August 5, 2010
Owner and Contact Person:
|Owner/Operator||Owner/Operator #: 9098803|
|Three Corporate Drive|
|Lake Zurich, IL 60047|
|Contact Name:||Kathleen Crowder|
|Title:||Senior Manager, Regulatory Affairs|
|Address:||Three Corporate Drive|
|Lake Zurich, IL 60047|
Autopheresis – C Plasmapheresis System
Automated Blood Cell Separator (Filtration Separation Principle)
21 CFR 864.9245 Automated Blood Cell Separator
Automated blood cell separator devices operating by centrifugal or filtration separation principle 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).
81 GKT (Hematology panel)- Separator, Automated, Apheresis
Legally Marketed Device under Which Substantial Equivalence is being Claimed:
Fenwal, Inc. is claiming substantial equivalence of the Autopheresis-C Plasmapheresis System with the currently marketed version of the Autopheresis-C Plasmapheresis System which was approved to market under PMA BP850001 on March 24, 1986 and subsequently downclassified to Class II and cleared under BK100041, along with its additional operating protocols, software updates and disposables changes subsequently reported in PMA Supplements or PMA Annual Reports.
The Autopheresis-C system is an automated plasmapheresis system comprised of the Autopheresis-C Instrument and the Plasmacell-C disposable set. The system achieves a rapid, but gentle separation of whole blood into concentrated cellular components and virtually cell-free plasma by means of a rotating membrane filter. The concentrated cellular components are reinfused back to the donor and plasma collected for transfusion is transfused or processed as Fresh Frozen Plasma (FFP).Collected plasma may also be processed as Source Plasma.
The collection of plasma by the Autopheresis-C system is a fully automated procedure with the donor connected to the disposable set throughout the collection process. Multiple safety systems and alarm functions are incorporated into the plasmaphereisis system to ensure donor and operator safety.
The collection procedure requires a single venipuncture, which means that one access site is used to draw whole blood and return concentrated cellular components. Because of this, the procedure involves sequential cycles of alternating phases, one in which plasma is separated and collected, and the other in which residual cellular components are reinfused. Venous pressure is continuously monitored to optimize fluid flow without exceeding the flow capacity of the donor's vein.
Operating panel keys and message displays allow the operator to control the procedure, gather important information on its status and handle error conditions that may arise.
The Plasma Bridge is an optional component of the Autopheresis-C system, which facilitates data transfer from the Autopheresis-C system to the outside electronic data world. It features both wired and wireless modes of transfer.
Statement of Intended Use
The Autopheresis-C Plasmapheresis System is an automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration. Plasma intended for transfusion must be transfused or processed as Fresh Frozen Plasma within eight hours of venipuncture or in accordance with local regulatory requirements. Collected plasma may also be processed as Source Plasma.
The intended use of the Autopheresis-C plasmapheresis system has not been changed as a result of the modifications that have been made.
Technological Characteristics as Compared to the Predicate Device
The technological characteristics of the Autopheresis-C separator remain the same as the currently marketed device. It is a continuous flow filtration separation device that uses disposable kits made of Nylon, Acrylic, Polyethylene and PVC plastics.
"Turbo Mode" is the Fenwal name for the mode of operation in which the maximum extraction pump speed in 120 mL/min and the maximum reinfusion pump speed is 150 mL/min. This is increased from the current defaults of 100 mL/min and 130 mL/min. Two additional parameters (cuff delay time and vein settle time) are also modified from current defaults.
An optional Plasma Bridge may be used to add wireless and wired data export technology to the Autopheresis-C Plasmapheresis System. The Plasma Bridge collects data from the Autopheresis-C Plasmapheresis System and can:
• Transmit procedure data electronically to an 802.11b/g compatible wireless access point connected to the center's local area network
• Transmit data in a wired (Ethernet) format to the center's local area network
• Transmit data in a standard format (WPA-PSK encrypted, TCP/IP)
Testing has been conducted to verify the safety and performance of the Autopheresis-C Plasmapheresis System with optional Plasma Bridge. EMC, Electrical Safety, Verification, Validation, and Coexistence testing were completed successfully. Clinical testing demonstrated donor safety with Turbo Mode.
Based on the validation and verification activities performed on Autopheresis-C system, the Autopheresis-C Plasmapheresis System with Turbo Mode and optional Plasma Bridge is safe and effective, meets its intended use, and is acceptable for release.