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Valid for SPI Version/Build:
|510(k) summary for SPI 3.1.0|
December 09, 2010
|T,C||IT||Andrew Matys (CSL Behring AG)|
|F||QA||Peter Stettler (CSL Behring AG)|
|*A: Author, T: Technical check, C: Overall content check, F: Formal check|
|Document filed in:||"Systemdocumentation SPI"|
510(k) Owner Information and Contact During Review
|Applicant/Owner||CSL Behring AG|
|Direct phone||+41 (0)31 344 12 48|
|Direct fax||+41 (0)31 344 12 13|
|Contact Person||Andrew Matys|
|Date||May 10, 2011|
|Product||System for Plasma Identification (SPI), version 3.1.0|
|Product Trade Name||SPI version 3.1.0|
|Common Name||Blood Establishment Computer Software|
|Classification Name||Unclassified (no classification regulation)|
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) Owner||ZLB Behring AG, Bern, Switzerland (now called CSL Behring AG)|
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:
|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.|
|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.|
|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.|
|o Electronically receive test result information from testing laboratories.|
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.
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:
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.
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.