Vaccines, Blood & Biologics
Resources for You
January 16, 2009
SCC Soft Computer
Attention: Ms. Kathryn Branca
5400 Tech Data Drive
Clearwater, FL 33760
SoftDonor® Version 4.5
Dear Ms. Branca:
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 has been classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. Also, please note the regulation entitled, ²Misbranding by reference to premarket notification² (21CFR Part 807.97). 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) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm.
Sheryl A. Kochman
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
510(k) Number: BK080069
Device Name: SoftDonor® Version 4.5
Indications For Use:
SoftDonor is intended to be a decision support system used by knowledgeable users to document steps in the manufacture of blood and blood components. The software also maintains that data which blood center personnel use in making decisions regarding the suitability/deferral of donors and the release of blood or blood components for transfusion purposes or for further manufacture. It will support the following functionality:
- The registration of suitable donors in multiple locations with real time evaluation of eligibility from registration through phlebotomy
- The automatic or manual deferral of donors based on history review, donation interval based on last procedure, inappropriate responses to donor history questions, results of donor physical exams and transfusion transmitted disease test results.
- Documentation of test results for the donor and for the donated unit
- The labeling and distribution of blood and blood components and management of inventory including recall of inventory
- Quarantine or removal from production of components that do not meet prescribed production timeframes or guidelines
- Quarantine or removal of components that have positive test results
- The coordination and linking of autologous and directed donations with the appropriate recipient
- The documentation of current Good Manufacturing Practices (cGMP) 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
- Supports ISBT 128 label printing
The use of the SoftScape User Interface with SoftDonor provides a graphical presentation layer to the legacy ASCII application. The Database Management System Interface (DMSI) allows utilization of current application calls to access the Oracle™ database through use of the Dora library.