(52 days)
Not Found
Yes
The device description explicitly mentions the use of "multivariate pattern recognition methods" for tissue segmentation and classification, which is a common technique used in machine learning for image analysis.
No
The device is a computer-aided detection (CAD) software that assists radiologists in analyzing breast ultrasound images for screening and diagnosis. It provides information and analysis but does not directly cure, mitigate, treat, or prevent disease. Patient management decisions should not be made solely on its results.
Yes
The text explicitly states in the "Intended Use / Indications for Use" section that "When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis." It also notes its assistance to radiologists in analyzing breast ultrasound images, which is a diagnostic activity.
Yes
The device is explicitly described as a "computer-aided detection (CAD) software application" and its function is to analyze existing breast ultrasound images. It does not include any hardware components for image acquisition or display, relying on external DICOM-compliant devices and standard PCs.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: B-CAD analyzes breast ultrasound images, which are generated by a medical imaging device (ultrasound machine). It does not process or analyze biological samples.
- The intended use is image analysis: The intended use clearly states that B-CAD is designed to assist radiologists in analyzing breast ultrasound images.
Therefore, B-CAD falls under the category of medical image analysis software, not In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI).
The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis process. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR-BI-RADS® Ultrasound Lexicon Classification Form.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
B-CAD is a computer-aided detection (CAD) software application, designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The device uses multivariate pattern recognition methods to perform tissue segmentation and classification of images.
For breast ultrasound, these pattern recognition methods are used by a radiologist to analyze such features as shape and orientation [refer to American College of Radiology's (ACR) Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas and ACR-BI-RADS® Ultrasound lexicon].
The software application consists of proprietary software developed by The Medipattern Corporation. The software is a Windows 2000/XP, DICOMcompatible platform that may be installed on a standalone PC, PACS, or embedded in software applications cleared for use in medical imaging. The B-CAD user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.
The Medipattern software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors.
To initiate B-CAD analysis and processing, images are acquired and pushed to the software application from an ultrasound imager for review and further analysis on a monitor. The user selects a ROI by clicking on a seed point and dragging the cursor to the selected boundary of the ROI. A circle appears, defining the region of interest. Once the ROI is selected, the B-CAD software initially displays a gallery of up to six segmented views on the monitor. The user may select any view for further analysis of anatomy and pathology. The software allows the user to annotate, tag, measure, and automatically record selected views. Results of the analysis are displayed on the monitor and may be selected by the user for automated reporting.
The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select inputs for the report from various pull-down menus and toggle buttons and the user may direct the B-CAD software to prepopulate various fields contained in the report. All fields may be modified by the user at any time during the analysis and prior to archiving.
B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to Breast Intaging Five with the ACR-BI-RADS® Ultrasound Lexicon Classification Form.
An output may be viewed and sent to standard film or paper printers or sent An output may or rivranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists / clinical setting
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)
Not Found
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.
K043216, K021966, K023877, K040227
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
K050846
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as Print of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.
1. Identification of Submitter:
| Submitter: | The Medipattern Corporation |
|---|---|
| Address: | 2300 Sheppard Ave W Suite 204 |
| Toronto, ON, Canada M9M 3A4 | |
| Phone: | 416-744-0009 |
| Fax: | 416-744-6899 |
| Contact: | Patricia A. Milbank |
| Title: | Regulatory Consultant |
| Phone: | 425-894-9733 |
| Fax: | 425-865-9023 |
March 31, 2005 Summary Date:
2. Identification of Product:
| Device Name: | B-CAD System, Version 1.0 |
|---|---|
| Device Common Name: | Picture and archive communications system |
| Device Classification: | 21 CFR 892.2050, Class II, LLZ (90) |
The Medipattern Corporation Manufacturer
3. Marketed Devices
The B-CAD System provides viewing and post-acquisition image analysis of user-selected regions of interest on breast ultrasound images and automatically generates reports from user inputs annotated during the image analysis process. This software medical device is substantially equivalent to the devices listed below:
| Model: | CADstream |
|---|---|
| Manufacturer: | Confirma, Inc. |
| 510(k) Number: | K043216 |
| Model: | QLAB Software |
| Manufacturer: | Phillips Ultrasound |
| 510(k) Numbers: | K021966, K023877 and K040227 |
1
4. Device Description:
B-CAD is a computer-aided detection (CAD) software application, designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The device uses multivariate pattern recognition methods to perform tissue segmentation and classification of images.
For breast ultrasound, these pattern recognition methods are used by a radiologist to analyze such features as shape and orientation [refer to American College of Radiology's (ACR) Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas and ACR-BI-RADS® Ultrasound lexicon].
The software application consists of proprietary software developed by The Medipattern Corporation. The software is a Windows 2000/XP, DICOMcompatible platform that may be installed on a standalone PC, PACS, or embedded in software applications cleared for use in medical imaging. The B-CAD user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.
The Medipattern software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors.
To initiate B-CAD analysis and processing, images are acquired and pushed to the software application from an ultrasound imager for review and further analysis on a monitor. The user selects a ROI by clicking on a seed point and dragging the cursor to the selected boundary of the ROI. A circle appears, defining the region of interest. Once the ROI is selected, the B-CAD software initially displays a gallery of up to six segmented views on the monitor. The user may select any view for further analysis of anatomy and pathology. The software allows the user to annotate, tag, measure, and automatically record selected views. Results of the analysis are displayed on the monitor and may be selected by the user for automated reporting.
The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select inputs for the report from various pull-down menus and toggle buttons and the user may direct the B-CAD software to prepopulate various fields contained in the report. All fields may be modified by the user at any time during the analysis and prior to archiving.
2
B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to Breast Intaging Five with the ACR-BI-RADS® Ultrasound Lexicon Classification Form.
An output may be viewed and sent to standard film or paper printers or sent An output may or rivranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
5. Indications for Use
B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically asoments and classifies shape and orientation characteristics of user-selected regions of interest (ROI).
The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis process. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR-BI-RADS® Ultrasound Lexicon Classification Form.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.
6. Comparison with Predicate Devices
The B-CAD System is substantially equivalent to software devices that provide display and post-acquisition image analysis of breast ultrasound images.
The image viewing capabilities of the B-CAD System are substantially equivalent to other commercially available image display products that have been cleared for use with ultrasound image files, specifically the CADstream, Version 4.0, software device manufactured by Confirma, and the QLAB software device manufactured by Phillips Ultrasound.
3
The Region of Interest quantification capabilities of the B-CAD software are substantially equivalent to other commercially available products that have been cleared for use with breast imaging studies, specifically the CADstream, Version 4.0, software device manufactured by Confirma, and the QLAB software device manufactured by Phillips Ultrasound.
The automated reporting features are substantially equivalent to other commercially available multi-modality products used for post-processing analysis, including CADstream, Version 4.0, manufactured by Confirma.
7. Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514.
8. General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the B-CAD software.
9. Software
Software development for the B-CAD System follows documented processes for software design, verification and validation testing. A risks assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product.
10. Conclusions
The B-CAD software is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on ultrasound devices. The system is designed to incorporate components common to all image viewing systems including display, post-processing analysis, archiving, and retrieval capabilities within a clinical setting.
The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The System has been shown to be substantially equivalent to the predicate devices, and no new issues of safety or effectiveness are raised.
4
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Ms. Patricia A. Milbank Regulatory Consultant The Medipattern Corporation 2300 Sheppard Ave W Suite 204 Toronto, ON, M9M 3A4 CANADA
Re: K050846 Trade/Device Name: B-CAD System, Version 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system -Regulatory Class: II Product Code: LLZ Dated: March 31, 2005 Received: April 6, 2005
Dear Ms. Milbank:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one 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 the cherobate) to regard ment 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 actives, salise requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your at 110 to subject to such additional controls. Existing major regulations affecting your Approval), It ifally of 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 I toase of advised 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 1 od in bailers and regulating, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legal This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The FDA Inding of Sacsamial or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation cinned, "thisonalians of our responsibilities under the Act from the Act from the 807.97). You may obtain other general mornation on your aspective at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication(s) for Use Statement
510(k) Number:
B-CAD System, Version 1.0 Device Name:
Indications for Use:
B-CAD is a computer-aided detection (CAD) software application designed to B-CAD Is a computer arded deterst of (essound images. B-CAD automatically assist rationogists to unary2e oreals ======================================================================================================================================== regions of interest (ROI).
The software allows the user to annotate, tag, measure, and automatically The software anows the ason to antonatically generates reports from user fecord selected vicws. The software adversions of the output may be viewed mputs annotated during the miage and your printers or sent electronically to an intranet and sent to standard film of paper printers may retrieve archived reports from a web server or other DICOM device.
B-CAD includes the option to add annotations based on the ACR-BI-RADS® B-CAD merduces the operon to in addition, the report form has been designed to Bicast Innaging Attas: In add ACR-BI-RADS® Ultrasound Lexicon Classification Form.
When interpreted by a skilled physician, this device provides information that when interpreted by a similar posis. Patient management decisions may be useful in screening and anguits of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.
Use Prescription (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leggett
(Division Sign-Off) Division of Reproductive. Ab and Radiological Devic 510(k) Number