(140 days)
No
The description focuses on image processing techniques to calculate volumetric density and does not mention AI or ML algorithms. The performance studies described are based on measurement accuracy, reproducibility, consistency, and comparison to visual assessment and a predicate device, not on training or validation of an AI/ML model.
No.
The device is described as a software application for volumetric density assessment of digital x-ray images of the breast to aid healthcare professionals in assessing breast tissue composition. It is explicitly stated that it is "not a diagnostic aid and should be used only as adjunctive information." It does not provide any treatment or direct therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Insight BD is not a diagnostic aid".
No
The device is described as a "software option for the Siemens digital mammography systems" and can be installed on "Siemens released PC hardware or on the Siemens digital mammography systems." This indicates that the software is integrated with or dependent on specific hardware components (the mammography systems or dedicated PC hardware), and is not a standalone software application.
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.
- Device Function: Insight BD analyzes digital x-ray images of the breast. It does not perform tests on biological samples. It processes medical images to provide information about tissue composition.
- Intended Use: The intended use clearly states it's for "volumetric density assessment of digital x-ray images of the breast" and is "not a diagnostic aid."
Therefore, Insight BD falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.
Product codes
LLZ
Device Description
The Siemens volumetric breast density analysis application software Insight BD provides volumetric assessment of digital x-ray images of the breast, including both digital mammograms and raw tomosynthesis projection images.
The assessment consists of generating and evaluating density maps where the value at each pixel represents the thickness of fibroglandular tissue above that pixel. From those density maps the software calculates quantitative values, namely
- . volume of fibroglandular tissue in the breast in cm³
- breast volume in cm³ .
- . volumetric breast density in %
- . breast density grade
The breast density grade is computed by thresholding of the volumetric breast density and conforms to BI-RADS® 5th Edition breast composition categories. The masking effect of dense fibroglandular tissue is automatically included in the results.
Insight BD is a software option for the Siemens digital mammography systems. Insight BD may be installed either on Siemens released PC hardware or on the Siemens digital mammography systems. Breast Density results are stored in the DICOM header and can be used for further documentation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital x-ray images of the breast, digital mammograms, raw tomosynthesis projection images
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
The Siemens Insight BD has been verified and validated according to the company's design control process. 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.
Density parameters were evaluated using various image data sets and results were compared against predicate performance, when appropriate.
- . Measurement accuracy was assessed by comparing Insight BD estimates with known values from breast phantoms.
- . Reproducibility was assessed by running Insight BD 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 Insight BD over substantial data sets where the same woman had been imaged on Siemens mammography systems in both tomosynthesis (DBT) and mammography (FFDM) modes, and the results were compared to confirm they were similar.
- . Reproducibility was assessed by running Insight BD over substantial datasets where the same women had been imaged on Siemens units running in both mammography and PRIME modes and the results were compared to confirm they were similar.
- . Consistency was assessed by running Insight BD over substantial datasets where the women's age was known and results were compared with the expected and known decrease in breast density with age.
- . Relationship to visual assessment was assessed by running Insight BD over x-ray images for which a BI-RADS® 5th Edition density category was available from MQSA qualified radiologists followed by a comparison of the two sets of data.
- . Equivalence was assessed by running both the predicate device Volpara and Insight BD over substantial datasets and the results were compared to confirm they were similar.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Siemens Medical Solutions, Inc Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN, PA 19355
February 6, 2018
Re: K172832
Trade/Device Name: Insight BD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: February 1, 2018 Received: September 19, 2017
Dear Denise Adams:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mechat D. O'Hara For
Robert A. 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) K172832
Device Name Insight BD
Indications for Use (Describe)
Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.
| 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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510(k) Summary: Insight BD
Company Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared December 15, 2017
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. General Information
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site
Siemens Healthcare GmbH Siemensstr. 1 91031 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person
Denise Adams, RAC Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 adams.denise@siemens-healthineers.com
Alternate Contact Person
Patricia D. Jones, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 patricia.d.jones@siemens-healthineers.com
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-
- Device Name and Classification
| Trade Name | Insight BD |
|---|---|
| Classification Name | System, Image Processing, Radiological |
| Classification Panel | Radiology |
| Classification Regulation | 21 CFR §892.2050 |
| Device Class | Class 2 |
| Product Code | LLZ |
4. Legally Marketed Predicate Device
| Trade Name | Volpara Imaging Software |
|---|---|
| 510(k) # | K152028 |
| Clearance Date | 10/26/2015 |
| Classification Name | System, Image Processing, Radiological |
| Classification Panel | Radiology |
| Classification Regulation | 21 CFR §892.2050 |
| Device Class | Class 2 |
| Product Code | LLZ |
| Recall Information | This device has not been subject to a design |
| related recall |
5. Device Description
The Siemens volumetric breast density analysis application software Insight BD provides volumetric assessment of digital x-ray images of the breast, including both digital mammograms and raw tomosynthesis projection images.
The assessment consists of generating and evaluating density maps where the value at each pixel represents the thickness of fibroglandular tissue above that pixel. From those density maps the software calculates quantitative values, namely
- . volume of fibroglandular tissue in the breast in cm³
- breast volume in cm³ .
- . volumetric breast density in %
- . breast density grade
The breast density grade is computed by thresholding of the volumetric breast density and conforms to BI-RADS® 5th Edition breast composition categories. The masking effect of dense fibroglandular tissue is automatically included in the results.
5
Insight BD is a software option for the Siemens digital mammography systems. Insight BD may be installed either on Siemens released PC hardware or on the Siemens digital mammography systems. Breast Density results are stored in the DICOM header and can be used for further documentation.
6. Indications for Use
Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.
7. Substantial Equivalence
The Siemens Insight BD volumetric breast density application software is substantially equivalent to the commercially available Volpara Imaging Software (K152028).
The Insight BD has the same intended use, fundamental scientific technologies and performance characteristics as the predicate device Volpara Imaging Software and the performance of the Insight BD application software has been verified with similar tests as the predicate. The substantial equivalence comparison table below compares the main performance data of the subject device Siemens Insight BD to the cleared predicate Volpara Imaging Software (K152028).
| Features /
Technology | Subject Device
Insight BD | Predicate Device
Volpara Imaging Software
K152028 | Remarks |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Indications for Use | Insight BD is a software
application for the volumetric
density assessment of digital
x-ray images of the breast to
aid health care professionals
in the assessment of breast
tissue composition. Insight
BD is not a diagnostic aid and
should be used only as
adjunctive information when
the final assessment of
breast density category is
made visually by medical
professionals. | 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 | Same meaning,
only wording is
different |
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| Features /
Technology | Subject Device
Insight BD | Predicate Device
Volpara Imaging Software
K152028 | Remarks |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | | information. It is not an
interpretive or diagnostic aid. | |
| Intended Users | Health Care Professionals | Health Care Professionals | Same |
| Image Source | Digital mammograms from
• mammography or
• tomosynthesis systems | Digital mammograms from
• mammography or
• tomosynthesis systems | Same |
| Anatomical Area | Breast | Breast | Same |
| Assessment Scope | Volumetric | Volumetric | Same |
| Operating
Environment | Windows | Windows | Same |
| Image Storage and
Report Generation | Yes
Output to the console | Yes
Output to the console | Same |
| Numeric Output | • Volume of Fibroglandular
tissue
• Volume of Breast
• Volumetric Breast Density
• Siemens Breast Density
Grade corresponding to
BI-RADS® 5th Edition
Breast Density Category | • Volume of Fibroglandular
tissue
• Volume of Breast
• Volumetric Breast Density
• Volpara Density Grade
corresponding to BI-RADS®
4th and 5th Edition Breast
Density Category | Siemens
volumetric breast
density
information
corresponds to BI-
RADS® 5th Edition
breast density
category only |
| Storage of Breast
Density Information
in Image | Yes | No | Siemens
volumetric breast
density
information is
stored in the
DICOM header |
| Classification | 21 CFR 892.2050; LLZ | 21 CFR 892.2050; LLZ | Same |
| Software Level of
Concern | Moderate | Moderate | Same |
8. Summary of Technological Characteristics of Subject Device as Compared with the Predicate Device
The Insight BD software is based on similar technology and algorithms to calculate the volumetric density as the predicate Volpara Imaging Software.
9. Performance Data
The Siemens Insight BD has been verified and validated according to the company's design control process. 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.
7
The device was tested and determined to be compliant to the following standards:
| ISO 14971 | Medical devices – Application of risk management to medical devices |
|---|---|
| ISO 62304 | Medical device software – Software life cycle processes |
| NEMA PS 3.1-3.20 | Digital Imaging and Communications in Medicine (DICOM) Set |
Density parameters were evaluated using various image data sets and results were compared against predicate performance, when appropriate.
- . Measurement accuracy was assessed by comparing Insight BD estimates with known values from breast phantoms.
- . Reproducibility was assessed by running Insight BD 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 Insight BD over substantial data sets where the same woman had been imaged on Siemens mammography systems in both tomosynthesis (DBT) and mammography (FFDM) modes, and the results were compared to confirm they were similar.
- . Reproducibility was assessed by running Insight BD over substantial datasets where the same women had been imaged on Siemens units running in both mammography and PRIME modes and the results were compared to confirm they were similar.
- . Consistency was assessed by running Insight BD over substantial datasets where the women's age was known and results were compared with the expected and known decrease in breast density with age.
- . Relationship to visual assessment was assessed by running Insight BD over x-ray images for which a BI-RADS® 5th Edition density category was available from MQSA qualified radiologists followed by a comparison of the two sets of data.
- . Equivalence was assessed by running both the predicate device Volpara and Insight BD over substantial datasets and the results were compared to confirm they were similar.
8
10. 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 the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification and validation testing to ensure that the product meets its intended uses.
11.Conclusion as to Substantial Equivalence
The Siemens volumetric breast density analysis application software Insight BD has the same intended use, fundamental scientific technology and performance characteristics as the predicate device. The 510(k) premarket notification for Insight BD contains adequate information and data to demonstrate substantial equivalence to the predicate device.