(193 days)
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.
The provided document is a 510(k) Premarket Notification from the FDA for the Fresenius Kabi AMICUS Separator System. This document is a regulatory approval letter and a summary of the device and its modifications, not a study report. As such, it does not contain the detailed performance study data, acceptance criteria, ground truth establishment methods, or sample sizes typically found in a clinical study report or a pre-market approval application for a novel device or a significant new indication.
The document states that the primary changes to the AMICUS device are:
- Replacement of obsolete controller circuit boards and associated redesign of other internal boards.
- Modification to the rear door design to accommodate new USB ports, Ethernet port, serial port, and Wi-Fi antenna.
- An update to the 6.0 software, including a change in the operating system from pSOS to QNX, to run on the proposed device with the new hardware.
- Qualification of a new off-the-shelf USB barcode scanner.
It explicitly states: "The software changes do not involve changes to the core blood component collection or therapeutic procedure functionality." and "The AMICUS disposable apheresis kits remain the same as the currently cleared kits, including design, materials and manufacturing methods."
The conclusion section states: "Software and systems verification testing of impacted requirements were performed with the replacement hardware components and updated 6.0 software. Regression testing was performed including paired testing with the predicate device on key product quality and performance characteristics. Results from the software and systems verification testing indicate that the subject device is as safe and performs as well as the predicate device."
Therefore, based on the provided text, I cannot extract the specific information requested in the prompt regarding acceptance criteria tables, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies, because these types of studies were not conducted or reported in this 510(k) summary for a device modification, where the manufacturer is claiming substantial equivalence to a previously cleared predicate device due to hardware and software updates that do not alter core functionality. The "performance data" section primarily refers to verification testing (software and systems verification, regression testing compared to predicate, and electrical safety/EMC testing) rather than clinical performance studies with human subjects or expert readers that would typically involve the criteria you've listed.
In summary, the document describes a device modification rather than a new device or significant new indication. The approval relies on demonstrating substantial equivalence to existing, cleared devices, primarily through engineering verification and validation testing, and not necessarily new extensive human-based performance studies as would be the case for an AI/ML algorithm with diagnostic capabilities.
§ 864.9245 Automated blood cell separator.
(a)
Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.(b)
Classification. Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”