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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK100043 Summary

510(K) SUMMARY


MANUFACTURER SUBMITTING 510(K) NOTIFICATION:

Mediware Information Systems Inc.
1900 Spring Road, Suite 450
Oak Brook, IL 60523 

CONTACT PERSON:

James McGaha
Director of Regulatory Affairs and Quality Assurance
1900 Spring Road, Suite 450
Oak Brook, IL 60523 

DEVICE NAME:

Proprietary Name:
Common Name:
Classification Name:
LifeTrak®/Donor, Version 4.6.0
Software, Blood Bank, Stand Alone
Unclassified

PREDICATE DEVICES:

LifeTrak®/Donor, Version 3.01
ePROGESA - Version 5.0.1 

DEVICE DESCRIPTION:

The LifeTrak®/Donor system is a stand-alone blood bank software device that aids in the management of blood donors, their eligibility status, donations, deferrals, notification, communication, registration with health history and physical findings, and on-line donor questionnaire to be utilized by center staff and/or the donor, special donation registration, and HLA/RBC capabilities. Additionally, LifeTrak®/Donor includes mobile recruitment, telerecruitment, fixed site management, staff scheduling, and production control/transportation. LifeTrak®/Donor is usable with wired/wireless networks supporting TCP/IP protocol.

INDICATIONS FOR USE:

LifeTrak®/Donor is a computerized system intended to be used by trained staff who are actively engaged in functions that encompass:

• Maintaining a reliable donor database
• Rolling donor eligibility status
• Registering and auditing donations and deferrals
• On-line health history, physical findings, and donor questionnaire
• Inter-active donor questionnaire (staff and/or donor)
• Maintaining accurate records of communication with donors
• Donor notification
• HLA/RBC searching and matching
• Special donations registration
• Organizing mobile recruitment and telerecruitment activities
• Planning, scheduling, and conducting drives
• Donor scheduling
• Scheduling collection staff
• Maintaining collection goals and calculating achievement statistics
• Production control and transportation for collection activities
• LifeTrak®/Donor is usable with wired/wireless networks supporting TCP/IP protocol 

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE DEVICE:

The following table provides a detailed comparison of the technological characteristics of LifeTrak®/Donor to the predicated devices:

CharacteristicLifeTrak®/Donor,
Version 4.6.0
LifeTrak®/Donor,
Version 3.01
ePROGESA-
Version 5.0.1
DatabaseOracle RDMSOracle RDMSOracle RDMS
Server
Operating
System

Oracle Enterprise
Linux AS Release 5
Update 4

Or

Red Hat EnterpriseLinux AS Release 5 Update 4

Compat-Oracle-
rhe 14-1.0-5i.386.rpm

Oracle Enterprise Edition (EE) Oracle 109 R2 (10.2.0.4) for Linux Intel

Or

Oracle Standard
Edition (SE) Oracle
10g R2 (10.2.0.4) for Linux Intel

Oracle Application Server Forms and Reports Services (10.1.2.0.2) Linux x86 (32-bit) with patch 3 (10.1.2.3)

Database:
HP 9000 systems --
HP UX 11 (B.11.00)
Oracle 9i (9.2.04)
Enterprise Edition

Or

Intel based Unixsystem -- Red Hat
Linux Version
AS/ES 2.1 (2.4.9)
Oracle 9I Standard
Edition (9.2.0.4)

Or

Intel based NT
systems -- NT 4 with
Service Pack 6

Application:
MS Windows NT 4
with SP6
Windows 2000
Server with SP2

FTP server

Sun Solaris 10.5 or
IBM AIX or HP/UX
11 or Linux
WebSphere,
WebLogic, Tomcat
Server
Hardware
Xeon 5460(3.16
GHz 1333FSBO
8GB memory
Integrated RAID
Controller
2x72 GB Disks
Raid1
2x146 GB Disks
RAID1
2xGigabit Ethernet
Base TLAN Adaptor

Large Unix Systems
(HP-UX) - HP 9000
PA-RISC based
processor

Or

Small Unix System
(Linux) - Intel CISC
based processor

Or

Windows NT
Systems - Intel
CISC based

SUN VSeries or IBM PSeries or HP 9000 Series or Intel - Xeon server
Client
Operating
System- workstation

Microsoft Windows XP SP2/SP3

Or

Microsoft Windows Vista

MS Windows NT 4.0 Workstation or
Server with SP 6a
MS Windows 20000
with SP2
MS Windows XP
with SPI
Microsoft Windows 2000 or Windows XP or Vista
Client
Hardware - workstation
Pentium 4 CPU 3 GHz1GB RAM
80 GB Hard Drive
Intel 10/100 Ethernet
Network Interface
Card (NIC)
Printers:
Canon Bubblejet
BJC-80
Okidata inkjet
OkiPage 8W
Bar Code Scanners:
Symbol LS2208-
SR20401R
Symbol LS4004_i
049
Symbol LS2208-
SR20371R
Symbol LS4208
Pentium processor
64 MB RAM base
memory
800 MB disk
available

Ethernet Network
Interface Card

Qualified printers
include:
HP LaserJet 500, 600
series
Canon BJC 80
OkiPage 8W
Epson LQ 870, 1100
series, 2000 series
Epson DFX 5000
series
Qualified bar code
scanners include:
Symbol LS 4004
Welch Allyn IT3800
Welch Allyn ST5700
• Pentium III and IV
• Ethernet compatible or wireless network
Touch Screen: ELO
ET 1715L
PDA:
Symbol/Motorola MC
3090
Signature Tablet:
TOPAZ Systems
model T-L462-HSB
Finger Print: Yubee
DPL 103700YB
Barcode scanner:
Metrologic MS 9520
Mobile PC Operating SystemMS Windows XP
SP2/SP3
MS Windows Vista
Business (remote
upload download
PC)
MS Windows NT 4.0 Workstation or Server with SP 6a MS Windows 20000 with SP2 MS Windows XP with SP2MS Windows 2003 or Linux Tomcat
Mobile PC HardwareLookup PC, Replication Server, Upload/download PC: Lenovo T500 2.20HzCPU 3 OB RAM memory 75 OB hard disk 10/100/1000 Ethernet Interface or Wireless network Client PC:
Lenovo T60
1.8 OHz CPU
1.50BRAM
memory
75 OB hard disk
10/100 Ethernet
Network Interface or
wireless card
Pentium processor 512 MB RAM base memory 10 OB hard disk available PCMCIA or built-in NIC for docking and update• Pentium 3, 40Hz, 4Gb RAM • Ethernet compatible or wireless network

SAFETY AND EFFECTIVENESS DATA:

LifeTrak®/Donor, Version 4.6.0 was developed using an established design control process for software development. The product was subjected to extensive verification and validation testing including system testing to ensure the product meets its intended use including safety critical requirements.

Nonclinical (alpha) testing was performed by Mediware and demonstrates that LifeTrak®/Donor, Version 4.6.0 design input requirements were met. The design validation process demonstrated that LifeTrak®/Donor, Version 4.6.0 meets the requirements for intended use.

Clinical/user site (use acceptance) testing was conducted to validate LifeTrak®/Donor, Version 4.6.0. The results of this user site testing demonstrated that LifeTrak®/Donor, Version 4.6.0 meets the required specifications and functioned as expected with no degradation in response times.

CONCLUSIONS:

Mediware Information Systems, Inc. concludes that LifeTrak®/Donor, Version 4.6.0 is substantially equivalent to the predicate devices listed in that it has the same intended use with similar technological features and capabilities. LifeTrak®/Donor, Version 4.6.0 extends some of the functional capability. Testing was conducted as required by Mediware's Design Control Validation and Verification processes to evaluate the extended functional capabilities of LifeTrak:®/Donor, Version 4.6.0. The results of this testing demonstrates that LifeTrak:®/Donor, Version 4.6.0 performs as expected and that the extended functional capabilities do not effect safety or effectiveness.