Vaccines, Blood & Biologics
Name and Address of Manufacturer
Blood Bank Computer Systems
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
Contact: Tom Metcalf, Director of Customer Service and Operations
Date summary prepared: May 18, 2012
Device Trade Name
BBCS BloodTrack Interface (BBCSBT), BT 1.0.0
Blood Establishment Computer Software
Unclassified, product code 81MMH
2. Substantial Equivalence Claim
BBCS BloodTrack Interface (BBCSBT), BT 1.0.0 is substantially equivalent to the currently marketed Blood Bank Control System (BBCS), V 5.0 and BBCS Hospital Interface Application (BBCSH), H 1.0.0, manufactured by Blood Bank Computer Systems Inc.
BK040056 was submitted for Blood Bank Control System (BBCS), V 5.0 and was cleared for distribution on October 22, 2004.
BK090081 was submitted for BBCS Hospital Interface Application (BBCSH), H 1.0.0 and was cleared for distribution on January 20, 2010.
3. Device Description
The BloodTrack Interface Application (BBCSBT) establishes bidirectional communication with the Neoteric BloodTrack System (BloodTrack). The interface sends informational messages based on events occurring in the BBCS Primary Application (BBCSP). The interface accepts BloodTrack messages, processes them, and sends appropriate responses in order to allow for automated remote allocation of blood for eligible patients. The interface also handles notifications for blood products that are manually allocated to a patient in the BBCSP application and then sent to the BloodTrack monitored device.
4. Intended Use of the Device
BBCS BloodTrack Interface (BBCSBT), BT 1.0.0 is intended to assist the center's Transfusion Service Technicians in the handling and distribution of products. BBCSBT allows for the automated creation and automated notice of distribution of orders, all in an effort to assist in effectively utilizing inventory and reducing waste.
The interface primarily runs on a PC server. The principle PC modules are BloodTrack Interface (BTInterface), which provides the core message processing functions, and BloodTrack User Interface and Configuration (BTConfig), which allows the user to monitor the interface status and provide configuration data. Also included on the PC are several smaller modules that are broken out to perform critical algorithms.
iSeries modules also exist as part of the BloodTrack Interface. These modules monitor for and process events that cause messages to be sent out across the interface.
5. Substantial Equivalence Comparison
|Device||Predicate Device||Predicate Device|
|Manufacturer||Blood Bank Computer Systems, Inc.||Blood Bank Computer Systems, Inc.||Blood Bank Computer Systems, Inc.|
|Trade Name||BBCS BloodTrack Interface (BBCSBT), BT 1.0.0||Blood Bank Control System Application (BBCS), V 5.0||BBCS Hospital Interface Application (BBCSH), H 1.0.0|
|510(k) Reference Number||BK040056||BK090081|
|Intended Use||BBCS BloodTrack Interface (BBCSBT), BT 1.0.0 is intended to assist the center's transfusion service technicians in the handling and distribution of products. BBCSBT allows for the automated creation and automated notice of distribution of orders, all in an effort to assist in effectively utilizing inventory and reducing waste.||BBCS Application, V 5.0 is intended to address all phases of donor and transfusion services. The software is designed to assist personnel in recruitment, blood collection services, inventory control, donor testing, shipping/ receiving, transfusion services, reference laboratory, and quality assurance, and provides management controls and information services modules for configuration assistance.||BBCS Hospital Interface Application (BBCSH), H 1.0.0 is intended to assist personnel in shipping/receiving and transfusion services, while utilizing the BBCS V5.0. The BBCSH Application is an adjunct software application for use with the Blood Bank Control System Application (BBCS). BBCSH receives and sends messages and uploads the information into BBCS.|
|Patient Order Creation||The BloodTrack Interface (BTInterface) and Automated Order Processing (AUTOORDR) modules in BBCSBT allow patient orders to be created based on information received in communication with the Neoteric BloodTrack Manager. Order information is stored in the BBCS database. Received information is checked for validity.||The Patient Order Processing (420) module in BBCS allows patient orders to be manually created by a user via a traditional user interface. Entered information is checked for validity.|
|Order Fulfillment||BBCSBT calls on the BBCS application's Order Product Processing (BBC470) module to handle order fulfillment operations. BBCSBT does not select blood products for fulfillment on orders. The Neoteric BloodTrack Manager proposes a unit in much the same way that a user would. The BBCS module then affirms or denies eligibility based on an electronic crossmatch and a variety of other defined requirements. To aid in the automated fulfillment process, all necessary physical testing is performed at the time the blood product is moved into the Hemosafe.||The Order Product Processing (BBC470) module in BBCS handles order fulfillment. BBCS does not select blood products for fulfillment on orders. Users manually select products and BBCS affirms or denies eligibility based on crossmatch testing and a variety of other defined requirements. Required testing may be performed before, or at the time of, order fulfillment.|
|Order Issuing||The Order Distribution Updates (BBC475) module in BBCS handles order issuing BBCSBT application. The process is identical to that of the BBCS application.||The Order Distribution Updates (BBC475) module in BBCS handles order issuing for the BBCS application.|
|Order Shipping||The Update Distribution Records (UPDIST) module in BBCS handles order shipment for the BBCSBT application. The process is identical to that of the BBCS application. Physically, shipment means the dispensing of the product from the Hemosafe.||The Update Distribution Records (UPDIST) module in BBCS handles order shipment for the BBCS application.|
|Hardware||IBM iSeries (AS/400), Intel compatible PC/Server||IBM iSeries (AS/400)||IBM iSeries (AS/400)|
|Operating System||IBM iSeries OS V6R1, Microsoft Windows 7||IBM iSeries OS V5R3||IBM iSeries OS V5R3|
|Application Language||IBM RPG III|
|IBM RPG III|
Java 2 SE 1.4
|IBM RPG III|
Java 2 SE 1.4
|Database||IBM DB/400||IBM DB/400||IBM DB/400|
6. Summary of the Clinical and Non-Clinical Testing
BBCS BloodTrack Interface (BBCSBT), BT 1.0.0, has been developed using a defined development process encompassing all phases from design initiation through change implementation, verification and validation and product release.
Verification and validation were driven by comprehensive Scenario Validation Protocols (SVP) and Risk Mitigation Validation Guides (RMVG) supporting a thorough hazard analysis. Use Case testing was performed that included scenario testing based on the intended use of the device. Any subsequent changes to the modules were assessed for necessary re-testing. The results of the verification and validation demonstrate that BBCS BloodTrack Interface (BBCSBT), BT 1.0.0, meets the requirements of the intended use.
The conclusions drawn from validation demonstrate that BBCS BloodTrack Interface (BBCSBT), BT 1.0.0 meets its specifications and functions as expected within its intended use.