(86 days)
No
The summary mentions "CAD (Computer Aided Diagnostics) markers" which is a form of image processing, but does not explicitly mention AI, ML, or deep learning. The description of testing focuses on functional and integration testing, not performance studies typically associated with AI/ML models.
No
The device is described as a software environment for reviewing and processing medical images, specifically for breast imaging, to aid radiologists in diagnosis. It does not exert any direct therapeutic action on a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "both screening and diagnostic mammography as well as digital breast tomosynthesis," and that it "provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images." This indicates that the device is intended to assist in the diagnosis of medical conditions.
Yes
The device is described as an "optional software application" and a "software solution" that runs on a PC and works with cleared monitors. The description focuses entirely on the software's functionality for image viewing and processing, without mentioning any accompanying hardware developed or included by the manufacturer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MAMMOVISTA B.smart is a software application for reviewing and processing medical images (mammography, tomosynthesis, MRI, ultrasound). It works with images generated by other medical devices, not with biological specimens.
- The intended use clearly states it's for the "review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images" by a qualified radiologist. This is image interpretation, not in vitro testing.
Therefore, MAMMOVISTA B.smart falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.
Product codes
LLZ
Device Description
MAMMOVISTA B.smart is an optional software application for the Siemens Healthineers syngo.via platform (K191040). MAMMOVISTA B.smart is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of digital tomosynthesis and the display of multi-modality breast images, such as those from MRI and ultrasound. Individual workflows can be adapted for either screening or diagnostic purposes.
MAMMOVISTA B.smart runs on a PC and can be used for Mammography image review together with monitors cleared for Mammography diagnostics. The software solution provides for the display of DICOM compatible information, such as breast density and CAD (Computer Aided Diagnostics) markers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MG (Digital Mammography X-Ray)
MG Tomo (Mammography Tomosynthesis images)
MR (Magnetic Resonance)
US (Ultrasound)
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiologist
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
Not Found
Summary of Performance Studies
Non-clinical tests were conducted for the MAMMOVISTA B.smart software 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.
Siemens did not conduct any clinical tests for the subject device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Martin Rajchel Sr. Manager, Regulatory Affairs 40 Liberty Boulevard MALVERN PA 19355
November 12. 2021
Re: K212621
Trade/Device Name: MAMMOVISTA B.smart Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 17, 2021 Received: August 18, 2021
Dear Martin Rajchel:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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 and Part 809; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MAMMOVISTA B.smart
Indications for Use (Describe)
MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.
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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Image /page/3/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots. Below the logo is the text "K212621".
510(k) Summary: MAMMOVISTA B.smart
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355
Date Prepared: August 18, 2021
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:
Martin Rajchel Sr. Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA martin.rajchel@siemens-healthineers.com
Alternate Contact Person:
Denise Adams, RAC Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355, USA adams.denise@siemens-healthineers.com
3. Device Name and Classification :
| Trade Name: | MAMMOVISTA B.smart |
|---|---|
| Classification Name: | Medical Image Management and Processing System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.2050 |
| Device Class: | II |
| Product Codes: | LLZ |
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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
4. Legally Marketed Predicate Device:
Trade Name: synqo.Breast Care 510(k) Number: K123420 (Cleared February 1, 2013) Classification Name: Picture Archiving and Communications System Classification Panel: Radiology Classification Regulation: 21 CFR § 892.2050 Device Class: . Product Codes: LLZ
5. Device Description:
MAMMOVISTA B.smart is an optional software application for the Siemens Healthineers syngo.via platform (K191040). MAMMOVISTA B.smart is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of digital tomosynthesis and the display of multi-modality breast images, such as those from MRI and ultrasound. Individual workflows can be adapted for either screening or diagnostic purposes.
MAMMOVISTA B.smart runs on a PC and can be used for Mammography image review together with monitors cleared for Mammography diagnostics. The software solution provides for the display of DICOM compatible information, such as breast density and CAD (Computer Aided Diagnostics) markers.
6. Indication for Use:
MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.
7. Substantial Equivalence:
The MAMMOVISTA B.smart software device is substantially equivalent to the commercially available syngo.Breast Care (K123420, cleared February 1, 2013).
The device remains within the same classification regulation for the same technology as the predicate device. The new software design was completed in accordance with Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software.
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Summary of Technological Characteristics of the S 8. Compared with the Predicate Device:
MAMMOVISTA B.smart has a similar indications for use as the predicate synqo.Breast Care. MAMMOVISTA B.smart is a software-only solution that runs on a compatible client server environment together with monitor displays cleared for Mammography.
Optional software packages provide for the specific customer needs such as the display of tomosynthesis datasets with tomosynthesis specific layouts and tools.
The following table compares the main performance data of the subject device with the predicate device.
Comparison of the Subject Device (MAMMOVISTA B.smart) to Predicate Device (syngo.Breast Care)
| Feature | Subject device | Predicate device
(K123420) | Comment |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Regulation
Description | System, image processing,
radiological | System, image processing,
radiological | N/A |
| Device
Name | MAMMOVISTA B.smart | syngo.Breast Care | N/A |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A |
| Classification
Product
Code | LLZ | LLZ | N/A |
| Indications
for use | MAMMOVISTA B.smart is
a dedicated softcopy review
environment for both
screening and diagnostic
mammography as well as
digital breast
tomosynthesis. Its user
interface and workflow have
been optimized to support
experienced mammography
and tomosynthesis
reviewers in both screening
and diagnostic reading.
Efficiency and reading
quality are supported by
various specialized
features.
MAMMOVISTA B.smart
provides visualization and
image enhancement tools | syngo.Breast Care is a
dedicated softcopy review
environment for both
screening and diagnostic
Mammography as well as
digital breast
tomosynthesis. Its user
interface and workflow have
been optimized to support
experienced mammography
and tomosynthesis
reviewers in both screening
and diagnostic reading.
Efficiency and reading
quality are supported by
various specialized
features.
syngo.Breast Care provides
visualization and image
enhancement tools to aid a | Subject
device
Indications for
Use includes
multi-modality
images (e.g.,
MRI and
ultrasound) |
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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
| | to aid a qualified radiologist
in the review of digital
mammography and digital
breast tomosynthesis
datasets, as well as other
modalities of breast images. | qualified radiologist in the
review of digital
mammography images and
digital breast tomosynthesis
datasets. The radiologist is
responsible for making the
diagnosis of the images
presented | |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Architecture | Client / server environment | Client / server environment | N/A |
| Display of 3rd
party
Computer
Aided
Diagnostics
(CAD)
markers | Yes | Yes | N/A |
| Display and
processing of
DBT images | Yes | Yes | N/A |
| DICOM 3.0 | Same | Same | N/A |
| DICOM
compatible
modalities | MG (Digital Mammography
X-Ray)
MG Tomo (Mammography
Tomosynthesis images)
MR (Magnetic Resonance)
US (Ultrasound) | MG (Digital Mammography
X-Ray)
MG Tomo (Mammography
Tomosynthesis images)
MR (Magnetic Resonance)
US (Ultrasound) | N/A |
| Display of
breast
density
values | Yes | Yes | N/A |
9. Summary of Non-Clinical Tests:
Non-clinical tests were conducted for the MAMMOVISTA B.smart software during product development. The MAMMOVISTA B.smart software conforms to the following voluntary standards:
| Standards
Reference Number and
| Date | Title of Standard |
|---|---|
| IEC 62366-1 2015 Ed 1.0 | Medical devices – Application of usability |
| engineering to medical devices |
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Image /page/7/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
| ISO 14971: 2019 | Medical devices – application of risk
management to medical devices |
|-------------------------|------------------------------------------------------------------------|
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle
processes |
| NEMA PS 3.1 - 3.20 2016 | Digital Imaging and Communications in
Medicine (DICOM) Set |
| IEC 82304-1: 2016 | Health software – Part 1: General
requirements for product safety |
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005, is also included as part of this submission. Non-clinical tests (integration and functional) were conducted on the MAMMOVISTA B.smart 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.
Siemens did not conduct any clinical tests for the subject device.
10. 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.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. Furthermore, the operators are qualified healthcare professionals familiar with and responsible for the review of digital mammography images and digital breast tomosvnthesis datasets.
11. Conclusion as to Substantial Equivalence:
The MAMMOVISTA B.smart' s Indication for Use is similar to that of the predicate device. The Indications for Use statement has been revised for clarity and includes multi-modality image reading (e.g., MRI and ultrasound) and does not impact the intended use. The operating environment and software design are similar. Image display devices (monitors) with the same or similar specifications will be used to display the mammography images.
Verification and validation testing demonstrate that the MAMMOVISTA B.smart performs as intended. The non-clinical test data demonstrate that the MAMMOVISTA B.smart device performance is comparable to the predicate device that is currently marketed for the same intended use.
It is Siemens' opinion that the MAMMOVISTA B.smart does not introduce any new potential safety risks and is substantially equivalent to the syngo.Breast Care.
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12. Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:
Content of Premarket Submission for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005
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
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005