(256 days)
Unknown
The description mentions automated analysis and calculation of breast density, which could potentially be implemented using traditional image processing techniques or AI/ML. However, there is no explicit mention of AI, ML, or related terms like neural networks or deep learning in the provided text. The performance studies describe comparisons to expert visual assessment and interactive thresholding software, which doesn't definitively indicate the use of AI/ML.
No
The device is a software application that aids in the assessment of breast tissue composition by calculating breast density, providing information for diagnostic purposes, not for treatment or therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic aid."
Yes
The device is explicitly described as a "standalone software application" and its function is to analyze existing digital mammograms to provide breast density information. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, ClariSIGMAM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- ClariSIGMAM's Function: ClariSIGMAM analyzes digital mammography images, which are medical images, not biological specimens. It processes existing image data to calculate breast density.
- Intended Use: The intended use clearly states it's a software application for use with mammography systems to calculate percent breast density and provide breast density group information. It explicitly states it is not a diagnostic aid.
Therefore, ClariSIGMAM falls under the category of medical image analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
Product codes
QIH
Device Description
ClariSIGMAM software is a standalone software application that automatically analyzes "for presentation" 2D digital mammograms to assess breast tissue composition.
The software assesses the breast density of women and generates a breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense) in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scale.
Output of breast density by ClariSIGMAM is designed to display on a mammography workstation or PACS as DICOM mammography structured report or secondary capture. The reports are configured to provide the following data:
- Breast area (cm²) for each breast
- Fibroglandular tissue area (cm²) for each breast
- Percent breast density for each breast
- Breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
full field digital mammography systems
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interpreting Physicians, Radiologists and Specialists
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
A reference standard dataset for BI-RADS breast density category was established by a consensus visual assessment of expert readers according to BI-RADS 5th Edition. ClariSIGMAM results were compared to a consensus assessment from four expert readers' independent assessments of breast density category on a dataset that spanned all compatible FFDM systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing:
- ClariSIGMAM-generated breast density estimates on substantial data sets were compared with Gold Standard breast density estimates which were established by generating breast density measurements using an interactive thresholding software (Cumulus, Sunnybrook Health Sciences Centre, Toronto, ON, Canada) by expert radiologist.
- Reproducibility for what is known to decrease breast density with age was evaluated by running ClariSIGMAM on a substantial data set.
- Breast density estimates with ClariSIGMAM were made on a paired set of mammograms with a maximum imaging period of a one year apart in order to assess if ClariSIGMAMgenerated breast density estimates were reproducible over time.
- ClariSIGMAM was run over substantial data sets and the breast density estimates for left and right breasts were compared to confirm that the results are similar for each view.
- Comparison of breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) between experts' visual assessment and automated assessment with ClariSIGMAM was assessed on reference standard dataset for BI-RADS breast density category that was established by a consensus visual assessment of expert readers according to BI-RADS 5th Edition.
- ClariSIGMAM results were compared to a consensus assessment from four expert readers' independent assessments of breast density category on a dataset that spanned all compatible FFDM systems.
Key results from binary breast density task (BI-RADS A+B as fatty vs. BI-RADS C+D as dense):
- n=837
- Kappa 0.734 [0.688, 0.781]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
- For Fatty (ClariSIGMAM vs. Readers' consensus): 86.6% (293/338)
- For Dense (ClariSIGMAM vs. Readers' consensus): 87.3% (436/499)
Predicate Device(s)
Reference Device(s)
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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ClariPi Inc. % Harry Park President ClariPi Detroit Office 1645 Park Creek Ct. Rochester Hills DETROIT MI 48309
September 10, 2021
Re: K203785
Trade/Device Name: ClariSIGMAM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: August 9, 2021 Received: August 9, 2021
Dear Harry Park:
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 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-reporting
1
combination-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 medical devices and radiation-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.
Jessica Lamb
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
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Indications for Use
510(k) Number (if known) K203785
Device Name ClariSIGMAM
Indications for Use (Describe)
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
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
Image /page/3/Picture/1 description: The image shows the logo for "Clariπ MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, and the pi symbol is in blue. Below the word "Clariπ" is the phrase "MEDICAL IMAGING SOLUTIONS" in a smaller, gray font.
K203785
This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c).
- l. SUBMITTER
ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu Seoul, Korea, Republic of [03088] Tel: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com
Contact person: Ms. Hyun-Sook Park, CEO Date Prepared: September 09, 2021
- II. DEVICE
Name of Device: ClariSIGMAM Common or Usual Name: Automated Radiological Image Processing Software Classification Name: Medical image management and processing (21 CFR 892.2050) Regulatory Class: II Product Code: QIH
III. PREDICATE DEVICE
This predicate has not been subject to a design-related recall. The ClariSIGMAM software device, addressed in this premarket notification, is substantially equivalent to the following commercially available software:
| Device Classification Name | System, Image processing, Radiological |
|---|---|
| 510(k) Number | K170540 |
| Device Name | DM-Density |
| Applicant | Densitas, Inc. |
| 1344 Summer Street, Suite 311.2 | |
| Halifax, CA B3h 0A8 | |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 02/13/2017 |
| Decision Date | 02/23/2018 |
| 510k Review Panel | Radiology |
Further to the predicate device, ClariPi has identified the following currently marketed devices as reference predicate device of proposed ClariSIGMAM:
| Device Classification Name | System, Image processing, Radiological |
|---|---|
| 510(k) Number | K132742 |
| Device Name | iReveal (formerly M-Vu Breast Density) |
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Image /page/4/Picture/0 description: The image shows the logo for Clariπ Medical Imaging Solutions. The word "Clari" is in black, followed by a lowercase "i" with a dot above it, also in black. To the right of the "i" is the Greek letter pi in blue. Below the word "Clariπ" are the words "MEDICAL IMAGING SOLUTIONS" in a smaller font size.
| Applicant | iCAD, Inc. (formerly VuCOMP, Inc.)
98 Spit Brook Road, Suite 100
Nashua, NH 03062 USA |
|-----------------------------|---------------------------------------------------------------------------------------------|
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/03/2013 |
| Decision Date | 12/03/2013 |
| 510k Review Panel | Radiology |
IV. DEVICE DESCRIPTION
ClariSIGMAM software is a standalone software application that automatically analyzes "for presentation" 2D digital mammograms to assess breast tissue composition.
The software assesses the breast density of women and generates a breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense) in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scale.
Output of breast density by ClariSIGMAM is designed to display on a mammography workstation or PACS as DIOCM mammography structured report or secondary capture. The reports are configured to provide the following data:
- Breast area (cm²) for each breast
- Fibroglandular tissue area (cm²) for each breast
- Percent breast density for each breast
- · Breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense)
V. INDICATIONS FOR USE
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
VI. SUBSTANTIAL EQUIVALENCE TABLE
The subject device (ClariSIGMAM) is substantially equivalent to the predicate devices (K170540, DM-Density) which also calculate breast density as a ratio of fibro-glandular tissue and total breast area estimates. Both devices are not to be used as diagnostic aids, but to provide adjunctive information only. Users in both cases must be qualified medical practitioners and exercise their professional judgment when formulating diagnostic decisions and selecting appropriate treatment paths that are supported by breast density data. Both devices utilize standard DICOM communications protocol to receive Digital mammograms, processes them and automatically transfers the DICOM summary report to the picture archiving and communication system (PACS).
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Image /page/5/Picture/0 description: The image shows the logo for "ClariPi MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, and the pi symbol is in a light blue color. Underneath the logo is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, lighter font.
The difference lies in image source modalities and breast density category. The subject device is compatible and validated to certain Hologic and GE digital mammography systems whereas the predicate device (K170540) is compatible with Hologic Selenia Dimensions and Hologic Lorad Selenia the reference device (K132742) is compatible with all digital radiography (DR) systems and computer radiography (CR) systems. The predicate device reports four BI-RADS categories as the output of the device whereas the subject device reports dense (BI-RADS C+D) versus fatty (BI-RADS A+B). It has no effect on the safety or efficacy of the subject device and does not raise any potential safety risks, and the subject device is identical in performance to the legally marketed device.
| Item | Subject Device -
ClariSIGMAM | Predicate Device-
DM-Density
(K170540) | Reference Device -
M-Vu Breast Density
(K132742) |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use /
Indication
for Use | ClariSIGMAM is a
software application
intended for use with
compatible full field
digital mammography
systems.
ClariSIGMAM
calculates percent
breast density defined
as the ratio of
fibroglandular tissue to
total breast area
estimates and
provides breast
density group
information (BI-RADS
A+B as fatty and BI-
RADS C+D as dense)
to aid radiologists in
the assessment of
breast tissue
composition.
ClariSIGMAM
produces adjunctive
information. It is not a
diagnostic aid. | DM-Density is a
software application
intended for use with
compatible full field
digital mammography
systems. DM-Density
calculates percent
breast density defined
as the ratio of
fibroglandular tissue to
total breast area
estimates. DM-Density
provides these
numerical values for
each breast as well as
a density category to
aid interpreting
physicians in the
assessment of breast
tissue composition.
DM-Density produces
adjunctive information.
It is not a diagnostic
aid. | M-Vu Breast Density is
a software application
intended for use with
digital mammography
systems. M-Vu Breast
Density calculates
breast density as a
ratio of fibroglandular
tissue and total breast
area estimates. M-Vu
Breast Density
provides these
numerical values for
each breast as well as
a density category to
aid radiologists in the
assessment of breast
tissue composition. M-
Vu Breast Density
produces adjunctive
information, It is not an
interpretive or
diagnostic aid. |
| Intended
User | Interpreting
Physicians,
Radiologists and
Specialists | Interpreting Physicians | Interpreting Physicians |
| Image
Source
Modalities | GE Senograph 2000D
GE Senograph DS
GE Senographe
Pristina
Hologic Selenia
Dimensions
Hologic Lorad Selenia | Hologic Selenia
Dimensions
Hologic Lorad Selenia | All digital radiography
(DR) systems and
computed radiography
(CR) systems |
| Image | DICOM digital | DICOM full field digital | DICOM digital |
| Item | Subject Device –
ClariSIGMAM | Predicate Device–
DM-Density
(K170540) | Reference Device –
M-Vu Breast Density
(K132742) |
| Format | mammography imager
– For Presentation;
RCC, LCC, RMLO,
LMLO | mammography imager
– For Presentation;
RCC, LCC, RMLO,
LMLO | mammography imager
– For Processing;
RCC, LCC, RMLO,
LMLO |
| Output
Data | For each breast:
• Area of fibroglandular
tissue ( $cm^2$ )
• Area of breast ( $cm^2$ )
• Area-based breast
density (%)
For each patient:
• Breast density group
information for the
patient (BI-RADS
A+B as fatty and BI-
RADS C+D as
dense) | BI-RADS 4th Ed.
For each breast:
• Area of fibroglandular
tissue ( $cm^2$ )
• Area of breast ( $cm^2$ )
• Area-based breast
density (%)
For each patient: DM-
Density breast density
grade and percent
breast density
BI-RADS 5th Ed.
For each patient: DM-
Density breast density
grade | For each breast:
• Area of fibroglandular
tissue ( $cm^2$ )
• Area of breast ( $cm^2$ )
• Area-based breast
density (%)
For each patient:
VuCOMP density
grade/BIRADS breast
density |
The following information compares the predicate devices and the subject device.
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Image /page/6/Picture/0 description: The image shows the logo for "Clariπ MEDICAL IMAGING SOLUTIONS". The word "Clari" is in black, and the pi symbol is in blue. The words "MEDICAL IMAGING SOLUTIONS" are in a smaller font size and are located below the word "Clari".
VII. PERFORMANCE DATA
Non-clinical performance testing has been performed on ClariSIGMAM, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- . ISO 14971 Medical devices - Application of risk management to medical devices
- NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM) ●
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
- Design Considerations and Pre-market Submission Recommendations for Interoperable ● Medical Devices issued September 6, 2017.
- . The subject device, was tested in accordance with the internal Verification and Validation processes of ClariPi Inc. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results. Validation testing included:
- ClariSIGMAM-generated breast density estimates on substantial data sets were compared with Gold Standard breast density estimates which were established by generating breast density measurements using an interactive thresholding software (Cumulus, Sunnybrook Health Sciences Centre, Toronto, ON, Canada) by expert radiologist.
- Reproducibility for what is known to decrease breast density with age was evaluated by running ClariSIGMAM on a substantial data set.
- Breast density estimates with ClariSIGMAM were made on a paired set of mammograms with a maximum imaging period of a one year apart in order to assess if ClariSIGMAMgenerated breast density estimates were reproducible over time.
- ClariSIGMAM was run over substantial data sets and the breast density estimates for left and right breasts were compared to confirm that the results are similar for each view.
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Image /page/7/Picture/0 description: The image shows the logo for ClariPi Medical Imaging Solutions. The word "Clari" is in bold black font, followed by a stylized blue pi symbol. Below the word "ClariPi" is the text "MEDICAL IMAGING SOLUTIONS" in a smaller, lighter font.
-
Comparison of breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) between experts' visual assessment and automated assessment with ClariSIGMAM was assessed on reference standard dataset for BI-RADS breast density category that was established by a consensus visual assessment of expert readers according to BI-RADS 5th Edition.
ClariSIGMAM results were compared to a consensus assessment from four expert readers' independent assessments of breast density category on a dataset that spanned all compatible FFDM systems. The results for the binary density task using are summarized below: -
· Confusion matrix for ClariSIGMAM and the reference standard on binary breast density task (BI-RADS A+B as fatty vs. BI-RADS C+D as dense).
| Readers' consensus | ||||
|---|---|---|---|---|
| Fatty | Dense | Accuracy | ||
| ClariSIGMAM | Fatty | 293 | 63 | 86.6% |
| Dense | 45 | 436 | 87.3% | |
| Total | 338 | 499 |
n=837; Kappa 0.734 [0.688, 0.781]
The test results in this 510(k), demonstrate that ClariSIGMAM:
- . complies with the aforementioned international and FDA-recognized consensus standards and
- . FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use. ●
Therefore, ClariSIGMAM, is substantially equivalent to the currently marketed predicate devices, in terms of safety and effectiveness.
Clinical Testing:
ClariSIGMAM does not require clinical studies to demonstrate substantial equivalence to the predicate devices.
VIII CONCLUSIONS
Verification and Validation activities required to establish safety and effectiveness of ClariSIGMAM, were performed. Testing involved system level tests, performance tests, and safety tests from risk analysis. These tests demonstrated the subject device meets pre-defined functionality requirements.
The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Test results with the substantial datasets demonstrate that the subject device is as safe and effective as the predicate devices. Therefore the subject device is substantially equivalent to the predicate devices.