DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Attention: Ms. Tina Chang
375 Bishops Way, Suite 105
Brookfield, WI 53005
Trade/Device Name: iTrace for Blood Centers, v 1.0.924.0
Regulation Name: Software, Blood Bank, Stand Alone Products
Product Code: MMH
Dated: May 14, 2013
Received: May 28, 2013
Dear Ms. Chang,
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 (the 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. Please note: CBER does not evaluate information related to contract liability warranties. 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 contact 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. 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, MD
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
510(k) Number: BK120067
Device Name: iTrace for Blood Centers, v 1.0.924.0
Indications for Use:
iTrace for Blood Centers (herein referred to as “RFID Application” or “iTrace”) interfaces through a server with Blood Establishment Computer Software (BECS) to receive and store data used by blood establishments during the manufacturing process, including information related to collection, component processing and labeling including verifying the product code, expiration, and ABO/Rh information. iTrace is intended to be used by trained personnel as a tool in streamlining blood collection and processing and aiding in product tracking and reconciliation. The application’s main functions are to use RFID technology to:
1. Assist in enhancing blood safety by preventing the release of unsuitable blood components.
2. Increase the ability to physically locate products by increasing granularity and timeliness of product location information.
3. Build product/container relationships to enable better shipment tracking and reconciliation to the BECS shipment records.
4. Scan multiple products simultaneously without a line of sight restriction to improve efficiency. This functionality is inherent in the use of RFID technology, when deploying the application in RFID mode.
5. Aid in physically tracking products from product donation through shipment from the blood center.
The application is designed to augment existing blood bank systems and to work in conjunction with barcode identification and labeling processes currently in place. The RFID application will not perform critical decisions or functions relating to collection, manufacturing, labeling, distribution, and transfusion of blood products; rather, those functions will remain unchanged within the existing blood system applications. The RFID application is designed to enhance human interventions including function, e.g., reconciliation of physical components that make up the collection, and verification of the container’s contents.
The application may be deployed with barcode use only mode or with RFID tags. If an RFID tag becomes non-functional, the RFID application is designed to allow use of a barcode scan as required. Because the RFID application is designed to co-exist with existing barcode systems and processes, in the event of a full failure of the RFID application or system, a blood center will be able to conduct all operations as currently supported via its barcode and back-end system processes.
The RFID application adheres to data and information standards for blood products per ISBT Code 128 as defined by ICCBBA. The system is configurable to allow the institution to 1) use the RFID tags as “license plates” to track blood products but with no information being written to the RFID tag user data area, or 2) write data to the user data portion of the RFID tag during the collection operation. The minimum data set to be contained on a blood or product bag tag includes the donation identification number (DIN), product code, ABO/Rh, and expiration date. Container and location tag adheres to ISO/IEC 18000-3 Mode 1 RFID standards.