May 19, 2011
Owner and Contact Person:
|Owner/Operator||Owner/Operator #: 9098803
Three Corporate Drive
Lake Zurich, IL 60047
Regulatory Affairs Specialist
Three Corporate Drive
Lake Zurich, IL 60047
AMICUS Separator System
Automated Blood Cell Separator (Centrifugal Separation Principle)
21 CFR 864.9245
Automated blood cell separators that are based on centrifugation-type 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-Nov-07).
Device Description :
The AMICUS separator and disposable apheresis kits constitute a system for centrifugal blood separation. The AMICUS separator system is comprised of the AMICUS separator instrument, spool, spool holder and a disposable device specific to the procedure being performed. The separator instrument is a continuous-flow, centrifugal device that separates whole blood into its components. The instrument operates using pumps, clamps and valves that move patient blood through a single-use, sterile fluid path disposable kit with the use of saline. The cells are centrifugally separated within the kit by density differences.
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 warned of problems with messages on the screen and 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.
Modification to the Existing Device:
Software version 4.3 has been created for use with the AMICUS separator. This new software adds the ability to receive donor and procedure parameters from the Fenwal DXT Relay system, with User Confirmation. Additionally, for platelet procedures, the calculation for "Total Plasma Loss" and "Total RBC Loss" has been automated and is displayed and output as part of the procedure results.
The AMICUS Operator's Manual has been updated to include information on the software enhancements and to allow for exported data to be used for medical decision making.
Statement of Intended Use:
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/μL.
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)
- Fresh Frozen Plasma
- Source Plasma
- Red Blood Cells, Leukocytes Reduced (by apheresis)
- Mononuclear Cells
Platelets 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 (lntersol) (single, double, triple).
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
Fenwal, Inc. is claiming substantial equivalence of the revised AMICUS separator system with the currently marketed version of the AMICUS separator system. This includes all operating protocols and changes previously cleared for the AMICUS separator system.
Technological Characteristics as compared to the Predicate Device:
The AMICUS Separator hardware and disposables remain unchanged from the existing AMICUS Separator System. The only difference between the systems is a software revision that allows for the use of two-way communication to program the procedure parameters. The data which is sent must be confirmed by the operator and still gets checked by the AMICUS separator to ensure that the values are within the procedures limits. It is treated the same as data entered manually.
This new software also allows for the display/reporting of additional parameters that could only be calculated manually in previous versions of software, and associates additional data with the exported event records.
Verification and Validation testing was performed on AMICUS 4.3 software. This testing demonstrates that the device is as safe and effective as the predicate device(s). Additionally, risk controls are in place to ensure the safe and effective usage of exported data for medical decision making.