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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK100002 510K Summary

PDF Version (25KB)

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:             January 28, 2010
Trade name:                 Component Manufacturing Interface for ElDorado Donor
Common name:            Blood establishment computer software
Classification name:   Software, blood bank, stand alone products
Substantial equivalence claimed to: Test Result Interface for ElDorado Donor®, ElDorado Donor®

Device Description

The Component Manufacturing Interface for ElDorado Donor receives and processes files containing manufacturing data for components that have been manufactured using manufacturing equipment.

The Component Manufacturing Interface performs the following functions:
   Receives manufacturing information from multiple types of component manufacturing equipment.
   Parses the data in the file.
   Validates the data received in the Component Manufacturing file.
   Translates external values for manufacturing programs, equipment, tests, and operators into manufacturing processes, equipment, tests, and users defined in ElDorado Donor.
   Formats the message into a standard format for further processing including database updates by the core ElDorado Donor system.

The Component Manufacturing Interface requires a User ID and password for access.

The Component Manufacturing Interface for ElDorado Donor has the following limitations:
   Does not interface with test result analyzers.
   Does not interface with electronic health history questionnaires.
   Must be used with the ElDorado Donor system.

Intended Use

The Component Manufacturing Interface is an adjunct device to ElDorado Donor, aiding in the transfer of component manufacturing information for components into the ElDorado Donor database.  The Component Manufacturing Interface is intended to receive, parse, validate, and translate component manufacturing information from component manufacturing equipment.

Technological Comparison

The Component Manufacturing Interface is technologically equivalent to the predicate devices.  The Component Manufacturing Interface shares the same technological characteristics as both ElDorado Donor and the Test Result Interface for ElDorado Donor.  The application language, database, operating system, and hardware technologies are the same for the Component Manufacturing Interface and the predicate devices.

Area of Comparison

Component Manufacturing Interface for ElDorado Donor

Test Result Interface for ElDorado Donor

ElDorado
Donor

Application Language

C#

C#

C#

Database

Oracle

Oracle

Oracle

Application Server
Operating System

Windows 2003
Server R2, and
Windows 2003
Advanced Server

Windows 2003
Server R2, and
Windows 2003
Advanced Server

Windows 2003
Server R2, and
Windows 2003
Advanced Server

Client Operating System

Windows XP

Windows XP

Windows XP

Client Workstation
Hardware

Standard PC

Standard PC

Standard PC

Safety and Effectiveness Data

The Component Manufacturing Interface for ElDorado was developed and validated using established procedures for software development.  The device was verified, validated and beta (user) tested, with acceptable results.  All tests had a final result of pass, except for one which is included on the Unresolved Software Anomalies list. This anomaly was determined to be non-critical.

Conclusions

Based on the comparison of the Component Manufacturing Interface to its predicate devices, the Component Manufacturing Interface is substantially equivalent to the predicates. The results of testing demonstrate that the device is safe and effective for its intended use.