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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK110064 Letter

September 6, 2012

IT Synergistics, LLC
Attention:  Ms. Melinda Bryant
115 Tree Street
Flowood, MS  39232
 
Re:   BK110064
Device Name:            DoVac Elite 1.0
Regulation Name:      Software, Blood Bank, Stand Alone
Regulatory Class:       Unclassified
Product Code:           MMH
Dated:                      August 28, 2012
Received:                  August 28, 2012
 
Dear Ms. Bryant:
 
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 807); labeling (21 CFR 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 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 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, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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,
/s/ 
 
for
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:           BK110064
 
Device Name:               DoVac Elite 1.0
 
Indications for Use:
 
The DoVac Elite v1.0 system is a web-based application that provides functions for self administered medical history questionnaires and donation procedure consents in real time as well as in an off-line configuration.  The questionnaire is both an interactive and an intuitive process for the donor, offering the presentation of text graphics, and audio recordings of medical history questions.  The system identifies donor responses to be considered ‘high-risk’ to the general blood supply and allow a staff member to complete a review of all donor response to determine donor suitability. The DoVac Elite v1.0 application is capable of capturing electronic signatures for both the donor and staff members administering the exam.  The system maintains a complete record of all donor responses for each donation presented which can be printed to hard copy.
 
The DoVac Elite v 1.0 System has been designed to operate on tablet style touch screen devices as well as standard pc workstations.  These devices may be configured to utilize current wireless networking protocols (IEEE_802.11) or where wireless communication is not feasible, establishing a physical network connection via an Ethernet (LAN) cabling that maintains a secure connection and transmission of data from the application device to the database.
 
DoVac Elite is intended to be used in conjunction with the DoVac v1.0 (510(k) BK040026) and LifeTec Elite v1.0(510(k) BK060032).  An initial donor registration, physical exam data, and phlebotomy data is completed using the DoVac v1.0 system.  Specific unit level holds generated from DoVac Elite v1.0 due to a question response are displayed in the LifeTec Elite v1.0 System.