This amended alternative standard was originally approved and became effective on May 31, 2002. It was last amended on October 26, 2007. It has no time limit. It defines the conditions under which the mammography equipment evaluations performed after some computer software upgrades may be performed either by a medical physicist on site or under the conditions of Medical Physicist Oversight. If these conditions are not met, the mammography equipment evaluation after the upgrade must be performed by a medical physicist on site.
The original standard is contained within 21 CFR 900.12(e)(10):
(10) Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a unit or processor is installed, a unit or processor is dissembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.
The approved alternative and the conditions for its use are:
Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade. The mammography equipment evaluation must be performed and all failures to meet the applicable standards must be corrected before the affected equipment is used for patient examinations. The tests to be included in the mammography equipment evaluation must be specified by the manufacturer and must meet the following conditions:
- The specified tests must be adequate for determining whether all of the standards of 21 CFR 900.12(b) and (e) that are applicable to the upgrade are met.
- All the tests included in the mammography equipment evaluation must be either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer, or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of the quality assurance program required by the manufacturer.
- None of the necessary tests after the software upgrade are required to be performed by the medical physicist.
Additional conditions for using this alternative requirement in association with a software upgrade are that
The manufacturer must notify FDA of its intention to install the upgrade. The notification must include a brief description of the upgrade, the model(s) of the units that will be upgraded, a list of the post installation tests that the facility needs to perform, and a copy of the information to be provided to each facility describing the upgrade and the facility's post installation responsibilities.
- The manufacturer must confirm in the notification to FDA that the tests to be performed for the mammography equipment evaluation are either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of that quality assurance program.
- The manufacturer must confirm that none of the required tests must be performed by a medical physicist.
- The manufacturer must receive an acknowledgement from FDA of receipt of the upgrade notification before beginning the upgrade installation.
- By the completion of each individual upgrade, the manufacturer must inform the facility in writing of its post installation responsibilities under the alternative requirement, which are that the facility must:
- conduct a mammography equipment evaluation after installation of the upgrade, either during a medical physicist onsite visit or under Medical Physicist Oversight,
- include in its mammography equipment evaluation the tests specified by the manufacturer,
- perform the mammography equipment evaluation and correct all test failures before the affected equipment is used for patient examinations, and
- keep records of the test results and follow-up actions in accordance with 21 CFR 900.12(d)(2).
If all the above (1-8) conditions are met, then the mammography equipment evaluation may be conducted either during an onsite visit by a medical physicist or under Medical Physicist Oversight. If any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.
FDA’s acknowledgement as stated in item 7 above does not constitute approval of the type of testing of the software upgrade in question. FDA will contact the FFDM manufacturer if any issues arise concerning the upgrade in question. As a result, FDA may disallow testing the software upgrade under Medical Physicist Oversight if it determines that one or more of the above conditions were not met.
|Date||Software Upgrade Name/Description||GE FMI#||Comments|
|April 2003||Field Modification Instruction (FMI) No. 11497, “ADS & RWS software upgrade.”||11497 - ADS & RWS software upgrade||Upgrade applied to facilities with RWS V9.1 software on their review workstation.|
|May 2003||Service Note (SN) “IDC DIONE 3 INTRODUCTION” combining FMI No. 11496 and FMI No. 11497||11496 and 11497||Combined software upgrade V 10.2 (#11497) with hardware (#11496)|
|December 2004||Field Modification Instruction (FMI) “ADS software upgrade to V31.3” for the Senographe DS, full-field digital mammography system||12027||Operation of the system to perform stereotactic procedures, (outside MQSA), and to address an issue relating to image labeling (MQSA)|
|November 2005||Field Modification Instruction (FMI) No. 12026 , “Seno Advantage Upgrade to Version 1.2”||12026||Applied to the SenoAdvantage Workstation- final interpretation of clinical mammograms|
Two software upgrades for the Seno Advantage (SA) diagnostic workstation:
|July 2006||Senographe 2000 D AWS v17.4.5 Upgrade.|
|January 2007||LUT Printing Correction. Seno Advantage Software Upgrade||12078||Corrects errors in printing hard copies from the SenoAdvantage 1.2 and 2.0 Workstations.|
|May 2007||Senographe DS Stereotaxy Upgrade||12083|
1. Corrects a previous AWS software issue so that the “view name” appears in the axillary position when printing any FFDM image from the AWS. In addition, while not an MQSA issue, this software upgrade corrects a “bug” that caused an error message when the system was used in the stereotaxy mode .
2. A new label is to be placed on the unit’s radiation shield indicating that the position of the “view name” label may not be near the axilla when images are viewed at the AWS.
Seno Advantage RWS Software Upgrades as follows:
Field Modification Instruction (FMI) No. 12075, “Senographe DS and Senographe Essential IS4-3 upgrade” as follows:
Notification of Software Upgrades Under Amended Alternative Standard #6
The new amendments provide a revised FDA approval process for new software upgrades that eliminates the need for FDA to specifically approve each new software upgrade for which mammography equipment evaluation (MEE) testing may be conducted by the radiologic technologist under medical physicist oversight. Instead, FFDM manufacturers are required to notify FDA of their new software upgrades for which the MEE may be conducted under medical physicist oversight. FDA will then simply acknowledge receiving this notification, and the manufacturer may then proceed with disseminating the upgrade.
1. GE Healthcare - Effective 10/29/07
Several software upgrades identified as:
- SA2_07.1, which was also distributed as Field Modification Instruction (FMI) 12092, “PV3 for SenoAdvantage 2.0 and 2.1.”
- SA21_05.1, which was also distributed as FMI 12092.
- SMFitAct 3.3.0 CD
The first four of these upgrades are intended to address image presentation issues on various versions of the SenoAdvantage workstation. The fifth is an upgrade of the software used to calibrate the displays. The issues addressed by these upgrades are described in more detail in the MEE instructions to be provided to the facility.
2. Hologic - Effective 11/21/07
Software upgrade v. 3.3 as described in “Selenia Release Notes 184.108.40.206” - The release notes include the description of the upgrade, the model, and all tests that are required to evaluate the equipment after the software change (upgrade). The Release Notes are provided to mammography facilities to inform them of which tests are to be performed for the MEE after installation, and as information regarding the Selenia software change. They include revisions back to the “Selenia 3.1.2” version and they are not meant to replace the Selenia operator’s manual. Furthermore, this software upgrade allows the configuration of the Selenia FFDM system with a tungsten (W) x-ray tube and rhodium (Rh) and silver (Ag) filtration.
3. GE Healthcare - Effective 3/14/2008
A software upgrade identified as:
- SA_04.2 that will be distributed with Field Modification Instruction (FMI) 12026A: Upgrade to Seno Advantage 1.2 (SA_04.2.1)
This software upgrade applies to the Seno Advantage 1.0, 1.1, and 1.2 Workstations that are intended for final interpretation of clinical mammograms. The issues addressed by this upgrade are described in more detail in the MEE instructions that will be provided to the facility.
4. Fuji Systems - Effective 4/2/2008
A retroactive software upgrade identified as:
- “Software Upgrade for FCRm V.4” is described in a document entitled Description of Overall Version 4 Software Changes.
This software upgrade does not require any testing by the facility prior to implementation and therefore does not require MEE testing under medical physicist oversight as called for under the amended Alternative Standard # 6.
Note: This upgrade was reviewed and approved by FDA's Office of Device Evaluation (ODE) in May 2007 as part of a pre-market approval (PMA) device modification submission.
5. Fuji Systems - Effective 4/25/08
A retroactive software upgrade identified as:
"Fuji IIPm (CR-IR348) Version 5.0(B) Software Changes." This may also be referred to as a software upgrade V5 for FCRm. This upgrade applies to the FCR Image Console (lIP), which is a dual modality workstation used for both FCRm digital mammography and general radiographic (CR) studies. It includes new functions, enhancements, and corrections in both areas. The following items of the upgrade are intended for "performance correction" and are the only ones that apply to mammography in the United States:
- Software version HF0040 (Base:V5.0(B)) for FCR CR Console
- Improved performance of mammography image positioning.
- Software version HF0100 (Base:V5.0(B)) for FCR CR Console
- The process has been added to retry JPEG process when the system fails to store an image due to JPEG lossless compression error after receiving it from the reader unit. This HotFix allows the study to continue by using a remaining ST image when JPEG compression error occurs.
- An additional log is output when the recovery process is performed.
The Fuji representative, Customer Solutions Engineer (CSE), has/will perform a reboot of your PC from the start menu and verify that the most current software version number is indicated on the initialization screen.
This upgrade does not require any testing by the facility prior to implementation; therefore, it does not require mammography equipment evaluation (MEE) testing under medical physicist oversight as called for under amended Alternative Standard #6.
6. General Electric Seno Advantage Diagnostic Workstations – Effective 6/20/08
These upgrades will be distributed as Field Modification Instruction (FMI) 12092, “PV3 for Seno Advantage 2.0 and 2.1.” The software upgrades address image presentation issues on various versions of the Seno Advantage workstation. The issues addressed by these upgrades are described in detail in the Mammography Equipment Evaluation (MEE) instructions to be provided to the facility. They are identified by General Electric (GE) Healthcare as SA2_08.1 and SA21_05.1
The software upgrades are intended to improve the operation of image processing algorithms for some exceptional cases and there are no routine quality control (QC) tests intended to directly evaluate the system performance under such cases. A checklist will be provided by the installer informing the operator which upgrade was performed and what MEE tests need to be done. GE Healthcare believes that all of the specified tests can be performed by the QC Technologist. None of the tests are required to be done by a medical physicist. The facility’s post-installation responsibilities are included in the information to be provided to each facility.
The software upgrade identified as SA21_05.1 affects the content of the QC manual for the Seno Advantage workstation. This upgrade facilitates the operation of the workstation with either Siemens monitors or Barco monitors, and the QC manual has been revised to accommodate the differences in the details of the QC software between these two monitor types. No tests have been added or deleted. No action limits have been changed.
A copy of the new revision of the QC manual will be included with upgrade SA21_05.1. While it will be “backward compatible” and could be used by facilities that do not have Barco displays installed, there is no need for facilities with Siemens monitors to obtain a copy of the later revision.
7. General Electric Senographe 2000 D FFDM Systems – Effective 7/14/08
This upgrade is identified as Field Modification Instruction (FMI) 12063A, “Senographe 2000 D AWS v17.5 Upgrade.” This upgrade will:
- fix an Acquisition Workstation (AWS) software issue that affects the printing of images from the AWS. The printing issue relates to MQSA Quality Mammography Standards 21 CFR 900.4(c)(2)(viii)(C) and 900.12(c)(5)(iii), which specify that, on mammography images, the view name and laterality shall be displayed near the axilla. As part of the software upgrade, a new label is being provided to clarify the labeling of images viewed on the AWS.
- provide supplementary information regarding monitor cleaning.
It is anticipated that when this upgrade is performed, in over 90% of the systems, no detector calibration information will be lost and that there will be no change in patient dose. However, in some cases it will be necessary to upgrade the Image Detection Controller (IDC). Following this upgrade the Detector Conversion Factor and AOP calibrations, among others, must be done, and these calibrations could affect patient dose. For those cases where this occurs, the facility will be informed by the installer that the Alternative Standard may not be applied and the facility’s physicist must be contacted to perform an in-person Mammography Equipment Evaluation (MEE). By means of a checklist, the facility will be informed of the extent of the upgrades and the effect of the upgrades on the facility’s responsibilities regarding the MEE.
Following this software upgrade, the user will be instructed to check that the label regarding view and laterality labeling has been affixed to the radiation shield of the mammography system, and to print films from the AWS that demonstrate correct labeling of the images. The user is further instructed to acquire a phantom image and score it on all display devices.
8. Fuji IIPm (CR-IR348) Version 6.0(B) Software Changes – Effective 7/29/08
The FCR Image Console (IIP) is a dual modality workstation. It is used for both FCRm digital mammography and general radiographic (CR) studies. This document identifies new functions, feature enhancements and performance corrections related to software version upgrades. Some of these changes are related to mammographic applications and are identified below.
Description of Change:
Version 6.0(B) Mammography Specific Software Updates:
(1) Readability of the menu items displayed on a monochrome (gray scale) monitor will be improved by enhancing appearance of user utility.
(2) A function to embed annotation markers automatically into images will be added.
(3) A function allowing the user to confirm on the CR Console screen the current age of patients at the time of irradiation will be added.
(4) The film format for pantomography images will be expanded.
(5) The automatic stitching function will be expanded. (Addition of preview-display upon stitch operations and auto-stitching function on the QA screen).
(6) A function to delete patient information from log data will be added.
(7) A function allowing the user to select an arbitrary exam at the CR Console and create PDI will be added.
(8) A warning will be displayed should the date and time appeared upon application startup are older than those of the previous startup.
Note: There was NO CHANGE to the image processing in software version V6.0(B). The above listed changes were not due to changes in the Intended Use, and did not significantly affect safety and effectiveness of the device.
There are no applicable post-upgrade tests required to be performed by the facility. The Fuji representative, CSE (Customer Solutions Engineer), will reboot the PC from the start menu and verify that the version number indicated on the initialization screen is V6.0(B).
9. Siemens Mammomat NovationDR & Mammomat NovationS: (VA20C/VA20D to VA20E) – Effective 9/26/08
Acquisition work station software update to add new features and bug-fixes (Siemens identification numbers VA20C/VA20D to VA20E).
Acquisition work station software update to enhance image viewing features to meet country specific regulations and enhance user preference (Siemens identification numbers VA20A to VA20C).
Patch to fix “re-enter function.” Resolution of an issue with system hang-up when re-entering an exam (Siemens identification number VA20C Build 153).
10. Siemens Syngo MammoReport: VB20R/VB21 to VB22D) – Effective 9/26/08
Soft-copy review station software update to add new workflow functions and to add security hotfixes for Windows XP (Siemens identification number VB20R/VB21 to VB22D). The QC Manual for this software version is SPB7-420.621.60.01.02.
Soft-copy review station software update to provide improved performance and dedicated error correction for select systems. The update includes enhanced worklist management and support for the new IHE Mammography Image Integration profile as actor display. (Siemens identification number VB20R to VB21E). The current QC Manual for this software version is SPB7-420.621.40.01.02.
11. Software upgrades to the General Electric Seno Advantage workstation: SA2_08.1, SA21_05.1 and SA21_06.1 – Effective 12/8/08
In part, these software upgrades address image presentation issues on various versions of the Seno Advantage workstation. The issues addressed by these upgrades are described in detail in the Mammography Equipment Evaluation (MEE) instructions to be provided to the facility. These upgrades are also intended to improve the operation of image processing algorithms and primarily affect the productivity of image review. There are no routine QC tests intended to directly evaluate the system performance under such cases.
Upgrades SA21_05.1 and SA21_06.1 affect the content of the QC manual for the Seno Advantage workstation. These facilitate the operation of the workstation with either Siemens monitors or Barco monitors, and the QC manual has been revised to accommodate the differences in the details of the QC software between these two monitor types. No tests have been added or deleted. No action limits have been changed.
Upgrades SA2_08.1 and SA21_06.1 will be distributed as Field Modification Instruction (FMI) 12092, “Introduction of PV4 for Seno Advantage 2.1 and PV3+ for SA 2.0.” Upgrade SA21_05.1 will be distributed as a part ordered separately from the FMI.
12. Fuji Systems - Effective 1/23/2009
Software updates for Software Version 7.0(B) New Functions/Enhancements
- A Dose Area Product (DAP) meter connection has been added. The workstation now has the ability to capture dose area product information provided by a DAP meter and included as part of the output data to a PACS or RIS device.
- A new PACS security function has been implemented to prevent an operator from changing FCR image processing parameters.
Software updates for Version 7.0(B) Performance Corrections
- In the past, the application (IIPInput.exe) did not function or stalled when starting multiple studies retrieved from the mammography workstation when the second study menu name was less than six characters. This has been corrected to allow menu names less than six characters.
- When executing the retake analysis function, the conversion process for the exposure result and mis-exposure did not function when the requesting department entry had more than 16 characters. This has been corrected to allow requesting department entries of more than 16 characters.
Post-Upgrade Installation Responsibilities of the Facility
There are no applicable post-upgrade tests required to be performed by the facility. There are no items which need to be checked by a medical physicist for revision V7.0 (B).
13. Hologic - Effective 4/10/2009
Software update for Selenia Dimensions 2D FFDM System
The software upgrade to version 1.0.4 to the Selenia Dimensions FFDM system does not require any evaluation by the medical physicist. This software upgrade is intended to achieve the following:
- Improve the reliability of the internal system communication.
- Reduce the likelihood of reported faults during the system start-up and following rebooting.
- Improve the operating efficiency of the paddle shift motor and
grid control motor.
Following the upgrade, the radiologic technologist will perform signal-to-noise and contrast-to-noise measurements and perform a phantom image evaluation following the procedures described in the corresponding technologist QC sections of the Selenia QC manual.
14. Hologic - Effective 4/21/2009
Selenia Software Upgrade Version 3.4
This software upgrade adds new implant algorithm and minor work flow enhancements. It is described under Selenia 3.4 Release notes and includes the following:
- The Selenia SNR/CNR QC Test has been automated so that the calculations are performed by the software.
- Gain calibration has been automated and small and large focal spots are calibrated separately
- Digital Marker default locations can be defined by user preference
- Errors in view identification can be corrected on both the image and the DICOM heading. The image will hang correctly based upon identification of laterality.
- Image Processing for Implants has been modified and the RT must select the implant present tag so that the implant processing algorithm will run
- Additional view support for LM ID, and ML ID has been added
- Repeat Analysis is now based on reasons. Patient habitus and wire localization are not counted.
- Two additional Loc Paddles have been added: 10 cm Rect and 10 cm Perf
Following the upgrade, the radiologic technologist will perform: 1) detector flat-field calibration, 2) signal-to-noise and contrast-to-noise measurements, and 3) a phantom image evaluation, following the procedures described in the corresponding technologist QC sections of the Selenia QC manual.
15. Siemens - Effective 5/5/09
Software update for Siemens Mammomat Novation with serial numbers below 2153
Update instruction SP037/08/P - software update to accept the retrofit silicone sleeve protector for the high voltage (HV) connector:
Normally, there is a very small gap at the connection of the mini-HV plug of the HV cable to the receptacle of the HV transformer, so that the plug can be inserted into the receptacle. Under certain conditions, arcing may occur within this air gap. It was observed that such arcing, if it happens frequently and over longer periods of time, may eventually lead to damage of the HV plug and / or the HV transformer. As a precaution, the use of a gap-filling silicone sleeve was introduced. The HV plugs are being fitted with this gap-filling silicone sleeve on systems beginning with serial number 2153. Systems with serial numbers below 2153 will receive this modification.
Following the upgrade, the technologist will be instructed to perform a phantom image quality test.
16(a). Software update VB23 on selected Siemens Mammo Report Plus and syngo Mammo Report - Effective 6/19/09
The VB23 update will be performed on systems where the users have reported user interface issues. It will improve system performance when handling patient studies and user information on the display, as well as enhance navigation of the MammoBrowser, and enable the system to receive future software updates and applications.
After the installation of this upgrade, the mammography technologist will perform the daily QC tests as described in the syngo Mammo Report QC manual.
16(b). Software update SP016/09/P on Mammomat Novation systems (model # 6646900) - Effective 6/19/09
This performance update will replace the detector read out sequence on the acquisition workstation to correct a faulty detector configuration file that is causing sporadic delays during image acquisition.
After installation of this update, the mammography technologist will perform the daily QC tests as described in the Mammomat Novation QC manual.
16(c). Software update v4.5.1 for the Image Diagnost Mammo Workstation - Effective 6/19/09
This software update has been developed to improve the performance of some features and address some software problems/ issues. None of the changes effect the way the image is displayed, the image viewing software, or anything that would impact the final interpretation of mammograms. Acceptance testing will be performed by the field engineer following the upgrade, and no further testing by the medical physicist or under medical physicist oversight is expected to be required.