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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK090082 Letter

October 1, 2010

Biomat USA, Inc.
Attention: Mr. Charles E. Auger
13111 Temple Avenue
City of Industry, CA  91746

Re: BK090082
Trade/Device Name: SGP Version 7.0 (Plasma Management System)
Product Name: Software, Blood Bank, Stand Alone
Regulatory Class: Unclassified
Product Code: MMH
Dated: September 10, 2010
Date Received: September 13, 2010

Dear Mr. Auger:

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.

Sincerely yours,

 

Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research 

Enclosure 


Indications for Use

510(k) Number: BK090082                               

Device Name: SGP Version 7.0 (Plasma Management System)

Indications For Use:

SGP (acronym for Sistema de Gestión del Plasma or Plasma Management System) Version 7.0 is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility.  This includes all activities, from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.

Radio Frequency Wireless Technology is used for limited functions within SGP 7.0 and is restricted to logistics functions within the warehouse involving the management of cases or pallets but not individual plasma units.

SGP Main Functions:
1 - Reception/Data Introduction: Maintenance of plasma unit inventory, controlling locations at the warehouse. Wireless capabilities are used for managing shipment case logistics, such as shipment case assignment and cancel shipment case assignment.
2 - Rejects Registration: Control of individual plasma unit status (pending, released, or rejected for delivery to the fractionation facility).
3 - Plasma Clearance: Assist in the process of 100% inspection of units prior to their shipment to a customer or to a fractionation facility.
4 - Final Shipment Preparation: Organization of shipments to a customer or to fractionation facility.
5 - Data introduction of Post Donation Information and Look-Back Communication: Assist in the segregation of plasma units due to both post-donation information and look-backs.
6 - Other Functions: Furthermore, the system has a set of other functions relating to warehouse management, deviation management, and customer sample logistics.  Within warehouse management, wireless capabilities are used for managing pallet logistics, such as building pallets, removing cases, locating pallets, removing pallets and setting up special pallets.  It also manages reporting functionalities such as pallet query/location content and physical inventory check.