PREMARKET NOTIFICATION 510(k) SUMMARY (amended)
as required by 807.92(a)
|Trade Name:||ANTIGEN PLUS|
|Common/Classification Name:||Blood establishment standalone software|
|Classification Name:||Software, Blood Establishment, Stand Alone Products|
|Classification Regulation:||No classification regulation|
|Premarket Notification owner/submitter:|
|Company Name:||ROWNY SYSTEMS, INC.|
|Company Address:||7555 SPRING LAKE DRIVE|
|BETHESDA, MD 20817|
|Preparation Date:||APRIL 12, 2012|
|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)
The submitted device, ANTIGEN PLUS, 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 printed versions of the reagent red cell descriptions.
ANTIGEN PLUS 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 ANTIGEN PLUS includes -
- Copies the reagent data from a master file 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- Lists the red cells in the inventory available for testing and clearly identifies the outdated red cells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 reagent 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
- Counts the number of rule outs provided by the selected non-reacting red cells
- Allows the saving and printing of a worksheet of selected red cells for posting lab results and historical records
C. Device Claims -as required by 807.92(a)(4)
ANTIGEN PLUS 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 printed versions of the reagent data.
ANTIGEN PLUS makes no decision about which antibodies are present. It helps the technologist set up the testing of red cells, see which antibodies could be ruled out. With these tools, the technologist can determine which antibodies are present.
D. Product and Technical Specifications -as required by 807.92(a)(4)
ANTIGEN PLUS is a program installed by the user on a PC workstation or on the server of a local area network (LAN). ANTIGEN PLUS will connect on demand to a proprietary website, using secured communication, for the purpose of downloading manufacturers’ reagent data. It does not have any interfaces to other application software or hardware.
ANTIGEN PLUS automates the primary steps of antibody identification in the blood bank laboratory:
- Selecting cells for testing either by choosing a commercial panel or searching for and selecting cells with the desired characteristics to build a selected panel,
- Entering the testing results for each cell and applying the logic patterns to identify antibodies that may be present in the patient’s blood,
- Searching for and selecting additional cells from an inventory of red cells present in the ANTIGEN PLUS database.
E. Intended use -as required by 807.92(a)(5)
ANTIGEN PLUS 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. ANTIGEN PLUS is an educational tool to graphically demonstrate the laboratory procedures used to identify red blood cell antibodies. ANTIGEN PLUS is used to search a laboratory’s inventory of reagent or patient red blood cell samples for any pattern of positive or negative antigens that will best help complete antibody identification.
ANTIGEN PLUS duplicates the existing antibody test procedures used in blood reference laboratories in a graphical electronic form.
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.
Rowny Systems, Inc. acknowledges this guidance but believes that the submitted product, ANTIGEN PLUS, has at worst 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)
Antigen Plus Version 7 must be run from inside Microsoft Windows. The software was developed in Microsoft Windows XP Professional, Service Pack 3, and tested and validated on Windows 7, 64-bit edition (in 32-bit mode)using an Intel Core i3 processor. It requires a printer that can print in Landscape format (11 x 8½”).
ANTIGEN PLUS has these same technological characteristics as the predicated device, Antibody Check.
- Blood bank software used by reference laboratories and transfusion services—an application with functionality specifically for blood establishments
- The software shows which antibodies are ruled out based on negative test results for homozygous positive antigens on reagent cells.
- The software automates the searching of red blood cell inventory 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.
- The software allows for explanatory notes for each saved custom worksheet.
- Reagent 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 reagent descriptions, and transmits these data in encrypted form.
- The software automates the searching of all data in the inventory for reagent cells with specific antigen characteristics.
- Reagent data is available for query in retained files.
- Provides a User Manual (Exhibit 3) to aid blood establishment technologists.
- For aid in software validation, the submitter provides customers a validation SOP (Exhibit 4).
ANTIGEN PLUS has these additional characteristics:
- ANTIGEN PLUS displays reagent cell antigens in the various antigen display orders used by the manufacturer, for ease of comparison and verification of the data.
- ANTIGEN PLUS allows for the entry and storage of individual donor cells.
- ANTIGEN PLUS allows for the specification of unlimited rare antigens.
- ANTIGEN PLUS includes the specification of location, gender, blood group, out-of-stock, and frozen status.
- ANTIGEN PLUS includes notes for individual donors.
- ANTIGEN PLUS shows which antibodies are ruled out based on negative test results for both homozygous and heterozygous positive antigens on reagent cells, and displays a count of these rule-outs.
H. Performance Data Testing and Review -as required by 807.92(b)(1) [Exhibit 4]
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. Antigen Plus has undergone two rounds of testing. The functions called for by the software requirements and design have been tested and the results of those tests appear in the document entitled “Antigen Plus Version 7.4 Verification, Validation, and Testing.” Further validation procedures are recommended to the end-user and carried out by Rowny Systems as well. The results of those tests are included in the document entitled “Antigen Plus V7.4 End-Users Validation Plan Pre-release Documentation.” The “Antigen Plus V7.4 End-Users Validation Plan” that should be performed by each user in a clinical setting according to their laboratory SOP is also included in this submission.
I. Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1))
The submitted device, ANTIGEN PLUS, 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 ANTIGEN PLUS 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, ANTIGEN PLUS is safe and effective for the intended use described above.