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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK130004 Summary

510(K) SUMMARY

Date Prepared:
February 20, 2013

Owner and Contact Person:

Owner/Operator Owner/Operator #: 9098803
Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL  60047
Contact Name:
Title:
Address:

Telephone:
Fax:
E-mail:
John Maibauer
Regulatory Affairs Specialist
Three Corporate Drive
Lake Zurich, IL  60047
847-550-2966
847-550-2960
john.maibauer@fenwalinc.com

Device Name(s):
ALYX Component Collection System

Common Name:
Automated Centrifugal Blood Cell Separator

Classification Name:
21 CFR 864.9245 Automated Blood Cell Separators
Automated blood cell separators which 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).

Classification Panel:
81 GKT (Hematology panel) - Separator, Automated, Apheresis

Device Description
The ALYX Component Collection System is a continuous-flow, centrifugal device that separates whole blood into its components. The operator is responsible for preparing and monitoring the donor as well as operating and monitoring the ALYX instrument during the procedure.

The operator controls the instrument through a touch screen. When necessary, the operator is notified of potential problems with the procedure or instrument via messages on the screen with corresponding audible alarms.

Blood components are collected using sterile fluid path, single-use, apheresis kits. These kits are provided in either closed or functionally closed configurations. The cells are centrifugally separated within the kit by density differences.

The ALYX instrument can collect plasma concurrently with other blood components, or can collect plasma only. During this process whole blood is collected from the donor and separated by centrifugation into plasma and cellular components.

Indications for Use
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.

Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for:

  • Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced
    • Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced
    • Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as
    • Fresh Frozen Plasma,
      • Must be prepared and placed in a freezer at -18°C or colder within 8 hours of collection
    • Source Plasma
    • Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
      • Must be stored at 1-6°C within 8 hours of collection and prepared and frozen 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 Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
      • Can be stored at room temperature for up to 24 hours after collection. Product must be prepared and frozen within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  • Collection of Plasma as
    • Source Plasma

Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
Fenwal, Inc. is claiming substantial equivalence with the currently cleared version of the ALYX Component Collection System. The ALYX Component Collection System was most recently cleared to market under 510(k) BK120041 on October 4, 2012.

Technological Characteristics as Compared to the Predicate Device
The technological characteristics of the ALYX Component Collection System remain the same as
the currently cleared device. Both devices are continuous flow centrifugal separation devices. They both use sterile fluid path disposable kits made of non-PVC polyolefin and PVC plastics. No
changes have been made to the instrument or the disposable devices used. The ALYX Component Collection System is already cleared for export of data.  This application allows for use of an Ethernet port when a donor is connected.

Performance Data
The following testing was performed in support of this submission:

  • Dielectric Strength testing was performed, in accordance with IEC 60601-1, to evaluate the proposed configuration of 4R5707 while the isolator was connected.
  • EMC Testing was performed to demonstrate that the device still meets emissions standards when an Ethernet cable is connected.
  • Functional testing was done to verify communication while the isolator was connected. The results of the testing were acceptable.

Conclusions:
Based on the validation and verification activities performed, the modifications made to the ALYX Component Collection System provide a device system that is substantially equivalent to the currently marketed ALYX Component Collection System.