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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK070064 Summary

510(k) Number:BK070064
Submitter:Wyndgate Technologies
Address:4925 Robert J Mathews Pkwy., Suite 100, El Dorado Hills, CA 95762
Phone number:916-404-8400
Fax number:916-404-8484
Contact person:Debra Csore
Date prepared:February 11, 2008
Trade name:ElDorado Donor
Common name:Blood establishment computer software
Classification name:Software, blood bank, stand alone products
Substantial equivalence claimed to:SafeTrace, BK950059

Device Description

  1. ElDorado Donor is a comprehensive blood establishment software application designed to provide for the information system needs of a blood bank. ElDorado Donor helps facilities manage, automate, and control activities associated with donors, donations, testing, manufacturing, inventory, and distribution. Many of the features in ElDorado Donor are site configurable to maximize site efficiency while helping to ensure safety.

    ElDorado Donor encompasses the following:

    • Provides the ability to manage donors, donor visits and the collection of blood.
    • Provides for site-defined donor identifiers and donor pictures.
    • Provides automatic calculation of blood loss and eligibility based on site-defined tables.
    • Provides the ability to automatically post deferrals based on medication, travel, results of testing, and other site-defined parameters.
    • Provides the ability to record the manufacture of components using site-defined component manufacturing processes.
    • Provides the ability to record the results of donor and component testing using site-defined tests.
    • Provides the ability to manage special collection requests for patients
    • Provides the ability to manage and track the inventory and final disposition of blood components and related blood products and supply items.
    • Provide the ability to label and label verify blood components, including Codabar and ISBT 128.
    • Provides the ability to ship blood components and related blood products and supply items.
    • Provides security and auditing functions that support industry regulations.
    • Performs extensive safety checks throughout the system.

    ElDorado Donor is to be used by trained and qualified users and in accordance with labeling.

    ElDorado Donor has the following limitations:

    *It does not provide transfusion management capabilities.
    *It does not support the collection, manufacture, or release of cellular therapy or tissue products.

Intended Use

ElDorado Donor is intended for use in facilities that manage donors and blood products, including:  donor and blood collection management, eligibility and blood loss calculation, posting of deferrals, recording the manufacture of components, recording the results of testing, management of special collection requests for patients, and tracking the status and final disposition of blood components, related blood products and supply items, and their distribution.

Technological Comparison

ElDorado Donor is technologically similar to the predicate device in that the same database, a key component of any software application, is used. ElDorado Donor was programmed in the C # (Sharp) language while SafeTrace was programmed in Cobol.

Area of ComparisonElDorado DonorSafeTrace
Application LanguageC#Cobol
DatabaseOracleOracle
Application Server Operating SystemWindows 2003 Server R2, and Windows 2003 Advanced ServerUNIX
Client Operating SystemWindows XPN/A – mainframe application
Client Workstation HardwareStandard PCN/A – mainframe application

Safety and Effectiveness Data

ElDorado Donor was developed using an established procedure for software development. The system was verified and validated. Validation test results are available in a supplement to this submission. The results of this testing demonstrated that ElDorado Donor met the specified requirements and functioned as expected.

Conclusions

Based on the comparison of ElDorado Donor to its predicate device, ElDorado Donor is substantially equivalent to the predicate. The results of testing demonstrate that the device is safe and effective for its intended use.