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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK090044 Summary

510(k) Summary
for Sunrise Blood Bank version 2.0 SP2

1. SUBMITTER/510(K) HOLDER  
       
  Eclipsys Corporation
450 Lapp Road
Malvern, PA 19355
 
       
  Contact Person:
Telephone:
Frank Romanoski, Regulatory Affairs
Office: (610) 722-7827 Cellular: (215) 542-8830
       
  Date Prepared: July 31, 2009  
       
2. DEVICE NAME  
  Proprietary Name:
Common/Usual Name:
Classification Name:
Sunrise Blood Bank, version 2.0 SP2
Transfusion Information Management System
Blood Establishment Computer Software
       
3. PREDICATE DEVICES
       
 
  • PowerBank Enterprise Edition version 1.0, Eclipsys (India) PVT LTD, BK060014
       
4. DEVICE DESCRIPTION
       
  Sunrise Blood Bank version 2.0 SP2 is an evolutionary release of the previously cleared Eclipsys PowerBANK Enterprise Edition 1.0 product. The device was modified to replace the underlying database and incorporate new features to enhance the usability of the system.
       
5. INTENDED USE
       
  Sunrise Blood Bank version 2.0 SP2 is a computer software system designed to support the transfusion service in medical facilities. It is a decision support system that collects and maintains information utilized by competent medical professionals in the transfusion of blood and blood based products.
       
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
       
  The overall design and operational characteristics of the proposed Sunrise Blood Bank version 2.0 SP2 are identical to that of the parent PowerBANK Enterprise Edition version 1.0. The proposed Sunrise Blood Bank version 2.0 SP2 represents a new release of the software that constituted the parent PowerBANK Enterprise Edition version 1.0. The proposed Sunrise Blood Bank version 2.0 SP2 was modified to replace the underlying database with a new database environment and incorporate new features to enhance the usability of the system.
       
7. PERFORMANCE TESTING
       
  Eclipsys verification and validation efforts for the proposed Sunrise Blood Bank version 2.0 SP2 included design reviews, unit testing, GUI validation checks, and product testing inherent in the development lifecycle Beta testing was performed to verify and validate the performance of the proposed Sunrise Blood Bank version 2.0 SP2 in a user environment. The results confirm that the proposed Sunrise Blood Bank version 2.0 SP2 is safe and effective for its intended use.