Vaccines, Blood & Biologics
BK120039 Summary
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 4.6.0 | LifeTrak® Version 2012 (LifeTrak®/Donor component) |
|---|---|---|
| Database | Oracle Standard Edition (SE) Oracle 10g
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 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 | VMWARE ESXi 4.1 Oracle Enterprise Or Red Hat Enterprise Compat-Oracle- Oracle enterprise Edition (EE) Oracle | 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 2xGigabit Ethernet BaseT LAN | 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 Microsoft Windows Vista | Microsoft Windows 7 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 Printers: BarCode Scanners: | 2.26 GHz CPU Printers: BarCode Scanners: |
Mobile PC Operating | MS Windows XP SP2/SP3 | Microsoft Windows Server 2008 R2 |
| Mobile PC Hardware | Lookup PC, Replication Server, upload/download PC: | 2.26 GHzCPU |
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 | VMWARE ESXi 4.1 Oracle Enterprise Or Red Hat Enterprise Compat-Oracle- 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 |
| Database Server Hardware | Xeon 5460(3016 GHz 1333FSB) 8GB memory Integrated RAID Controller 2x72 GB Discs 2x146 GB Discs 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 2 x PCI Gigabit Ethernet BaseT LAN |
Client Hardware - workstation | Pentium 4 CPU 3 GHZ Bar Code Scanners: | 2.26 GHz CPU Printers: BarCode Scanners: |
| Client Software -workstation | Microsoft Windows XP SP2/SP3 Or Microsoft Windows Vista Internet Explorer Version 7 or 8 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 |
| Hematrax Print Server PC Workstation Hardware | 2.4 GHZ Celeron Processor CD ROM | 2.4 GHz CPU |
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 |
| Scales | Sartorius TE 6100 | Sartorius TE6100 |
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.
