(79 days)
Not Found
No
The description details a rule-based algorithm for calculating breast density based on image analysis and predefined boundaries, with no mention of AI or ML techniques.
No
Explanation: The device provides a breast density category to aid healthcare professionals in assessment and is explicitly stated as "not a diagnostic aid." It does not provide any treatment or therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic aid."
Yes
The device description explicitly states that the PowerLook Density Assessment software is a "stand-alone executable operating within the larger software framework provided by PowerLook AMP" and is "purely focused on processing tomosynthesis 2D synthetic images and is not concerned with system issues such as managing DICOM image inputs or managing system outputs to a printer, PACS or Mammography Workstation." This indicates it is a software component that processes existing image data and outputs results, without including or requiring specific hardware components for its core function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PowerLook Density Assessment software analyzes medical images (digital breast tomosynthesis synthesized 2D images) to assess breast tissue composition. It does not analyze biological samples from the patient.
- Intended Use: The intended use is to provide a breast density category based on image analysis, to aid healthcare professionals in assessing breast tissue composition. This is a function related to medical imaging interpretation, not laboratory testing of biological samples.
Therefore, the PowerLook Density Assessment software falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.
Product codes
LLZ
Device Description
The PowerLook Density Assessment Software analyzes digital breast tomosynthesis 2D synthetic images to calculate the dense tissue area of each breast. The measured dense tissue area is then used to provide a Category of 1-4 consistent with ACR BI-RADS 5th edition a-d. The top-level design sub-systems are as follows: Initialization, Breast Segmentation, Breast Thickness Correction, Breast Density Computation, and then generates density-based outputs for left and right breasts.
The assessment results in a final density map and, in conjunction with its pixel size (in square cm), is used to compute the area of the dense tissue (square cm). The area of the breast (square cm) is computed by counting the total number of pixels in the valid regions of the breast segmentation mask). The ratio of the dense area to the total breast area gives the percent breast density (PBD) for the given view.
The dense areas, breast areas, percent breast densities, and dispersion for the CC and MLO views are averaged in order to report measurements for each breast. The average PBD and the average dispersion are then taken, and mapped to a density category from 1 through 4 consistent with ACR BI-RADS 5th edition a-d for each breast, using a set of calibrated boundaries. The higher category of the two breasts is reported as the overall case score.
The PowerLook Density Assessment is designed as a stand-alone executable operating within the larger software framework provided by PowerLook AMP. As such, the PowerLook Density Assessment software is purely focused on processing tomosynthesis 2D synthetic images and is not concerned with system issues such as managing DICOM image inputs or managing system outputs to a printer, PACS or Mammography Workstation. The PowerLook Density Assessment software is automatically invoked by PowerLook AMP.
The results of PowerLook Density Assessment are designed to display on a mammography workstation, high resolution monitor, or in a printed case report. PowerLook Density Assessment is designed to process approximately 60-120 cases per hour.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital breast tomosynthesis synthesized 2D images from tomosynthesis exams.
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals / Not Found
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
PowerLook Density Assessment Software was run over a set of digital breast tomosynthesis synthesized 2D images from for which BI-RADS scores were obtained from radiologists followed by a comparison of the results between the predicate results, desired results, and observed performance for various parameters including kappa score, percent correct in each BI-RADS category, and combined A/B and C/D BI-RADS categories. PowerLook Density Assessment performed substantially equivalent to the predicate device.
Key Metrics
kappa score, percent correct in each BI-RADS category, and combined A/B and C/D BI-RADS categories.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Below the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iCAD. Inc % Mr. John DeLucia VP, Regulatory Affairs, Clinical Affairs and Quality Assurance 98 Spitbrook Road, Suite 100 NASHUA NH 03062
Re: K180125
Trade/Device Name: PowerLook Density Assessment Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 12, 2018 Received: January 16, 2018
Dear Mr. DeLucia:
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);
April 5, 2018
1
Page 2 - Mr. John DeLucia
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K180125
Device Name PowerLook Density Assessment Software
Indications for Use (Describe)
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 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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SECTION 1: 510k Summary
Prepared:
April 2, 2018
Submitter:
iCAD, Inc. 98 Spit Brook Road Suite 100 Nashua, NH 03062
Contact Person:
John DeLucia VP, Regulatory Affairs, Clinical Affairs and Quality Assurance Email: jdelucia@icadmed.com Phone: (603) 309-1945 Fax: (603) 880-3043
Submission Date:
January 12, 2018
Trade Name:
PowerLook Density Assessment Software
Common Name:
Medical Imaging Software
Classification Name
System, Image Processing, Radiological; 21 CFR 892.2050
Product Code
LLZ
Device Classification
Class II
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SECTION 5: 510(K) Summary (con't)
Legally Marketed Devices to Which Substantial Equivalence is Claimed
PowerLook Density Assessment Software is substantially equivalent to the following legally marketed predicate devices.
| Device Name | Manufacturer | 510(k) Reference # | Concurrence Date |
|---|---|---|---|
| iReveal V1.0* | iCAD Inc. | K132742 | December 3, 2013 |
| Volpara Imaging | |||
| Software | Matakina Technology | K152028 | October 26, 2015 |
- Cleared under the M-Vu Brand Name (VuCOMP Inc.) iCAD Acquired VuCOMP.
Device Description
The PowerLook Density Assessment Software analyzes digital breast tomosynthesis 2D synthetic images to calculate the dense tissue area of each breast. The measured dense tissue area is then used to provide a Category of 1-4 consistent with ACR BI-RADS 5th edition a-d. The top-level design sub-systems are as follows:
5
Image /page/5/Figure/0 description: The image shows a flowchart of a process. The process starts with "Initialization", followed by "Breast Segmentation", then "Breast Thickness Correction", and "Breast Density Computation". The process ends with "Generate density-based outputs for left and right breasts".
The assessment results in a final density map and, in conjunction with its pixel size (in square cm), is used to compute the area of the dense tissue (square cm). The area of the breast (square cm) is computed by counting the total number of pixels in the valid regions of the breast segmentation mask). The ratio of the dense area to the total breast area gives the percent breast density (PBD) for the given view.
The dense areas, breast areas, percent breast densities, and dispersion for the CC and MLO views are averaged in order to report measurements for each breast. The average PBD and the average dispersion are then taken, and mapped to a density category from 1 through 4 consistent with ACR BI-RADS 5th edition a-d for each breast, using a set of calibrated boundaries. The higher category of the two breasts is reported as the overall case score.
The PowerLook Density Assessment is designed as a stand-alone executable operating within the larger software framework provided by PowerLook AMP1. As such, the PowerLook Density Assessment software is purely focused on processing tomosynthesis 2D synthetic images and is
1 iCAD PowerLook AMP is a Class I medical device exempt per 21 CFR § 892.2010 (Medical image storage device) and 21 CFR § 892.2020 (Medical image communications device). The PowerLook AMP is a device that provides electronic storage functions for medical images and also provides electronic transfer of medical image data between medical devices.
6
not concerned with system issues such as managing DICOM image inputs or managing system outputs to a printer, PACS or Mammography Workstation. The PowerLook Density Assessment software is automatically invoked by PowerLook AMP.
The results of PowerLook Density Assessment are designed to display on a mammography workstation, high resolution monitor, or in a printed case report. PowerLook Density Assessment is designed to process approximately 60-120 cases per hour.
Intended Use / "Indications for Use"
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.
Summary of Technological Characteristics
The technological characteristics of PowerLook Density Assessment Software are the same as the secondary predicate iReveal V1.0 cleared under K132742. Their major subsystems are the same except that:
-
For PowerLook Density Assessment intensity information is used to make the threshold adjustable and the intensity threshold process in iReveal V1.0 is not used.
-
The breast assessment method differs as well. iReveal V1.0 utilizes percentage of tissue that appears to be dense and PowerLook Density Assessment Software utilizes percentage and dispersion of tissue that appears to be dense.
The indications for use are similar to the primary predicate Volpara Imaging Software cleared under K152028.
General Safety and Effectiveness Concerns
The device labeling 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. Any potential hazards are controlled via software development, verification and validation testing.
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Assessment of Non-Clinical Performance Data
PowerLook Density Assessment Software has been verified and validated according to iCAD's design control processes. All supporting documentation has been included in this 510(k) Premarket Notification. Verification activity included unit, integration, and system level testing. Validation included the following:
PowerLook Density Assessment Software was run over a set of digital breast tomosynthesis synthesized 2D images from for which BI-RADS scores were obtained from radiologists followed by a comparison of the results between the predicate results, desired results, and observed performance for various parameters including kappa score, percent correct in each BI-RADS category, and combined A/B and C/D BI-RADS categories. PowerLook Density Assessment performed substantially equivalent to the predicate device.
- PowerLook Density Assessment Software is deployed on a DICOM platform that has been . successfully tested for clinical network integration.
Comparison with Predicate Devices
The Summary of Substantial Equivalence Table below details the similarities and differences between PowerLook Density Assessment and the predicates. PowerLook Density Assessment has a similar indication as the primary predicate Volpara Imaging Software (K152028). They both calculate a density map to determine breast density from tomosynthesis exams. Volpara calculates a density map from tomosynthesis projection data and PowerLook Density Assessment calculates density map from tomosynthesized 2D images. From a technology standpoint, PowerLook Density Assessment is similar to iReveal V1.0 (K132742). Their major subsystems are the same except that for tomosynthesis synthetic 2D images (PowerLook Density Assessment), intensity information is used to make the threshold adjustable and the intensity threshold process is not used.
Conclusion:
Based upon the information presented in this submission, it is concluded that PowerLook Density Assessment Software is substantially equivalent to the named predicate devices.