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The Haemonetics® Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.

The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615) The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615) The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615) The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615) The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: - Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)(BK960005, BK990009) - Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol)(single, double or triple units) (BK090065) - Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039) - Mononuclear Cells (BK000047) - Plasma (BK960005, BK120041) - Fresh Frozen Plasma - Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy. - Plasma Frozen Within 24 Hours After Phlebotomy (PF24) - Must be stored at 1-6°C within eight hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. - Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) - Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. - Source Plasma The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter. Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double or triple units). The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure."

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a singleuse, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alerts. Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615) The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615) The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615) The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615) The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: - · Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) (BK960005) (BK990009) - · Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units) (BK090065) - · Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039) - Mononuclear Cells (BK000047) - · Plasma (BK960005, BK120041) - o Fresh Frozen Plasma · Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) - Must be stored at 1-6℃ within 8 hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy. · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) - · Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. o Source Plasma The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. (BK080018) Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double, or triple units). (BK090065) The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure." (BK040059, BK150242)

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms. Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in Therapeutic Plasma Exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System is an automated blood component separator indicated to perform Red Blood Cell Exchange (RBCX), including Exchange and Depletion/Exchange procedures, for the transfusion management of Sickle Cell Disease in adults and children. (K180615) The AMICUS Exchange Kit - Therapeutics is indicated for use in Therapeutic Plasma Exchange (TPE) and Red Blood Cell Exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615) The Waste Transfer Set is indicated for use in Red Blood Cell Exchange (RBCX). The set is for use with the AMICUS separator. (K180615) The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms. Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The Haemonetics Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection. The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite/Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The subject of this Special 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System software and hardware to enable use of wired and wireless connectivity.

The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: - · Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) - · Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units) - · Red Blood Cells, Leukocytes Reduced (by apheresis) - Mononuclear Cells - Plasma - o Fresh Frozen Plasma - · Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) - · Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) - Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. - o Source Plasma Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double, or triple units). The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure." NOTE - No changes to the AMICUS Separator System indications for use are requested in this 510(k) filing.

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms. Once the cell separation is complete, the operator removes the needle(s) from the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The Haemonetics Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection. The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm. The Cell Saver Elite System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The AMICUS Separator System is an automated blood cell separator intended for use in therapeutic apheresis applications and may be used to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator intended for use in the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: - Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) . - Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double . or triple units) - Red Blood Cells, Leukocytes Reduced (by apheresis) . - . Mononuclear Cells - Plasma . - o Fresh Frozen Plasma - . Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) - Must be stored at 1-6°C within 8 hours after phlebotomy and placed . in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma. - o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) - . Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. - Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma. - o Source Plasma Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences. The operator is responsible for preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms. Once the cell separation is complete, the operator removes the needle(s) from the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange procedure. For use with the AMICUS Separator System.

The AMICUS separator is a continuous-flow, centrifugal device that separates whole blood into its components. Blood components are collected using sterile fluid path, single-use, apheresis kits. The cells are centrifugally separated within the kit by density differences. The Therapeutic Plasma Exchange (TPE) procedure is an apheresis collection procedure coupled with an infusion procedure. The collected plasma, which contains most of the anticoagulant, is pumped to a waste container(s). The patient's WBCs, the majority of platelets and a small amount of plasma and anticoagulant are mixed with a physician-prescribed replacement fluid, such as FFP, human albumin and/or crystalloid solutions, and returned to the patient. This process continues until the target plasma volume has been removed and replaced per physician order. The operator is responsible for preparing and monitoring the patient as well as operating and monitoring the AMICUS separator during the TPE procedure. The operator controls the separator through a touch screen. When necessary, the operator is alerted to problems, or given notes via messages displayed on the screen with corresponding audible alarms. Once complete, the operator disconnects the donor/patient, removes the kit, and disposes of the kit per institutional SOPs. The kit is packaged in a recyclable plastic tray. The Blood Component Filter Set with Vented Spike and Luer Adapter is an optional accessory intended to be used in conjunction with the AMICUS Separator System in Therapeutic Plasma Exchange (TPE) procedures to administer physician prescribed replacement fluids during the TPE procedure, when blood component filtration is needed (e.g. when using fresh frozen plasma). The filter set has a common blood transfusion set design and is comprised of a blood component filter, tubing, vented spike and a luer lock/cap. The filter set is a single use, sterile fluid path intravascular administration set. The filter set is connected to the TPE kit via the male luer connector and the vented spike is used to access the prescribed replacement fluid container. The flow rate through the filter set is controlled by the AMCUS Separator System.