(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and performance studies do not mention any AI/ML techniques. The density calculation is described as a process of generating and validating density maps and computing statistics, which doesn't inherently imply AI/ML.
No
The device is described as providing "adjunctive information" to aid in the assessment of breast tissue composition, not as an interpretive or diagnostic aid. Its purpose is to quantify breast density, which is a risk factor, but it does not treat or cure any condition.
No
The "Intended Use / Indications for Use" section explicitly states: "It is not an interpretive or diagnostic aid."
Yes
The device description explicitly states "The Volbara 1.5.1 software provides volumetric assessment..." and details its operation on a Windows server, processing digital x-ray images. It does not mention or include any hardware components as part of the device itself. The interaction is solely with existing digital breast x-ray systems for data input.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Volpara is a software application used with raw data from breast x-ray systems to calculate breast density. It provides numerical values and a BI-RADS category to aid healthcare professionals in assessing breast tissue composition. Crucially, it explicitly states: "It is not an interpretive or diagnostic aid." IVDs are typically intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Volpara's role is adjunctive information, not a diagnostic determination.
- Device Description: The description reinforces that Volpara provides volumetric assessment and generates density maps and statistics. It operates on a server and does not contact the patient. This aligns with a medical image processing software, not a device used to examine specimens derived from the human body.
- Regulation Number: The provided regulation number is 21 CFR 892.2050: System, Imaging Processing: LLZ. This regulation falls under the category of Radiology devices, specifically imaging processing systems. IVDs are regulated under different sections of 21 CFR, typically starting with 864 (Hematology and Pathology Devices) or 866 (Immunology and Microbiology Devices).
- Lack of Specimen Analysis: IVDs are designed to perform tests on specimens (like blood, urine, tissue samples) derived from the human body. Volpara operates on raw image data, not biological specimens.
In summary, Volpara is classified as a medical image processing software used to provide quantitative information about breast density from x-ray images. Its function is to process imaging data, not to perform diagnostic tests on biological specimens, which is the core characteristic of an IVD.
N/A
Intended Use / Indications for Use
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates 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 produces adjunctive information. It is not an interpretive or diagnostic aid.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Volbara 1.5.1 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessments 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, for example, volume of fibroglandular tissue in cm³, volume of breast in cm3, and their ratio, the volumetric breast density, along with a Bl-RADS 4th Edition, 5th Edition breast density category by simple thresholding of the volumetric breast density.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
raw data from digital breast x-ray systems, including tomosynthesis
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals / outside the patient environment
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)
- 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.
- 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-ray 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.
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2015
Matakina Technologies Limited % Sheila Pickering, Ph.D. Consultant Sheila Pickering 2081 Longden Circle LOSALTOS CA 94024
Re: K152028
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 24, 2015 Received: September 24, 2015
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. 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.
1
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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152028
Device Name Volpara Imaging Software
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates 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 produces adjunctive information. It is not an interpretive or diagnostic aid.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Mātākina Technology. The logo features a stylized blue crescent shape, resembling a wave or a partial circle, with the words "mātākina" and "technology" stacked on top of each other in a sans-serif font. The word "mātākina" is in a slightly larger and bolder font than "technology." There is a trademark symbol after the word "technology."
510(k) Summary Prepared 30th May 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: | ralph.highnam@matakina.com |
| Submission Date: | 17th July, 2015 |
| Device Name: | Volpara Imaging Software 1.5.1 |
| Common Name: | Imaging Software |
| Classification: | Regulatory Class: II |
| Review Category: Class II | |
| Classification Panel: Radiology | |
| System, Imaging Processing: 21 CFR 892.2050: LLZ |
Legally Marketed Predicate Devices:
The modified software is substantially equivalent to the Volpara Imaging Software ("Volpara") 1.3 cleared pursuant to K102556 (Matakina Technology Limited) cleared October 7th, 2010.
Predicate Device Description:
4
Image /page/4/Picture/0 description: The image shows the logo for Mātākina Technology. The logo features a light blue circle with a white crescent shape in the upper left corner. To the right of the circle, the words "mātākina technology" are written in a dark color, with "technology" appearing in a smaller font size below "mātākina". The letters "TM" are in superscript to the right of the word "technology".
Volpara Imaging Software 1.3 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.
Volpara Imaging Software 1.3 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 1.5.1 works in the same way as Volpara Imaging Software 1.3, but is updated to make it clearer that both digital mammograms from conventional mammography machines and from raw tomosynthesis projections can serve as inputs.
| Predicate Device | Submission Device, | |
|---|---|---|
| Volpara, 1.3 | Volpara 1.5.1 | |
| 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." | "Volpara is a software application | |
| intended for use with the raw data | ||
| from digital breast x-ray systems, | ||
| including tomosynthesis. Volpara | ||
| calculates 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 | ||
| produces adjunctive information. It is | ||
| not an interpretive or diagnostic aid" | ||
| Intended Users | Radiologists | Health Care Professionals |
| Image Source | Digital mammography images | Digital mammography images. |
| Image Sources | Digital mammograms from | |
| mammography systems. | Digital mammograms from | |
| mammography or tomosynthesis | ||
| systems. | ||
| Anatomical Area | Breast | Breast |
| Assessment Scope | Volumetric | Volumetric |
| Operating Environment | Windows or Linux computers | Windows |
| Image Storage and Report | ||
| Generation | Yes | |
| Output to the console | Yes | |
| Output to the console |
Substantial Equivalence Comparison Table
5
Image /page/5/Picture/0 description: The image shows the logo for Mātākina Technology. The logo features a blue circle with a white crescent moon shape at the top left. The words "mātākina technology" are written in a stylized font, with "mātākina" in a larger, bolder font than "technology". The letters are black, and the TM symbol is in the bottom right corner.
| Type: | Report | ||
|---|---|---|---|
| DMS No: | mtk1658-007-2 | Rev. Date: | 19th Sept 2015 |
| DMS Ref: | Eng/Robin | Page | 4 of 6 |
| Title: | Volpara Imaging Software 510(k) Summary |
| Output features | Quantitative density map based
statistics, namely: | Quantitative density map based
statistics, namely: |
|---------------------------|-------------------------------------------------------|-------------------------------------------------------|
| | Volume of Fibroglandular tissue | Volume of Fibroglandular tissue |
| | Volume of Breast | Volume of Breast |
| | Volumetric Breast Density | Volumetric Breast Density |
| | BIRADS 4th Edition Breast Density
Category | BIRADS 4th or 5th Edition Breast
Density Category |
| 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 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 produces adjunctive information. It is not an interpretive or diagnostic aid.
Device Description
The Volbara 1.5.1 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessments 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, for example, volume of fibroglandular tissue in cm³, volume of breast in cm3, and their ratio, the volumetric breast density, along with a Bl-RADS 4th Edition, 5th Edition breast density category by simple thresholding of the volumetric breast density.
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.
6
Image /page/6/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 black text to the right of the circle, with "technology" in a smaller font size and with a trademark symbol.
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 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 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.
- o 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.
- o 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.
- Reproducibility was assessed by running over substantial data sets where the . same woman had been imaged on one of GE, Hologic and Siemens
7
Image /page/7/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. Inside the circle, the word "mātākina" is written in a stylized font above the word "technology," which is in a smaller, sans-serif font. The letters "TM" are written as a superscript to the right of the word technology.
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-ray ● 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:
- o 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 adeguate information and data to demonstrate substantial equivalence to the predicate device.