PowerLook Density Assessment V4.0

K211506 · Icad, Inc. · QIH · Jul 12, 2021 · Radiology

Device Facts

• Record ID: K211506
• Device Name: PowerLook Density Assessment V4.0
• Applicant: Icad, Inc.
• Product Code: QIH · Radiology
• Decision Date: Jul 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

Software application for digital breast tomosynthesis (DBT) exams; processes synthetic 2D images generated from DBT data. Operates on PowerLook AMP platform; manages input/output via PowerLook DICOM server. Algorithm assesses breast tissue composition; outputs ACR BI-RADS Atlas 5th Edition breast density category and fractional distance within category. Used by radiologists in clinical settings; results displayed on mammography review workstations, reporting applications, RIS, or printed reports. Provides adjunctive information; not a diagnostic aid. Benefits include standardized, automated breast density assessment to assist clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation performed via unit and integration testing. System performance evaluated using Hologic C-View, GE V-Preview V3, and GE V-Preview V4.1 datasets. Results compiled into confusion matrices; performance met desired thresholds, confirming accurate calculation of BI-RADS breast density categories across all tested image sources.

Technological Characteristics

Software-only device; runs on PowerLook AMP platform. Inputs: DICOM synthetic 2D images from DBT systems (Hologic C-View, GE V-Preview). Outputs: DICOM structured report or secondary capture. Connectivity: Networked via DICOM. Architecture: Custom software application independent of previous versions.

Indications for Use

Indicated for symptomatic and asymptomatic women undergoing mammography to aid healthcare professionals in assessing breast tissue composition via ACR BI-RADS Atlas 5th Edition density categorization.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• PowerLook Density Assessment, V3.4 (K180125)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) 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) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: [e-mail] Phone: [phone] Fax: [phone]

## 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

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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<br>PowerLook Density Assessment | MODIFIED Device<br>PowerLook Density Assessment V4.0 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | iCAD, Inc. | iCAD, Inc. |
| Classification Name | System, Image Processing,<br>Radiological | Medical Image Management and<br>Processing System |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | QIH |
| 510(k) # | K180125 | Pending |
| | UNMODIFIED Device<br>PowerLook Density Assessment | MODIFIED Device<br>PowerLook Density Assessment V4.0 |
| Intended Use / Indication for<br>Use | PowerLook Density Assessment is a<br>software application intended for use<br>with digital breast tomosynthesis<br>synthesized 2D images from<br>tomosynthesis exams. PowerLook<br>Density Assessment provides an ACR<br>BI-RADS Atlas 5th Edition breast<br>density category to aid health care<br>professionals in the assessment of<br>breast tissue composition. PowerLook<br>Density Assessment produces<br>adjunctive information. It is not a<br>diagnostic aid. | PowerLook Density Assessment is a<br>software application intended for use<br>with digital breast tomosynthesis<br>synthesized 2D images from<br>tomosynthesis exams. PowerLook<br>Density Assessment provides an ACR<br>BI-RADS Atlas 5th Edition breast<br>density category to aid health care<br>professionals in the assessment of<br>breast tissue composition. PowerLook<br>Density Assessment produces<br>adjunctive information. It is not a<br>diagnostic aid. |
| End User | Radiologists | Radiologists |
| Patient Population | Symptomatic and asymptomatic women<br>undergoing mammography. | Symptomatic and asymptomatic women<br>undergoing mammography. |
| Image Source Modalities | Synthetic views from tomosynthesis<br>systems | Synthetic views from tomosynthesis<br>systems |
| Input: Image Data Format | DICOM synthetic 2D images generated<br>from breast tomosynthesis data | DICOM synthetic 2D images generated<br>from breast tomosynthesis data |
| Output Format | DICOM structured report or DICOM<br>secondary capture. | DICOM structured report or DICOM<br>secondary capture. |
| Output Data | For each patient:<br>ACR BI-RADS® Atlas 5th<br>Edition breast density<br>categoryFractional indication of<br>distance inside breast density<br>category | For each patient:<br>ACR BI-RADS® Atlas 5th<br>Edition breast density<br>categoryFractional indication of<br>distance inside breast density<br>category |
| Deployment | Standalone computer | Standalone computer |
| Supported Digital Breast<br>Tomosynthesis Systems | Hologic Selenia<br>Dimensions/3Dimensions<br>(C-View)GE Senographe Essential<br>with SenoClaire (V-Preview)GE Senographe Pristina (V-<br>Preview) | Hologic Selenia<br>Dimensions/3Dimensions<br>(C-View)GE Senographe Essential<br>with SenoClaire (V-Preview)GE Senographe Pristina (V-<br>Preview) |

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### 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.