Vaccines, Blood & Biologics
Resources for You
September 28, 2009
Attention: Mr. John Sokolowski
400 Wood Road
Braintree, MA 02184-9114
Dear Mr. Sokolowski:
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.
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 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, ²Misbranding by reference to premarket notification² (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: BK090041
Device Name: Symphony System 3.0
Indications For Use:
SYMPHONY is a suite of computer software that includes the Prelude, Interlude and Maestro applications, as well as other non-regulated modules. Symphony is intended for use by trained personnel as an aid in the management of blood establishment operations. Applications in Symphony can be stand-alone systems or can support two-way communications with other Symphony modules and other remote systems to become a complete blood collection and component manufacturing system. The Symphony user’s manual contains information that is common to all the modules within the Symphony suite of software. A separate user’s manual for each individual application contains information that is specific to that particular module.
PRELUDE is a computerized system intended to be used by blood donors and trained personnel to aid in and document the donation collection process, including donor demographics, health history, physical examination, eligibility determination and phlebotomy data. Prelude supports synchronization of data collected at mobile operations. The system can be stand-alone or interface with other systems to allow for two-way communication of donor and donation information.
INTERLUDE is a computerized system intended to be used by trained personnel to aid in and document component manufacturing, labeling, order entry and distribution, and management of a blood establishment’s inventory. Interlude receives donor and donation information from a remote donor system and test results from a remote laboratory information system. This information is linked with blood components in Interlude. The system can be stand-alone or interface with other systems to allow for twoway communication of donor, donation and distribution information.
MAESTRO is a computerized system intended to be used by trained personnel to aid in comprehensive donor management and maintenance of donor records, including: donor eligibility; investigation and resolution of duplicate donors; manual entry of donation records and test results; automatic deferrals and attributes; and generation of donor correspondence, including notification letters. The system can be standalone or interface with other systems to allow for two-way communication of donor and donation information.
Prescription Use ___X____ AND/OR Over-The-Counter Use _______
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)