(145 days)
No
The summary describes standard image processing algorithms and hardware improvements, with no mention of AI or ML.
No
The device is described as a digital mammography system used for imaging (mammography exams, screening, diagnosis, biopsies) and not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnosis" and "biopsies," which are diagnostic procedures. Additionally, the "Device Description" mentions its use for "diagnostic" procedures.
No
The device description clearly states it is a floor-mounted, full field digital mammography system consisting of physical components like an examination stand, gantry, detector, and acquisition workstation, in addition to software.
Based on the provided information, the MAMMOMAT B.brilliant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment.
- MAMMOMAT B.brilliant Function: The MAMMOMAT B.brilliant is a digital mammography system that uses X-rays to create images of the breast. It is used for imaging the body directly, not for analyzing specimens taken from the body.
- Intended Use: The intended use clearly states it's for "mammography exams, screening, diagnosis, biopsies and dual energy procedures." These are all procedures performed on the patient's body. While it has a biopsy option to image excised tissue, this is for verifying the tissue sample during the biopsy procedure, not for laboratory analysis of the tissue itself.
Therefore, the MAMMOMAT B.brilliant falls under the category of an imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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. 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 codes
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Mammographic
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The needle tip must be no more than +/-1 mm in x, y, z direction from the selected target point.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1715 Full-field digital mammography system.
(a)
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.(b)
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.
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)
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)
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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.
-
- 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
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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 Mammography System | Same or better than predicate | passed |
| Dual energy imaging | Ensure non-inferiority to predicate | Performance tests | Same or better than predicate | passed |
| Targeting accuracy | Ensure accuracy of the biopsy device | Accuracy tests with phantom and calibration needle. | The needle tip must be no more than +/-1 mm in x, y, z | passed |
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| | | | 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.
10. 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.
11. 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.
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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.
12. 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.
13. 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.