Volpara Imaging Software

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services - USA. To the right of the seal is the FDA logo in blue, with the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" to the right of the square. Volpara Health Technologies Limited % Ralph Highnam, Ph.D. CEO Level 14-15, Simpl House, 40 Mercer Street. Wellington Central Wellington, 6011 NEW ZEALAND Re: K211279 Trade/Device Name: Volpara Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 25, 2021 Received: July 2, 2021 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. 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/cfpmn/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. 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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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211279 Device Name Volpara Imaging Software Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (i.e., dose and pressure) to aid healthcare professionals in the assessment of breast composition. Volpara Imaging Software is not a 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> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Volpara Health Technologies. The word "volpara" is written in a bold, dark blue font. Above the word is a stylized checkmark in two shades of blue. Below the word "volpara" is the phrase "health technologies" in a smaller, less bold font. #### Volpara Imaging Software Special 510(k) Summary #### Sponsor: Volpara Health Technologies Limited #### Company Address: Level 14-15, Simpl House, 40 Mercer Street, Wellington, 6011, New Zealand Contact Person: Ralph Highnam Telephone: +64 4 499 6029 Fax: +64 4 499 6029 Email: ralph.highnam@volparahealth.com Submission Date: 15 April 2021 Device Name: Volpara Imaging Software # Common Name: Imaging Software #### Regulatory Classification: Class II Review Category: Class II ## Classification Panel: Radiology; System, Imaging Processing; 21 CFR 892.2050; LLZ ## Legally Marketed Predicate Devices: The modified software, Volpara Imaging Software ("Volpara") 3.2 is substantially equivalent to the Volpara Imaging Software 1.5.6 cleared pursuant to K182310 (Volpara Health Technologies Limited), which serves as the primary predicate. ## Predicate Device Description: The Volpara Imaging Software 1.5.6 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both raw digital mammograms and raw tomosynthesis projections (the central projections of which are just raw digital mammograms). The assessment takes the form of generating and validating density maps wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based statistics are computed as follows: {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Volpara Health Technologies. The word "volpara" is written in a bold, dark blue font. Above the word "volpara" is a stylized graphic of two curved shapes in light blue and dark blue. Below the word "volpara" is the phrase "health technologies" in a smaller, less bold font. - Volume of Fibroglandular Tissue in cm3 - Volume of Breast in cm3 - Volumetric Breast Density (the percentage of fibroglandular tissue in breast) - Average thickness of dense tissue in cm - Maximum thickness of dense tissue in cm - Maximum volume of dense tissue above any 1 cm² square region (and location) - Image quality assurance metrics From the volumetric breast density, a Bl-RADS 4th Edition breast density category can be attained by applying thresholds set by the software. The device outputs those metrics along with the density maps themselves marked with the location of the various maxima. Volpara Imaging Software 1.5.6 operates on a Windows or Linux 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. ## Comparison with Predicate Device: Volpara Imaging Software 3.2 is the same core software as the predicated device Volpara Imaging Software 1.5.6 with the addition of the following software and labeling updates. The modified device is similar to the predicate, except for: - Modified overall software architecture - Improved combo study logic - Ability to process Giotto Class 2D images - Providing additional quality assurance outputs - Improved density sanity checking - Better support for Hologic Tomosynthesis images - . Updated user manual to include recent updates to accepted manufacturers and Intended Use statement. The minor change to the Intended Use statement is to accommodate the QA metrics (i.e., dose and pressure). #### Table 1. Substantial Equivalence Comparison | | Predicate Device<br>Volpara Imaging Software 1.5.6<br>(K182310) | Submission Device<br>Volpara Imaging Software 3.2 | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | VolparaDensity is a software<br>application intended for use with the<br>raw data from digital breast x-ray<br>systems, including tomosynthesis.<br>VolparaDensity calculates and<br>quantifies 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 | Volpara Imaging Software¹ is a<br>software application intended for use<br>with the raw data from digital breast<br>x-ray systems, including<br>tomosynthesis. Volpara Imaging<br>Software calculates and quantifies a<br>density map and from that<br>determines volumetric breast density<br>as a ratio of fibroglandular tissue and<br>total breast volume estimates. | ⁴ Standardizing on the use of the term Volpara Imaging Software as the name of the cleared medical device. As described in previous 510(k) submissions, Volpara Imaging Software, Volpara and Volpara Density have been used interchangeably. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Volpara Health Technologies. The logo is composed of the word "volpara" in a bold, dark blue font, with the "®" symbol next to it. Above the word "volpara" are two curved shapes in light and dark blue, resembling stylized wings or leaves. Below "volpara" is the phrase "health technologies" in a smaller, lighter font. | DMS # | mtk5970-5 | | | |---------------|----------------------------------------------------|----------|-------------| | Base Template | mtk2327-1 | Rev Date | 2021-07-26 | | Title | Volpara Imaging Software Special 510(k)<br>Summary | | Page 3 of 5 | | | Predicate Device | Submission Device | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Volpara Imaging Software 1.5.6<br>(K182310) | Volpara Imaging Software 3.2 | | | numerical values along with a BI-RADS<br>breast density 4th or 5th Edition<br>category to aid health care<br>professionals in the assessment of<br>breast tissue composition.<br>VolparaDensity is not an interpretive<br>or diagnostic aid and should be used<br>only as adjunctive information when<br>the final assessment of breast density<br>category is made by an MQSA-<br>qualified interpreting physician. | Volpara Imaging Software provides<br>these numerical values along with a<br>BI-RADS breast density 4th or 5th<br>Edition category and quality<br>assurance metrics (i.e., dose and<br>pressure) to aid healthcare<br>professionals in the assessment of<br>breast composition. Volpara Imaging<br>Software is not a diagnostic aid and<br>should be used only as adjunctive<br>information when the final<br>assessment of breast density category<br>is made by an MQSA-qualified<br>interpreting physician. | | Intended Users | Health Care Professionals | Health Care Professionals | | Image Source | Digital mammography images | Digital mammography images | | Image Sources | Digital mammograms from<br>mammography or tomosynthesis<br>systems, including those obtained<br>using with curved paddles. | Digital mammograms from<br>mammography or tomosynthesis<br>systems, including those obtained<br>using with curved paddles. | | Anatomical<br>Area | Breast | Breast | | Assessment<br>Scope | Volumetric | Volumetric | | Operating<br>Environment | Windows/Linux² | Windows/Linux | | Image Storage<br>and Report<br>Generation | Yes; output to console | Yes; output to console | | Numeric Output | Volume of Fibroglandular tissue Volume of Breast Volumetric Breast Density BIRADS 4th or 5th Edition Breast<br>Density Category, with<br>highlighting above a certain<br>volumetric threshold or if focal<br>density present Average thickness of dense tissue Maximum thickness of dense<br>tissue (and location) | Volume of Fibroglandular tissue Volume of Breast Volumetric Breast Density BIRADS 4th or 5th Edition Breast<br>Density Category, with<br>highlighting above a certain<br>volumetric threshold or if focal<br>density present Average thickness of dense tissue Maximum thickness of dense<br>tissue (and location) | | | Predicate Device<br>Volpara Imaging Software 1.5.6<br>(K182310) | Submission Device<br>Volpara Imaging Software 3.2 | | | ● Maximum volume of dense tissue<br>above any 1 cm² square region<br>(and location)<br>● Image quality assessment metrics | ● Maximum volume of dense tissue<br>above any 1 cm² square region<br>(and location)<br>● Image quality assessment metrics | | Image Output | Density map in DICOM SCI format, for<br>visualization as user specifies | Density map in DICOM SCI format, for<br>visualization as user specifies | | Classification | 21 CFR 892.2050; LLZ | 21 CFR 892.2050; LLZ | | Level of<br>Concern | Moderate | Moderate | ² Volpara Imaging Software has been previously cleared for both Windows and Linux, which was missed off the 2018 submission. We are now correcting this error. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Volpara Health Technologies. The word "volpara" is written in a bold, dark blue font. Above the word "volpara" are three curved shapes in light and dark blue. Below the word "volpara" is the phrase "health technologies" in a smaller, red font. ## Intended Use: Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (i.e., dose and pressure) to aid healthcare professionals in the assessment of breast composition. Volpara Imaging Software is not a 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: Volpara Imaging Software 3.2 analyzes raw ("For Processing") digital mammograms or raw DBT projections in a fully automated, volumetric fashion. It produces a quantitative assessment of breast composition in the form of a Volpara density map, wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based metrics are computed as follows: - volume of fibroglandular tissue in cm3 - volume of breast in cm³ - the volumetric breast density (the percentage of fibroglandular tissue in breast) - average thickness of dense tissue in cm - maximum thickness of dense tissue in cm - maximum volume of dense tissue above any 1 cm² square region (and location) - image quality assessment metrics Volpara Imaging Software typically receives four standard views from the digital x-ray system following a mammographic or digital breast tomosynthesis screening examination (i.e., left CC, right CC, left MLO, right MLO). The generated results are then displayed via either of the following: - A Volpara scorecard (a DICOM Secondary Capture Image) - A DICOM Mammography CAD Structured Report {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Volpara Health Technologies. The logo features the word "volpara" in a bold, dark blue font, with a stylized graphic of three blue teardrop shapes above the "a". Below "volpara" is the phrase "health technologies" in a smaller, less bold font, also in dark blue. The overall design is clean and professional, reflecting the company's focus on health technology. The device outputs those metrics along with the density maps themselves marked with the location of the various maxima. Using the volumetric breast density, a Bl-RADS 4th Edition and 5th Edition breast density category is generated by applying thresholds set by the software. Volpara Imaging Software operates on a Microsoft Azure-connected, off-the-shelf virtual appliance, which provides a secure, pre-configured virtual host. Volpara Imaging Software does not contact the patient, nor does it control any life-sustaining devices. #### Performance Data: Volpara Imaging Software has been verified and validated according to the company's design control process. All the documents specified in the FDA's various software guidance documents have been submitted in this Special 510(k) Notification. An ISO 14971 compliant risk analysis 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 is 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; ISO 62304:2006 Software Life Cycle Processes, DICOM 2016. In addition to the verification and validation testing conducted for the specific modification to the software detailed in this Special 510(k) submission, complete verification and validation data testing conducted for the predicate was repeated to ensure integration and backwards compatibility. #### 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 Special 510(k) Premarket Notification for Volpara Imaging Software 3.2 contains adequate information and data to demonstrate substantial equivalence to the predicate device.