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 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.

AI/ML Overview

The provided text describes MAMMOVISTA B.smart (VB70), a software device for mammography image review. However, it does not explicitly state acceptance criteria or a dedicated study proving performance against such criteria. The submission is a 510(k) premarket notification for substantial equivalence, comparing the new VB70 version to a predicate device, MAMMOVISTA B.smart VB60 (K212621).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria or device performance metrics for the VB70 version beyond a feature-by-feature comparison to the predicate device. The performance is described in terms of functional equivalence and safety.

Feature/Criterion	Acceptance Criteria (Implied)	Reported Device Performance (VB70)
Functional Equivalence	Functions identically to predicate device (VB60).	"MAMMOVISTA B.smart VB70 has the same indications for use 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." "Verification and validation testing demonstrate that the MAMMOVISTA B.smart performs as intended."
Safety	No new safety risks compared to predicate device.	"It 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." Risk analysis completed and controls implemented.
Compliance with Standards	Conforms to relevant software and medical device standards.	Complies with IEC 62366-1 2015 Ed 1.0, IEC 62304 2015, Ed.1.1, and NEMA PS 3.1 - 3.20 2016.
DICOM Compatibility	Compatible with DICOM 3.0 and various modalities.	Same as predicate, supports MG, MG Tomo, MR, CR, CT, DR, NM, US, SC, PET.
Display of CAD Markers	Ability to display third-party CAD markers.	Yes, same as predicate.
Display/Processing of DBT	Ability to display and process Digital Breast Tomosynthesis images.	Yes, same as predicate.
Display of Breast Density	Ability to display breast density values.	Yes, same as predicate.
Configuration/Settings	Workflow, layout, image viewing, and tool settings function as intended. Minimal impact on safety/effectiveness for new settings.	Includes automatic study grouping, diagnostic display responsibility, client compatibility check, image rendering performance, layout settings, ReportFlow settings, custom image text settings, image navigation settings, image viewing preferences, image tool settings, workflow settings, screening case detection, double blind reading. "The new settings do not impact safety and effectiveness."
MR Support	MR Layouts and functionality (e.g., color overlay, time curve analyzer) function as intended. Minimal impact on safety/effectiveness for new MR features.	New MR layouts (MR.Kaiser, MR.MPR, MR.DWI, MR.FollowUp), color overlay, time curve analyzer. "The new MR features do not impact safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Non-clinical tests (integration and functional) were conducted on the MAMMOVISTA B.smart during product development." It further notes, "Siemens did not conduct any clinical tests for the subject device." Therefore, the "test set" in this context refers to software testing and verification/validation, not a clinical data set for performance evaluation in a medical context.

Sample Size for Test Set: Not specified, as it refers to internal software testing, not a clinical population.
Data Provenance: Not applicable for a software-only 510(k) submission based on substantial equivalence and non-clinical testing. No patient data or clinical images are mentioned as being part of a "test set" for performance evaluation in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This was a non-clinical software verification and validation study, not a clinical performance study requiring expert ground truth for medical diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. This was a non-clinical software verification and validation study, not a clinical performance study involving human adjudication of medical findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "Siemens did not conduct any clinical tests for the subject device." The device is a "softcopy review environment" that provides "visualization and image enhancement tools to aid a qualified radiologist," meaning it's a viewing workstation, not an AI or CAD device that provides interpretations or assists directly with diagnostic accuracy in a quantifiable way like an AI algorithm.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. The device is a viewing and processing software. It is not an algorithm designed to provide standalone diagnostic interpretations. Its purpose is to "aid a qualified radiologist in the review" of images.

7. The Type of Ground Truth Used:

Not applicable. As a software viewing platform, the concept of "ground truth" (pathology, expert consensus, outcomes data) for its own performance is not directly relevant. Its performance is related to its ability to display images correctly, adhere to DICOM standards, and provide tools as specified, which are verified through non-clinical software testing.

8. The Sample Size for the Training Set:

Not applicable. This device is a software viewing platform, not an AI/Machine Learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned or implied for this type of device.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 adams.denise@siemens-healthineers.com

Alternate 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

3. Device Name and Classification:

Trade Name:	MAMMOVISTA B.smart (VB70)
Classification Name:	Medical Image Management andProcessing System
Classification Panel	Radiology
Classification Regulation:	21 CFR § 892.2050
Device Class	II
Product Codes:	LLZ

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4. Legally Marketed Predicate Device:

Trade Name:	MAMMOVISTA B.smart
510(k) Number:	K212621 (Cleared 11/12/2021)
Classification Name:	Medical Image Management andProcessing System
Classification Panel	Radiology
Classification Regulation:	21 CFR § 892.2050
Device Class	II
Product Codes:	LLZ

5. Device Description:

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

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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(K212621)	Comment
RegulationDescription	System, image processing,radiological	System, image processing,radiological	same
DeviceName	MAMMOVISTA B.smart	MAMMOVISTA B.smart	same
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	same
ClassificationProductCode	LLZ	LLZ	same
Indicationsfor use	MAMMOVISTA B.smart isa dedicated softcopy reviewenvironment for bothscreening and diagnosticmammography as well asdigital breasttomosynthesis. Its userinterface and workflow havebeen optimized to supportexperienced mammographyand tomosynthesisreviewers in both screeningand diagnostic reading.Efficiency and readingquality are supported byvarious specializedfeatures.MAMMOVISTA B.smartprovides visualization andimage enhancement toolsto aid a qualified radiologistin the review of digitalmammography and digitalbreast tomosynthesisdatasets, as well as othermodalities of breast images.	MAMMOVISTA B.smart isa dedicated softcopy reviewenvironment for bothscreening and diagnosticmammography as well asdigital breasttomosynthesis. Its userinterface and workflow havebeen optimized to supportexperienced mammographyand tomosynthesisreviewers in both screeningand diagnostic reading.Efficiency and readingquality are supported byvarious specializedfeatures.MAMMOVISTA B.smartprovides visualization andimage enhancement toolsto aid a qualified radiologistin the review of digitalmammography and digitalbreast tomosynthesisdatasets, as well as othermodalities of breast images	same
Architecture	Client / server environment	Client / server environment	same
Display of 3rdpartyComputerAidedDiagnostics(CAD)markers	Yes	Yes	same
Display andprocessing ofDBT images	Yes	Yes	same
DICOM 3.0	Same	Same	same
DICOMcompatiblemodalities	MG (Digital MammographyX-Ray)MG Tomo (MammographyTomosynthesis images)MR (Magnetic Resonance)CR (ComputedRadiography)CT (ComputedTomography)DR (Digital X-Ray)NM (Nuclear Medicine)US (Ultrasound)SC (Secondary Capture)PET (Positron -Emission-Tomography)	MG (Digital MammographyX-Ray)MG Tomo (MammographyTomosynthesis images)MR (Magnetic Resonance)CR (ComputedRadiography)CT (ComputedTomography)DR (Digital X-Ray)NM (Nuclear Medicine)US (Ultrasound)SC (Secondary Capture)PET (Positron -Emission-Tomography)	same
Display ofbreastdensityvalues	Yes	Yes	same
Configuration andSettings	Automatic study groupingDiagnostic displayresponsibilityClient compatibility checkImage renderingperformanceLayout settingsReportFlow settingsCustom image text settingsImage Navigation settingsImage viewing preferencesImage tool settings	Automatic study groupingDiagnostic displayresponsibilityClient compatibility checkImage renderingperformanceLayout settingsReportFlow settingsCustom image text settingsImage Navigation settingsImage viewing preferencesImage tool settings	The newsettings do notimpact safetyandeffectiveness
	Workflow settingsScreening case detectionDouble blind reading	Workflow settings
MRSupport	MR LayoutsEmpty Layout Dynamic Layout MR.Dynamic MR.Kaiser MR.MPR MR.DWI MR.FollowUp Color overlayTime curve analyzer	MR LayoutsEmpty Layout Dynamic Layout MR.Dynamic	The new MRfeatures do notimpact safetyandeffectiveness

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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:

StandardsReference 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.

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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

Regulation Number and Section

§ 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).