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The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.

The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.

The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key, and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.

The Stöckert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a cardiopulmonary bypass speed control device that is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP System TC has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures. The SCP System TC controls a Tubing Clamp that is positioned at the pump outlet to occlude the arterial line if the reservoir blood level, microbubble activity, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure.

The Stockert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a modification of the Stöckert Centrifugal Pump (SCP). The proposed SCP System TC is identical in intended use and fundamental scientific technology to the parent SCP. The parent SCP is identical to the proposed SCP System TC with the exception of the addition of an Electrical Remote-Controlled Tubing Clamp (Tubing Clamp) that is positioned at the pump outlet to occlude the arterial line. The Tubing Clamp is designed to automatically close if the reservoir blood level, microbubble activity, flow rate, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure. The Tubing Clamp can also be manually opened and closed by the operator via membrane keys on the SCP Pump Control Panel. The proposed Tubing Clamp is connected to the Stöckert Centrifugal Pump Console (SCPC System) or a Stöckert Compact (SC) or Stöckert S3 System (S3) heart-lung machine console via a CAN/24V connection cable. Mains power and emergency power is provided by the connected SCPC System or SC/S3 System. Both automatic and manual operation of the clamp is controlled via the SCP System microprocessor control system.

The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.

The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip. The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.

The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava. The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.

The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit: - . Pressure - Temperature . - Level monitoring/bubble detection . - Elapsed time . The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.

The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components: - SCP Control Panel . - SCP Drive Unit . - Flow Probe . - Emergency Drive Unit . The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.