion Bag by the clinician, and the Autotransfusion Bag is attached directly to the side of the Pleur-evac Chest Drainage Unit, using the metal frame on the bag and the hooks provided on the chest drainage unit. This means of attachment is employed by the currently marketed Pleur-evac Model A-6000 Chest Drainage System. Tubing connectors are provided for attaching the Pleur-evac Sahara Autotransfusion Bag to the appropriate Pleur-evac Sahara Chest Drainage Unit. The connectors are color coded for ease of proper connection. Tubing clamps are located on each of the tubing ports on the Autotransfusion Bag. The tubing clamps must be closed in order to occlude the patient drainage tube prior to disconnecting the connectors. An injection site is located on one set of connectors through which anti-coagulants may be added to the Autotransfusion Bag or from which samples of the drainage fluid mav be taken. A hanger strap located on the top of the unit provides a means for suspending the Autotransfusion Bag from an I.V. pole during reinfusion. The Models S-100 and the A-1500 Autotransfusion Bags have similar face graphics, j box graphics, and instructions for use. The labeling for the Model S-100 Autotransfusion Bag also includes reference and use of the Easy-Link Adaptor.