Mammomat Fusion with Stereotactic Biopsy

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 10, 2017 Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355 Re: K163252 Trade/Device Name: Mammomat Fusion with Stereotactic Biopsv Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: November 17, 2016 Received: November 18, 2016 Dear Ms. Adams: 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 (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: CDRH 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Sincerely yours. Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163252 Device Name Mammomat Fusion with Stereotactic Biopsy Indications for Use (Describe) The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast. Type of Use (Select one or both, as applicable) | <span style="font-size: 12pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <span style="font-size: 12pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Healthcare # 510(k) Summary: Mammomat Fusion with Stereotactic Biopsy Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: January 10, 2017 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. ### 1. General Information: Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869 Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim Germany Establishment Registration Number: 3004977335 ### 2. Contact: Siemens Medical Solutions USA, Inc. Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code: 65-1A Malvern, PA 19355-9998, USA Phone: +1.610.448.6139 Mobile: +1.610.944.4686 adams.denise@siemens.com #### 3. Device Name and Classification: | Trade Name: | Mammomat Fusion with Stereotactic Biopsy | |-------------------------|----------------------------------------------| | Device: | Full Field Digital Mammographic X-Ray system | | Reg. Medical Specialty: | Radiology | | Review Panel: | Radiology | | Product Code: | MUE | Siemens Medical Solutions USA, Inc. {4}------------------------------------------------ | Submission Type: | Traditional 510(k) | |--------------------|--------------------| | Regulation Number: | 21 CFR 892.1715 | | Device Class: | 2 | ## 4. Legally Marketed Predicate Devices: | Primary predicate | | |-------------------------|----------------------------------------------| | Trade Name: | Mammomat Inspiration | | Device: | Full Field Digital Mammographic X-Ray system | | Reg. Medical Specialty: | Radiology | | Review Panel: | Radiology | | Product Code: | MUE | | Submission Type: | 510(k) (K122286, 02/22/2013) | | Regulation Number: | 21 CFR 892.1715 | | Device Class: | 2 | | Reference predicate | | | Trade Name: | Mammomat Fusion | | Device: | Full Field Digital Mammographic X-Ray system | | Reg. Medical Specialty: | Radiology | | Review Panel: | Radiology | | Product Code: | MUE | | Submission Type: | 510(k) (K151645, 09/14/2015) | | Regulation Number: | 21 CFR 892.1715 | | Device Class: | | # 5. Device Description: Mammomat Fusion is a floor-mounted full field digital mammography system for screening and diagnostic procedures on standing, seated or recumbent patients. The stereotactic biopsy accessory uses a computer and imaging performed in at least two planes to localize a target lesion (such as a tumor or micro calcifications in the breast) in three-dimensional space and guide the removal of tissue for examination by a pathologist under a microscope. The biopsy is attached to the Mammomat Fusion examination stand and comprises a control panel for automatic motorized movement of the needle holder to the pre-set position. There are special biopsy compression plates as well as a face shield to protect the patient from movements of the swivel arm. The display and control of the biopsy unit are performed via the workstation. Biopsy examinations can be executed with vertical and horizontal needle guidance. For stereo exposures the swivel arm of the Mammomat Fusion is tilted ± 15° to both sides. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a teal or turquoise color. The letters are evenly spaced and the word is horizontally oriented. ## 6. Indication for Use: The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast. ## 7. Substantial Equivalence: The Siemens Mammomat Fusion with Stereotactic Biopsy is substantially equivalent to the commercially available Siemens Mammomat Inspiration (primary predicate) (K122286) and Mammomat Fusion (reference predicate) (K151645). The Mammomat Fusion with Stereotactic Biopsy is the same system as the reference predicate the Mammomat Fusion with the exception of the biopsy feature. The stereotactic biopsy accessory is identical to the stereotactic biopsy accessory used with the primary predicate the Mammomat Inspiration. | Attributes | Subject device<br>Mammomat Fusion with<br>Stereotactic Biopsy | Primary predicate<br>K122286<br>Mammomat Inspiration | Remarks | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Stereotactic Biopsy Option | | | | | Indications for<br>Use | The Mammomat Fusion system<br>generates digital mammographic<br>images that can be used for<br>screening and diagnosis, and<br>stereotactic biopsies of the breast<br>under supervision of medical<br>professionals. The Mammomat<br>Fusion system is intended to be<br>used in the same clinical<br>applications as traditional film-<br>screen mammography systems.<br>The Mammomat Fusion system<br>may also be used for additional<br>diagnostic workup of the breast. | The Mammomat Inspiration system<br>is intended for mammography<br>exams, screening, diagnosis, and<br>stereotactic biopsies under the<br>supervision of medical<br>professionals.<br>Mammographic images can be<br>interpreted by either hard copy film<br>or soft copy workstation. | Same for<br>biopsy | | Hardware | Biopsy unit slides onto object<br>table | Biopsy unit slides onto object<br>table | Same | | Patient<br>positioning | Stereotactic biopsy can be<br>performed on seated and<br>recumbent patients | Stereotactic biopsy can be<br>performed on seated and<br>recumbent patients | Same | | Accuracy | +/-1 mm in X, Y and Z axis | +/-1 mm in X, Y and Z axis | Same | | Biopsy volume<br>(vertical needle<br>guidance) | 50 mm x 40 mm x 110 mm (2" x<br>1.6" x 4.3") | 50 mm x 40 mm x 110 mm (2" x<br>1.6" x 4.3") | Same | | Biopsy volume | 50 mm x 40 mm x 60 mm (2" x | 50 mm x 40 mm x 60 mm (2" x | Same | ### Table 1: Comparison of the Subiect to the Primary Predicate {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and appear to be a logo or brand name. | Attributes | Subject device<br>Mammomat Fusion with<br>Stereotactic Biopsy | Primary predicate<br>K122286<br>Mammomat Inspiration | Remarks | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------| | (lateral needle<br>guidance) | 1.6" x 2.4" | 1.6" x 2.4" | | | Tube swivel<br>range in stereo<br>mode | -15° and + 15° | -15° and + 15° | Same | | Biopsy<br>compression<br>plate with<br>window | 96 mm x 100 mm (3.8" x 3.9")<br>(window size 52 mm x 42 mm<br>(2" x 1.7"), vertical needle<br>guidance | 96 mm x 100 mm (3.8" x 3.9")<br>(window size 52 mm x 42 mm<br>(2" x 1.7"), vertical needle<br>guidance | Same | | Biopsy<br>compression<br>plate without<br>window | 96 mm x 100 mm (3.8" x 3.9")<br>(lateral needle guidance) | 96 mm x 100 mm (3.8" x 3.9")<br>(lateral needle guidance) | Same | | Software controlled functions for stereotactic biopsy | | | | | Workflow | Automated workflow | Automated workflow | Same | | Image<br>processing | OpView, the image impression<br>for biopsy images and<br>screening/diagnostic images is<br>identical | OpView, the image impression for<br>biopsy images and<br>screening/diagnostic images is<br>identical | Same | # Table 2: Comparison of the Subject to the Reference Predicate | Attributes | Subject device<br>Mammomat Fusion with<br>Stereotactic Biopsy | Reference predicate<br>K151645 Mammomat Fusion | Remarks | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Indications for<br>use | The Mammomat Fusion system<br>generates digital mammographic<br>images that can be used for<br>screening and diagnosis, and<br>stereotactic biopsies of the breast<br>under supervision of medical<br>professionals. The Mammomat<br>Fusion system is intended to be<br>used in the same clinical<br>applications as traditional film-<br>screen mammography systems.<br>The Mammomat Fusion system<br>may also be used for additional<br>diagnostic workup of the breast. | The Mammomat Fusion system<br>generates digital mammographic<br>images that can be used for<br>screening and diagnosis of the<br>breast under supervision of<br>medical professionals. The<br>Mammomat Fusion system is<br>intended to be used in the same<br>clinical applications as traditional<br>film-screen mammography<br>systems. The Mammomat Fusion<br>system may also be used for<br>additional diagnostic workup of<br>the breast. | Same except<br>for biopsy | | System configuration | | | | | X-ray Stand | Floor mounted X-ray system | Floor mounted X-ray system | Same | | X-ray | 5 kW | 5 kW | Same | | Generator | 30kV, 1s | 30kV, 1s | Same | | X-ray Tube | Same tube but only Tungsten is<br>used | Same tube but only Tungsten is<br>used | Same | | Attributes | Subject device<br>Mammomat Fusion with<br>Stereotactic Biopsy | Reference predicate<br>K151645 Mammomat Fusion | Remarks | | Beam Limiting<br>Device | Automatic for all sizes | Automatic for all sizes | Same | | Compression<br>unit | Automatic and manual operation | Automatic and manual operation | Same | | Object table | Carbon fiber mammography<br>support system | Carbon fiber mammography<br>support system | Same | | Grid | Reciprocating 5:1 ratio | Reciprocating 5:1 ratio | Same | | Magnification<br>table | Magnification 1.5 and 1.8 | Magnification 1.5 | Adding 1.8<br>table | | Biopsy unit | Yes | No | Reason for<br>510(k) | | Power<br>requirements | 208V, 220V, 230V, 240V,<br>277V, ± 10%, single-phase<br>208V, 220V, 230V, 240V,<br>277V, ± 10%, two-phase,<br>50/60 Hz | 208V, 220V, 230V, 240V,<br>277V, ± 10%, single-phase<br>208V, 220V, 230V, 240V,<br>277V, ± 10%, two-phase, 50/60<br>Hz | Same | | Monitor/<br>Display | 19" and 21" TFT display | 19" and 21" TFT display | Same | | | | | | | Software controlled functions | | | | | AEC Calculation | AEC calculation is done in the | AEC calculation is done in the | Same | | Calculation | acquisition workstation | acquisition workstation | | | Detector<br>Controller<br>Software | detector controller software | detector controller software for | Same | | Software | for PaxScan 3023M detector | PaxScan 3023M detector | | | Operating<br>System | Windows 7 | Windows 7 | Same | | Network<br>Interfaces<br>DICOM Send | Yes | Yes | Same | | DICOM Print | Yes | Yes | Same | | DICOM Query<br>/ Retrieve | Yes | Yes | Same | | DICOM<br>Get work list /<br>MPPS | Yes | Yes | Same | | DICOM Dose<br>Structured<br>Report | Yes | Yes | Same | | Detector | | | | | Detector<br>manufacturer | Varian | Varian | Same | | Detector TFT | Cesium Iodide (Csl) and<br>amorphous Silicon (a-Si) | Cesium Iodide (Csl) and<br>amorphous Silicon (a-Si) | Same | | Detector size | 23 cm x 30 cm | 23 cm x 30 cm | Same | | Attributes | Subject device<br>Mammomat Fusion with<br>Stereotactic Biopsy | Reference predicate<br>K151645 Mammomat Fusion | Remarks | | Array size | 2790 x 3580 | 2790 x 3580 | Same | | Pixel size | 83 um x 83 um | 83 um x 83 um | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the word "SIEMENS" in a bold, teal-colored font. The letters are all capitalized and evenly spaced. The word appears to be a logo or brand name. {8}------------------------------------------------ The Mammomat Fusion with Stereotactic Biopsy has the same intended use, fundamental scientific technology and performance characteristics as the predicates. Documentation is provided to support a claim of substantial equivalence to Siemens' predicate devices the Mammomat Inspiration and the Mammomat Fusion (K122286 and K151645). # 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices: Mammomat Fusion with Stereotactic Biopsy is based on the same mechanical stand as the primary. X-ray generation and control are the same. The Collimator, Compression unit and AEC technology are the same. The image processing algorithms are identical to those of the predicates. Mammomat Fusion with Stereotactic Biopsy will now feature the same biopsy accessory as the primary predicate Mammomat Inspiration. # 9. Summary of Non-Clinical Tests: The Siemens Mammomat Fusion with Stereotactic Biopsy was tested and complies with the voluntary standards listed in the table below: # Table 3: Conformance to Standards Reference Number, Date and Title of Standard AAMI ANSI, ES 60601-1: 2005 /( R ) 2012, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: 2007. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-3 2008 + A1: 2013 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices ISO 14971:2012, Medical devices - application of risk management to medical devices IEC 62304: 2006, Medical device software - Software life cycle processes ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process IEC 60601-2-28: 2010. Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis -Ed. 1.0 IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments - {9}------------------------------------------------ # Healthcare Reference Number, Date and Title of Standard Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment IEC 60601-2-45: 2011, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices NEMA PS 3.1 - 3.20: 2016, Digital Imaging and Communications in Medicine (DICOM) Set IEC 60336: 2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots In addition, the following bench tests were also conducted and passed: | Test | Objective | Test Method | Acceptance Criteria | Results | | | | | |------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Targeting<br>accuracy | Ensure<br>accuracy<br>of the<br>biopsy<br>device | Remove plastic tray, attach<br>phantom and compress manually. | The needle<br>tip must be<br>no more<br>than +/-1<br>mm in x, y,<br>z direction<br>from the<br>selected<br>target point. | Within 1<br>mm of<br>target | | | | | | | | Take a scout exposure and a stereo<br>pair and check reference points. | | | | | | | | | | Set an accurate target mark then<br>select needle. Select target mark | | | | | | | | | | with corresponding needle and<br>needle holder. Transmit the target | | | | | | | | | | mark to the biopsy unit. Mount the | | | | | | | | | | calibration needle and check the | | | | | | | | | | needle tip position of the | | | | | | | | | | calibration needle. | | | | | | | | | | Biopsy<br>needle | | | Correct<br>biopsy<br>needle<br>will be<br>used | Position biopsy phantom on object<br>table and compress. Acquire scout | A message<br>will appear<br>that the<br>target<br>cannot be<br>reached<br>with this<br>needle and<br>an<br>appropriate<br>needle<br>length is<br>suggested. | The<br>message<br>was<br>received<br>that the<br>target<br>could not<br>be reached<br>with that<br>needle and<br>an<br>appropriate<br>needle<br>length was<br>suggested. | | | | | | | | and check that target for biopsy is | | | | | | | | | | within the possible biopsy volume. | | | | | | | | | | Acquire stereo pair and check and | | | | | | | | | | adapt reference marks if | | | | applicable. Set target in both | | | | | | | | | | stereo images and select | | | | | | | | | | calibration needle. Check that | | | | | | | | | | target coordinates and calculated | | | | | | | | | | distance between needle tip and | | | | | | | | | | biopsy table are displayed. Set<br>further target at the border of the<br>biopsy volume. Select a needle<br>that won't reach the target. | | | | | | | | | # Table 4: Summary of Bench Tests {10}------------------------------------------------ # Healthcare The following quality assurance measures were applied to the development of the system: - Risk Analysis - Requirement Specification Reviews - Design Reviews - Integration testing (System verification) General Safety and Effectiveness Concerns: Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Mammomat Fusion with Stereotactic Biopsy is continually monitored and if an error occurs the system functions will be blocked and an error message will be displayed. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing. # 10. Conclusion as to Substantial Equivalence: The Mammomat Fusion with Stereotactic Biopsy has the same intended use, fundamental scientific technology and performance characteristics as the predicate devices. Therefore the Mammomat Fusion with Stereotactic Biopsy is substantially equivalent to the primary predicate the Mammomat Inspiration and the reference predicate the Mammomat Fusion.