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PREMARKET NOTIFICATION 510(k) SUMMARY
as required by 807.92(a)
|Common/Classification Name:||Blood establishment standalone software|
|Classification Name:||Software, Blood Bank, Stand Alone Products|
|Classification Regulation:||No classification regulation|
|Product Code (procode):||MMH|
|Premarket Notification owner/submitter:|
|Company Name:||BBK Technology LLC|
|Company Address:||2910 E Highland|
|Phoenix, AZ 85016|
|Preparation Date:||June 1, 2010|
|A. Legally Marketed Predicate Device|
|FDA Preparation Date:||March 30, 2007|
|8960 E. Anna Place|
|Tucson, AZ 85710|
B. Device Description -as required by 807.92(a)(4) (Exhibit 3)
The submitted device, RC-AID, is a computer inventory used in the identification of red cell antibodies. It is intended to aid the technologist in selecting red cells and ruling out antibodies by automating the same logic pattern followed when using the printed versions of the red cell panels.
RC-AID makes no decision about which antibodies are present. It helps the technologist select the best red cells for testing, analyze which antibodies are ruled out and decide which antibodies are present.
Some of the functionality available in RC-AID includes -
- Copies the panels from a master file of panels into the subscriber's inventory file
- Lists the red cells in the inventory available for testing and clearly identifies the outdated red cells
- Allows the technologist to eliminate the red cells with the patient's previously identified antibodies from the list of red cells
- Allows the technologist to select the best cells to rule out the remaining antibodies
- Analyzes the number of rule outs provided by the selected non-reacting red cells
- Prints out a worksheet of selected red cells for posting lab results and historical records
C. Device Claims -as required by 807.92(a)(4)
RC-AID is a computer inventory used in the rule out of antibodies. It is intended to assist the medical technologist in selecting the best red cells for testing and help the technologist analyze the planned or completed testing by automating the same logic pattern followed when using the manually created versions of the panels.
RC-AID makes no decision about which antibodies are present. It helps the technologist set up the testing of red cells, see which antibodies would be or are ruled out, and helps interpret the data. With these tools, the technologist can determine which antibodies are present.
D. Product and Technical Specifications -as required by 807.92(a)(4) (Exhibit 4)
RC-AID is resident on a web server and is accessed by the technologist via the Internet. RC-AID does not require any networking and does not have any interfaces to other application software or hardware.
E. Intended use -as required by 807.92(a)(5)
RC-AID is an electronic aid to trained blood transfusion service technologists for use in the identification and ruling out of antibodies to human red blood cell antigens from antibody test systems. RC-AID is updated with the red cells in the inventory and it assists technologists in quickly choosing the best cells to complete the identification. RC-AID searches the cells in the inventory for specific cells that have the antigens that will complete the identification.
RC-AID duplicates the logic used in manual ruleouts and existing antibody test systems in an electronic version of the custom panel created by the technologist.
F. Level of Concern as requested by recent FDA guidance
The FDA guidance document "Guidance For the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005 identifies that all devices with the indications for use like the submitted device are considered by FDA to be a Major Level of Concern.
BBK Technology LLC acknowledges this guidance but believes that the submitted product, RC-AID, has at best a Level of Concern that is at the lowest level of any Major concern. The product makes no decisions regarding which antibodies are present and only aids the technologist to see which antibodies are ruled out, providing an aid to the interpretation of the data and an aid to deciding which antibodies are present.
G. Technical Characteristics Summary -as required by 807.92(a)(6)
RC-AID has the same technological characteristics as the predicated device, Antibody Check.
- Both devices show which antibodies are ruled out based on negative test results for homozygous positive antigens on reagent cells.
- The software automates the searching of select panels for reagent cells with specific antigen characteristics to aid in identifying unexpected antibodies.
- The software's results are repeatable so a reviewer may check the technologists' work and decisions.
- Panel data is updated by the submitter from data sheets provided with each new lot of reagent cells distributed by the original manufacturers.
- The submitter for a high degree of accuracy verifies data in the electronic versions of the printed panels.
- Panel data is available for query in retained files.
- Provides user aids for blood establishment technologists including:
- Installation materials (Exhibit 5)
- Training materials (Exhibit 6)
- User Manual (Exhibit 7)
RC-AID has these additional characteristics:
- Test results are not entered into RC-AID. Instead the medical technologist selects the non-reacting cells.
- RC-AID shows which antibodies are ruled out based on negative test results for both homozygous and heterozygous positive antigens on reagent cells.
- The software automates the searching of all panels in the inventory for reagent cells with specific antigen characteristics.
- RC-AID generates a worksheet or custom panel of all red cells selected for testing.
- A single copy of RC-AID resides on a web server and is accessed by all technologists via the Internet. For easier validation, the submitter provides laboratory customers a validation of the single copy of the software (Exhibit 9).
- All inventories, i.e. the master inventory and all site inventories, reside on a single database.
- Once the site inventory manager copies the panels from the master file into the laboratory site's inventory file, the inventory manager has full control of the panels.
H. Performance Data Testing and Review -as required by 807.92(b)(1) [Exhibit 9]
The submitted device has undergone significant verification and validation testing. Validation includes testing of all executable code and functionality and confirmation that all identified hazards have been adequately addressed by software functionality and the user documentation.
I. Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1))
The submitted device, RC-AID, has the same indications for use as the predicate device, Antibody Check, that is a software application intended for use by professionals in blood establishments. The submitter has carried out validation and performance testing to document substantial equivalence. The results of this testing substantiates that RC-AID performs as well as the predicate device.
J. Conclusions from non-clinical data per 807.92(b)(3)
Based on the indications for use, technological characteristics and performance testing, RC-AID is safe and effective for the intended use described above.