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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK090025 Letter

Healthcare Management Systems, Inc.
Attention: Ms. Nancy Smith
3102 West End Avenue, Suite 400
Nashville, TN  37203

 

Re:                               BK090025
Trade Name:                  HMS Blood Administration Module, Release 9.0
Regulation Number:         21 CFR 864.9175
Regulation Name:           software, blood bank, stand alone products
Regulatory Class:           Unclassified
Product Code:               MMH
Dated:                         February 23, 2010
Received:                     February 23, 2010

 

Dear Ms. Smith:

 

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.  We remind you, however, that device labeling must be truthful and not misleading.

 

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” (21 CFR 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



Indications for Use

510(k) Number: BK090025

Device Name: HMS Blood Administration Module, Release 9.0

Indications For Use:

  • Allow controlled access to the Blood Administration module.
  • Receive orders for blood testing and blood products electronically.
  • Enter patient testing results for blood type, antibody screens and other Blood Bank procedures manually.
  • Record the entry of crossmatch results of a blood or blood component to a patient.
  • Allow the user to issue blood products under normal and emergency conditions.
  • Track the disposition of blood components from the time a blood component has been crossmatched to a patient, through the release of the blood component for transfusion purposes, and record the final disposition of the blood or blood component. 
  • Provide result reports to the physician and other appropriate clinicians.
  • Provide management reports that track the disposition of all blood components, the detail of a patient’s transfusion history, or the history of a specific unit number.