Volpara Imaging Software

K153427 · Matakina Technology, Ltd. · LLZ · Jan 7, 2016 · Radiology

Device Facts

• Record ID: K153427
• Device Name: Volpara Imaging Software
• Applicant: Matakina Technology, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 7, 2016
• 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 the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

Device Story

Software application; processes raw digital breast x-ray/tomosynthesis data; generates density maps where pixel values represent fibroglandular tissue thickness; computes quantitative statistics including fibroglandular volume, total breast volume, volumetric breast density percentage, BI-RADS 4th/5th Edition category, average/maximum dense tissue thickness, and maximum dense tissue volume per 1cm² region; operates on Windows server outside patient environment; used by healthcare professionals; output provided to console/viewing station; provides adjunctive information for breast density assessment; assists MQSA-qualified interpreting physicians in final clinical categorization; benefits include standardized, objective quantification of breast density.

Clinical Evidence

Bench testing only. Verification included measurement accuracy against breast phantoms; comparison to 3D breast MRI ground truth; reproducibility across age groups, breast views (CC/MLO), and different imaging systems (GE, Hologic, Siemens); and comparison to radiologist BI-RADS visual assessments. Clinical validation included beta site testing for system integration and usability, and collection of density metrics for database comparison. All acceptance criteria met.

Technological Characteristics

Software-based; operates on Windows server; DICOM 2015 compliant; utilizes density map generation and quantitative statistical computation; no patient contact; non-life-sustaining. Standards: ISO 14971:2012 (risk management), ISO 62304:2006 (software life cycle).

Indications for Use

Indicated for use by health care professionals to aid in the assessment of breast tissue composition in patients undergoing digital breast x-ray or tomosynthesis imaging.

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

• Volpara Imaging Software 1.5.1 (K152028)
• K102556

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

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

January 7, 2016

Matakina Technology Ltd. % Ralph Highnam, Ph.D. CEO Level 12, 86 Victoria Street Wellington, 6011 NEW ZEALAND

Re: K153427

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: November 19, 2015 Received: November 25, 2015

Dear Dr. Highnam:

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. 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K153427

Device Name Volpara Imaging Software

#### Indications for Use (Describe)

Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 100%;"> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <span style="font-size: 100%;"> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Mātākina Technology. The logo features the word "mātākina" in bold, dark green letters above the word "technology" in a smaller, lighter blue font. The words are set against a light blue circular background with a crescent shape cut out of the top left portion.

## 510(k) Summarv Prepared 13th November 2015

| Sponsor: | Matakina Technology Limited |
|----------------------------------------------------------|-------------------------------------------------------------|
| Company Address: | Level 12, 86 Victoria Street, Wellington, 6011, New Zealand |
| Contact Person: | Ralph Highnam |
| Telephone: | +64 - 4 - 499 - 6029 |
| Fax: | +64 - 4 - 499 - 6029 |
| Email: | [e-mail] |
| Submission Date: | 16th November 2015 |
| Device Name: | Volpara Imaging Software |
| Common Name: | Imaging Software |
| Classification:<br>Regulatory Class:<br>Review Category: | II<br>Class II |

eyol y Classification Panel: Radiology System, Imaging Processing; 21 CFR 892.2050; LLZ

## Legally Marketed Predicate Devices:

The modified software, Volpara Imaging Software ("Volpara") 1.5.2 is substantially equivalent to the Volpara Imaging Software 1.5.1 cleared pursuant to K152028 (Matakina Technology Limited) on October 26th, 2015, which serves as the primary predicate, as well as K102556 cleared on 7th October, 2010.

## Predicate Device Description:

Volpara Imaging Software 1.5.1 generated and validated density maps from digital x-ray images of the breast and from those density maps computed various quantitative densitymap based statistics, for example, volume of fibroglandular tissue in cm³, volume of breast in cm³, and their ratio, the volumetric breast density, and then provided a mechanism to generate a Breast Imaging-Reporting and Data System (BI-RADS) breast density category from the volumetric breast density.

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Image /page/4/Picture/0 description: The image shows a document header with the Mātakina Technology logo on the left. The document type is a report, with DMS number mtk1956-007-6 and DMS reference Eng/Angel. The revision date is December 26th, 2015, and it is page 2 of 5. The title of the document is "Volpara Imaging Software 510(k) Summary".

Volpara Imaging Software 1.5.1 operates on a Windows server that meets Volpara data input and output requirements and generally is located outside the patient environment.

#### Comparison with Predicate Device:

Volpara Imaging Software 1.5.2 works in the same way as Volpara Imaging Software 1.5.1 but also provides the density maps via user selectable viewing options along with additional quantitative statistics computed on the density map.

#### Substantial Equivalence Comparison Table

| | Predicate Device | Submission Device, |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Volpara, 1.5.1 (K152028) | Volpara 1.5.2 |
| Intended Use (difference is underlined) | "Volpara is a software application<br>intended for use with the raw data<br>from digital breast x-ray systems,<br>including tomosynthesis. Volpara<br>calculates a density map and from<br>that determines volumetric breast<br>density as a ratio of fibroglandular<br>tissue and total breast volume<br>estimates. Volpara provides these<br>numerical values along with a BI-<br>RADS breast density 4th or 5th<br>Edition category to aid health care<br>professionals in the assessment of<br>breast tissue composition. Volpara<br>produces adjunctive information. It<br>is not an interpretive or diagnostic<br>aid" | "Volpara is a software application<br>intended for use with the raw data<br>from digital breast x-ray systems,<br>including tomosynthesis. Volpara<br>calculates and quantifies a density<br>map and from that determines<br>volumetric breast density as a ratio<br>of fibroglandular tissue and total<br>breast volume estimates. Volpara<br>provides these numerical values<br>along with a BI-RADS breast<br>density 4th or 5th Edition category to<br>aid health care professionals in the<br>assessment of breast tissue<br>composition. Volpara is not an<br>interpretive or diagnostic aid and<br>should be used only as adjunctive<br>information when the final<br>assessment of breast density<br>category is made by an MQSA-<br>qualified interpreting physician." |
| Intended Users | Health Care Professionals | Health Care Professionals |
| Image Source | Digital mammography images | Digital mammography images. |
| Image Sources | Digital<br>mammograms from<br>mammography or tomosynthesis<br>systems. | Digital<br>mammograms from<br>mammography or tomosynthesis<br>systems. |
| Anatomical Area | Breast | Breast |
| Assessment Scope | Volumetric | Volumetric |
| Operating Environment | Windows | Windows |
| Image Storage and Report Generation | Yes<br>Output to the console | Yes<br>Output to the console |
| Numeric Output | Volume of Fibroglandular tissue<br>Volume of Breast | Volume of Fibroglandular tissue<br>Volume of Breast |

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Image /page/5/Picture/0 description: The image shows the logo for Mātākina Technology. The logo features a blue circle with a white crescent shape at the top left. The words "mātākina technology" are written in dark blue on the right side of the circle, with "mātākina" stacked on top of "technology".

| | Volumetric Breast Density<br>BIRADS 4th or 5th Edition Breast<br>Density Category | Volumetric Breast Density<br>BIRADS 4th or 5th Edition Breast<br>Density Category |
|---------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | | Average thickness of dense tissue |
| | | Maximum thickness of dense<br>tissue (and location). |
| | | Maximum volume of dense tissue<br>above any 1cm² square region<br>(and location). |
| Image Output | None | Density map in DICOM SCI format,<br>for visualization as user requires. |
| Classification | 21 CFR 892.2050; LLZ | 21 CFR 892.2050; LLZ |
| Software Level of Concern | Moderate | Moderate |

### Intended Use:

Volpara is a software application intended for use with the raw data from digital breast xray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a Bl-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA-qualified interpreting physician.

### Device Description

The Volpara 1.5.2 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessment takes the form of generating and validating density maps where the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From those density maps various quantitative densitymap based statistics are computed, namely:

- volume of fibroglandular tissue in cm3, ●
- volume of breast in cm3 ●
- the volumetric breast density in %,
- a BI-RADS 4th Edition or 5th Edition breast density category ●
- average thickness of dense tissue
- maximum thickness of dense tissue
- maximum volume of dense tissue above any 1cm² square region ●

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Image /page/6/Picture/0 description: This image contains document information for a report. The report is titled "Volpara Imaging Software 510(k) Summary". The DMS number is mtk1956-007-6, the DMS reference is Eng/Angel, and the revision date is December 26th, 2015. This is page 4 of 5.

The device outputs those numbers along with the density maps themselves marked with the location of the various maxima.

Volpara operates on a Windows server that meets Volpara data input and output requirements and generally is located outside the patient environment. The device does not contact the patient, nor does it control any life-sustaining devices.

## 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 various software guidance documents have been submitted in the Special 510(k) Notification. A risk analysis compliant with ISO 14971 has been provided 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.

The modified device was tested and determined to be compliant to the following standards: ISO 14971:2012 Medical devices – Application of risk management to medical devices; 1SO 62304-2006 Software Life Cycle Processes, DICOM 2015.

In addition to the verification and validation testing conducted for the specific modification to the software detailed in this Special 510(k), complete verification and validation data testing conducted for the predicate was repeated in order to ensure integration and backwards compatibility.

Verification Bench Testing Included:

- . Measurement accuracy was assessed by comparing Volpara estimates with known values from breast phantoms.
- . Relationship to ground truth was assessed by running Volpara over x-ray images of breasts for which there was 3D breast MRI data available with a comparison of estimates of fibroglandular tissue.
- Reproducibility was assessed by running Volpara over substantial datasets where ● we have the women's age and results compared with the expected and known decrease in breast density with age.
- Reproducibility was assessed by running Volpara 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 similar for each view and each breast.
- . Reproducibility was assessed by running Volpara 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.

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Image /page/7/Picture/0 description: The image is a logo for a company called "Mātakina Technology". The logo features a stylized crescent moon shape in light blue, with the company name written in a modern sans-serif font. The word "mātakina" is in a slightly larger font size than "technology", and there is a trademark symbol after the word "technology". The logo has a clean and professional look.

- Reproducibility was assessed by running over substantial data sets where the . same woman had been imaged on one of GE, Hologic and Siemens tomosynthesis -compatible units running in both tomosynthesis and mammography modes, and the results were compared to confirm they were similar.
- . Relationship to visual assessment was assessed by running Volpara over x-rav images for which a BI-RADS 4th and 5th Edition density category was available from MQSA qualified radiologists followed by a comparison of the two sets of data.

## Clinical Validation Testing 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.

### 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 Volpara contains adequate information and data to demonstrate substantial equivalence to the predicate device.