(59 days)
Not Found
Unknown
The document describes an algorithm for assessing breast density but does not explicitly mention the use of AI or ML. While image processing is mentioned, this alone does not confirm AI/ML. The description of performance studies focuses on testing against different datasets and summarizing results in confusion matrices, which is common for various algorithms, not exclusively AI/ML. The lack of mention of training data or specific AI/ML techniques makes it impossible to definitively confirm or deny the presence of AI/ML.
No.
The device is a software application that provides a breast density category to aid healthcare professionals in assessment; it is not a diagnostic aid and does not provide therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic aid." It provides an ACR BI-RADS Atlas 5th Edition breast density category to aid healthcare professionals in assessment, which is "adjunctive information," not a diagnosis.
Yes
The device is explicitly described as a "software application" and its function is to process existing digital images to provide a breast density category. While it works in conjunction with a DICOM server platform and its results can be displayed on various hardware, the core medical device function is performed by the software itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this software is used with "digital breast tomosynthesized 2D images from tomosynthesis exams." These are medical images, not biological specimens like blood, urine, or tissue samples.
- The intended use is to aid in the assessment of breast tissue composition from images. This is a function related to medical imaging analysis, not the analysis of biological samples.
Therefore, while it is a medical device used in healthcare, it does not fit the definition of an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
QIH
Device Description
PowerLook Density Assessment 4.0 is a software application intended for use with mammography exams containing synthetic 2D images generated from Digital Breast Tomosynthesis (DBT) data. The PowerLook Density Assessment software assesses breast tissue composition and provides a breast density category aligned with BI-RADS® 5th Edition density lexicon. The PowerLook Density Assessment 4.0 algorithm is designed to be used with cases containing up to four synthetic 2D views. When exams contain only DBT and synthetic 2D images generated from DBT, the 4.0 algorithm is used. The PowerLook Density Assessment software is designed to work in conjunction with iCAD's PowerLook DICOM server platform, which is a Class I exempt medical device. The PowerLook Density Assessment 4.0 utilizes data management capabilities of PowerLook for controlling input to and output from the PowerLook Density Assessment algorithm. Results of the PowerLook Density Assessment software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
synthetic 2D images from tomosynthesis exams
Digital Breast Tomosynthesis (DBT) data
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
Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0, results were compiled into confusion matrices and then summarized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification activity included unit, integration testing was performed. Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0, results were compiled into confusion matrices and then summarized. The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data.
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
July 12, 2021
Image /page/0/Picture/1 description: The image contains 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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iCAD, Inc. % Ms. Heather Reed Vice President, Quality Assurance and Regulatory Affairs 98 Spit Brook Rd. Suite 100 NASHUA NH 03062
Re: K211506
Trade/Device Name: PowerLook Density Assessment V4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: May 6, 2021 Received: May 14, 2021
Dear Ms. Reed:
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/cfpmp/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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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) K211506
Device Name PowerLook Density Assessment V4.0
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) |
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 iCAD. The logo is in dark blue and features the letters "iCAD" in a serif font. To the right of the "D" is a stylized image of a person with their arms raised above their head. A curved line extends from the bottom of the "i" to the person, underlining the text.
510k Summary K211506
Date Prepared: May 7, 2021
Submitter:
iCAD, Inc. 98 Spit Brook Road Suite 100 Nashua, NH 03062
Contact Person:
Heather Reed Vice President, Quality Assurance and Regulatory Affairs Email: hreed@icadmed.com Phone: (603) 309-1945 Fax: (603) 880-3043
Device Name:
| Trade Name: | PowerLook Density Assessment V4.0 |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification: | Medical Image Management and Processing System |
| Product Code: | QIH |
| Regulation Number: | 21 CFR 892.2050 |
| Review Panel: | Radiology |
Predicate Device:
| 510k Number: | K180125 |
|---|---|
| Manufacturer: | iCAD, Inc. |
| Device Name: | PowerLook Density Assessment, V3.4 |
Device Description
PowerLook Density Assessment 4.0 is a software application intended for use with mammography exams containing synthetic 2D images generated from Digital Breast Tomosynthesis (DBT) data. The PowerLook Density Assessment software assesses breast tissue composition and provides a breast density category aligned with BI-RADS® 5th Edition density lexicon. The PowerLook Density Assessment 4.0 algorithm is designed to be used with cases containing up to four synthetic 2D views. When exams contain only DBT and synthetic 2D images generated from DBT, the 4.0 algorithm is used. The PowerLook Density Assessment software is designed to work in conjunction with iCAD's PowerLook DICOM server platform, which is a Class I exempt medical device. The PowerLook Density Assessment 4.0 utilizes data management capabilities of PowerLook for controlling input to and output from the PowerLook Density Assessment algorithm. Results of the PowerLook Density Assessment
4
software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.
Technical Characteristics:
PowerLook Density Assessment V4.0 contains a new custom software application specifically designed to run on the PowerLook AMP, which is a Class I exempt medical device. The PowerLook Density Assessment utilizes data management capabilities of the PowerLook AMP for controlling input and output to the PowerLook Density Assessment. This functionality was validated to support the addition of GE V-Preview V4.1. This custom software application is new and independent from PowerLook Density Assessment V3.4 cleared in K180125.
Supported Digital Breast Tomosynthesis Systems
The following Digital Breast Tomosynthesis systems have been tested and are compatible with PowerLook Density Assessment V4.0 software:
- Hologic Selenia Dimensions/3Dimensions (C-View)
- GE Senographe Essential with SenoClaire (V-Preview)
- GE Senographe Pristina (V-Preview) ●
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.
| | UNMODIFIED Device
PowerLook Density Assessment | MODIFIED Device
PowerLook Density Assessment V4.0 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | iCAD, Inc. | iCAD, Inc. |
| Classification Name | System, Image Processing,
Radiological | Medical Image Management and
Processing System |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | QIH |
| 510(k) # | K180125 | Pending |
| | UNMODIFIED Device
PowerLook Density Assessment | MODIFIED Device
PowerLook Density Assessment V4.0 |
| Intended Use / Indication 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. | 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. |
| End User | Radiologists | Radiologists |
| Patient Population | Symptomatic and asymptomatic women
undergoing mammography. | Symptomatic and asymptomatic women
undergoing mammography. |
| Image Source Modalities | Synthetic views from tomosynthesis
systems | Synthetic views from tomosynthesis
systems |
| Input: Image Data Format | DICOM synthetic 2D images generated
from breast tomosynthesis data | DICOM synthetic 2D images generated
from breast tomosynthesis data |
| Output Format | DICOM structured report or DICOM
secondary capture. | DICOM structured report or DICOM
secondary capture. |
| Output Data | For each patient:
ACR BI-RADS® Atlas 5th
Edition breast density
categoryFractional indication of
distance inside breast density
category | For each patient:
ACR BI-RADS® Atlas 5th
Edition breast density
categoryFractional indication of
distance inside breast density
category |
| Deployment | Standalone computer | Standalone computer |
| Supported Digital Breast
Tomosynthesis Systems | Hologic Selenia
Dimensions/3Dimensions
(C-View)GE Senographe Essential
with SenoClaire (V-Preview)GE Senographe Pristina (V-
Preview) | Hologic Selenia
Dimensions/3Dimensions
(C-View)GE Senographe Essential
with SenoClaire (V-Preview)GE Senographe Pristina (V-
Preview) |
5
6
Summary of Indications for Use:
The "Indications for Use" remain unchanged from the Predicate UNMODIFIED Device PowerLook Density Assessment.
Summary of Technological Characteristic
Many technological characteristics of Modified PowerLook Density Assessment V4.0 remain unchanged from Unmodified Device PowerLook Density Assessment as the predicate. PowerLook Density Assessment V4.0 contains a new custom software application specifically designed to run on the PowerLook AMP, which is a Class I exempt medical device. PowerLook Density Assessment utilizes data management capabilities of the PowerLook AMP for controlling input and output to the PowerLook Density Assessment. This functionality was validated to support the addition of GE V-Preview V4.1. This custom software application is new and independent from PowerLook Density Assessment V3.4 cleared in K180125.
These changes do not raise different questions of safety and effectiveness.
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 and mitigate potential hazards. Any potential hazards are controlled via software development, verification, and validation testing.
Assessment of Non-Clinical Performance Data
PowerLook Density Assessment V4.0 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 testing was performed. Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0, results were compiled into confusion matrices and then summarized. The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data.
Conclusion:
Based upon the information presented in this submission, it is concluded that PowerLook Density Assessment V4.0 is substantially equivalent to the named predicate device.