510(k) Summary

Submitter’s Name, address, phone number and contact person

Duley Hopkins and Associates

1200 Mountain Creek Road #215
Chattanooga, TN 37405
Voice: (423) 877-1220
Fax: (423) 877-1569

Questions or requests for further information should be addressed to:

Larry Hopkins
President
(423) 877-1220

Date Summary was prepared: 20-November-2009

Date Summary was revised: 05-January-2010

Name of Device

Proprietary Name: Blood Bank Information Management System (BBIMS) v2.05.01

Common Name: Blood Establishment Computer Software
Product Code: MMH

Premarket Notification of Blood Establishment Computer Systems

 510(k) for BBIMS 2.05.01
Identification of Legally Marketed Predicate Devices

BBIMS v2.05.01 is substantially equivalent to the following systems:

Predicate Device 1:

Manufacturer: Misys Healthcare Systems

Common Name: Blood Bank System
Trade Name: Misys Laboratory Blood Bank and Blood Donor version 6.0.1
510(k) number: BK040065

Predicate Device 2:

Manufacturer: Wyndgate Technologies

Common Name: Transfusion Service Management Information System
Trade Name: SafeTrace Tx, Version 1.0
510(k) Number: BK980023 (January 29, 1999)

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 510(k) for BBIMS 2.05.01
Device Description BBIMS 2.05.01

Blood Bank Information Management System (BBIMS)

BBIMS 2.05.01, with its Automated Questionnaire System (AQS) component, is a full service
Blood Bank Information Management System.

BBIMS Features:

Billing
• Generate and Maintain Invoices
• Maintain Billing Codes
• Query Orders and Shipments
• Billing for Transfers

Components
• Component Labeling
• Component Preparation and Maintenance
• Plasma Freezing
• Unit and Component Quarantine
• Receiving Components
• Create Pooled Products

Donor
• Self-administered health history questionnaire
• Donor Registration and validation
• Staff entered physical
• Maintain Donor Information
• Donor Search Capability
• Continuous Donor Record
• Merge Duplicate Donors
• Donation Tracking
• Scheduling of Appointments
• Public web site for scheduling appointments
• Donation Unit Entry (DUE)

Inventory
• Statistics by Blood Type
• Statistics by Product Type
• Shipment Information

Laboratory
• Manual Crossmatch Consultation
• Unit Testing
• Transfer of Test Results from Lab equipment (Surround)
• Maintain Lab Codes
• Cryo Batch Release
• Unit and Component Disposal and Biohazard
• ISBT 128 and Codabar Barcode Support

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 510(k) for BBIMS 2.05.01
Recruiting
• Email Support
• Maintain Groups
• Mobile Drives

Shipping
• Order Processing
• Packing Components
• Shipping Components
• Clearing Recovered Products
• Returns of components

System Administration
• Application Security
• Staff Maintenance
• System Code Maintenance
• Application Maintenance
• Administrative Reports

Auditing
• Completely Configurable auditing by table and action
• Audit reports

Operating Environment

BBIMS 2.05.01 is a modern web-based application intended to be deployed on a secure

corporate intranet and accessed via thin-client workstations using an internet browser.

BBIMS 2.05.01 is implemented in proven-technology Oracle Forms and Oracle Reports from an
Oracle application server platform. BBIMS data is stored in an Oracle database.

BBIMS 2.05.01 has been validated on all of the configurations listed below:

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 510(k) for BBIMS 2.05.01

Validated Operating System and Hardware Implementations

Server Configuration 1)

Application Server
Hardware
Dell PowerEdge 1750, Xeon processor, 2 GB RAM, 150 GB disk
Operating System
Microsoft Windows 2003 Server, service pack 1
Application server technology Stack
Oracle Application Server 10g 10.1 .2 Enterprise Edition
Forms and Reports 10g
Oracle Jinitiator 1.3.1.22
Oracle Webutil 1.0.6
Label Printer Server (runs on the application server machine)
Digi-Trax Hematrax Print Server 3.0.1
Database Server
Hardware
Dell PowerEdge 850, Xeon processor, 2 GB RAM
Operating System
Sun Solaris 10 x86_64
Database Server Software
Oracle Database Server 10g 10.1.0 Enterprise Edition

Server Configuration 2)
Application Server
Hardware
IBM x3650, two dual core Xeon processors, 8 GB RAM, 750 GB disk
Operating System
Oracle Enterprise Linux 4 U6, 86x64
Application Server technology Stack
Oracle Application Server 10g 10.1 .2 Enterprise Edition
Forms and Reports 10g
Oracle Jinitiator 1.3.1.22
Oracle Webutil 1.0.6
Label Printer Server (runs on the application server machine)
Digi-Trax Hematrax Print Server 3.0.1
Database Server
Hardware
IBM x3650, two dual core Xeon processors, 8 GB RAM, 750 GB disk
Operating System
Oracle Enterprise Linux 4 U6, 86x64
Database Server Software
Oracle Database Server 10g 10.2.1 Enterprise Edition

Client
Windows XP Professional workstation
Internet Explorer 7 – Required
Adobe Acrobat Reader – to preview and print reports
Windows Media player – to play audio in health history questionnaire
Printer
Digi-Trax Z4MPlus barcode label printer
Scanner
Symbol Tech. LS-2208 Codabar and ISBT 128
Page 5 Premarket Notification of Blood Establishment Computer Systems
 510(k) for BBIMS 2.05.01

Intended Use

BBIMS v2.05.01 is intended for use by trained healthcare professionals responsible for the safe
collection, preparation, and distribution of blood products in the following ways:
• Self-Administered health history questionnaire to determine donor eligibility
• Staff entered physical to determine donor eligibility
• Provide information regarding the suitability of a donor making a donation
• Defer donors when they are prohibited from making a donation
• Store patient information during the manual crossmatch / consultation process
• Store and review test results for all units processed at a blood center, both through
manual entry and/or instrument interfaces
• Record information about the preparation and maintenance of blood products
• Label components based on Codabar and ISBT standards
• Maintain manufactured and blood product inventories by blood type and product type
• Maintain historical records of all donations made by a donor
• Store component information from products received from other facilities
• Maintain a product history from time received until final disposition
• Perform quality assurance checks and maintain quality assurance records

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Comparison of Technological Characteristics
BBIMS v2.05.01
Operating
Environment
Database Oracle relational database
Configuration 1
10g 10.1.0
Configuration 2
10g 10.2.1
Server OS Configuration 1
Sun Solaris 10 (database)
Windows 2003 Server
(application server)
Configuration 2
Oracle Enterprise Linux
R4u6
Both database server and
application server
Client OS Microsoft Windows XP
professional and Internet
Explorer 7
Programming Oracle Forms and Reports
Language 10g, SQL and PL/SQL
Input Barcode scanner, keyboard,
interfaces with blood
grouping instruments
Table Allows user with security
Administration authorization to add update
or outdate data.
Provides hard-copy listing of
each table and contents.
Contains administrative
functions for the
maintenance of tests
products services and
providers.
Data Backup Data archival and retrieval
Page 7 Premarket Notification of Blood Establishment Computer Systems
510(k) for BBIMS 2.05.01
Misys Laboratory Wyndgate
Bloodbank and SafeTrace Tx, v1.0
BloodDonor v6.0.1
InterSystems Cache Oracle relational
post relational database ver. 7.3
Database version
4.1.12 and 4.1.16
Unix IBM AIX Unix and Windows NT
version 5.1 operating Systems
operating system
(database and
application server)
Microsoft Windows Microsoft Windows
2000 or XP NT
Professional (client
processing
environment)
Visual Basic, Visual Delphi SQL
C++, Cache
Barcode scanner, Barcode scanner,
keyboard, interfaces keyboard, interfaces
with blood grouping with blood grouping
instruments instruments
Allows user with Allows user with
security security authorization
authorization to add to add update or
update or outdate outdate data.
data. Provides functionality
to build user-defined
Provides tables. Provides hard-
functionality to build copy listing of each
user defined tables. table and contents.
Contains
Prints hard copy administrative
listing of each table functions for the
and contents maintenance of tests
products services and
providers.
Data archival and Data backup
 510(k) for BBIMS 2.05.01
and Restore via system level backups retrieval via system
level backups
Access Manages user ID and Manages user ID Manages user ID and
Security password combinations. and password password
combinations. combinations.
Manages access to Manages access to
system across and system. Maintains
within facilities. login histories.
Maintains login Repository for all user
histories. security profiles
across all facilities
Audit Trail Comprehensive history of Comprehensive Audit data changes.
all changes to blood data. history of all Review Audit records
Data accessible for review changes to blood
via blood product history data. Data
report. accessible for
review via on-line
inquiry screen and
blood product
history report

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 510(k) for BBIMS 2.05.01

Description and Conclusions of Testing

BBIMS v2.05.01 was developed and validated using established procedures for software
development. As such, it is anticipated that this system is as safe and effective as, and will
perform as well or better than the identified predicate devices when utilized within its intended use
as verified by the non-clinical testing that was performed.

Non-Clinical Testing

BBIMS v2.05.01 was developed and validated using established procedures for software
development.

Unit and functional testing (including integration) and regression testing was performed internally
by Duley Hopkins and Associates development and quality control personnel.

Duley Hopkins and Associates performed all of the unit testing.

Duley Hopkins and Associates performed all of the functional testing.
Duley Hopkins and Associates performed all of the regression testing.

The assessment of this testing verifies that BBIMS v2.05.01 design input requirements were met.

Clinical Testing

BBIMS v2.05.01 has been beta tested by a commercial blood bank.

beta testing included exactly the same tests conducted by Duley Hopkins and Associates

Duley Hopkins and Associates ensures that all safety critical items have been thoroughly tested
and can demonstrate that all methods of control for intended use and general implementation
hazards have been tested.

Page 9 Premarket Notification of Blood Establishment Computer Systems