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BK120039 Summary

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510(K) SUMMARY

In accordance with 21 CFR 807.92, Mediware submits the following 510(k) Summary for the
LifeTrak®Version 2012, blood bank stand-alone software device:

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

DEVICE NAME:
 

Proprietary Name: LifeTrak®, Version 2012
Common Name: Software, Blood Bank, Stand Alone
Classification Name:       Unclassified

PREDICATE DEVICES:

LifeTrak® /Donor, Version 4.6.0
LifeTrak® /Lab and Distribution, Version 4.6.0

DEVICE DESCRIPTION:

LifeTrak®Version 2012 is a stand-alone software device that consists of three separate components LifeTrak®/Donor, LifeTrak® /Lab, and LifeTrak® /Distribution:

LifeTrak®/Donor is a computerized component 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 is usable with wired/wireless networks supporting TCP/IP protocol.

LifeTrak® /Lab is a computerized component intended to be used by trained personnel who are actively engaged in the management of blood and blood products through: Material Check-in, Component Production, Testing, and Labeling. LifeTrak® /Lab also supports: Nursing Audit, Sample Management, and Imported Blood Processing.

LifeTrak® /Distribution is a computerized component intended to be used by trained personnel who are actively engaged in the management of blood product inventory. The module is designed to track blood products from point of placement into inventory until final disposition to assure that: Only authorized entries or overrides to the system occur, Blood product identified as unsuitable are not released to inventory, Blood products are properly stored, Control of products identified as needing to be quarantined, Blood products that have been identified as unsuitable
are not released for distribution, and Traceability of products is maintained.

INDICATION 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 TCPIIP protocol

LifeTrak®/Lab is a comprehensive modular computerized system intended to be used by trained personnel as a tool in the management of data related component production, testing, and labeling of donated blood and testing of external samples. User access to individual modules is controlled through defined access levels. Modules may be used independently and include the following:

  • Material check-in
  • Component production
  • Testing Labeling
  • Special processing
  • Nursing audit
  • Testing services
  • Imported blood processing

LifeTrak®/Distribution is a comprehensive modular computerized system intended to be used by trained personnel as a tool in the management of data related to order entry and allocation, pricing, order processing, inventory management, packaging and shipping, transfers, customer debit/credit and quality services. User access to individual modules is controlled through defined access levels. Modules may be used independently and include the following:

  • Order Module
  • Distribution Module
  • Inventory Management
  • Offline Data Entry
  • Customer Credit/Debit

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE DEVICES:

The following tables provide a detailed comparison of the technological characteristics of LifeTrak®Version2012 to the predicated devices:

Characteristic:LifeTrak®/Donor, Version 4.6.0LifeTrak® Version 2012
(LifeTrak®/Donor component)
Database

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)

Oracle Standard Edition (SE) Oracle
11g (11.2.0.3) for Linux Intel

Oracle Fusion Middleware (FMW) 11g (11.1.2)  Oracle Forms and Reports for Linux Intel

Oracle Web Logic Server 10.3.5

Oracle JDK 1.6.0_ 29

Server Operating
System

VMWARE ESXi 4.1

Oracle Enterprise
Linux AS Release 5
Update 4

Or

Red Hat Enterprise
Linux AS Release 5
Update 4

Compat-Oracle-
rhe 14-l.0-5i.386.rpm

Oracle enterprise Edition (EE) Oracle
10g (10.2.0.4) for Linux Intel

VMWARE ESXi 4.1

Oracle Linux Release 5 Update 7 (64- bit)

Or

Red Hat Enterprise Linux ES Release 5 Update 7 (64-bit)

Server Hardware

Xeon 5460 (3.16 GHZ 1333FSB) 8GB memory

Integrated RAID Controller

2x72 GB Disks
RAID 1
2x146 GB Disks
RAID 1

2xGigabit Ethernet BaseT LAN
adapter

1 x Intel® Xeron® E5504 (4 core, 2.00 GHz, 4MB L3, 80W
 

12 GB memory

Integrated RAID controller

2 x 72 GB disks in RAID1 configuration (72 GB useable)

2x146GB disks in RAID1 configuration (146 GB useable)

2 x PCI Gigabit  Ethernet BaseT LAN adapter

Client Operating
System - workstation

Microsoft Windows XP SP2/SP3

Or

Microsoft Windows Vista

Microsoft Windows 7

Or

Microsoft Windows XP SP2/SP3

Internet Explorer Version 7, 8 or 9

JAVA JRE Version  1.6.0_29

Adobe Acrobat Reader Version 9 or 10

 

Client Hardware - workstation

Pentium 4 CPU 3 GHz
1 GB RAM
80 GB Hard Drive
Intell 10/100 Ethernet Network
Interface Card (NIC)

Printers:
Canon Bubblejet BJC-80
OkiPage 8W

BarCode Scanners:
Symbol LS2208-SR20401R
Symbol LS 2208-SR 20371R
Symbol LS 4208

2.26 GHz CPU
4 GB RAM
80 GB Hard Drive
Intel 10/100 Ethernet Network
Interface

Printers:
HP LaserJet 4000
HP LaserJet 4015
HP LaserJet 4050

BarCode Scanners:
Symbol DS6708-SR20007ZZR Symbol LS2208-SR20401R
Symbol LS 2208-SR20371R
Symbol LS 4208

Mobile PC Operating
System

MS Windows XP SP2/SP3
MS Windows Vista Business (remote upload download PC)

Microsoft Windows Server 2008 R2
Mobile PC Hardware

Lookup PC, Replication Server, upload/download PC:
Lenovo T500
2.2 GHz CPU
3 GB RAM memory
75 GB hard disk
10/100 /1000 Ethernet Interface or wireless card

2.26 GHzCPU
4GB RAM
250GB hard disk
l 0/100/1000 Ethernet NIC
Intel 5100 wireless network card
Battery

Database

Oracle Enterprise Edition (EE) Oracle l0g 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)

 

Oracle Standard Edition (SE) Oracle 11g (11.2.0.3) for Linux Intel

Oracle Fusion Middleware (FMW) 11g (11.1.2)  Oracle Forms and Reports for Linux Intel

Oracle Web Logic Server 10.3.5

Oracle JDK 1.6.0_29

Server Operating
System

VMWARE ESXi 4.1

Oracle Enterprise
Linux AS Release 5
Update 4

Or

Red Hat Enterprise
Linux AS Release 5
Update 4

Compat-Oracle-
rhe 14-l.0-5i.386.rpm

Oracle enterprise Edition (EE) Oracle l0g (10.2.0.4) for Linux Intel

VMWARE ESXi 4.1

Oracle Linux Release 5 Update 7 (64- bit)

Or

Red Hat Enterprise Linux ES Release
5 Update 7 (64-bit)

Database Server
Hardware

Xeon 5460(3016 GHz 1333FSB)

8GB memory

Integrated RAID Controller

2x72 GB Discs
Raid 1

2x146 GB Discs
RAID 1

2xGigabit Ethernet BaseT LAN Adaptor

 

1 x Intel® Xeon® E5504 (4 core, 2.00 GHz, 4MB L3, 80W)

12 GB memory

Integrated RAID controller

2 x 72 GB disks in RAID1 configuration (72 GB useable)

2x146 GB disks in RAID1
configuration

2 x PCI Gigabit Ethernet BaseT LAN
adapter

Client Hardware - workstation

Pentium 4 CPU 3 GHZ
1 GB RAM
80 GB Hard Drive
Intel 10/100 Ethernet Network Interface
Card (NIC)

Bar Code Scanners:
Symbol LS 2208-SR20401R
Symbol LS 40041049
Symbol LS 2208-SR 20371R
Symbol LS 4208

2.26 GHz CPU
4 GB RAM
80 GB Hard Drive
Intel l0/100 Ethernet Network Interface

Printers:
HP LaserJet 4000
HP LaserJet 4015
HP LaserJet 4050

BarCode Scanners:
Symbol DS6708-SR20007ZZR Symbol LS2208-SR20401R
Symbol LS 2208-SR20371R
Symbol LS 4208

Client Software -workstation

Microsoft Windows XP SP2/SP3

Or

Microsoft Windows Vista

Internet Explorer Version 7 or 8
JAVA JRE Version 1.6.0  12
Adobe Acrobat Reader Version 9

WinWedge 3.4.2 (Serial software interface for scale. Lab only.)

 

Microsoft Windows 7

Or

Microsoft Windows XP SP2/SP3

Internet Explorer Version 7, 8 or 9
JAVA JRE Version 1.6.0_29
Adobe Acrobat Reader Version 9 or 10

WinWedge 3.4.2 (Serial software interface for scale. LifeTrak Lab only.)
Hematrax Print
Server PC
Workstation
Hardware
 

2.4 GHZ Celeron Processor CD ROM
1 GB RAM
40 GB internal disk
Ethernet 10/100 NIC
Serial port for each serially connected printer

2.4 GHz CPU
CD ROM
2GB RAM
80 GB internal disk
Ethernet 10/100 NIC
Serial port for each serially connected printer

Hematrax Integration         Server Software
 

VMWARE ESXi 3.5 (optional)

Microsoft Windows Server 2003

Digi-Trax Hematrax 3.0.2

VMWARE ESXi 5 (optional)
 

Microsoft Windows Server 2008 R2

Digi-Trax Hematrax 3.0.3
Barcode Printers

Digi-Trax Zebra 4000BB

Or

Digi-Trax Zebra Q-4M BBE+

With Digi-Trax printer firmware and 300 dots per inch (dpi) print head for ISBT compatibility.

Digi-Trax Zebra BB-ZM400+ Digi-Trax Zebra Z-4M BBE+ Digi-Trax Zebra 4000BB

With Digi-Trax printer firmware and
300 dots per inch (dpi) print head for ISBT compatibility.

Scales

Sartorius TE 6100
Sartorius BL 6
Sartorius PT 6
AND EK 6000G

Mettler Toledo Viper PM BM 6

Sartorius TE6100
Sartorius BL6
Sartorius PT6
AND EK 6000G

Mettler Toledo Viper PM BM 6

SAFETY AND EFFECTIVENESS DATA:

LifeTrak® Version 2012 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® Version 2012 meets the requirements for intended use.

Clinical/user site (use acceptance) testing was conducted to validate LifeTrak® Version 2012. The results of  user sites testing demonstrated that LifeTrak® Version 2012 meets the required specifications and functioned as expected with no degradation in response times.

Conclusions:

Mediware Information Systems Inc. concludes that LifeTrak® Version 2012 is substantially equivalent to the predicate devices listed in that it has the same intended use with similar technological features and capabilities. LifeTrak® Version 2012 provides some minor extensions of the functional capability. Testing was conducted as required by Mediware's Design Control Validation and Verification processes to evaluate these changes in functional capabilities of LifeTrak® Version 2012. The results of this testing demonstrates that LifeTrak® Version 2012 performs as expected and that the minor changes in functional capabilities do not effect safety or effectiveness.