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The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.)

The modified and predicate Capiox® SX18/25 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The modified and predicate Capiox® SX18/25 Oxygenator has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood. With respect to the filtration of blood, the modified and predicate Capiox® Hardshell Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood. The subject of this Special 510(k) is a modification being made to the Hardshell Reservoir. The reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K130359) - except the modified device will include PVC tubing (with TOTM plasticizer) for a flared venous inlet drop tube, auxiliary tube, sampling manifold tubing, and purge line tubing.

The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI™ 500 Monitor . - Arterial and/or Venous Blood Parameter Modules (BPM) . - CDI™ H/S Probe . - CDI™ 540 Gas Calibrator and Calibration Gases (A and B) . - CDI™ 510H Shunt Sensor . - Shunt Bypass Line . - CDI™ H/S Cuvette with or without extension tubing . - Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) . - . Printer Paper The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1 is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the TCVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The Sarns™ Soft-Flow Aortic Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.

The design of the Sams™ Soft-Flow Aortic Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.

The Sarns™ High-Flow Aortic Arch Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.

The design of the Sams™ High-Flow Aortic Arch Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.

The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir(s) is (are) used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The reservoir may also be used for Post Operative Chest Drainage Procedures. The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours. The CAPIOX® RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min when used with a 3 Liter Reservoir). The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The modified and predicate Capiox RX Oxygenator utilize a porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A wound fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The modified and predicate Capiox RX device have an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood. With respect to the filtration of blood, the modified Capiox RX Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood. The subject of this Special 510(k) is a modification being made to the Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K062381) - except that a positive pressure relief valve will be included on the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures.

The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.) The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line. And the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours.

The modified and predicate Capiox SX Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The modified and predicate Capiox SX Oxygenator has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood. With respect to the filtration of blood, the modified and predicate Capiox Hardshell Reservoir relies upon mechanical entrapment of particulates and emboli within the filter media as a means to remove those particulates from the blood. The design of the modified Capiox SX oxygenator device is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K961000, K962667, K993772, and K013526) except that a positive pressure relief valve will be included in the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures. The materials that are used in the construction of the CAPIOX® SX Oxygenator/Hardshell Reservoir may include, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene, and X-Coating™.

The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI™ 500 Monitor - Arterial and/or Venous Blood Parameter Modules (BPM) - CDI™ Hematocrit/Saturation (H/S) Probe - CDI™ 540 Gas Calibrator and Calibration Gases (A and B) - CDI™ 510H Shunt Sensor - Shunt Bypass Line - CDI™ H/S Cuvette with or without extension tubing - Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) - Printer Paper The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

The TLink™ DMS is an electronic clinical record keeping and reporting system indicated for use in collecting, displaying, storing and managing data from external medical devices. The system facilitates the creation of electronic patient records and enables post-procedural case reviews. Data and records can be viewed on local workstations or transferred to a central computer or hospital network for storage and post-case analysis/reporting.

The TLink™ DMS consists of the TLink™ software and hardware accessories including computers meeting minimum requirements, data entry devices (barcode laser scanner, touch screen stylus, keyboard), mounting trays and brackets, and serial converters. The system can interface with a variety of external medical devices including, but not limited to, heart-lung machines, blood parameter monitoring systems, centrifugal systems, blood gas devices, patient monitors and anesthesia monitors. Case data can be entered manually by the user or collected automatically from independent medical devices. Screen layouts are customizable to meet hospital and user requirements for patient/case records. Physiological data can be graphed at user defined time intervals for event recording. Certain calculations routinely performed by the clinician during surgery can be performed by the TLink™ DMS, e.g., Body Surface Area (based on patient height and weight data) and Fluid Balance (based on fluid input and output data). Case templates and administrative information are developed on a central computer and transferred to the satellite computer(s) connected to the external medical device(s) in the procedure rooms. Case records are then transferred back to the central computer or hospital information system for central storage and post-case analysis/reporting. All transfers between satellite and central computers are via network and/or removable media. A variety of post-procedure reports are available including case report, clinical activity, case checklist, quality assurance, audit summary report, and audit detail report.

The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.