(246 days)
Yes
The device description explicitly states that it employs a convolutional network (CNN) which has been trained on a large database of mammography exams. CNNs are a type of artificial neural network commonly used in machine learning for image analysis.
No.
The device is a software application that assesses breast density, aids radiologists in assessment, and is explicitly stated as "not a diagnostic aid." It does not provide therapy or treatment.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic aid."
Yes
The device is described as a "software application" that runs as an "add-on module" to an existing software product (Visage 7). It processes medical images and provides a classification, with the results displayed and stored by the host software. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Visage Breast Density analyzes medical images (mammography studies) to assess breast density. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's a software application for use with imaging systems to aid radiologists in assessing breast tissue composition from mammography studies.
Therefore, Visage Breast Density falls under the category of medical imaging software, not an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid.
Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images.
Product codes
QIH
Device Description
Visage Breast Density is a software application that assesses breast density from a mammography study and provides a density category A, B, C, or D according to the ACR BI-RADS Atlas 5th Edition to aid radiologists in the assessment of breast tissue composition.
Visage Breast Density is designed as an add-on module to the Visage 71 product for distributing, viewing, processing, and archiving medical images. The assessment of breast density is performed from mammography studies stored on the Visage 7 server. The resulting breast density classification is displayed by the Visage 7 client on a computer monitor and stored in the database on the Visage 7 server.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Visage Breast Density employs a convolutional network (CNN) for the automatic classification of breast density. The CNN has been trained on a large database of mammography exams. When applied to a mammography image, the CNN computes four likelihoods corresponding to the four breast density categories. The classifications of the individual images are merged into a general classification of the mammography study.
Input Imaging Modality
full field digital mammography and digital breast tomosynthesis systems
mammography study
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
Description of the training set, sample size, data source, and annotation protocol
The CNN has been trained on a large database of mammography exams.
Description of the test set, sample size, data source, and annotation protocol
Visage Breast Density was tested against two independent data sets of 500 and 700 studies from two different sites. Three board certified radiologists with MQSA qualification per site performed a breast density classification and the consensus of the three reviewers was determined for each study.
The predicted breast density category of Visage Breast Density was related to the ground truth from the clinical reports and the consensus of the three reviewers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The accuracies per category and the total accuracy were computed for the classification into the four categories of the ACR BI-RADS Atlas 5ª Edition as well as for the binary classification 'dense' versus 'non-dense'.
The resulting accuracies were compared to the corresponding values of the predicate device. Visage Breast Density achieved similar accuracies per category and similar total accuracies compared to the predicate device.
The validation showed that the results of Visage Breast Density regarding the classification of breast density categories are in sufficient accordance with the results of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracies per category and total accuracy
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).
0
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
Visage Imaging GmbH % Juliane Dinter Lead Project Manager QiP GmbH Struveweg 40 LUDWIGSFELDE, BRANDENBURG 14974 GERMANY
January 29, 3021
Re: K201411
Trade/Device Name: Visage Breast Density Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: QIH Dated: December 21, 2020 Received: December 23, 2020
Dear Juliane Dinter:
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
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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 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 (OS) 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 mediation-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 Division 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
510(k) Number (if known) K201411
Device Name Visage Breast Density
Indications for Use (Describe)
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid.
Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical 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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Traditional 510(k) Summary Visage Breast Density
Image /page/3/Picture/2 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with the words "Visage Imaging" to the right of it. The geometric shape is made up of three overlapping squares in green, gray, and black. The word "Imaging" has a registered trademark symbol next to it.
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
Submitter
| Name | Visage Imaging GmbH |
|---|---|
| Address | Lepsiusstrasse 70 |
| 12163 Berlin | |
| Germany | |
| Contact Person | Stefan Strowich |
| Manager of Quality Systems and Regulatory Affairs | |
| sstrowich@visageimaging.com | |
| Phone Number | +49 30 700968-41 |
| Date Prepared | January 28, 2021 |
Device
| Trade Name | Visage Breast Density |
|---|---|
| Common Name | Medical Imaging Software |
| Classification Name | Automated Radiological Image Processing Software |
| Regulatory Number | 21 CFR 892.2050 |
| Product Code | QIH |
| Device Class | Class II |
| Review Panel | Radiology |
Predicate Device
| Trade Name | PowerLook Density Assessment |
|---|---|
| Common Name | Medical Imaging Software |
| Classification Name | System, Image Processing, Radiology |
| Regulatory Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Device Class | Class II |
| Review Panel | Radiology |
| Submitter | iCAD, Inc. |
| 510(k) Number | K180125 |
| Clearance | April 5, 2018 |
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Image /page/4/Picture/1 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with the words "Visage Imaging" to the right of it. The geometric shape is made up of three overlapping squares in green and gray. The words "Visage Imaging" are in a serif font, with the word "Imaging" in a slightly smaller font than the word "Visage".
Device Description
Visage Breast Density is a software application that assesses breast density from a mammography study and provides a density category A, B, C, or D according to the ACR BI-RADS Atlas 5th Edition to aid radiologists in the assessment of breast tissue composition.
Visage Breast Density employs a convolutional network (CNN) for the automatic classification of breast density. The CNN has been trained on a large database of mammography exams. When applied to a mammography image, the CNN computes four likelihoods corresponding to the four breast density categories. The classifications of the individual images are merged into a general classification of the mammography study.
Visage Breast Density is designed as an add-on module to the Visage 71 product for distributing, viewing, processing, and archiving medical images. The assessment of breast density is performed from mammography studies stored on the Visage 7 server. The resulting breast density classification is displayed by the Visage 7 client on a computer monitor and stored in the database on the Visage 7 server.
Indications for Use
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid.
Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images.
Comparison with Predicate Device
The technical characteristics of Visage Breast Density and the predicate device PowerLook Density Assessment are comparable.
The devices under comparison are software applications that assess breast density and provide a density category according to the ACR BI-RADS Atlas 5th Edition. Both devices are intended as an interpretative aid in the assessment of breast tissue composition. They have the same product classification, same level of concern, same patient population and similar intended users.
Visage Breast Density uses a trained convolutional network with digital mammography images. The predicate device determines the density category of tomosynthesis images based on a calculation of area covered by dense tissue. Despite the different analysis techniques, non-clinical testing showed that Visage Breast Density achieves similar accuracies compared to the predicate device.
Both applications are designed as a software extension meant to operate within a larger software framework intended for managing medical images.
² Visage 7 is a Class II medical device. It has been cleared with the former trade name Visage PACS/CS under K082269.
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Image /page/5/Picture/1 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with the words "Visage Imaging" to the right. The geometric shape is made up of three overlapping squares in green and gray. The text is in a bold, sans-serif font.
Performance Data
Visage Breast Density was tested against two independent data sets of 500 and 700 studies from two different sites. Three board certified radiologists with MQSA qualification per site performed a breast density classification and the consensus of the three reviewers was determined for each study.
The predicted breast density category of Visage Breast Density was related to the ground truth from the clinical reports and the consensus of the three reviewers. The accuracies per category and the total accuracy were computed for the classification into the four categories of the ACR BI-RADS Atlas 5ª Edition as well as for the binary classification 'dense' versus 'non-dense'.
The resulting accuracies were compared to the corresponding values of the predicate device. Visage Breast Density achieved similar accuracies per category and similar total accuracies compared to the predicate device.
The validation showed that the results of Visage Breast Density regarding the classification of breast density categories are in sufficient accordance with the results of the predicate device.
Conclusion
The differences in technological characteristics between Visage Breast Density and the predicate device do not raise new questions of safety or effectiveness. The differences in indications for use do not change the intended use nor raise new questions of safety and effectiveness.
Based on the information presented in this premarket notification, and in accordance with the indications for use, technological characteristics and validation testing, it is concluded that Visage Breast Density is substantially equivalent to the predicate device PowerLook Density Assessment.