(218 days)
GE Senographe Essentials, Hologic Selenia Dimension systems
Unknown
The description mentions "proprietary algorithms" and comparison to "qualified databases containing images previously visually assessed by radiologists," which could potentially involve ML, but it doesn't explicitly state the use of AI or ML. The lack of information on training and test sets also makes it difficult to confirm.
No
The device aids radiologists in assessing breast density but is explicitly stated as not being a diagnostic aid, and it does not treat or cure any condition.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician." It provides "adjunctive information" to aid radiologists, but the final diagnostic assessment rests with the physician.
Yes
The device is described as a "software application" that analyzes digital mammograms. It runs on standard computer operating systems and requires a web browser for the user interface. While it interacts with mammography systems for input, the device itself is solely the software performing the analysis and providing the output.
Based on the provided information, DenSeeMammo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- DenSeeMammo's Function: DenSeeMammo analyzes images (mammograms) obtained from a medical imaging system (Full Field Digital Mammography). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a software application for use with mammography systems to estimate breast density from processed digital mammograms. It explicitly states it is not a diagnostic aid and provides adjunctive information.
Therefore, DenSeeMammo falls under the category of medical imaging software or a medical device accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems.
DenSeeMammo estimates Bl-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers. DenSeeMammo is compatible for images obtained from GE Senographe Essentials and Hologic Selenia Dimension systems.
Product codes
LLZ
Device Description
DenSeeMammo analyzes processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density category.
DenSeeMammo handles processed images extracted from DICOM files as input.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo software is a component which accepts digital mammography images as an input. The software processes and analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously assessed by radiologists. For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts.
The patient population is symptomatic and asymptomatic women undergoing mammography. The software does perform illustrative image display but only for illustrative purposes and not for interpretation or diagnostic.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
processed digital 2D mammograms
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
DenSeeMammo v1.2 software was run over twice on data sets of images to test reproducibility.
DenSeeMammo v1.2 software was run over on a sample of exams and left and right breast densities were compared to test reproducibility.
DenSeeMammo v1.2 software results were compared to visual assessment from MQSA-qualified radiologists.
DenSeeMammo v1.2 software was run over substantial data sets of two views images (CC + MLO) from GE and Hologic systems, which had been previously assessed by MQSA-qualified radiologists.
DenSeeMammo v1.2 software was run over substantial data sets of one view images from GE (CC) and Hologic (CC or MLO) systems, which had been previously assessed by MQSA-qualified radiologists. Visual assessments were performed from two views CC + MLO images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Verification and validation testing
- Sample Size: Not specified, but "substantial data sets" mentioned for imaging tests
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: All verification and validation testing was successful in that established acceptance criteria was met for all of the tests conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
STATLIFE % Mrs. Valérie Hélin Authorized Correspondent EPIDEMIO3D 50 Milk Street, 16th Floor BOSTON MA 02109
June 26th, 2018
Re: K173574
Trade/Device Name: DenSeeMammo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: May 29, 2018 Received: May 31, 2018
Dear Mrs. Hélin:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
Page 2 - Mrs. Valérie Hélin
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Balyer
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number K173574
Device Name DenSeeMammo
Indications for Use (Describe)
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems.
DenSeeMammo estimates Bl-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers. DenSeeMammo is compatible for images obtained from GE Senographe Essentials and Hologic Selenia Dimension systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) র
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
Prepared June 20, 2018
Submitter Information 1
| Company Name: | STATLIFE |
|---|---|
| Company Address: | 39 RUE CAMILLE DESMOULINS |
| 94800 VILLEJUIF FRANCE | |
| Company Phone: | +33 660 848 385 |
| Company Facsimile: | +33 185 091 475 |
| Contact Person: | Stéphane Ragusa, CEO |
| Authorized Correspondent Phone | Valérie Hélin, Director of medical and regulatory affair |
| +33 682 437 010 |
2 Trade name and Common name
| Trade Name: | DenSeeMammo |
|---|---|
| Software Version: | 1.2 |
| Common Name: | Imaging Software |
3 Device Classification
| Regulatory Class: | II |
|---|---|
| Review category: | Class II |
| Classification Panel: | Radiology; |
| Product Code: | LLZ |
| Classification: | System, Image Processing, Radiological: 21 CFR § 892.205 |
Identification of Predicate Device 4
The modified software is substantially equivalent to DenSeeMammo Software version 1.0 cleared pursuant to K152009 cleared December 5吨, 2017
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5 Predicate Device Description
DenSeeMammo analyzes processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density category.
DenSeeMammo handles processed images extracted from DICOM files as input.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo software is a component which accepts digital mammography images as an input. The software processes and analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously assessed by radiologists. For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts.
The patient population is symptomatic and asymptomatic women undergoing mammography. The software does perform illustrative image display but only for illustrative purposes and not for interpretation or diagnostic.
б Comparison with Predicate device
DenSeeMammo software version 1.2 works in the same way as DenSeeMammo software 1.0 but is updated to make it compatible with digital mammograms from Hologic mammography systems and can work with a pair of images composed of two views (craniocaudal (CC) and mediolateral oblique (MLO)) or with an image composed of one view (CC for GE images, and CC or MLO for Hologic images).
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Table 1 Substantial Equivalence comparison table
| Characteristics | Predicate Device
DENSEEMAMMO v1.0 (K152009) | Submission Device
DENSEEMAMMO v1.2 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | LLZ | LLZ |
| Classification | 892.2050 | 892.2050 |
| Software level of concern | Moderate | Moderate |
| Device type | Not an interpretive or diagnostic aid | Not a diagnostic aid |
| Intended Use | DenSeeMammo is a software
application intended for use with digital
mammography systems.
DenSeeMammo estimates BI-RADS
breast density value by analyzing
processed digital 2D mammograms
using a fully automated comparison
procedure.
DenSeeMammo provides a BI-RADS
breast density 5th Edition category to
aid radiologists in the assessment of
breast density.
DenSeeMammo produces adjunctive
information. It is not an interpretive or
diagnostic aid when the final
assessment of breast density category is
made by an MQSA-qualified interpreting
physician.
DenSeeMammo core software has been
built and tested on OS X based
computers. DenSeeMammo graphical
use interface software has been built
and tested on Windows, OS X and Linux
based computers. | DenSeeMammo is a software application
intended for use with Full Field Digital
Mammography systems.
DenSeeMammo estimates BI-RADS
breast density category by analyzing
processed digital 2D mammograms using
a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS
breast density 5th Edition category to aid
radiologists in the assessment of breast
density.
DenSeeMammo produces adjunctive
information. It is not a diagnostic aid
since the final assessment of breast
density category is made by an MQSA
qualified interpreting physician.
DenSeeMammo core software has been
built and tested on OS X based
computers.
DenSeeMammo graphical use interface
software has been built and tested on
Windows, OS X and Linux based
computers.
DenSeeMammo v1.2 is compatible for
images obtained from GE Senographe
Essentials and Hologic Selenia Dimension
systems. |
| Intended users | Radiologists | Radiologists |
| Patient population | Symptomatic and asymptomatic women
undergoing mammography | Symptomatic and asymptomatic women
undergoing mammography |
| Image source | Digital mammography images | Digital mammography images |
| Compatibility | GE Digital Mammography systems | GE and Hologic Digital Mammography
systems |
| Anatomical area | Breast | Breast |
| Assessment scope | Provides results per patient based on
the maximum density category of the
two breasts | Provides results per patient based on the
maximum density category of the two
breasts |
| Assessment type | Comparison to qualified databases
containing images previously visually
assessed by MQSA-qualified radiologists
using ACR BI-RADS V recommendations | Comparison to qualified databases
containing images previously visually
assessed by MQSA-qualified radiologists
using ACR BI-RADS V recommendations |
| Characteristics | Predicate Device
DENSEEMAMMO v1.0 (K152009) | Submission Device
DENSEEMAMMO v1.2 |
| Measures provided | For each breast: BI-RADS V breast
density category
For each patient: BI-RADS V breast
density category | For each breast: BI-RADS V breast
density category
For each patient: BI-RADS V breast
density category |
| Operating environment | Software core: OS X based computers
Software graphical user interface:
Windows, OS X or Linux based
computers | Software core: OS X based computers
Software graphical user interface:
Windows, OS X or Linux based
computers |
| Deployment | Stand-alone computer | Stand-alone computer |
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7 Indications for Use
DenSeeMammo is a software application intended for use with Field Digital Mammography systems.
DenSeeMammo estimates BI-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.
DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo v1.2 is compatible for images obtained from GE Senographe Essentials and Hologic Selenia Dimension systems.
Technological Characteristics 8
DenSeeMammo is a software that aims at assessing the breast density of a woman. The software use processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density category. The software processes and analyses the image according to proprietary algorithms that allow comparison to qualified databases containing images previously visually assessed by radiologists. For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts.
The software works in a client-server mode and requires that the user computer be on the same local network as the server. Computations are made on the server part of the system that also
7
provide the graphical user interface to display the results. A web browser is required to display the graphical user interface: to select the patients' images and to display the assessment of the breast density according to the BI-RADS standards and the similar images.
The software was developed using the Java-1.8 language as a 3-component web application (See 11.1 Components). The software was developed following an adapted version of the model – view – controller software architectural pattern.
The device does not contact the patient, nor does it control any life-sustaining devices.
ਰੇ Performance Testing
The DenSeeMammo software has been verified and validated according to the company's design control process and particularly according the IEC 62304 standard. A risk analysis compliant with ISO 14971 has been provided. Software testing included both unit level and integrated system level testing.
In addition to the verification and validation testing conducted for the specific modification to the software detailed in this 510(k), complete verification and validation data testing conducted for the predicate was repeated in order to ensure integration and backwards compatibility.
Verification bench testing included:
-
DenSeeMammo v1.2 software was run over twice on data sets of images to test reproducibility.
-
DenSeeMammo v1.2 software was run over on a sample of exams and left and right breast densities were compared to test reproducibility.
-
DenSeeMammo v1.2 software results were compared to visual assessment from MQSA-qualified radiologists.
-
DenSeeMammo v1.2 software was run over substantial data sets of two views images (CC + MLO) from GE and Hologic systems, which had been previously assessed by MQSA-qualified radiologists.
-
DenSeeMammo v1.2 software was run over substantial data sets of one view images from GE (CC) and Hologic (CC or MLO) systems, which had been previously assessed by MQSA-qualified radiologists. Visual assessments were performed from two views CC + MLO images.
8
Clinical validation testing included:
Beta site testing to assess the ability of physicians to successfully integrate the software into their existing systems as well as assess usability for target users.
All verification and validation testing was successful in that established acceptance criteria was met for all of the tests conducted.
10 General Safety and Effectiveness Concerns
The device contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
Conclusions Drawn from Studies 11
The 510(k) Premarket Notification for DenSeeMammo v1.2 contains adequate information and data to demonstrate substantial equivalence to the predicate device.