SIEMENS K233539 Full Field Digital Mammography System Instructions

: June 1, 2024
: SIEMENS

Table of Contents

SIEMENS K233539 Full Field Digital Mammography System
SIEMENS K233539 Full Field Digital Mammography
Indications for Use
Summary of Clinical Tests
References
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SIEMENS K233539 Full Field Digital Mammography System

SIEMENS K233539 Full Field Digital Mammography

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 before May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified by 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 control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS 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 the FDA’s issuance of a substantial equivalence determination does not mean that the FDA has determined 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 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-reporting-combination-products); good manufacturing practice requirements as outlined in the quality systems (QS) 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-devices/medical-device-safety /medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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

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 lnSpect feature for MAMMOMAT B. brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

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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 by the requirements of SMDA 1990 and 21 CFR § 807.92.

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

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, Regulatory Affairs
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
martin.rajchel@siemens-healthineers.com

Device Name and Classification:

Trade Name : MAMMOMAT B.brilliant
Classification Name: Full Field Digital, System, X-Ray Mammographic
Classification Panel : Radiology
Classification Regulation : 21 CFR § 892.1715
Device Class : II
Product Code: MUE

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

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 a mammography support table, including a 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 headrest have been added.

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 to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

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.

| 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

Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens to allow rapid verification that the correct tissue has been excised with the

biopsy procedure.

| 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 to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

changed; new Collision detection zone;

fixed headrest 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/AI (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;

a new generation of the detector; same supplier, same

technology;

Detector software| PEGASUS| PEGASUS| Minor;

new SW Revision

Detector

manufacturer

and 1.8

| Magnification 1.5 and

1.8

| Minor;

Lower contour adapted;

same material

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;

The algorithm is the same; Parameters adapted due to X-ray spectra; increased mean energy of the X-ray

spectrum

AEC

Calculation

| AEC calculation| AEC calculation| Different;

The algorithm is the same. AEC parameters were adjusted due to x-ray spectra.

AEC pre-shot acquired

for Tomo biopsy adapted

Same algorithms; different implementation (now on GPU) to accelerate the 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 MAMMOMAT

Revelation VC20, K193166

| Subject device MAMMOMAT

B.brilliant

| Remarks
---|---|---|---
Anti Scatter Grid| Yes| Yes| Same
Headrest Face shield| Face shield mounted on the tube head| Separate stationary headrest with optional face shield| Different;

New to support patient positioning;

The face shield material is identical.

PRIME| yes| yes| Different; Functionality same; adjustments due to new filter; Application range

reduced.

other
Accessories| Compression plate holders| Compression plate 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

Summary of Technological Characteristics of the Subject Device as 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 the MAMMOMAT Revelation

A new generation of detector
New tube with flying focal spot
New and changed filter materials
New AWS-PC with state-of-the-art performance
Improved comfort for patients due to new positioning support
Improvements concerning usability like a ComfortGuide Display and the adapted lighting concept.

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)
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 of 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 Mammography

System

device

| Accuracy tests with phantom and calibration needle.| The needle tip must be no more than +/-1

mm in x, y, z

| passed
| | | direction from

the selected target point.

|
---|---|---|---|---
Biopsy images| Ensure non- inferiority to predicate| Performance tests| Same or better than predicate| passed
PRIME| Ensure non- inferiority to

predicate

| Performance tests| Same or better than predicate| passed

The following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirement Specification Reviews
Design Reviews
Integration testing (System verification)

The data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MAMMOMAT B.brilliant during product development. The risk analysis was completed, and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.

Summary of Clinical Tests

Siemens conducted a clinical image evaluation to determine if the FFDM images, when reviewed by expert radiologists, are of acceptable quality for mammographic usage. The image evaluation was carried out according to FDA’s Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The image sets consisted of 19 FFDM cases including 4 cases with biopsy, 2 with PRIME, 3 with contrast-enhanced mammography cases (TiCEM), 3 of those cases with magnification views. The radiologists found all image sets to be of acceptable overall clinical image quality. The clinical image evaluation performed by 3 expert readers, together with the nonclinical testing conducted to support the change, demonstrates that the image quality of the MAMMOMAT B.brilliant with VA10 is substantially equivalent to the predicate device, the MAMMOMAT Revelation with VC20. The clinical image evaluation showed that the new MAMMOMAT B.brilliant system generates high-quality images. In summary, this clinical image evaluation, serving as supporting evidence, together with the non-clinical testing, has met the objective in demonstrating substantial equivalence when comparing the Siemens MAMMOMAT B.brilliant with VA10 to the Siemens MAMMOMAT Revelation with VC20.

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 safely and effectively. Several safety features, including visual and audible warnings, are incorporated into the system design.In addition, the MAMMOMAT B.brilliant is continuously 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.

Conclusion as to Substantial Equivalence:
The MAMMOMAT B. brilliant with VA10 has the same intended use, fundamental scientific technology, and performance characteristics as the predicate, MAMMOMAT Revelation with VC20 (K193166). Therefore, the MAMMOMAT B.brilliant with VA10 is substantially equivalent to the predicate MAMMOMAT Revelation with VC20.

Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:

Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on June 6, 2022.
Guidance for Industry and Food and Drug Administration Staff – Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on March 27, 2012
Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on June 14, 2023
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices – Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.
The 510(k) Program: Evaluation Substantial Equivalent in Premarket Notifications 510(k) – Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014
Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry and Food and Drug Administration Staff Document issued October 2, 2023
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023.