SCC Soft Computer, Inc.
Attention: Ms. Laurie Sapp
5400 Tech Data Drive
Clearwater, FL 33760
Re: BK100045 Trade/Device Name: SoftBank® II Version 25.1 Product Name: Software, Blood Bank, Stand Alone Product Regulatory Class: Unclassified Product Code: MMH Dated: July 7, 2010 Date Received: July 12, 2010
Dear Ms. Sapp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Richard J. Davey, M.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
510(k) Number: BK100045
Device Name: SoftBank® II, Version 25.1
Indications For Use:
The SoftBank II Version 25.1 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:
- 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
- Patient results management of:
- Patient History
- ABO and Rh
- Antibody screen
- Antigen testing
- Antibody identification
- Transfusion reaction workup and documentation
- Documentation of compatibility between patients and blood products
- Electronic determination of compatibility while maintaining decision support capability
- Recording the release of blood, components, tissue, and derivative products to recipients
- Warnings to alert the user on various control points in the selection and issuance process
- Documentation of the receipt of reagents used in testing
- Recording test results for daily reagent quality control
- Use in a multi-facility environment
- Producing reports to be used in utilization review
- FDA has not cleared or reviewed this software for use with tissue products.