MAMMOVISTA B.smart (VB70)

K223363 · Siemens Medical Solutions USA, Inc. · LLZ · Jan 12, 2023 · Radiology

Device Facts

• Record ID: K223363
• Device Name: MAMMOVISTA B.smart (VB70)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 12, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

MAMMOVISTA B.smart is a software-only application for the syngo.via platform; functions as a dedicated softcopy review environment for breast imaging. Inputs include DICOM-compatible datasets from digital mammography, digital breast tomosynthesis (DBT), MRI, ultrasound, CT, and PET. The software provides visualization, image enhancement, and layout tools to assist radiologists in screening and diagnostic reading. It supports display of third-party CAD markers and breast density values. Used in clinical settings by radiologists; operates on a PC within a client-server environment. Output is displayed on cleared mammography-grade monitors. Enhances workflow efficiency and reading quality for breast image interpretation; aids clinical decision-making by providing specialized viewing layouts and analysis tools.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing, including integration and functional testing, confirmed that software specifications met acceptance criteria and performed comparably to the predicate device.

Technological Characteristics

Software-only application; client-server architecture. Complies with IEC 62366-1 (usability), IEC 62304 (software lifecycle), and NEMA PS 3.1-3.20 (DICOM). Operates on standard PCs with cleared mammography monitors. Moderate level of concern software.

Indications for Use

Indicated for qualified radiologists performing screening and diagnostic review of digital mammography, digital breast tomosynthesis, and other breast imaging modalities.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MAMMOVISTA B.smart (K212621)

Reference Devices

• syngo.via platform (K191040)

Submission Summary (Full Text)

{0}------------------------------------------------

January 12, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which 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. % Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K223363

Trade/Device Name: MAMMOVISTA B.smart (VB70) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 25, 2022 Received: November 3, 2022

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 (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/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.

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 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team 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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K223363

Device Name MAMMOVISTA B.smart (VB70)

### Indications for Use (Describe)

MAMMOVISTA B.smart is a dedicated softoopy 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)

| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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: MAMMOVISTA B.smart

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 – 1A Malvern, PA 19355

#### Date Prepared: October 25. 2022

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:

### lmporter / 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 Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355, USA [e-mail]

### Alternate Contact Person:

Martin Rajchel Sr. Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA [e-mail]

#### 3. Device Name and Classification:

| Trade Name: | MAMMOVISTA B.smart (VB70) |
|----------------------------|---------------------------------------------------|
| Classification Name: | Medical Image Management and<br>Processing System |
| Classification Panel | Radiology |
| Classification Regulation: | 21 CFR § 892.2050 |
| Device Class | II |
| Product Codes: | LLZ |

{4}------------------------------------------------

#### 4. Legally Marketed Predicate Device:

| Trade Name: | MAMMOVISTA B.smart |
|----------------------------|---------------------------------------------------|
| 510(k) Number: | K212621 (Cleared 11/12/2021) |
| Classification Name: | Medical Image Management and<br>Processing System |
| Classification Panel | Radiology |
| Classification Regulation: | 21 CFR § 892.2050 |
| Device Class | II |
| 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 to either screening or diaqnostic 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 mammoqraphy as well as digital breast tomosynthesis. lts 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 MAMMOVISTA B.smart VB60 (K212621 cleared on 11/12/2021). 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 is the same as it was for the predicate device.

#### 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

MAMMOVISTA B.smart VB70 has the same indications for use as the predicate device. MAMMOVISTA B.smart is a software-only solution to run on compatible client server environment together with monitor displays cleared for

{5}------------------------------------------------

Mammography.

Optional software packages provide for the specific customer needs such as the display of tomosynthesis or MR datasets with specific layouts and tools.

The following table compares the main performance data of the subject device with the predicate device to substantiate equivalence of the subject device and predicate device.

### Comparison of the Subject Device (MAMMOVISTA B.smart VB70) to Predicate Device(MAMMOVISTA B.smart VB60)

| Feature | Subject device | Predicate device<br>(K212621) | Comment |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Regulation<br>Description | System, image processing,<br>radiological | System, image processing,<br>radiological | same |
| Device<br>Name | MAMMOVISTA B.smart | MAMMOVISTA B.smart | same |
| Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | same |
| Classification<br>Product<br>Code | LLZ | LLZ | same |
| Indications<br>for use | MAMMOVISTA B.smart is<br>a dedicated softcopy review<br>environment for both<br>screening and diagnostic<br>mammography as well as<br>digital breast<br>tomosynthesis. Its user<br>interface and workflow have<br>been optimized to support<br>experienced mammography<br>and tomosynthesis<br>reviewers in both screening<br>and diagnostic reading.<br>Efficiency and reading<br>quality are supported by<br>various specialized<br>features.<br>MAMMOVISTA B.smart<br>provides visualization and<br>image enhancement tools<br>to aid a qualified radiologist<br>in the review of digital<br>mammography and digital<br>breast tomosynthesis<br>datasets, as well as other<br>modalities of breast images. | MAMMOVISTA B.smart is<br>a dedicated softcopy review<br>environment for both<br>screening and diagnostic<br>mammography as well as<br>digital breast<br>tomosynthesis. Its user<br>interface and workflow have<br>been optimized to support<br>experienced mammography<br>and tomosynthesis<br>reviewers in both screening<br>and diagnostic reading.<br>Efficiency and reading<br>quality are supported by<br>various specialized<br>features.<br>MAMMOVISTA B.smart<br>provides visualization and<br>image enhancement tools<br>to aid a qualified radiologist<br>in the review of digital<br>mammography and digital<br>breast tomosynthesis<br>datasets, as well as other<br>modalities of breast images | same |
| Architecture | Client / server environment | Client / server environment | same |
| Display of 3rd<br>party<br>Computer<br>Aided<br>Diagnostics<br>(CAD)<br>markers | Yes | Yes | same |
| Display and<br>processing of<br>DBT images | Yes | Yes | same |
| DICOM 3.0 | Same | Same | same |
| DICOM<br>compatible<br>modalities | MG (Digital Mammography<br>X-Ray)<br>MG Tomo (Mammography<br>Tomosynthesis images)<br>MR (Magnetic Resonance)<br>CR (Computed<br>Radiography)<br>CT (Computed<br>Tomography)<br>DR (Digital X-Ray)<br>NM (Nuclear Medicine)<br>US (Ultrasound)<br>SC (Secondary Capture)<br>PET (Positron -Emission-<br>Tomography) | MG (Digital Mammography<br>X-Ray)<br>MG Tomo (Mammography<br>Tomosynthesis images)<br>MR (Magnetic Resonance)<br>CR (Computed<br>Radiography)<br>CT (Computed<br>Tomography)<br>DR (Digital X-Ray)<br>NM (Nuclear Medicine)<br>US (Ultrasound)<br>SC (Secondary Capture)<br>PET (Positron -Emission-<br>Tomography) | same |
| Display of<br>breast<br>density<br>values | Yes | Yes | same |
| Configura<br>tion and<br>Settings | Automatic study grouping<br>Diagnostic display<br>responsibility<br>Client compatibility check<br>Image rendering<br>performance<br>Layout settings<br>ReportFlow settings<br>Custom image text settings<br>Image Navigation settings<br>Image viewing preferences<br>Image tool settings | Automatic study grouping<br>Diagnostic display<br>responsibility<br>Client compatibility check<br>Image rendering<br>performance<br>Layout settings<br>ReportFlow settings<br>Custom image text settings<br>Image Navigation settings<br>Image viewing preferences<br>Image tool settings | The new<br>settings do not<br>impact safety<br>and<br>effectiveness |
| | Workflow settings<br>Screening case detection<br>Double blind reading | Workflow settings | |
| MR<br>Support | MR Layouts<br>Empty Layout Dynamic Layout MR.Dynamic MR.Kaiser MR.MPR MR.DWI MR.FollowUp Color overlay<br>Time curve analyzer | MR Layouts<br>Empty Layout Dynamic Layout MR.Dynamic | The new MR<br>features do not<br>impact safety<br>and<br>effectiveness |

{6}------------------------------------------------

{7}------------------------------------------------

#### Summary of Non-Clinical Tests: 9.

Non-clinical tests were conducted for the MAMMOVISTA B.smart software during product development. The MAMMOVISTA B.smart software complies with the following voluntary standards:

| Standards<br>Reference Number | Title of Standard |
|-------------------------------|---------------------------------------------------------------------------|
| IEC 62366-1 2015 Ed 1.0 | Medical devices – Application of usability engineering 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 |

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. The data demonstrates continued conformance with special controls for medical devices containing software. 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.

{8}------------------------------------------------

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 tomosynthesis datasets.

#### 11. Conclusion as to Substantial Equivalence:

The MAMMOVISTA B.smart' s Indication for Use is identical to that of the predicate device. The operating environment and software design are similar. lmage 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.

lt is Siemens' opinion that the MAMMOVISTA B.smart does not introduce any new potential safety risks and is substantially equivalent to the MAMMOVISTA B.smart VB60.

#### 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

The Special 510(k) Program Guidance for Industry and Food and Drug Administration Staff Document issued September 13, 2019