QUANTRA

K120472 · Hologic, Inc. · LLZ · Jun 22, 2012 · Radiology

Device Facts

• Record ID: K120472
• Device Name: QUANTRA
• Applicant: Hologic, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K120472 · Jun 22, 2012	QUANTRA	Hologic, Inc.	Retrospective clinical database of digital mammography images (approx. 1,000 patients); Radiologist-assigned BI-RADS density ratings	The device used a large retrospective clinical database to establish reference mean values for volumetric breast density scores and to validate the software's density categorization against the consensus of 15 radiologists.	Retrospective database; Breast density; BI-RADS; Clinical imaging cohort

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Reference Database Validation; Retrospective cohort analysis	Patients undergoing digital mammography; Sample Size: Approximately 1,000 patients	15 radiologists' BI-RADS density ratings	Volumetric breast density (Vbd) and fibroglandular tissue volume (Vfg) scores; BI-RADS-like breast composition categories

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Volumetric breast density	—	—	—	—	—	Validation study comparing Quantra values with MRI cases and BI-RADS density ratings from 15 radiologists on a large database of cases, and population distribution comparison across Hologic, GE, and Siemens FFDMs	15 (radiologists)
Area breast density	—	—	—	—	—	Validation study comparing Quantra values with hand-drawn dense areas annotated by an expert using Sectra IDS5 workstation, BI-RADS density ratings from 15 radiologists, and population distribution comparison across Hologic, GE, and Siemens FFDMs	15 (radiologists) + 1 (expert)
BI-RADS-like breast composition	—	—	—	—	—	Evaluation based on comparison of Quantra scores with BI-RADS values assigned by 15 radiologists on a large set of digital mammography cases and population distribution comparison across Hologic, GE, and Siemens FFDMs	15 (radiologists)

Indications for Use

Quantra™ is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BI-RADS-like breast composition categories, which may be useful in the reporting of consistent breast composition values as mandated by certain state regulations. Quantra provides these numerical values for each image, breast, and subject, to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.

Device Story

Quantra is a software application for digital mammography systems; it processes digital breast X-ray images to estimate breast tissue composition. The software calculates volumetric breast density (ratio of fibroglandular tissue to total breast volume) and area breast density (ratio of fibroglandular tissue area to total breast area). It categorizes density into BI-RADS-like composition groups and generates Vbd and Vfg scores based on a reference database of approximately 1,000 patients. The device runs on a Windows platform and is intended for use by radiologists as an adjunctive tool; it does not provide diagnostic or interpretive results. By providing standardized numerical values, it assists clinicians in reporting consistent breast composition as required by state regulations. The software does not contact the patient or control life-sustaining equipment.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing and validation studies. Volumetric breast density (Vbd) was validated via correlation with MRI cases and comparison to the mode BI-RADS density ratings from 15 radiologists. Area breast density was validated by comparing Quantra values against expert-annotated dense areas on the Sectra IDS5 workstation. Performance was evaluated across a large database of cases from Hologic, GE, and Siemens FFDMs to ensure distribution consistency. Statistical evaluation confirmed consistency between CC/MLO views and left/right breasts.

Technological Characteristics

Software application for Windows platform. Processes digital mammography images (FFDM). Calculates volumetric and area-based breast density metrics and BI-RADS-like composition categories. Developed per ISO 14971 (risk management) and ISO 62304 (software life cycle). No patient contact. Standalone software.

Indications for Use

Indicated for use by radiologists to aid in the assessment of breast tissue composition from digital breast X-ray images. Provides volumetric and area-based breast density measurements and BI-RADS-like composition categories. Not for diagnostic or interpretive use.

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

• Quantra (Volumetric Assessment) [Hologic, Inc.] (K082483)
• Sectra IDS5 Workstation [Sectra Imtec AB] (K050196)
• Volpara Imaging Software [Matakina Technology Limited] (K102556)

Submission Summary (Full Text)

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120472

Hologic, Inc. 35 Crosby Drive, Bedford, MA 01730 USA Main: +1.781.999.7300 Fax: [phone] JUN: 2 2 2012

# B. Administrative Information

B.1 510(k) Summary of Safety & Effectiveness (as required by 21 CFR §807.92c)

## Date Prepared: February 15, 2012 Submitted by:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 USA

## Name, Title and Phone Number of Contact:

Catherine A. Williams Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

### Trade Name and Common Name:

| Trade Name: | Quantra™ |
|-------------------|---------------------------------------------|
| Software Version: | 2.0 |
| Common Name: | Picture Archiving and Communications System |

#### Device Classification:

| Regulatory Class: | II |
|-------------------------|------------------|
| Classification Panel: | Radiology |
| Image Processing System | 21 CFR §892.2050 |
| Product Code | 90-LLZ |

### Predicate Devices:

The predicate devices for Quantra software are certain software functions contained in the following devices:

K082483, September 12, 2008 K050196, February 24, 2005 K102556, October 7, 2010 Limited]

Quantra (Volumetric Assessment) [Hologic, Inc.] Sectra IDS5 Workstation [Sectra Imtec AB] Volpara Imaging Software [Matakina Technology

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# Device Description:

Quantra is a software application that estimates breast tissue volume and area density. The estimations are made from images acquired using digital breastray systems.

Quantra has been designed and will be manufactured in accordance with the following standards:

- · ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
- ISO 62304: Medical Device Software - Software Life Cycle Processes

The performance of the software is also tested in accordance with Hologic's SOPs and testing procedures to demonstrate adequate performance.

## Intended Use:

· Quantra™ is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast demsity as a minori fibroglandular tissue and total breast volume estimates; and area breast density as of fibroglandular tissue area and total breast area estimates. It segregates breast de into BI-RADS-like breast composition categories, which may be useful in the report of consistent breast composition values as mandated by certain state regul · provides these numerical values for each image "breast" and subject, to ai the assessment of breast tissue composition. Quantra produces adjunctive information is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.

# Technological Characteristics:

Quantra is a software application that processes digital mammography images. The device does not contact the patient, nor does it control any life-sustaining devices.

## Performance/Bench Testing:

The volumetric breast density measures were validated by demonstrating correlation with the Quantra predicate device and with MRI cases of the same patients. The me also were compared to the mode (most common) BI-RADS density rating from 15 radiologists on a large database of cases. Finally, the Vbd values were compared a large population of cases from Hologic (Selenia and Dimensions), GE (Seniographe and similar. 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1

The area breast density measure was validated using a correlation-based assessme compare Quantra values with dense area measurement based on hand-drawn dense areas annotated by an expert using the predicate device Sectra IDS5 workstation. mode (most common) BI-RADS density rating from 15 radiologists on a large database of cases. Finally, the Abd values were compared across. large population of cases from Hologic (Selenia and Dimensions), GE (Senographe and

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Essential), and Siemens (Mammomat Novation) FFDMs to ensure the distributions were similar.

The volumetric breast density (Vbd) and volume of fibroglandular tissue (Vfg) values. were used to create two scores (Vbd-score and Vfg-score), which reflect the number of standard deviations between a subject's V.bd or Vig value and the corresponding mean value of approximately 1,000 patients in a reference database.

The BI-RADS-like breast composition measure (O abd), similar to the density grade measure in the Matakina predicate device, was evaluated based on a comparison of Q abd with BI-RADS values assigned by 15 radiologists on a large set of digital mammography cases. The continuous q. abd score was compared to the mean value of the 15 radiologists on the same large database of cases described above. Finally, the q abd values were compared across a large population of cases from Hologic (Selenia and Dimensions), GE (Senographe and Essential), and Siemens (Mammomat Novation) FFDMs to ensure the distributions were similar.

All Quantra density measures were evaluated statistically between CC and MLO views of the same breast and left and right breasts of the same women, using a substantially large number of images from Hologic (Selenia and Selenia Dimensions), GE (Senographe and Senographe Essential), and Siemens (Mammomat Novation) digital breast X-rav systems).

### 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. These potential hazards are, controlled via software development, verification and validation testing.

#### Conclusion:

The 510(k) Premarket Notification for Quantra contains adequate information and data to enable FDA/CDRH to determine substantial equivalence to the predicate devices:

The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Moderate".

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUN 2 2 2012

Ms. Catherine A. Williams Director, Regulatory Affairs Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K120472

Trade/Device Name: QuantraTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications svstem Regulatory Class: II Product Code: LLZ Dated: May 18, 2012 Received: May 21, 2012

Dear Ms. Williams:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket while and to finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 July 11 Species and the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. First 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# B.2 Indication(s) for Use Statement

510(k) Number (if known): K120472

Device Name:

Quantra™M

### Indications for Use:

Quantra™ is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BI-RADS-like breast composition categories, which may be useful in the reporting of consistent breast composition values as mandated by certain state regulations. Quantra provides these numerical values for each image, breast, and subject, to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.

Prescription Use X (Part 21 CFR§801 Subpart D) Over-The-Counter - Use (21 CFR §807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR .

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-
Divisiókf Radiologica: Devices
Office of In Vitro Diagnostic Device Evaluation and Safety.
K120472