Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes automated image analysis and calculation based on defined parameters (fibroglandular tissue and total breast area), but does not mention AI, ML, or any related concepts like training sets for learning algorithms. The performance studies focus on statistical comparisons with expert readings and expected trends, not on evaluating a learned model.

Therapeutic

No
The device is a software application that calculates breast density as a ratio of fibroglandular tissue and total breast area estimates to aid radiologists in the assessment of breast tissue composition. It provides adjunctive information and is not an interpretive, diagnostic, or therapeutic aid.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "It is not an interpretive or diagnostic aid."

SaMD (Software as a Medical Device)

Yes

The device is described as a "software application" and its function is to analyze existing digital mammograms and provide calculated breast density information. While it interoperates with hardware (digital mammography systems and workstations), the device itself is the software that performs the analysis and outputs the results. The description focuses on the software's functionality and validation, not on any accompanying hardware.

IVD (In Vitro Diagnostic)

No, 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 or other conditions.
Device Function: M-Vu Breast Density analyzes images (digital mammograms) of the breast. It does not analyze biological samples taken from the patient.
Intended Use: The intended use is to calculate breast density from mammography images to aid radiologists in assessing breast tissue composition. This is an image analysis tool, not a diagnostic test performed on a biological sample.

The device description and intended use clearly indicate that this software processes medical images, not biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

Product codes

LLZ

Device Description

M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense tissue area of each breast. The measured dense tissue area is then used to provide a Calibrated Density Category which maps the percentage of breast density to a BI-RADS category number (1 - 4).

M-Vu Breast Density is a stand-alone software application designed to interoperate with all digital radiography (DR) and computed radiography (CR) mammography systems. M-Vu Breast Density is displayed in the form of a DICOM mammography structured report or secondary capture and reports the following for output:

Breast Area (cm2) for cach breast .
Dense Area (cm2) for each breast .
Percent Breast Density for each breast .
. Breast Density Category for each case

The results of M-Vu Breast Density are designed to display on a mammography workstation, high resolution monitor. or in a printed case report. M-Vu Breast Density is designed to process approximately 60-120 cases per hour.

M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

All digital radiography (DR) systems and computed radiography (CR) systems

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

This submission contains no information from clinical studies.

Summary of Non-Clinical Performance Data:

M-Vu Breast Density has been verified and validated according to VuCOMP'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:

. M-Vu Breast Density was run over a set of x-ray images for which a BI-RADS scores were obtained from 13 expert radiologists followed by a comparison of the data sets using a weighted Kappa statistic
. Estimates of fibroglandular tissue were confirmed by verifying the M-Vu percent breast density (PBD) and the M-Vu breast area. The verification of fibroglandular area measurement follows by implication.
. M-Vu Breast Density was run over a data set where the women's age and results were compared with the expected and known decrease in breast density with age using the Spearman Rank Correlation test.
. Percent Breast Density measurements from the left and right breasts of the same patient were compared to confirm that the results were similar using Pearson's Correlation Coefficient.
Percent Breast Density measurements were made on patient images and . corresponding prior images with a maximum imaging period of two years apart and the results were compared to confirm that they were similar using Pearson's Correlation Coefficient.
M-Vu Breast Density is deployed on the M-Vu CAD Station. M-Vu CAD Station . was successfully tested for clinical network integration.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Quantra, by Hologic Inc., K082483, Volpara, Matakina Technology Limited, K102556

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

K132742
page 1 of 4

5 510(k) Summary

Prepared December 2, 2013

| Submitter: | VuCOMP, Inc.
2500 Dallas Parkway
Suite 500
Plano, TX 75093 | |
|------------------------|----------------------------------------------------------------------------------------|-------------|
| Contact Person: | Adrienne Hammond
Compliance Manager
Phone: (888) 266-7462
Fax: (877) 577-5658 | |
| Submission Date: | August 30, 2013 | DEC 03 2013 |
| Trade Name: | M-Vu® Breast Density | |
| Common Name: | Medical Imaging Software | |
| Classification Name: | System, Image Processing, Radiological;
21 CFR 892.2050; LLZ | |
| Device Classification: | Class II | |
| Predicate Device(s): | Quantra, by Hologic Inc., K082483
Volpara, Matakina Technology Limited, K102556 | |

Description of Device:

M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense tissue area of each breast. The measured dense tissue area is then used to provide a Calibrated Density Category which maps the percentage of breast density to a BI-RADS category number (1 - 4).

M-Vu Breast Density is a stand-alone software application designed to interoperate with all digital radiography (DR) and computed radiography (CR) mammography systems. M-Vu Breast Density is displayed in the form of a DICOM mammography structured report or secondary capture and reports the following for output:

Breast Area (cm2) for cach breast .
Dense Area (cm2) for each breast .
Percent Breast Density for each breast .
. Breast Density Category for each case

The results of M-Vu Breast Density are designed to display on a mammography workstation, high resolution monitor. or in a printed case report. M-Vu Breast Density is designed to process approximately 60-120 cases per hour.

M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).

1

Intended Use Statement:

M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

2

| Features and

Characteristics	Predicate Devices
	VuCOMP
M-Vu Breast Density	Hologic
Quantra
K082483	Matakina Technology
Volpara
K102556
Patient Population	Symptomatic and asymptomatic women undergoing mammography
End Users	Radiologists
Image Source Modalities	All digital radiography (DR) systems
and computed radiography (CR) systems	Hologic 2D, GE 2D, and Siemens
Mammiomat Novation digital
radiography (DR) systems only	All digital radiography (DR) systems and computed radiography (CR)
systems
Input: Image Data Format	DICOM digital mammography image	For processing: Views processed: RCC, LCC, RMLO, LMLO
Output Format	DICOM structured report and secondary capture
Output Data	For each breast:
• Area of fibroglandular tissue (cm²)
• Area of breast (cm²)
• Area-based breast density (%)

For each patient:
VuCOMP density grade/BIRADS
breast density | For each image, breast, and patient:
• Volume of fibroglandular tissue (cm³)
• Volume of breast (cm³)
• Volumetric breast density (%)
• Volume of fibroglandular score
• Volume of breast density score
• BIRADS-like breast density integer
score and fractional score | For each breast:
• Volume of fibroglandular tissue (cm³)
• Volume of breast (cm³)
• Volumetric breast density (%)

Summary of Technological Characteristics:

3

K132742
Page 4 of 4

Summary of Clinical Performance Data:

This submission contains no information from clinical studies.

Summary of Non-Clinical Performance Data:

M-Vu Breast Density has been verified and validated according to VuCOMP'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:

. M-Vu Breast Density was run over a set of x-ray images for which a BI-RADS scores were obtained from 13 expert radiologists followed by a comparison of the data sets using a weighted Kappa statistic
. Estimates of fibroglandular tissue were confirmed by verifying the M-Vu percent breast density (PBD) and the M-Vu breast area. The verification of fibroglandular area measurement follows by implication.
. M-Vu Breast Density was run over a data set where the women's age and results were compared with the expected and known decrease in breast density with age using the Spearman Rank Correlation test.
. Percent Breast Density measurements from the left and right breasts of the same patient were compared to confirm that the results were similar using Pearson's Correlation Coefficient.
Percent Breast Density measurements were made on patient images and . corresponding prior images with a maximum imaging period of two years apart and the results were compared to confirm that they were similar using Pearson's Correlation Coefficient.
M-Vu Breast Density is deployed on the M-Vu CAD Station. M-Vu CAD Station . was successfully tested for clinical network integration.

Conclusion:

Based upon the information presented in this submission, it is concluded that M-Vu Breast Density is safe and effective for the intended use, and is substantially equivalent to the named predicate devices.

4

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G604 Silver Spring, MD 20993-0002

December 3. 2013

VuCOMP, Inc. % Richard Morroney, RAC, CQA Director of Quality and Regulatory Affairs 2500 Dallas Parkway, Suite 500 PLANO TX 75093

Re: K132742

Trade/Device Name: M-Vu" Breast Density Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1J.Z. Dated: October 30, 2013 Received: October 31, 2013

Dear Mr. Morroney:

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. Insting 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 (IPMA). 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 (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

5

Page 2-Mr. Morroney

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

6

4 Indication(s) for Use Statement

510(k) Number (if known): K132742 Device Name: M-Vu Breast Density Indications for Use:

M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

Prescription Use X (Part 21 CFR 80) Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Smir to) Concurrence of Center for Devices and Radiological Health (CDRH) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K132742