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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK090082 Summary

510(k) Summary

1.Submitter Information
 510(k) Owner:Biomat USA, Inc.
 Contact Person:Charles E. Auger
 Address:13111 Temple Avenue
  City of Industry, CA 91746-1510
 Telephone No.:(323) 441-7711
 Fax No.:(323) 441-7913
 Date:28 September 2010

 

2.Device
 Trade Name:SGP Version 7.0 (Plasma Management System)
 Common Name:Blood Establishment Computer Software
 Classification Name:Unclassified
 Product Code:MMH

 

3.Predicate Device
 Name:System for Plasma Identification (SPI), Version 2.0.0
 Classification:Unclassified
 Product Code:MMH
 510(k) No.:BK050078
 Manufacturer:ZLB Behring AG

 

4.Device Description
 

SGP Version 7.0 (Plasma Management System) is a software application designed to manage the logistics of plasma from the central warehouse through distribution to a customer or fractionation facility.

Radio Frequency Wireless Technology, utilizing IEEE 802.11b protocol and Radio Frequency Terminals, is used for limited functions within SGP v7.0. Use is restricted only to the movement of cases and pallets within the warehouse, and is not involved with the identification of individual plasma units.

Functions included in SGP version 7.0 are as follows:

  1. Reception/Data Introduction
  2. Rejects Registration
  3. Plasma Clearance
  4. Final Shipment Preparation
  5. Data introduction of Post Donation Information and Look-Back Communication
  6. Other Functions:
  • Warehouse Management
  • Deviation Management
  • Customer Sample Logistics

Wireless capabilities are used within the Reception function for case logistics, such as shipment case assignment and cancel shipment case assignment.

Within the Warehouse Management function, wireless capabilities are used for pallet logistics, such as building pallets, removing cases, locating pallets, removing pallets, setting up special pallets, location content query, and physical inventory check.

 

5.Intended Use
 

SGP (acronym for Sistema de Gestión del Plasma or Plasma Management System) Version 7.0 is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities, from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
SGP main functions are:
 

  1. Reception/Data Introduction: Maintenance of plasma unit inventory, controlling locations at the warehouse.
  2. Rejects Registration: Control of individual plasma unit status (pending, released, or rejected for delivery to the fractionation facility).
  3. Plasma Clearance: Assist in the process of 100% inspection of units prior to their shipment to a customer or to a fractionation facility.
  4. Final Shipment Preparation: Organization of shipments to a customer or to fractionation facility.
  5. Data Introduction of Post Donation Information and Look-Back Communication: Assist in the segregation of plasma units due to both post-donation information and look-backs.
  6. Other Functions: Furthermore, the system has a set of other functions relating to warehouse management, deviation management, and customer sample logistics.

 

6.Technological Characteristics
  
 

SGP 7.0 application is based on Oracle 10g Database running on HP-UX platform and Oracle Internet Application Server running on Windows 2000 or 2003 Server.

SGP Client workstations require Windows 2000 or XP Professional and Internet Explorer as a browser to access Oracle Internet Application Server.

Below are comparison tables for intended use (Table 6.1) and technological characteristics (Table 6.2) between SGP 7.0 and SPI 2.0.0 ZLB Behring AG.

 

Table 6.1: A Comparison of Intended Use Between SGP 7.0 Biomat USA, Inc. and SPI 2.0.0 ZLB Behring AG
SGP 7.0 (Applicant: Biomat USA, Inc.)SPI 2.0.0 (Applicant: ZLB Behring AG)

SGP (acronym for Sistema de Gestión del Plasma or Plasma Management System) Version 7.0 is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities, from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.

SGP main functions are:

  1. Reception/Data Introduction: Maintenance of plasma unit inventory, controlling locations at the warehouse.
  2. Rejects Registration: Control of individual plasma unit status (pending, released, or rejected for delivery to the fractionation facility).
  3. Plasma Clearance: Assist in the process of 100% inspection of units prior to their shipment to a customer or to a fractionation facility.
  4. Final Shipment Preparation: Organization of shipments to a customer or to fractionation facility.
  5. Data Introduction of Post Donation Information and Look-Back Communication: Assist in the segregation of plasma units due to both post-donation information and look-backs.
  6. Other Functions: Furthermore, the system has a set of other functions relating to warehouse management, deviation management, and customer sample logistics.
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 communications 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.

 

Table 6.2:A Comparison of Technological Characteristics Between SGP 7.0 Biomat USA, Inc. and SPI 2.0.0 ZLB Behring AG
SGP 7.0 (Applicant: Biomat USA, Inc.)SPI 2.0.0 (Applicant: ZLB Behring AG)
SGP 7.0 application is based on Oracle 10g Database running on HP-UX platform and Oracle Internet Application Server running on Windows 2000 or 2003 Server.The SPI 2.0.0 utilizes the same software architecture, and is operated on the same database as SPI 1.0.
SGP Client workstations require Windows 2000 or XP Professional and Internet Explorer as a browser to access Oracle Internet Application Server.SPI Version 2.0 operating system is Windows 2000 with an Oracle 9i database. The application uses HTTPS protocol exchange data through the Internet and uses a Java Applet running on the client workstation to display the application.

 

7.Summary of Safety and Efficacy 
 The SGP Version 7.0 system has been designed, developed and implemented and all detected hazards were mitigated in order to install this software in Biomat, USA Inc. All the identified hazards were mitigated to an acceptable level, and therefore, the SGP application assures its intended use in terms of safety and effectiveness.