VOLPARA, VERSION 1.3

K102556 · Matakina Technology Limited · LLZ · Oct 7, 2010 · Radiology

Device Facts

• Record ID: K102556
• Device Name: VOLPARA, VERSION 1.3
• Applicant: Matakina Technology Limited
• Product Code: LLZ · Radiology
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values for each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux-based computers.

Device Story

Volpara Imaging Software is a fully automated, volumetric analysis tool for digital mammography. It accepts raw ('for processing') DICOM mammography images and associated calibration data as input. Operating on Windows or Linux-based computers, the software uses proprietary algorithms to calculate the volume of fibroglandular tissue, total breast volume, and the resulting volumetric breast density ratio. The output is provided to the radiologist via the console as adjunctive information to assist in assessing breast tissue composition. It does not perform image display or diagnostic interpretation. By providing objective, quantitative density metrics, the device aids clinicians in evaluating breast composition, which may assist in clinical decision-making regarding patient care. It is intended for use in clinical settings by radiologists.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and beta site usability testing. Bench testing included: measurements against standardized/calibrated breast phantoms; comparison of results against BI-RADS scores; comparison of fibroglandular tissue estimates against 3D breast MRI data; assessment of density trends relative to patient age; comparison of results across different views (CC/MLO) and breasts; and longitudinal consistency checks using images from GE and Hologic systems. Beta site testing assessed software integration and usability, and compared density ranges against existing databases. All acceptance criteria were met.

Technological Characteristics

Software-based image processing application. Inputs: raw DICOM digital mammography images and calibration data. Outputs: quantitative volumetric breast density metrics. Platform: Windows or Linux-based computers. Connectivity: DICOM-compatible. Verification/Validation: ISO 14971 compliant risk analysis, unit and integrated system testing, and testing across GE and Hologic detector datasets.

Indications for Use

Indicated for use by radiologists to aid in the assessment of breast tissue composition using digital mammography images. Provides quantitative volumetric breast density measurements (fibroglandular tissue volume, total breast volume, and density ratio). 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 (K082483)

Submission Summary (Full Text)

{0}------------------------------------------------

#### Section 5

#### 510(k) Summary Prepared September 30, 2010

OCT - 7 2010

| Sponsor: | Matakina Technology Limited |
|-----------------------|--------------------------------------------------|
| Contact Person: | Ralph Highnam |
| Telephone: | +64 - 4 - 385 9839 |
| Fax: | +64 - 4 - 385 9839 |
| Submission Date: | September 1, 2010 |
| Device Name: | Volpara Imaging Software |
| Common Name: | Imaging Software |
| Regulatory Class: | II |
| Review Category: | Class II |
| Classification Panel: | Radiology |
| | System, Imaging Processing; 21 CFR 892.2050; LLZ |

#### Classification:

#### A. Legally Marketed Predicate Devices

The modified software is substantially equivalent to the Quantra software cleared pursuant to K082483.

#### B. Device Description:

Volpara™ analyzes raw ("for processing") digital mammograms in a fully automated, volumetric fashion and produces a quantitative assessment of breast composition, namely volume of fibroglandular tissue in cubic centimeters (cm³) volume of breast tissue in cm³ and their ratio, volumetric breast density. Volpara v1.3 handles DICOM files as input

Volpara v1.3has been built and tested on Windows XP and Linux

Volpara software is a component which accepts as input digital mammography images along with associated calibration data. The software processes the image according to proprietary algorithms. It provides measures of:

- volume of fibroglandular tissue .
- volume of breast .
- . breast density

The software does not perform image display but outputs to the console.

{1}------------------------------------------------

# C. Intended Use

Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values for each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux-based computers.

# D. Substantial Equivalence

The submission device is substantially equivalent to the predicate. Hologic Quantra software with regard to both intended use and technological characteristics. The dev ices have substantially equivalent indications for use and technological characteristics. Both devices are labeled as providing adjunctive information which is not an interpretive or diagnostic aid.

| | Predicate Device<br>Quantra K082483 | Submission Device<br>Volpara |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantra software application intended for<br>use with Hologic digital mammography<br>systems. Quantra calculates volumetric<br>breast density as a ratio of fibroglandular<br>tissue and total breast volume estimates.<br>Quantra provides these numerical values<br>for each breast to aid radiologists in the<br>assessment of breast tissue composition.<br>Quantra produces adjunctive information.<br>It is not an interpretive or diagnostic aid.<br>Quantra is a software application which<br>runs on Hologic Cenova DICOM server. | Volpara is a software application intended<br>for use with digital mammography<br>systems. Volpara calculates volumetric<br>breast density as a ratio of fibroglandular<br>tissue and total breast volume estimates.<br>Volpara provides these numerical values<br>for each image to aid radiologists in the<br>assessment of breast tissue composition.<br>Volpara produces adjunctive information.<br>It is not an interpretive or diagnostic aid.<br>Volpara is a software application which<br>runs on Windows or Linux-based<br>computers |
| Intended Users | Radiologists | Radiologists |
| Image Source | Digital mammography images | Digital mammography images |
| Compatibility | Hologic Digital Mammography System | GE and Hologic Digital Mammography<br>Systems |
| Anatomical<br>Area | Breast | Breast |
| Assessment<br>scope | Average of images for each breast | Provides results per image |
| Assessment<br>type | Volumetric | Volumetric |
| Operating<br>environment | Not specified in product labeling | Windows or Linux-based computers |
| Image storage<br>and report<br>generation | Yes<br>appears to generate a DICOM structured<br>report to send to PACS | Yes<br>output to the console |

# Table 1 Substantial Equivalence Comparison Table

{2}------------------------------------------------

| Classification | 90LLZ<br>892.2050 | 90LLZ<br>892.2050 |
|------------------------------|-------------------|-------------------|
| Software Level<br>of Concern | Minor | Moderate |

# E. Performance Data

The Volpara software has been verified and validated according to the company's design control process. All of the documents specified in FDA's software guidance document have been submitted in the 510(k) Notification. A risk analysis compliant with ISO 14971 has been completed and incorporated into the development effort. Software testing included both unit level and integrated system level testing. A report of outstanding anomalies was included in the software information. Verification and Validation testing utilized images acquired from detectors manufactured by both GE and Hologic.

# Verification Bench testing of Volpara volumetric breast density software included:

- Measurements of Volpara as compared to known values of standardized and . calibrated breast phantoms
- Volpara was run over x-ray images for which a BI-RADS score was available . from a MQSA qualified radiologist followed by a comparison of the two sets of data
- . Volpara was run over x-ray images of breasts for which there was 3D breast MRI data with a comparison of estimates of fibroglandualar tissue
- . Volpara was run over substantial datasets where we have the women's age and results compared with the expected and known decrease in breast density with age
- . Volpara was run over substantial data sets and the results for left and right breasts and CC and MLO views were compared to confirm that the results were the similar for each view and each breast.
- Volpara was run over substantial data sets where the same woman had been . imaged on GE and Hologic systems one year apart and the results were compared to confirm they were similar.

# Clinical Validation testing of Volpara volumetric breast density software included :

- Beta site testing to assess the ability of physicians to successfully integrate the . software into their existing systems as well as assess usability for target users
- . Beta site testing to collect minimum, average and maximum Volpara breast densities and compare these to other existing databases

All verification and validation testing was successful in that established acceptance criteria was met for all of the tests conducted.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

#### 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

Matakina Technology Limited % Sheila W. Pickering, Ph.D. Consultant Sheila W. Pickering Consulting 2081 Longden Circle LOS ALTOS CA 94024

OCT - 7 2010

Re: K102556

Trade/Device Name: Volpara Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2010 Received: September 7, 2010

Dear Dr. Pickering:

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 comply with 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

{4}------------------------------------------------

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 5 00%) remarket notification. The FDA finding of substantial equivalence of your device to a legally renarketed 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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.

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,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### 510(k) Number (if known): K102556

Device Name:

Volpara Imaging Software

Indications for Use:

Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values for each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux based computers.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

OCT - 7 2010

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

Concurrence of CDRH, Office effective Examison (CDP) OTY)

(Division Sign-Off)

Division of Radiolog Office of In Vitro Dia anostic Device

510K K102556

1 1