(20 days)
Not Found
No
The description explicitly states that the region of interest is not automatically generated by the computer, and the quantification and markup are manually performed by the radiologist. There are no mentions of AI, ML, or related terms, nor any descriptions of training or test sets typically associated with AI/ML development.
No.
The device is a workstation for displaying and manipulating diagnostic breast images for radiologists to interpret, and does not provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists." Interpretation of medical images for diagnostic purposes is a core function of a diagnostic device. Furthermore, the "Device Description" explicitly calls it "a diagnostic breast imaging workstation."
Yes
The device description explicitly states "The WorkstationOne™ is a software system that can be installed on an off-the-shelf general-purpose computer". While it requires specific monitors and optionally a keypad/touchpad, these are described as components it interfaces with or is installed upon, not integral parts of the device itself as a medical device. The core functionality and the device being cleared is the software.
Based on the provided information, the WorkstationOne™ Breast Imaging Workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The WorkstationOne™ is used to display and manipulate medical images (X-ray mammography, breast US, breast MRI) acquired from the patient's body, not to analyze biological samples.
- The intended use is for softcopy reading and interpretation of digital mammography images by Radiologists. This is a diagnostic imaging workflow, not an in vitro diagnostic test.
- The device description focuses on image display, manipulation, and workflow integration. These are functions related to medical imaging interpretation, not laboratory testing.
- The listed product code (21 CFR 892.2050 Product Code LLZ) is for "System, Image Processing, Radiological". This classification clearly places the device within the realm of medical imaging, not in vitro diagnostics.
In summary, the WorkstationOne™ is a medical imaging workstation used for the interpretation of breast images, which is distinct from the function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
Product codes
LLZ
Device Description
The WorkstationOne™ is a diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation also supports media exchange and film printing. Optionally, the workstation can interface with a reporting system to generate an interpretation report.
The enterprise workflow of the workstation follows IHE integration profiles, specifically, MAMMO (Mammography Image Profile) and RWP (Reporting Workflow Profile). The workstation can be configured to use mammographic specific hanging protocol and reading workflow. The workstation obtains the source images and CAD reports either as the recipient of the push of that data, or by querying and retrieving them from a PACS archive. In both models, DICOM is used. The images can only be the lossless compressed or non-compressed DICOM images.
The WorkstationOne™ is a software system that can be installed on an off-the-shelf general-purpose computer with one or two aray-scale high-resolution monitors and one color monitor. The high-resolution monitors are used to display digital mammography images and associated overlays for the purpose of primary interpretation by radiologists. The color monitor is used for selecting studies, displaying color images, navigating workflow, and other user interface elements. Optionally, a dedicated keypad or touchpad is included for ergonomic reasons.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray mammography MG, breast US and breast MRI.
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists
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)
The potential hazards have been studied and controlled by a Risk Management Plan. The software testing procedure has been developed. The procedure with pass/fail criteria has been run to ensure that the product meets all the specified requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/1 description: The image is mostly black with some white markings. In the upper portion of the image, there are some white markings that appear to be text or symbols. The white markings are small and difficult to read. The rest of the image is mostly black, with a few small white dots scattered throughout.
Three Palm Software, LLC
5. 510(k) Summary (as required by section 807.92(c))
5.1. 510(k) Submitter
510(k) owner's name: Three Palm Software, LLC Address: 367 Penn Way, Los Gatos, CA 95032 USA Phone: 408-356-3240 Name of contact person: Heidi Daoxian Zhang Date the summary was prepared: November 19, 2007
DEC 1 1 2007
5.2. Device Name
Trade name: WorkstationOne™ Breast Imaging Workstation
Common name: Picture archiving and communications system
Classification name: System, Image Processing, Radiological (21 CFR 892.2050 Product Code LLZ)
5.3. Predicate Devices
WorkstationOne™ Breast Imaging Workstation is substantially equivalent to the devices listed below:
| Trade Name | Manufacturer | 510(k) Number |
|---|---|---|
| Seno Advantage | General Electric Medical | |
| Systems | K033400 | |
| Cedara | ||
| I-ReadMammo | Cedara Software Corp. | K040468 |
| Secta Workstation | Sectra Imtec AB | K063093 |
5.4. Device Description
The WorkstationOne™ is a diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation also supports media exchange and film printing. Optionally, the workstation can interface with a reporting system to generate an interpretation report.
The enterprise workflow of the workstation follows IHE integration profiles, specifically, MAMMO (Mammography Image Profile) and RWP (Reporting Workflow Profile). The workstation can be configured to use mammographic specific hanging protocol and reading workflow. The workstation obtains the source images and CAD reports either as the recipient of the push of that data, or by querying and retrieving them from a PACS archive. In both models, DICOM is used. The images can only be the lossless compressed or non-compressed DICOM images.
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Image /page/1/Picture/0 description: The image is a black and white photograph. The image is mostly black, with some white speckles scattered throughout. The white speckles are concentrated in the center and on the right side of the image.
Three Palm Software, LLC
The WorkstationOne™ is a software system that can be installed on an off-the-shelf general-purpose computer with one or two aray-scale high-resolution monitors and one color monitor. The high-resolution monitors are used to display digital mammography images and associated overlays for the purpose of primary interpretation by radiologists. The color monitor is used for selecting studies, displaying color images, navigating workflow, and other user interface elements. Optionally, a dedicated keypad or touchpad is included for ergonomic reasons.
5.5. Indications for Use
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
5.6. Technological Characteristics Comparison
WorkstationOne™ Breast Imaging Workstation has the similar technological characteristics to the equivalent devices as all support radiology workflow integration, obtaining, displaying, and manipulating of MG, US or MR images. Both the WorkstationOne™ Breast Imaging Workstation and the Sectra Workstation allow displaying of CAD reports.
5.7. Non-clinical Test
The potential hazards have been studied and controlled by a Risk Management Plan. The software testing procedure has been developed. The procedure with pass/fail criteria has been run to ensure that the product meets all the specified requirements.
5.8. Conclusions
The materials provided in this 510(k) submission have demonstrated the device is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized graphic of three wavy lines, which are meant to represent the flow of people and services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2007
Ms. Heidi Daoxian Zhang Vice President, Clinical Affairs Three Palm Software, LLC 367 Penn Way LOS GATOS CA 95032
Re: K073272
Trade/Device Name: WorkstationOne™ Breast Imaging Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 19, 2007 Received: November 21, 2007
Dear Ms. Zhang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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
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4. Indications for Use Statement
510(k) Number (if known): K073272
Device Name: WorkstationOne™ Breast Imaging Workstation
Indications for Use:
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
Prescription Use マ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CER 801 Subnart C (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hontmkhang
(Division Division of Reproductive, Abdominal an Page 6 of 48 Radiological Devices 510(k) Number _