(118 days)
DM-Density™ 2.1.0b K170540
No reference devices were used in this submission
Unknown
The summary mentions "proprietary algorithms" and "automatic analysis" of images, which are common in AI/ML applications, but it does not explicitly state that AI or ML is used. The absence of "AI", "DNN", or "ML" in the "Mentions AI, DNN, or ML" section further supports this ambiguity.
No.
The software application provides a breast density category to aid physicians in assessment and produces adjunctive information; it is explicitly stated that it is not a diagnostic aid. It does not treat or prevent a disease.
No
The "Intended Use / Indications for Use" section explicitly states "It is not a diagnostic aid." The device provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians, but specifically states it is adjunctive information and not for diagnosis.
Yes
The device description explicitly states it is a "standalone software application" and processes data from existing digital breast x-ray systems. There is no mention of accompanying hardware components or hardware-specific verification/validation.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is used to "aid interpreting physicians in the assessment of breast tissue composition." While it clarifies it's not a diagnostic aid itself, the core function is to analyze biological data (mammography images representing breast tissue) to provide information relevant to a medical assessment.
- Device Description: The device analyzes "for presentation" data from digital breast x-ray systems to "assess breast tissue composition." This involves processing images of biological tissue.
- Output: The output is a "Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) 5th edition density classification scale." This is a standardized medical classification system used in the assessment of breast tissue.
- Anatomical Site: The anatomical site is the "Breast," which is a part of the human body.
- Input Imaging Modality: The input is from mammography and tomosynthesis systems, which are used to image biological tissue.
While the device is a software application and doesn't directly interact with biological samples in the traditional sense of a lab test, the analysis of medical images representing biological tissue for the purpose of aiding in a medical assessment falls under the scope of an In Vitro Diagnostic device according to regulatory definitions. The fact that it provides adjunctive information and is not a standalone diagnostic aid doesn't preclude it from being classified as an IVD. Many IVDs provide information that is used in conjunction with other clinical data.
N/A
Intended Use / Indications for Use
Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Densitas densityai™ is a standalone software application that automatically analyzes "for presentation" data from digital breast x-ray systems, including digital breast tomosynthesis exams, to assess breast tissue composition.
The software processes the data 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) 5th edition density classification scale.
Densitas densityai™ 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. Densitas densityai™ reports are configured to provide the following data based on the BI-RADS 5th edition breast density classification grade:
BI-RADS 5th Edition
For each patient: DENSITAS breast density grade (BDG)
Alternative configuration options are available to match user preferences. Densitas densityai™ can process approximately 600 cases per hour.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
full field digital mammography and digital breast tomosynthesis systems.
Anatomical Site
Breast
Indicated Patient Age Range
Symptomatic and asymptomatic women.
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
Validation testing relied on expert radiologist visual assessments of mammography density. Densitas results were compared to a consensus assessment of four expert radiologists' independent readings of overall breast composition on a large dataset that spanned all compatible scanner types.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Validation testing relied on expert radiologist visual assessments of mammography density.
- Reliability was assessed using the Pearson's Correlation Coefficient by comparing the densitas densityai™ percent density, dense breast area and total area measurements for Left and Right breasts.
- Accuracy was assessed by validating densityai™ percent density and total area measurements. The accuracy of densityai™ 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 by running the algorithm twice over the same set of images.
- The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between densitas densityai™ percent density measures and age at time of screening for data sets where age was known.
Densitas results were compared to a consensus assessment of four expert radiologists' independent readings of overall breast composition on a large dataset that spanned all compatible scanner types.
Sample size: n=796.
Key Results:
Kappa 0.87 (0.87, 0.87) for 4x4 confusion matrix (Table 2).
Accuracy for 4x4 confusion matrix: A: 78%, B: 76%, C: 83%, D: 89%.
Kappa 0.84 (0.8, 0.88) for Fatty/Dense grouped confusion matrix (Table 3).
Accuracy for Fatty/Dense grouped confusion matrix: Fatty (A,B): 88%, Dense (C,D): 96%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reliability (Pearson's Correlation Coefficient), Accuracy (Kappa statistic), Reproducibility (Pearson Correlation Coefficient).
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.
DM-Density™ 2.1.0b K170540
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.
No reference devices were used in this submission
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).
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February 19, 2020
Densitas, Inc. % Alex Morris Director, Programs & Regulatory Affairs #66, 1344 Summer Street Halifax, NS B3H 0A8 CANADA
Re: K192973
Trade/Device Name: densitas densityai™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 13, 2020 Received: February 18, 2020
Dear Alex Morris:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 (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 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, Ph.D. 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) K192973
Device Name densitas densityai™
Indications for Use (Describe)
Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Densitas. The logo consists of a yellow honeycomb pattern on the left and the word "densitas" in lowercase letters on the right. The honeycomb pattern is made up of many small yellow circles arranged in a hexagonal grid.
Section 5 - Special 510(k) Summary
K192973
| Submitter: | Densitas, Inc.
#66, 1344 Summer Street
Halifax, NS, B3H 0A8 Canada |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 06-Feb-2020 |
| Contact Person: | Contact: Alex Morris, Dir., Programs and Regulatory Affairs
Direct: 647-470-4363
Office: 902-405-4610
Email: alex@densitas.health |
| Submission Date: | 21-Oct-2019 |
| Trade Name: | densitas densityai™ (formerly DM-Density™) 2.5.0 |
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Image Processing, Radiological
21 CFR 892.2050
LLZ |
| Device Classification: | Class II |
| Predicate Device(s): | DM-Density™ 2.1.0b K170540 |
| | No reference devices were used in this submission |
Description of Device:
Densitas densityai™ is a standalone software application that automatically analyzes "for presentation" data from digital breast x-ray systems, including digital breast tomosynthesis exams, to assess breast tissue composition.
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Image /page/4/Picture/1 description: The image shows the logo for "densitas". To the left of the word is a yellow hexagon made up of many small yellow circles. The word "densitas" is in a simple, sans-serif font and is black.
The software processes the data 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) 5th edition density classification scale.
Densitas densityai™ 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. Densitas densityai™ reports are configured to provide the following data based on the BI-RADS 5th edition breast density classification grade:
BI-RADS 5th Edition
For each patient: DENSITAS breast density grade (BDG)
Alternative configuration options are available to match user preferences. Densitas densityai™ can process approximately 600 cases per hour.
Indications for Use Statement:
Densitas densityal™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.
Comparison with Predicate device:
The focus of this submission is to introduce compatibility with new digital breast x-ray systems, including digital breast tomosynthesis.
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences | Intended Use /
Indications for Use | Densitas densityai™ is a
software application intended
for use with compatible full
field digital mammography and
digital breast tomosynthesis
systems. Densitas densityai™
provides an ACR BI-RADS Atlas
5th Edition breast density
category to aid interpreting
physicians in the assessment of
breast tissue composition.
Densitas densityai™ produces
adjunctive information. It is not
a diagnostic aid. | 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. | Addition of breast
tomosynthesis
systems |
|-------------------|-----------------------------------------------|----------------------------------------|-------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | Densitas, Inc. | Densitas, Inc. | | Patient Population | Symptomatic and
asymptomatic women
undergoing mammography | Symptomatic and
asymptomatic women
undergoing mammography | N/A |
| Trade Name | densitas densityai™
(formerly DM-Density™) | DM-Density™ | | End Users | Interpreting Physicians | Interpreting Physicians | N/A |
| 510(k) Number | K192973 | K170540 | N/A | Image Source
Modalities | FFDM
Hologic Selenia Dimensions
Hologic Lorad Selenia
GE Senographe Essential
GE Senographe Pristina
Siemens MAMMOMAT
Inspiration
Siemens MAMMOMAT
Novation DR
Siemens MAMMOMAT Fusion
Siemens MAMMOMAT
Inspiration Prime
Siemens MAMMOMAT
Revelation
Synthetic 2D
Hologic C-View | Hologic Selenia Dimensions
Hologic Lorad Selenia | Addition of new FFDM
scan types and
synthetic 2d
compatibility |
| Product Code | LLZ | LLZ | N/A | Input: Image Data
Format | DICOM digital mammography
imager - For Presentation;
RCC, LCC, RMLO, LMLO | DICOM full field digital
mammography imager – For
Presentation; RCC, LCC, RMLO,
LMLO | similar |
| Regulation Number | 21 CFR Part 892.2050 | 21 CFR Part 892.2050 | N/A | Output Data | BI-RADS 5th Ed. | BI-RADS 4th Ed.
For each breast:
• Area of fibroglandular tissue
(cm2) | Removed BI-RADS 4th
edition compatibility |
| Regulation Name | System, Image Processing, Radiological | System, Image Processing, Radiological | N/A | | | | |
Table 1 – Comparison of Characteristics
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Image /page/5/Picture/1 description: The image shows the word "densitas" in a simple, sans-serif font. To the left of the word is a geometric design made up of yellow circles. The circles are arranged in a pattern that resembles a cube or a three-dimensional grid, with the circles gradually decreasing in size towards the bottom.
6
DENSITAS, INC. Special 510(k) Premarket Submission densitas densityai™
Image /page/6/Picture/1 description: The image shows the logo for "densitas". To the left of the word is a yellow hexagon made up of many small yellow circles. The word "densitas" is in a simple, sans-serif font and is black.
| | For each patient: densitas
densityai™ breast density
grade | • 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 | |
|------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Measurement
Scales | 4-category breast density scale
from 5th Ed. ACR BI-RADS Atlas
2013 | 4-category breast density scale
from 4th Ed. ACR BI-RADS Atlas
2003
4-category breast density scale
from 5th Ed. ACR BI-RADS Atlas
2013 | Removed BI-RADS 4th
edition compatibility |
| Output Device | Mammography Workstation,
PACS, and RIS | Mammography Workstation,
PACS, and RIS | N/A |
| Output Format | DICOM Structured Report and
Secondary Capture | DICOM Structured Report and
Secondary Capture | N/A |
| Deployment | Standalone computer | Standalone computer | N/A |
| Data Throughput | 600 cases per hour | 600 cases per hour | N/A |
| Assessment scope | Results per image | Results per image | N/A |
| Assessment type | Image feature-based | Area-based | Adjusted to reflect
shift to image
feature-based
assessment type |
| Anatomical
Location | Breast | Breast | N/A |
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 densityai™ product specifications have been met. Supporting documentation is included in this Special 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
7
DENSITAS, INC. Special 510(k) Premarket Submission densitas densityai™
Image /page/7/Picture/1 description: The image shows the logo for "densitas". On the left side of the logo is a yellow hexagon made up of yellow dots. The dots are more dense in the center of the hexagon and less dense on the edges. To the right of the hexagon is the word "densitas" in black lowercase letters.
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 densitas densityai™ percent density, dense breast area and total area measurements for Left and Right breasts.
- · Accuracy was assessed by validating densityai™ percent density and total area measurements. The accuracy of densityai™ 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 by running the algorithm twice over the same set of images.
- The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between densitas densityai™ percent density measures and age at time of screening for data sets where age was known.
Densitas results were compared to a consensus assessment of four expert radiologists' independent readings of overall breast composition on a large dataset that spanned all compatible scanner types. Results for individual (Table 2) and grouped categories (Table 3) are summarized below.
| Table 2 - 4 X 4 confusion matrix for the density software and the reference standard using the |
|---|
| BI-RADS 5th edition breast density scale (A,B,C,D) (all scan types) |
| n=796; Kappa 0.87 (0.87, 0.87) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| the density software | |||||||||
| A | B | C | D | Accuracy | |||||
| Radiologist | |||||||||
| Consensus | A | 72 | 20 | 0 | 0 | 78% | |||
| B | 23 | 225 | 47 | 0 | 76% | ||||
| C | 0 | 16 | 262 | 37 | 83% | ||||
| D | 0 | 0 | 10 | 84 | 89% | ||||
| Total | 95 | 261 | 319 | 121 |
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Image /page/8/Picture/1 description: The image shows the logo for "densitas". On the left side of the logo is a yellow cube made up of many small yellow circles. To the right of the cube is the word "densitas" in a simple, sans-serif font. The word is in black.
Table 3 - Confusion matrix for the density software and the reference standard using the BL-RADS 5th edition breast density scale grouped into Fatty (A,B) and Dense (C,D) density categories (all scan types)
| n=796; Kappa 0.84 (0.8, 0.88) | ||||
|---|---|---|---|---|
| the density software | Accuracy | |||
| Fatty (A,B) | Dense (C,D) | |||
| Consensus | ||||
| Radiologist | Fatty (A,B) | 340 | 47 | 88% |
| Dense (C,D) | 16 | 393 | 96% | |
| Total | 356 | 440 |
Statement of Substantial Equivalence:
Densitas densityai™(formerly DM-Density) 2.5.0, is determined to be substantially equivalent to the predicate device, DM-Density 2.1.0b. Differences between the two devices do not raise new questions about the safety or effectiveness of the software.