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BK020006 Review Memo

Date:February 24, 2003
  
From:Linda Weir
Division of Blood Applications
HFM-390
To:File BK020006
  
Subject:SE BK020006

I reviewed SoftBank version 4.1, BK020006 and recommend that a determination of substantial equivalence be made.

The submission was an abbreviated 510(k).

Intended Use:

Softbank is intended to be a decision support system used to document steps in the manufacture of blood and blood components or for the maintenance of that data which blood center personnel use in making decisions regarding the suitability/deferral of donors and the release of blood components for transfusion purposes or for further manufacture. SoftDonor will support the following functions: p>

  • The registration of suitable donors in multiple location with time evaluation of eligibility from registration through phlebotomy.

  • The automatic or manual deferral of donors

  • Documentation of test results for the donor and for the donated unit

  • The distribution of blood and blood components and management of inventory including recall of inventory

  • Quarantine or removal from production of components that have positive test results

  • The coordination and linking of autologous and directed donation with the appropriate recipient

  • The documentation of Good Manufacturing Practices in the manufacture of blood components

  • The system may be configured for infectious disease testing to be done in-house or by external organizations

  • The system supports the search and retrieval of eligible donors by various criteria including ABO, Rh, HLA and antigen profiles

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Predicate Device:

Substantial equivalence was claimed to Safe Trace version 1.0, BK950059 and Blood Bank Control System version 4.0/4.1/4.2/4.3s, BK960044

Hardware and Software::

SoftBank runs on the IBM RISC 6000 using AIX as the operation system. It has the ability to work with any PC via a terminal emulator. The PC should run on Windows 3.0. Network software is optional.

Review History:

This review required three deficiency letters and subsequent responses from Soft Computer Consultants (SCC), the last two deficiency letters contained comments related to [---------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Recommendation:

I recommend that a determination of substantial equivalence be made.