AMICUS Separator System
20 April 2012
Owner and Contact Person:
Three Corporate Drive
Lake Zurich, Illinois 60047
Owner/Operator Number 9098803
|Barry G. Hicks|
Manager, Regulatory Affairs
Three Corporate Drive, 2nd Floor
Lake Zurich, Illinois 60047
AMICUS Separator System
The following disposable kits are affected by the modifications described in this premarket notification:
|Fenwal Product Code Number||Product Name|
|4R2337||AMICUS Apheresis Kit, Single Needle with Platelet Additive Solution Connector|
|4R2340||AMICUS Apheresis Kit, Double Needle with Platelet Additive Solution Connector|
|R4R2326||AMICUS Mononuclear Cell (MNC)Apheresis Kit, Double Needle|
Automated Blood Cell Separator (Centrifugal Separation Principle)
21 CFR 864.9245 - Automated Blood Cell Separator
Automated blood cell separators which are based on centrifugation technology have been classified by the Center for Biologics Evaluation and Research as Class II devices with Special Controls (Docket 2005N-0017, Final Rule 30 November 2007).
81 GKT (Hematology) –Separator, Automated, Apheresis
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
Fenwal Inc. is claiming substantial equivalence of the disposable apheresis kits with the 0.2 micron filter component sourced from a new vendor described in this 510(k) to the currently marketed versions of the kits cleared under BK000047 (31 July 2002) and BK090065 (04 March 2010). This includes associated operating protocols and interfaces to or with the apheresis instrument.
The AMICUS Separator System is a continuous flow centrifugal device that separates whole blood into its components. The operator is responsible for preparing and monitoring the donor and operating and monitoring the AMICUS Separator during the procedure.
The operator controls the separator through a touch screen. When necessary, the operator is notified of potential problems with the procedure or the instrument via on-screen messages and corresponding audible alarms.
Whole Blood and its components are collected using sterile fluid path single use apheresis kits. These kits are provided in either closed or functionally closed configurations. The blood components are separated within the kit by differences in density during centrifugation. Kits are packaged in recyclable plastic trays.
Modifications to the kits associated with this 510(k) are not intended to add, delete, or modify information regarding the description of the device.
Modification of Existing Device:
AMICUS Separator System disposable kits with spike assemblies have been modified to incorporate a 0.2 micron filter supplied by a new vendor. No changes have been made to the design or function of the hardware or the disposable kits.
Statement of Intended Use:
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:
- Platelet Pheresis, Leukocytes Reduced (single, double, or triple units)
- Platelet Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double, or triple units)
- Fresh Frozen Plasma (FFP)
- Source Plasma
- Red Blood Cells, Leukocytes Reduced (by apheresis)
- Mononuclear Cells
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)
Modifications to the kits associated with this 510(k) are not intended to add, delete, or modify information as described in labeling regarding the intended use of the device or the disposable kits.
Technological Characteristics as Compared to the Predicate Device:
Technological characteristics of the AMICUS Separator and the disposable kits remain the same as currently cleared. Modifications to the kits associated with this 510(k) are not intended to add, delete, or modify information regarding the technological characteristics of the device or the disposable kits.
Design Control Activities:
Design control activities for changes described in this premarket notification were conducted under Fenwal procedures for change control and assessment, risk assessment, and design verification and validation, in accordance with 21 CFR 820 Quality System Regulation requirements. Potential risks associated with the proposed changes were identified and testing was performed to verify that device function was maintained within established specifications.
Performance testing and data in previously cleared filings remains valid for demonstrating instrument and disposable kit performance.Additional testing and data described in this 510(k) was performed to verify that device function was maintained within established specifications.
The AMICUS disposable kits with the 0.2 micron filter component sourced from a new vendor described in this 510(k) are substantially equivalent to the current cleared and marketed devices.