BK090017 Indications for Use

510(k) Number: BK090017

Device Name: SoftBank II® Version 25

Indications For Use:

The SoftBank II® Version 25 application is a decision support software device that requires knowledgeable user intervention to document certain steps and events in a transfusion service. It will support the following functionality:

1. Inventory management:

• Documentation of the receipt of blood, component, and tissue product inventory from an outside source
• Documentation of the receipt of derivative products such as Rh Immune Globulin and albumin
• Confirmatory testing on blood and component products
• Recording of blood and component modification and producing on-demand ISBT compliant labels
• Antigen testing results
• Documentation of the final disposition of blood, components, tissue, and derivative products

2. Patient results management of:

• Patient History
• ABO and Rh
• Antibody screen
• Antigen testing
• Antibody identification
• Crossmatch
• Transfusion reaction workup and documentation

3. Documentation of compatibility between patients and blood products
4. Electronic determination of compatibility while maintaining decision support capability
5. Recording the release of blood, components, tissue, and derivative products to recipients
6. Warnings to alert the user on various control points in the selection and issuance process
7. Documentation of the receipt of reagents used in testing
8. Recording test results for daily reagent quality control
9. Use in a multi-facility environment
10. Producing reports to be used in utilization review

 

FDA has not cleared or reviewed this software for use with tissue products.