densitas densityai

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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. 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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}------------------------------------------------ 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 (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 {2}------------------------------------------------ # 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) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </div> | <div> <span> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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.<br>#66, 1344 Summer Street<br>Halifax, NS, B3H 0A8 Canada | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | 06-Feb-2020 | | Contact Person: | Contact: Alex Morris, Dir., Programs and Regulatory Affairs<br>Direct: 647-470-4363<br>Office: 902-405-4610<br>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<br>21 CFR 892.2050<br>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. {4}------------------------------------------------ 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 /<br>Indications for Use | Densitas densityai™ is a<br>software application intended<br>for use with compatible full<br>field digital mammography and<br>digital breast tomosynthesis<br>systems. Densitas densityai™<br>provides an ACR BI-RADS Atlas<br>5th Edition breast density<br>category to aid interpreting<br>physicians in the assessment of<br>breast tissue composition.<br>Densitas densityai™ produces<br>adjunctive information. It is not<br>a diagnostic aid. | DM-Density is a software<br>application intended for use<br>with compatible full field digital<br>mammography<br>systems. DM-Density calculates<br>percent breast density defined<br>as the ratio of fibroglandular<br>tissue to total<br>breast area estimates.<br>DM-Density provides these<br>numerical values for each<br>breast as well as a density<br>category to aid interpreting<br>physicians in the assessment of<br>breast tissue composition.<br>DM-Density produces<br>adjunctive information. It is not<br>a diagnostic aid. | Addition of breast<br>tomosynthesis<br>systems | |-------------------|-----------------------------------------------|----------------------------------------|-------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | | Densitas, Inc. | Densitas, Inc. | | Patient Population | Symptomatic and<br>asymptomatic women<br>undergoing mammography | Symptomatic and<br>asymptomatic women<br>undergoing mammography | N/A | | Trade Name | densitas densityai™<br>(formerly DM-Density™) | DM-Density™ | | End Users | Interpreting Physicians | Interpreting Physicians | N/A | | 510(k) Number | K192973 | K170540 | N/A | Image Source<br>Modalities | FFDM<br>Hologic Selenia Dimensions<br>Hologic Lorad Selenia<br>GE Senographe Essential<br>GE Senographe Pristina<br>Siemens MAMMOMAT<br>Inspiration<br>Siemens MAMMOMAT<br>Novation DR<br>Siemens MAMMOMAT Fusion<br>Siemens MAMMOMAT<br>Inspiration Prime<br>Siemens MAMMOMAT<br>Revelation<br>Synthetic 2D<br>Hologic C-View | Hologic Selenia Dimensions<br>Hologic Lorad Selenia | Addition of new FFDM<br>scan types and<br>synthetic 2d<br>compatibility | | Product Code | LLZ | LLZ | N/A | Input: Image Data<br>Format | DICOM digital mammography<br>imager - For Presentation;<br>RCC, LCC, RMLO, LMLO | DICOM full field digital<br>mammography imager – For<br>Presentation; RCC, LCC, RMLO,<br>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.<br>For each breast:<br>• Area of fibroglandular tissue<br>(cm2) | Removed BI-RADS 4th<br>edition compatibility | | Regulation Name | System, Image Processing, Radiological | System, Image Processing, Radiological | N/A | | | | | ### Table 1 – Comparison of Characteristics {5}------------------------------------------------ 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<br>densityai™ breast density<br>grade | • Area of breast (cm²)<br>• Area-based breast density<br>(%)<br>For each patient: DM-Density<br>breast density grade and<br>percent breast density<br><br>BI-RADS 5th Ed.<br><br>For each patient: DM-Density<br>breast density grade | | |------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Measurement<br>Scales | 4-category breast density scale<br>from 5th Ed. ACR BI-RADS Atlas<br>2013 | 4-category breast density scale<br>from 4th Ed. ACR BI-RADS Atlas<br>2003<br><br>4-category breast density scale<br>from 5th Ed. ACR BI-RADS Atlas<br>2013 | Removed BI-RADS 4th<br>edition compatibility | | Output Device | Mammography Workstation,<br>PACS, and RIS | Mammography Workstation,<br>PACS, and RIS | N/A | | Output Format | DICOM Structured Report and<br>Secondary Capture | DICOM Structured Report and<br>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<br>shift to image<br>feature-based<br>assessment type | | Anatomical<br>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<br>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 | | | | | {8}------------------------------------------------ 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<br>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.