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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK100056 Summary

510(k) Summary

Date Prepared:

August 31, 2010

Owner and Contact Person:

Owner/OperatorOwner/Operator #: 9098803
 Fenwal, Inc.
 Three Corporate Drive
 Lake Zurich, IL  60047
Contact Name:Kathleen Crowder
Title:Sr. Manager, Regulatory Affairs
Address:Three Corporate Drive
 Lake Zurich, IL  60047
Telephone847-550-7947
Fax847-550-2960
E-mail:kathleen.crowder@fenwalinc.com

Trade Name(s):

(4R5707, 4R5725)      ALYX Component Collection System

Common Name:

Automated Blood Cell Separator (Centrifugal Separation Principle)

Classification Name:

21 CFR 864.9245 Automated Blood Cell Separator

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

Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:

Fenwal, Inc. is claiming substantial equivalence of the revised ALYX Component Collection System with the currently marketed version of the ALYX Component Collection System which was cleared to market under 510(k) BK010033 on December 19, 1996, along with its additional operating protocols, software updates and disposables changes that were subsequently cleared.

Description510(k) NumberClearance Date
Automated Component Collection SystemBK01003308/27/2002
Cygnet 2RBC Female DonorBK02005611/18/2002
ALYX Component Collection System (Plasma)BK02005901/23/2003
ALYX/AMICUS effect of freezing and irradiationBK03008503/15/2004
ALYX Component Collection System (RBC-Plasma)BK04008403/15/2005
ALYX Component Collection System (2RBC-NLR Kit)BK06006102/09/2007
ALYX Electronic RepackagingBK08002406/24/2008
ALYX Component Collection System: SW 3.0 Single Unit RecoveryBK08005312/22/2008

Device Description:

The ALYX instrument and disposable apheresis kits constitute a system for centrifugal blood separation. The system is intended for use in blood collection establishments for the collection of blood products, the composition of which depends on the disposable kit and software protocol used. The instrument has pumps, clamps, and valves that move donor blood through the single-use, sterile fluid path disposable kit. Blood components are collected with the kit-defined solutions, and saline is administered intermittently to the donor throughout the process.

Statement of Intended Use:

The ALYX 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,
- Source Plasma
• Collection of Plasma as
- Fresh Frozen Plasma,
- Source Plasma

The intended use of the ALYX Component Collection System has not been changed as a result of the modifications that have been made, although the protocol-specific indications have been enumerated.

Technological Characteristics as compared to the Predicate Device:

The ALYX instrument itself remains the same. The only difference is that ALYX 3.0 software allows the use of data export via the Ethernet port. An optional off-the-shelf wireless adaptor accessory may be used to add wireless technology to the complete facility computer system.  The wireless technology enables the ALYX Instrument to export data via the Wi-Fi adapter, which 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 standard encrypted format
  • Allow easier movement of devices in the center by eliminating the need for Ethernet cabling for data export.

Performance Data:

Software Verification and Systems Validation including the data export functionality were performed under the ALYX SW 3.0 development project prior to market release. Testing has been conducted to verify the safety and performance of the ALYX Component Collection System with Wireless Modification. EMC, Electrical Safety, Validation, and Coexistence testing were completed successfully.

Conclusion:

Based on the validation and verification activities performed on the ALYX Component Collection System with the Lantronics WiBox, the ALYX instrument can export donation, procedure and instrument data using either an Ethernet cable or a wireless adaptor.