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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK100069 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:LifeTrak®/Plasma, version 1.0.0
Common Name:Software, Blood Bank, Stand Alone
Classification Name:Unclassified

Predicate Device:

Donor Information System (DIS) Version 5.0

Device Description:

LifeTrak®/Plasma is a stand-alone, blood establishment computer software device that is designed to assist trained plasma center personnel in the management of data related to plasma donors, their eligibility status, donations, notification/communication, registration with health history and physical findings and an on-line donor questionnaire to be utilized by center staff and/or the donor. LifeTrak®/Plasma also assists in managing data related to the plasma donation process, plasma processing, inventory management and shipping.

Indications for Use:

LifeTrak®/Plasma is a comprehensive modular computerized system intended to be used by trained personnel as a tool in the management of data related to donors, plasma collection, processing, testing, and distribution of Source Plasma for use in the production on injectable and non-injectable plasma derived products:

  • Maintaining a reliable source plasma donor database
  • Rolling source plasma donor eligibility status and calculation of donor status
  • On-line health history, physical findings, and donor questionnaire
  • Inter-active donor questionnaire (staff and/or donor)
  • Donor and product testing
  • Donor notification
  • Source plasma collection, processing, testing and distribution
  • Printing plasma and case labels

Data generated during donor eligibility determination, plasma collection and plasma processing for multiple plasma collection centers is consolidated in an enterprise centralized database that is accessible real-time through connection with a central computer system.


Comparison of Functional Characteristics to Predicate Device:

LifeTrak®/Plasma, version 1.0.0 is a stand alone, blood establishment computer software device that is intended to be used in the management of data related to donors/donations, testing, procurement, processing and shipping of Source Plasma collected by a plasma center. The functionality in LifeTrak®/Plasma compares to the predicate as follows:

 
Functional Characteristic:

LifeTrak®/Plasma, version 1.1.0

Donor Information System (DIS) Version 5.0

Maintaining a donor database

Yes

Yes

Donor eligibility status

Yes

Yes

On-line health history, physical findings, and donor questionnaire

Yes

Yes

Interactive donor questionnaire (staff and/or donor)

Yes

Yes

Maintaining accurate records of communication with donors

Yes

 

Donor notification

Yes

 

Plasma collection

Yes

Yes

Plasma production

Yes

Yes

Testing

Yes

Yes

Plasma labeling

Yes

Yes

Plasma distribution

Yes

Yes


Safety and Effectiveness Data:

LifeTrak®/Plasma, version 1.0.0 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®/Plasma, version 1.0.0 meets the requirements for its indications for use.

Nonclinical (alpha) testing was performed by Mediware and demonstrates that LifeTrak®/Plasma, version 1.1.0 design requirements were met. The design validation process demonstrated that LifeTrak®/Plasma, version 1.1.0 meets the requirements for intended use.

Clinical/user site (use acceptance) testing was conducted to validate LifeTrak®/Plasma, version 1.0.0. The results of this user site testing demonstrated that LifeTrak®/Plasma, version 1.0.0 meets the required specifications and functions as expected.

Conclusions:

Mediware Information Systems, Inc. concludes that LifeTrak®/Plasma, version1.0.0 is substantially equivalent to the predicate device listed in that it has the same intended use with similar functional characteristics. Testing was conducted as required by Mediware’ Design Control Validation and Verification processes to evaluate the functional capabilities of LifeTrak®/Plasma, version 1.0.0. The results of this testing demonstrates that LifeTrak®/Plasma, version 1.0.0 performs as expected and is safe and effective.