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BK110023 Summary

Doc. TypeSystem
FDA 510KSPI

Title:
Version:
Date from:
Replaces Document:
Valid for SPI Version/Build:
510(k) summary for SPI 3.1.0
01
December 09, 2010
New
3.1.0

Approvals:

Role*FunctionName
AAuthorb(4)
T,CITAndrew Matys (CSL Behring AG)
FQAPeter Stettler (CSL Behring AG)
*A: Author, T: Technical check, C: Overall content check, F: Formal check
Distribution list:N/A
  
Document filed in:"Systemdocumentation SPI"

510(k) Owner Information and Contact During Review

Applicant/OwnerCSL Behring AG
AddressWankdorfstrasse 10
3014 Bern
Switzerland
License No.1766
Direct phone+41 (0)31 344 12 48
Direct fax+41 (0)31 344 12 13
e-mailAndrew.Matys@cslbehring.com
Contact PersonAndrew Matys
DateMay 10, 2011

Device Information:

Supplierb(4)
ProductSystem for Plasma Identification (SPI), version 3.1.0
Product Trade NameSPI version 3.1.0
Common NameBlood Establishment Computer Software
Classification NameUnclassified (no classification regulation)
Product CodeMMH

Predicate Device Information:
Substantial equivalence is claimed to the following device, which is a predecessor software version of the SPI 3.1.0.

Predicate Device I

System for Plasma Identification (SPI) 2.0.0 (BK020020), cleared on November 22, 2005.
510(k) OwnerZLB Behring AG, Bern, Switzerland (now called CSL Behring AG)

Intended Use:
As the predicate device, SPI is a software application used to organize and control the transport of plasma from collection facilities to fractionators.

The features of SPI are as follows:

1.Center
 o Upload unit, carton and shipment information from collection facility data systems via electronic interface.
 o Create unit, carton and shipment information manually as necessary.
 o Identify and assign ancillary shipment contents, supplies and test kits.
 o Specify shipping statements as required by the fractionator to receive shipments processed.
 o Format and generate carton identification and shipping labels.
 o Record and resolve unit, carton and shipment discrepancies.
 o Create and iterate the status of post donation information notes.
 o Create staff members eligible to access the Center module of SPI.
 o Restrict shipment from center based on minimum testing requirement.
2.Consignee
 o Receive shipments from collection facilities.
 o Raise and report shipment and carton discrepancies.
 o Load cartons into containers designed and prepared by the fractionator.
 o Generate shipping documentation.
 o Process shipments to fractionator.
 o Report and investigate container discrepancies.
3.Fractionator
 o Design containers to be loaded by and received from consignees.
 o Consolidate shipments received from consignees.
 o Receive shipments from consignees and verify containers received.
 o Scan shipments into bins manually or via conveyor.
 o Label and sequence pools.
 o Transfer shipments, cartons and bins between storage locations.
 o Receive and follow post donation information notes to resolution.
 o Design pools and pool plasma as required.
 o Receive test results and resolve associated discrepancies.
4.Testing Laboratory
 o Electronically receive test result information from testing laboratories.

Device Description:
The System for Plasma Identification (SPI) is designed to provide collection facilities with the ability to directly communicate shipment information to their fractionator and to provide the fractionator with a control and communication mechanism that allows the fractionator to determine the flow of plasma shipments from a range of collection facilities, communicate post donation information to their collection facilities and sort, warehouse and pool the plasma it receives.

Technological Characteristics:
The SPI 3.1.0 system is technologically similar to the predicate device. Utilizing the same software architecture as SPI 2.0.0, SPI 3.1.0 runs on an upgraded version of an Oracle database.

Functionality and logical process management within SPI 3.1.0 are the same and are performed the same way as in the predicate device. The SPI 3.1.0 software code is congruent to the code of the the predicate device.
The major difference between SPI 2.0.0 and SPI 3.1.0 is an upgrade of the hardware and operating system. In addition, some smaller software bug fixes have been included in SPI 3.1.0 (for more details see "Substantial Equivalence" discussion).

Summary of Safety and Efficacy:
A complete software revalidation has been performed for SPI 3.1.0. A hazard analysis has been developed and all hazards identified have been mitigated. The application revalidation included: 

 
o
GxP compliance
 
o
Business compliance
 
o
Risk Management

The revalidation of SPI in version 3.1.0 has been carried out successfully. As the predicate device, SPI can be considered as safe and effective for its intended use.

Conclusion:
Based on the indications for use, technological characteristics and performance testing, the applicant has determined that the device SPI 3.1.0 is as safe and effective as the predicate devices.