Who is the manufacturer of MAMMOMAT B.brilliant?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MAMMOMAT B.brilliant (K233539).

What is the FDA product code for MAMMOMAT B.brilliant?

MUE. It is classified under 21 CFR 892.1715 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MAMMOMAT B.brilliant?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MAMMOMAT B.brilliant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MAMMOMAT B.brilliant

K233539 · Siemens Medical Solutions USA, Inc. · MUE · Mar 27, 2024 · Radiology

Device Facts

Record ID	K233539
Device Name	MAMMOMAT B.brilliant
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	MUE · Radiology
Decision Date	Mar 27, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1715
Device Class	Class 2

Intended Use

The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

Device Story

Floor-mounted full-field digital mammography system; used for screening, diagnosis, biopsies, and dual-energy procedures. Inputs: X-ray radiation; outputs: digital mammography images. Features: new detector, X-ray tube with flying focal spot, updated collimator, and biopsy attachment. Operated by medical professionals in clinical settings. Includes InSpect feature for rapid verification of core biopsy specimens. System provides high-quality images for interpretation via workstation or film. Enhancements include improved patient positioning (ComfortMove), ComfortGuide display, and updated image processing algorithms running on GPU for accelerated performance. Clinical decision-making supported by high-quality diagnostic images; benefits include improved workflow, patient comfort, and rapid biopsy verification.

Clinical Evidence

Clinical image evaluation performed by 3 expert readers on 19 FFDM cases (including biopsy, PRIME, and TiCEM cases). Radiologists confirmed acceptable overall clinical image quality. Study demonstrates substantial equivalence to predicate device.

Technological Characteristics

Floor-mounted digital mammography system. Components: X-ray generator, gantry, tube housing, support table, detector (LMAM3-DS85, a-Si TFT), acquisition workstation. Features: flying focal spot tube, automatic collimator, reciprocating 5:1 grid. Connectivity: DICOM. Software: VA10, GPU-accelerated image processing. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-45, ISO 10993-1, ISO 14971, IEC 62304.

Indications for Use

Indicated for mammography exams, screening, diagnosis, biopsies, and dual energy procedures in patients requiring mammographic imaging, performed under the supervision of medical professionals.

Regulatory Classification

Identification

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.

Predicate Devices

MAMMOMAT Revelation (K193166)

Related Devices

K193166 — MAMMOMAT Revelation · Siemens Medical Solutions USA, Inc. · Jun 12, 2020
K173408 — Mammomat Revelation · Siemens Medi Cal Solutions, Inc. · Mar 21, 2018
K122286 — MAMMOMAL INSPIRATION · Siemens Medical Solutions USA, Inc. · Feb 22, 2013
K163252 — Mammomat Fusion with Stereotactic Biopsy · Siemens Medical Solutions USA, Inc. · Jan 10, 2017
K151645 — MAMMOMAT Fusion · Siemens Medical Solutions USA, Inc. · Sep 14, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration". March 27, 2024 Siemens Medical Solutions USA, Inc. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN, PA 19355 Re: K233539 Trade/Device Name: MAMMOMAT B.brilliant Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: February 23, 2024 Received: February 23, 2024 Dear Denise 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming {1}------------------------------------------------ product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K233539 Device Name MAMMOMAT B.brilliant ## Indications for Use (Describe) The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary: MAMMOMAT B.brilliant (K233539) - Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 #### Date Prepared: March 27, 2024 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 ### Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA adams.denise@siemens-healthineers.com ### Alternate Contact Person: Martin Rajchel Sr. Manager, Requlatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA martin.rajchel@siemens-healthineers.com #### 3. Device Name and Classification: Trade Name: MAMMOMAT B.brilliant Full Field Digital, System, X-Ray Mammographic Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR § 892.1715 Device Class: Product Code: MUE {4}------------------------------------------------ #### 4. Legally Marketed Predicate Device | Trade Name: | MAMMOMAT Revelation | |----------------------------|------------------------------------------------| | 510(k) #: | K193166 | | Classification Name: | Full Field Digital, System, X-Ray Mammographic | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1715 | | Device Class: | II | | Product Code: | MUE | #### 5. Device Description: MAMMOMAT B.brilliant is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients. The system consists of an examination stand with x-ray generator, a gantry with tube housing assembly, and mammography support table, including detector and an acquisition workstation with a radiation shield. The MAMMOMAT B.brilliant comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures. The MAMMOMAT B.brilliant features an updated detector, a new image acquisition chain (tube, filter, collimator) and improvements to the image acquisition workflow and biopsy workflow. Adaptations have been made to the image processing due to the new image acquisition hardware and the Soft- and hardware feature improvements. Patient positioning features like a head rest have been added. #### 6. Indications for Use: The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure. #### 7. Substantial Equivalence: The Siemens MAMMOMAT B.brilliant with VA10 is substantially equivalent to the commercially available Siemens MAMMOMAT Revelation with VC20 (K193166). # Table 1: Comparison of the Subject to the Primary Predicate | Attributes | Predicate device MAMMOMAT Revelation VC20, K193166 | Subject device MAMMOMAT B.brilliant | Remarks | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The MAMMOMAT Revelation is intended to be | The digital mammography system MAMMOMAT | Same | | Attributes | Predicate device MAMMOMAT Revelation VC20, K193166 | Subject device MAMMOMAT B.brilliant | Remarks | | | used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure. | B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies, and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure. | | | Product Code | MUE | MUE | Same | | | System configuration | | | | X-ray Stand | Floor mounted X- ray system | Floor mounted X-ray system | Different; housing design changed; new Collision detection zone; fixed head rest and ComfortGuide Display added to support patient | | Attributes | Predicate device MAMMOMAT Revelation VC20, K193166 | Subject device MAMMOMAT B.brilliant | Remarks | | | | | positioning and technologist | | X-ray Generator kV range | 5 kW 23 kV to 35 kV 45 kV to 49 kV | 5 kW 23 kV to 40 kV 45 kV to 49 kV | Different; Increased kV range for FFDM | | X-ray Tube | P49 | STTA_P49_FFS | Different; increased x-ray output | | Anode-filter combinations | W / Rh (50 µm), W/Ti (1.0 mm) | W / Al (1.0 mm) W / Ti (1.3 mm) W/Al (0.7 mm) | Different; Thickness and material changed. | | Collimator | Automatic for all sizes | Automatic for all sizes | Different; more compact: Gain more space below collimator e.g. for Biopsy | | Compression unit | Automatic and manual operation | Automatic and manual operation | Different; Redesign for better access to emergency release | | Object table | Carbon fiber mammography support system | Carbon fiber mammography support system | Minor; Lower contour adapted; same material, same supplier | | Detector | LMAM2v2 | LMAM3-DS85 | Minor; new generation of detector; same supplier, same technology; | | Detector software | PEGASUS | PEGASUS | Minor; new SW Revision | | Detector manufacturer | Analogic Canada | Analogic Canada | Same | | Detector TFT | Amorphous Silicon (a-Si) | Amorphous Silicon (a-Si) | Same | | Detector size | 24 cm x 30 cm | 24 cm x 30 cm | Same | | Array size | 2816 x 3584 | 2816 x 3584 | Same | | Pixel size | 85 µm x 85 µm | 85 µm x 85 µm | Same | | Grid | Reciprocating 5:1 ratio | Reciprocating 5:1 ratio | Same | | Magnification table | Magnification 1.5 and 1.8 | Magnification 1.5 and 1.8 | Minor; Lower contour adapted; same material, same supplier | | Attributes | Predicate device MAMMOMAT Revelation VC20, K193166 | Subject device MAMMOMAT B.brilliant | Remarks | | Biopsy attachment | Yes | Yes | Minor; Design change and Lower contour adapted; same material | | Tomo-guided biopsy | Yes | Yes | Different; lateral biopsy optional with tomo pre- and postfire; | | Monitor/ Display | 19" and 21" TFT display | 19" and 21" TFT display | Same | | Software controlled functions | | | | | System software | VC20 | VA10 | Different; Improved functionality | | TiCEM | Dual energy imaging W/Ti 1,0 mm HE | Dual energy imaging W/Ti 1,3 mm HE | Different; Algorithm is the same; Parameters adapted due to x-ray spectra; increased tmean energy of the X-ray spectrum | | AEC Calculation | AEC calculation | AEC calculation | Different: Algorithm is the same. AEC parameters adjusted due to x-ray spectra. AEC pre-shot acquired for Tomo biopsy adapted | | Operating System | Windows 10 | Windows 10 | Same | | Image processing algorithms | Opview | Opview | Different; Same algorithms; different implementation (now on GPU) to accelerate process; state of the art on GPU as higher performance. Parameter adjustments due to new tube /x-ray spectra | | DICOM | Yes | Yes | Same | | Attributes | Predicate device ΜΑΜΜΟΜAT Revelation VC20, K193166 | Subject device ΜΑΜΜΟΜAT B.brilliant | Remarks | | Anti Scatter Grid | Yes | Yes | Same | | Headrest Face shield | Face shield mounted on tube head | Separate stationary head rest with optional face shield | Different; New to support patient positioning; Face shield material is identical. | | PRIME | yes | yes | Different; Functionality same; adjustments due to new filter; Application range reduced. | | Accessories | Compression plate holders | Compression holders | Different for Biopsy and magnification; Adapted as travel path distance for compression unit is changed; other holders are the same | | Accessories | Compression plates | Compression plates | same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Summary of Technological Characteristics of the Subject Device as 8. compared with the Predicate Devices: The MAMMOMAT B.brilliant is based on the same principle of operation. It features an updated detector, a new image acquisition chain (tube, filter, collimator) and improvements to the image acquisition workflow and biopsy workflow. The image processing algorithms for FFDM are identical to those of the predicate with parameter adjustments due to the new image acquisition chain. The subject device does introduce improvements to the present features. These improvements are: - . New software version - Improvements to the positioning of patients with ComfortMove functionality ● - Improvements to the Biopsy workflow ● - . Improvements to the Contrast Enhanced Mammography In addition, hardware changes are made compared to MAMMOMAT Revelation - New qeneration of detector ● - New tube with flying focal spot . {9}------------------------------------------------ - New and changed filter materials ● - New AWS-PC with state-of-the art performance ● - Improved comfort for patient due new positioning support ● - Improvements concerning usability like a ComfortGuide Display and the . adapted lighting concept. #### 9. Summary of Non-Clinical Tests: The Siemens MAMMOMAT B.brilliant was tested and complies with the voluntary standards listed in the table below: # Table 2: List of Standards | DICOM standard | Digital Imaging and Communications in Medicine Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052); English version EN ISO 12052 / NEMA PSE3 | |-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005 + A1:2012 Edition 3.1 + ANSI/AAMI ES 60601-1 /AMENDMENT 1: 2012 C1:2009/(R)2012 + A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | IEC 60601-1-2:2014 Edition 4.0 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests / Endorsement notice (EN 60601-1-2 Edition 4.0 / IEC 60601-1- 2:2014) | | IEC 60601-1-3: 2008 + A1: 2013 | Medical electrical equipment – Part 1: General requirements for safety - 3rd collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1- 3:2008) | | IEC 60601-1-6 Edition 3.2 2020-07 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-2:2013) | | IEC 60601-2-28:2017 Edition 3.0 | Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of Xray tube assemblies for medical diagnosis (IEC 60601-2-28:2017) | {10}------------------------------------------------ | IEC 60601-2- 45:2011+A1:2015 Ed 3.1 | Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011 + A1:2015) | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | | ISO 14971:2019 | Medical devices - Application of risk management to medical devices | | IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements | | IEC 62304:2006 + A1:2015 Edition 1.1 | Medical device software - Software life cycle processes | | IEC 62366-1 Edition 1.1 2020-06 | Medical devices - Part 1: Application of usability engineering to medical devices | | ISO 17664-2:2021 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices | In addition, the following tests were conducted: Table 3: Summary oof non-clinical Tests | Test | Objective | Test Method | Acceptance Criteria | Results | |--------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------| | Detector characteristics | Ensure non-inferiority to predicate | As described in FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammograph…