(365 days)
Not Found
No
The summary describes proprietary algorithms and validation against expert radiologist assessments, but there is no mention of AI, ML, deep learning, or neural networks. The performance metrics (Pearson's Correlation, Kappa) are also not typical for evaluating AI/ML models in this context.
No
The device is a software application that calculates percent breast density to aid interpreting physicians in the assessment of breast tissue composition. It provides adjunctive information and is explicitly stated as "not a diagnostic aid." It does not provide any treatment or direct therapy.
No.
The "Intended Use / Indications for Use" section explicitly states: "It is not a diagnostic aid." The device provides adjunctive information and aid in the assessment of breast tissue composition, but does not diagnose.
Yes
The device is explicitly described as a "standalone software application" that processes digital mammograms. While it interacts with mammography systems and workstations, the device itself is solely the software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states that the software "calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates." This calculation is performed on data derived from the patient (the mammogram images).
- Device Description: The device "automatically analyzes 'for presentation' full field digital mammograms to calculate breast tissue composition." Again, this analysis is performed on patient-derived data.
- Nature of the Data: Mammogram images are a form of in vitro diagnostic data, as they are obtained from the patient's body and analyzed outside of the body to provide information about the patient's health status.
- Purpose: While the device is described as providing "adjunctive information" and "not a diagnostic aid," the act of calculating breast density from a mammogram falls under the umbrella of in vitro diagnostics. It's providing objective measurements derived from a biological sample (the image representing the breast tissue) to aid in the assessment of a patient's condition (breast tissue composition).
Even though the software itself doesn't directly diagnose a disease, the process of analyzing the mammogram to determine breast density is an in vitro diagnostic procedure. The software is a tool used within that process.
The fact that it's a software application analyzing images doesn't preclude it from being an IVD. Many IVDs are software-based, analyzing data from various sources like imaging, genetic sequencing, or laboratory tests.
N/A
Intended Use / Indications for Use
DM-Density is a software application intended for use with compatible full field digital mammography systems. DM-Density calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
DM-Density is a standalone software application that automatically analyzes "for presentation" full field digital mammograms to calculate breast tissue composition.
The software processes full field digital mammograms according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scales.
DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems.
DM-Density data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS. DM-Density reports are configured to provide the following data based on the two available breast density classification grades:
BI-RADS 4th Edition
For each breast:
- Area of fibroglandular tissue (cm²)
- · Area of breast (cm2)
- Area-based breast density (%)
For each patient: DM-Density breast density grade and percent breast density
BI-RADS 5th Edition For each patient: DM-Density breast density grade
Alternative configuration options are available to match user preferences.
DM-Density can process approximately 600 cases per hour.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
full field digital mammography systems
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interpreting Physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that DM-Density product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
Verification testing consisted of unit and integrated system level testing. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort. Validation testing relied on expert radiologist visual assessments of mammography density, and is summarized as follows:
- Reliability was assessed using the Pearson's Correlation Coefficient by comparing the DM-Density percent density, dense breast area and total area measurements for Left and Right breasts as well as for CC and MLO views.
- Accuracy was assessed by validating DM-Density percent density and total area measurements. The . accuracy of DM-Density dense breast area measurements follows by implication.
- . Accuracy was further assessed by validating the Breast Density Grade assessments to known Breast Density Grade assessments using the Kappa statistic.
- Reproducibility was assessed with the Pearson Correlation Coefficient using a dataset from subjects . who had two mammograms acquired on compatible mammography acquisition systems within a two year time period.
- • The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between DM-Density percent density measures and age at time of screening.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
February 23, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a blue square.
Densitas, Inc. % Mr. Ken Pilgrim Director - RA & QA Emergo Group, Inc. 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746
Re: K170540
Trade/Device Name: DM-Density Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 9, 2018 Received: February 13, 2018
Dear Mr. Pilgrim:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Michael D. O'Hara 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
510(k) Number (if known) K170540
Device Name DM-Density
Indications for Use (Describe)
DM-Density is a software application intended for use with compatible full field digital mammography systems. DM-Density calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.
| 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) |
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
Image /page/3/Picture/0 description: The image shows the logo for DENSITAS. The logo features a blue square made up of smaller squares, with the company name "DENSITAS" written in a bold, sans-serif font below it. Underneath the company name, the tagline "Driven by Data" is written in a smaller, italicized font.
densitas, inc. Traditional 510(k) Premarket Submission DM-DENSITY
Section 5 – 510(k) Summary
K170540
| Submitter: | Densitas, Inc.
1344 Summer Street, Suite 311.2
Halifax, NS, B3H 0A8 Canada |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 12 Feb 2018 |
| Contact Person: | Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746 USA
Cell Phone: (604) 836.5020
Office Phone: (512) 327.9997
Contact: Ken Pilgrim, Sr. RA / QA Consultant
Email: project.management@emergogroup.com |
| Submission Date: | January 16, 2017 |
| Trade Name: | DM-Density |
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Image Processing, Radiological
21 CFR 892.2050
LLZ |
| Device Classification: | Class II |
| Predicate Device(s): | iReveal® by iCAD, Inc. (formerly M-Vu® by VuCOMP, Inc.)
K132742 |
| Section 5 | Page 1 of 6 |
4
Image /page/4/Picture/0 description: The image shows the logo for DENSITAS. The logo features a blue square made up of smaller squares, with the word "DENSITAS" written in blue below it. Underneath the word "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font.
Description of Device:
DM-Density is a standalone software application that automatically analyzes "for presentation" full field digital mammograms to calculate breast tissue composition.
The software processes full field digital mammograms according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scales.
DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems.
DM-Density data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS. DM-Density reports are configured to provide the following data based on the two available breast density classification grades:
BI-RADS 4th Edition
For each breast:
- Area of fibroglandular tissue (cm²)
- · Area of breast (cm2)
- Area-based breast density (%)
For each patient: DM-Density breast density grade and percent breast density
BI-RADS 5th Edition For each patient: DM-Density breast density grade
Alternative configuration options are available to match user preferences.
DM-Density can process approximately 600 cases per hour.
5
Image /page/5/Picture/0 description: The image shows the logo for DENSITAS. The logo features a blue square made up of smaller squares, with the word "DENSITAS" written in blue below it. Underneath the word "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font.
Indications for Use Statement:
DM-Density is a software application intended for use with compatible full field digital mammography systems. DM-Density calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.
Substantial Equivalence Discussion:
DM-Density and iReveal (formerly M-Vu Breast Density) calculate breast density as a ratio of fibroglandular tissue and total breast area estimates. Both devices are not to be used as diagnostic aids, but to provide adjunctive information only. Users in both cases must be qualified medical practitioners and exercise their professional judgment when formulating diagnostic decisions and selecting appropriate treatment paths that are supported by breast density data. Both devices are DICOM-compliant and rely on DICOM imaging data from digital mammography systems (data input).
| Table 5A – Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | 510(K) Submitter | Predicate | Significant |
| Differences | |||
| Densitas, Inc. | iCAD, Inc. (formerly | ||
| VuCOMP, Inc.) | |||
| Trade Name | DM-Density | iReveal (formerly M-Vu | |
| Breast Density) | |||
| 510(k) Number | N/A | K132742 | N/A |
| Product Code | LLZ | LLZ | N/A |
| Regulation | |||
| Number | 21 CFR Part 892.2050 | 21 CFR Part 892.2050 | N/A |
| Regulation Name | System, Image Processing, | ||
| Radiological | System, Image Processing, | ||
| Radiological | N/A | ||
| Intended Use / | |||
| Indications for Use | DM-Density is a software | ||
| application intended for use | |||
| with compatible full field digital | |||
| mammography systems. DM- | |||
| Density calculates percent | |||
| breast density defined as the | |||
| ratio of fibroglandular tissue to | |||
| total breast area | |||
| estimates. DM-Density | |||
| provides these numerical | M-Vu Breast Density is a | ||
| software application intended | |||
| for use with digital | |||
| mammography systems. M-Vu | |||
| Breast Density calculates breast | |||
| density as a ratio of | |||
| fibroglandular tissue and total | |||
| breast area estimates. M-Vu | |||
| Breast Density provides these | |||
| numerical values for each | N/A | ||
| values for each breast as well | |||
| as a density category to aid | |||
| interpreting physicians in the | |||
| assessment of breast tissue | |||
| composition. DM-Density | |||
| produces adjunctive | |||
| information. It is not a | |||
| diagnostic aid. | breast as well as a density | ||
| category to aid radiologists in | |||
| the assessment of breast tissue | |||
| composition. M-Vu Breast | |||
| Density produces adjunctive | |||
| information. It is not an | |||
| interpretive or diagnostic aid. | |||
| Patient Population | Symptomatic and | ||
| asymptomatic women | |||
| undergoing mammography | Same | N/A | |
| End Users | Interpreting Physicians | Same | N/A |
| Image Source | |||
| Modalities | Hologic Selenia Dimensions | All digital radiography (DR) | |
| systems and computed | |||
| radiography (CR) systems | N/A - Suite of image | ||
| source modalities that | |||
| are compatible with | |||
| iReveal include the | |||
| source modalities | |||
| compatible with DM- | |||
| Density. | |||
| Hologic Lorad Selenia | |||
| Input: Image Data | |||
| Format | DICOM full field digital | ||
| mammography imager – For | |||
| Presentation; RCC, LCC, RMLO, | |||
| LMLO | DICOM digital mammography | ||
| imager - For Processing; RCC, | |||
| LCC, RMLO, LMLO | DM-Density = For | ||
| Presentation; | |||
| iReveal = For | |||
| Processing | |||
| Output Data | BI-RADS 4th Ed. | ||
| For each breast: | |||
| • Area of fibroglandular | |||
| tissue (cm²) | |||
| • Area of breast (cm²) | |||
| • Area-based breast density | |||
| (%) | |||
| For each patient: DM-Density | |||
| breast density grade and | |||
| percent breast density | |||
| BI-RADS 5th Ed. | |||
| For each patient: DM-Density | |||
| breast density grade | For each breast: | ||
| • Area of fibroglandular | |||
| tissue (cm²) | |||
| • Area of breast (cm²) | |||
| • Area-based breast density | |||
| (%) | |||
| For each patient: | |||
| VuCOMP density grade/BIRADS | |||
| breast density | Subject device | ||
| provides breast | |||
| density grade | |||
| consistent with BI- | |||
| RADS 5th Ed.; | |||
| Predicate device does | |||
| not conform to the 5th | |||
| Ed. scale. | |||
| Measurement | |||
| Scales | 4-category breast density scale | ||
| from 4th Ed. ACR BI-RADS Atlas | |||
| 2003 | 4-category breast density scale | ||
| from 4th Ed. ACR BI-RADS Atlas | |||
| 2003 | Subject device | ||
| provides users with | |||
| the option of utilizing | |||
| either the 4th or 5th | |||
| edition scales; | |||
| Predicate Device | |||
| utilizes 4th edition | |||
| scale only | |||
| 4-category breast density scale | |||
| from 5th Ed. ACR BI-RADS Atlas | |||
| 2013 | |||
| Output Device | Mammography Workstation, | ||
| PACS, and RIS | Same | N/A | |
| Output Format | DICOM Structured Report and | ||
| Secondary Capture | Same | N/A | |
| Deployment | Standalone computer | Same | N/A |
| Data Throughput | 600 cases per hour | 60 – 120 cases per hour | N/A |
| Assessment scope | Results per image | Same | N/A |
| Assessment type | Area-based | Same | N/A |
| Anatomical | |||
| Location | Breast | Same | N/A |
Table 5A - Comparison of Characteristics
Section 5
6
Image /page/6/Picture/0 description: The image shows the logo for Densitas. The logo features a blue square made up of smaller squares, resembling pixels. Below the square is the word "DENSITAS" in a bold, blue font, and below that is the tagline "Driven by Data" in a smaller, italicized font.
7
Image /page/7/Picture/0 description: The image shows the logo for DENSITAS. The logo features a square grid of blue squares above the word "DENSITAS" in a bold, sans-serif font. Below the word "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font.
Clinical Performance Data:
There was no human clinical testing required to support the medical device.
Non-Clinical Performance Data:
Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that DM-Density product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
Verification testing consisted of unit and integrated system level testing. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort. Validation testing relied on expert radiologist visual assessments of mammography density, and is summarized as follows:
Section 5
8
Image /page/8/Picture/0 description: The image contains the logo for DENSITAS. The logo features a blue square made up of smaller squares, resembling a pixelated or digital design. Below the square is the word "DENSITAS" in a bold, sans-serif font, also in blue. Underneath "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font, also in blue.
- Reliability was assessed using the Pearson's Correlation Coefficient by comparing the DM-Density percent density, dense breast area and total area measurements for Left and Right breasts as well as for CC and MLO views.
- Accuracy was assessed by validating DM-Density percent density and total area measurements. The . accuracy of DM-Density dense breast area measurements follows by implication.
- . Accuracy was further assessed by validating the Breast Density Grade assessments to known Breast Density Grade assessments using the Kappa statistic.
- Reproducibility was assessed with the Pearson Correlation Coefficient using a dataset from subjects . who had two mammograms acquired on compatible mammography acquisition systems within a two year time period.
- • The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between DM-Density percent density measures and age at time of screening.
Statement of Substantial Equivalence:
DM-Density, as designed and developed by Densitas Inc., is determined to be substantially equivalent to the predicate device. Differences between the two devices do not raise new questions about the safety and effectiveness of DM-Density.