(91 days)
Not Found
No
The summary describes automated image analysis and calculation of metrics based on predefined thresholds, but does not mention AI or ML.
No
The device is described as software that calculates and quantifies breast density to aid healthcare professionals in assessment, and it explicitly states that it "is not a diagnostic aid." It does not provide any therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "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."
Yes
The device description explicitly states "Volpara Imaging Software" and details its function as analyzing raw data from digital breast x-ray systems and producing quantitative assessments and reports. It operates on a virtual appliance and does not include or control any hardware components beyond the software itself.
Based on the provided information, 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, conditions, or infections.
- Volpara Imaging Software's Function: Volpara Imaging Software analyzes raw data from digital breast x-ray systems. This is image data, not a biological sample taken from the patient.
- Intended Use: The intended use clearly states it's for use with "raw data from digital breast x-ray systems" to calculate and quantify breast density. It's an imaging software, not a diagnostic test performed on a biological specimen.
Therefore, Volpara Imaging Software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital breast x-ray systems, including tomosynthesis.
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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. 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
July 27, 2021
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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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:
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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
Volpara Imaging Software 1.5.6
(K182310) | Submission Device
Volpara Imaging Software 3.2 |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VolparaDensity is a software
application intended for use with the
raw data from digital breast x-ray
systems, including tomosynthesis.
VolparaDensity 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 | Volpara Imaging Software¹ 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. |
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.
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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) | ||
| Summary | Page 3 of 5 |
| Predicate Device | Submission Device | |
|---|---|---|
| Volpara Imaging Software 1.5.6 | ||
| (K182310) | Volpara Imaging Software 3.2 | |
| 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. | ||
| VolparaDensity 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. | 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. | ||
| Intended Users | Health Care Professionals | Health Care Professionals |
| Image Source | Digital mammography images | Digital mammography images |
| Image Sources | Digital mammograms from | |
| mammography or tomosynthesis | ||
| systems, including those obtained | ||
| using with curved paddles. | Digital mammograms from | |
| mammography or tomosynthesis | ||
| systems, including those obtained | ||
| using with curved paddles. | ||
| Anatomical | ||
| Area | Breast | Breast |
| Assessment | ||
| Scope | Volumetric | Volumetric |
| Operating | ||
| Environment | Windows/Linux² | Windows/Linux |
| Image Storage | ||
| and Report | ||
| 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 | |
| Density Category, with | ||
| highlighting above a certain | ||
| volumetric threshold or if focal | ||
| density present Average thickness of dense tissue Maximum thickness of dense | ||
| tissue (and location) | Volume of Fibroglandular tissue Volume of Breast Volumetric Breast Density BIRADS 4th or 5th Edition Breast | |
| Density Category, with | ||
| highlighting above a certain | ||
| volumetric threshold or if focal | ||
| density present Average thickness of dense tissue Maximum thickness of dense | ||
| tissue (and location) | ||
| Predicate Device | ||
| Volpara Imaging Software 1.5.6 | ||
| (K182310) | Submission Device | |
| Volpara Imaging Software 3.2 | ||
| ● Maximum volume of dense tissue | ||
| above any 1 cm² square region | ||
| (and location) | ||
| ● Image quality assessment metrics | ● Maximum volume of dense tissue | |
| above any 1 cm² square region | ||
| (and location) | ||
| ● Image quality assessment metrics | ||
| Image Output | Density map in DICOM SCI format, for | |
| visualization as user specifies | Density map in DICOM SCI format, for | |
| visualization as user specifies | ||
| Classification | 21 CFR 892.2050; LLZ | 21 CFR 892.2050; LLZ |
| Level of | ||
| 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.
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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.