(119 days)
Not Found
No
The document mentions image processing and display of CAD data, but there is no explicit mention of AI, ML, or related terms like DNN. The description focuses on image review, manipulation, and workflow features.
No
The device is described as a software for diagnostic review in breast imaging, focused on image manipulation and analysis, supporting healthcare professionals in diagnostic workflows. It does not exert any direct therapeutic action on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "SenoIris is designed for diagnostic review in diagnostic and screening breast imaging environments." It also mentions "image review, manipulation, analysis" and "integrated in-image reporting" for healthcare professionals, all of which are characteristic of diagnostic devices.
Yes
The device description explicitly states "It is a software product." and the intended use and device description focus solely on software functionalities for image review, manipulation, and workflow management. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic) in the broader sense of a medical device used for diagnosis, but it is not a traditional IVD that analyzes biological samples.
Here's why:
- Intended Use: The intended use clearly states "designed for diagnostic review in diagnostic and screening breast imaging environments" and "provides image review, manipulation, analysis, Post-Processing and printing capabilities". This indicates its purpose is to aid in the diagnostic process.
- Device Description: It is described as a "medical image review workstation software for diagnostic and screening mammography." This further reinforces its role in diagnosis.
- Input Imaging Modality: It processes medical images (FFDM, DBT, CESM, CAD, breast density assessments), which are used to make diagnoses.
- Intended User: It is intended for "women's healthcare professionals," who are involved in diagnosing and treating patients.
However, it's important to distinguish this from the typical definition of an IVD:
- Traditional IVDs: Traditionally, IVDs are devices that analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device does not do that.
In the context of medical device regulation (like in the US with the FDA), devices that process medical images for diagnostic purposes are considered medical devices and are subject to regulatory oversight, often under the umbrella of diagnostic imaging devices. While they might not be classified as "IVD" in the same category as a blood analyzer, they serve a diagnostic function.
Therefore, while not a traditional IVD analyzing biological samples, SenoIris is a medical device used for diagnostic purposes and would be regulated as such. The fact that it has a predicate device (MammoWorkstation) with a K number (K143361) further supports its classification as a regulated medical device.
In summary:
- Is it used for diagnosis? Yes.
- Does it analyze biological samples? No.
- Is it a regulated medical device? Yes, based on the information provided and the presence of a predicate device.
So, while not fitting the narrow definition of an IVD that analyzes biological samples, it functions as a diagnostic tool within the medical imaging workflow and is a regulated medical device.
N/A
Intended Use / Indications for Use
SenoIris is designed for diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images.
It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various modalities.
Image routing and compression, as well as centralized workflow steering. including double blind reading and integrated in-image reporting, are part of the solution to support the women's healthcare professionals to enrich existing workflows for breast imaging needs.
Various specific and general interfaces exist to synchronize to other external software on the front- and back-end side. The software also provides functions to directly import data from and export them to mobile storage media or onto the local operating system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The SenoIris is a medical image review workstation software for diagnostic and screening mammography.
SenoIris has the capability to review Digital Breast Tomosynthesis (DBT) images that are compatible with Breast Tomosynthesis Image Storage.
It is a software product
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
FFDM, DBT, and CESM images.
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, technologist's workplace, women's healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Clinical Tests:
A clinical reader study has been performed and has shown that the image quality of V-Preview of SenoIris is either better or equivalent to the image quality of V-Preview of the predicate device MammoWorkstation.
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.
MammoWorkstation (K143361)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
GE Healthcare (Image Diagnost International) % Mr. Mounir Zaouali Regulatory Affairs Leader Oskar-Schlemmer-Str. 11 Munich D-80807 GERMANY
Re: K160937
Trade/Device Name: SenoIris Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 23, 2016 Received: June 27, 2016
Dear Mr. Zaouali:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oaks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160937
Device Name SenoIris
Indications for Use (Describe)
Senolris is designed for diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images.
It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various modalities.
Image routing and compression, as well as centralized workflow steering. including double blind reading and integrated in-image reporting, are part of the solution to support the women's healthcare professionals to enrich existing workflows for breast imaging needs.
Various specific and general interfaces exist to synchronize to other external software on the front- and back-end side. The software also provides functions to directly import data from and export them to mobile storage media or onto the local operating system.
Contraindications
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless cleared for use in digital mammography.
Review monitors used for primary diagnostic interpretation of mammographic images must be cleared for use in digital mammography.
All images sent to or imported in the SenoIris must fulfill the regulatory requirements. Image quality must conform with applicable quality guidelines.
For Diagnose Mode, all modalities must be certified for soft-copy reading
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with the letters 'GE' in a stylized, cursive font at the center. The logo is colored in a light blue hue. The 'GE' letters are surrounded by a circular border that is adorned with wave-like or flame-like designs, also in the same light blue color.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 1, 2016 |
|---|---|
| Submitter: | GE Healthcare (Image Diagnost International) |
| Oskar-Schlemmer-Str. 11; | |
| 80807 München, Germany | |
| Primary Contact Person: | Mounir Zaouali, |
| Regulatory Affairs Leader | |
| GE Healthcare, | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC – FRANCE | |
| Phone : + 33 1 30 70 45 39 | |
| Fax : + 33 1 30 70 41 40 | |
| Email : Mounir.Zaouali@ge.com | |
| Secondary Contact Person: | Diane Uriell |
| Director of Regulatory Affairs, XR and Women's Health | |
| GE Healthcare, | |
| Atlanta | |
| Phone +1 262 290 8212 | |
| Email:Diane.Uriell@ge.com . | |
| Device Trade Name: | SenoIris |
| Common/Usual Name: | Medical imaging software |
| Classification Names: | Picture archiving and communication system |
| Class II CFR 892.2050 System, Image Processing, Radiological, | |
| Product Code: | LLZ |
| Predicate Device(s): | MammoWorkstation (K143361) |
| Device Description: | The SenoIris is a medical image review workstation software |
| for diagnostic and screening mammography. |
SenoIris has the capability to review Digital Breast Tomosynthesis
(DBT) images that are compatible with Breast Tomosynthesis
Image Storage.
It is a software product |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has decorative, swirling elements around its perimeter, giving it a distinctive and recognizable appearance.
GE Healthcare
| GE Healthcare | |
|---|---|
| 510(k) Premarket Notification Submission | |
| Intended Use: | SenoIris is designed for diagnostic and non- diagnostic review |
| in diagnostic and screening breast imaging environments | |
| through flexible and interactive manipulation of multi-modality, | |
| multi-vendor softcopy images. | |
| It provides image review, manipulation, analysis, Post- | |
| Processing and printing capabilities for FFDM, DBT, and | |
| CESM images. The software also supports the display of CAD, | |
| breast density assessments and other breast imaging data from | |
| various modalities. | |
| Image routing and compression, as well as centralized workflow | |
| steering, including double blind reading and integrated in-image | |
| reporting, are part of the solution to support the women's | |
| healthcare professionals to enrich existing workflows for breast | |
| imaging needs. | |
| Various specific and general interfaces exist to synchronize to | |
| other external software on the front- and back-end side. The | |
| software also provides functions to directly import data from | |
| and export them to mobile storage media or onto the local | |
| operating system. | |
| Contraindications | |
| Lossy compressed mammographic images must not be used for | |
| primary diagnostic interpretation unless cleared for use in | |
| digital mammography. | |
| Review monitors used for primary diagnostic interpretation of | |
| mammographic images must be cleared for use in digital | |
| mammography. | |
| All images sent to or imported in the SenoIris must fulfill the | |
| regulatory requirements. Image quality must conform with | |
| applicable quality guidelines. | |
| For Diagnose Mode, all modalities must be certified for soft- | |
| copy reading | |
| Technology: | SenoIris is a software product. It is designed to run on a |
| standard workstation with a minimum of three monitors, one | |
| control monitor and high-resolution monitor (s) that are cleared | |
| for mammography review. | |
| It runs on Windows Operating System. | |
| Comparison Of | The following is an overview of the differences between the |
| Technological | proposed SenoIris and the predicate MammoWorkstation. Refer |
| 510(k) Premarket Notification Submission | |
| Characteristics With The | |
| Predicate Device: | to the Comparison Matrix in Section 12.1 for additional |
| information regarding the changes. | |
| SenoIris Configurations | |
| As with the predicate device, SenoIris has 3 configurations or | |
| modes, The primary difference between the predicate device is | |
| that the naming convention and combining of modes into one | |
| mode to yield the Connect Mode. | |
| 1. The Diagnose Mode is designed to assist radiologists in | |
| conducting primary diagnostic interpretation for diagnostic | |
| and screening mammography through flexible and | |
| interactive manipulation of multimodality softcopy images. | |
| This mode has the same functionalities as the currently | |
| marketed MammoWorkstation | |
| 2. The Review Mode has been designed as the | |
| technologist's workplace for the management of clinical | |
| data and image display. The Review Mode provides easy | |
| access to prior images and reports. This mode has the same | |
| functionalities as the currently marketed | |
| MammoDocumentationStation. | |
| 3. The Connect Mode enables the SenoIris to send DICOM | |
| documents to external systems by telemammography. | |
| Furthermore it provides Central User Management, which | |
| allows organizing complex, multi-site processes like user- | |
| related worklists and automated double reading, particularly | |
| for screening. This mode combines the functionalities of the | |
| currently marketed Collaboration Server and DicomShuttle. | |
| DBT Review – 2D Synthesized Image | |
| SenoIris was designed to provide several additional tools for the | |
| review of DBT images and mainly to the synthetized 2D image | |
| that is called “V-Preview”. Modifications include image quality | |
| improvement, V-Preview Navigate and V-Preview Inspect. | |
| During GE DBT acquisition, 9 projections are performed by | |
| angulating the X-rays tube around the central projection (when the | |
| main X-ray beam is perpendicular to the detector). The V-Preview | |
| image is reconstructed from this central projection by | |
| incorporating other information from the other projections. | |
| V-Preview is an additional image for navigation use only and does | |
| not replace FFDM image. | |
| GE Healthcare | |
| 510(k) Premarket Notification Submission | |
| Image Quality Improvement | |
| SenoIris improves the image quality of V-Preview image by the | |
| implementation of a modified generation algorithm by lowering | |
| the artefacts and the noise of the image. | |
| V-Preview Navigate (with V-Preview Inspect V-Preview | |
| Bookmark) | |
| SenoIris adds V-Preview Navigate that uses a cross reference | |
| mechanism between every point of the V-Preview image to the | |
| associated DBT planes or slabs and position within those planes or | |
| slabs. So when the user indicates a location in a V-Preview image | |
| in one display monitor by clicking on it, the DBT plane or slab | |
| containing this structure will be directly displayed in the other | |
| second display monitor. | |
| When combined with V-Preview Inspect, the corresponding | |
| portion of slab or plane will be displayed in a pop-up small | |
| window on the V-Preview image itself. Also, when the V-Preview | |
| Bookmark feature is enabled, for every annotations made on any | |
| DBT slab or plane a navigation pointer will show on the | |
| corresponding area of the V-Preview image. | |
| Cybersecurity: | |
| The security of SenoIris is also improved from the predicate to be | |
| aligned to the recent FDA cybersecurity requirements enforcement | |
| through several guidance's (e.g. FDA Guidance, Content of | |
| Premarket Submissions for Management of Cybersecurity in | |
| Medical Devices, October 2, 2014). | |
| Usability: | |
| Other modifications are related to the improvement of the usability | |
| of the software with a redesigned user interface with a simpler | |
| look. Certain functions and preferences are bound to the user log- | |
| in. The software stores and remembers several settings from the | |
| last session of the user, for example the hanging protocols and | |
| tools bar position, | |
| SenoIris provides several images printing improvement including. | |
| the option for configuring multiple DICOM printers and several | |
| printing preferences. | |
| Accessories | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The SenoIris and its applications comply with voluntary | |
| standards as detailed in Section 9, 11 and 17 of this premarket | |
| submission. The following quality assurance measures were | |
| applied to the development of the system: | |
| • Risk Analysis | |
| • Requirements Reviews | |
| • Design Reviews | |
| • Testing on unit level (Module verification) | |
| • Integration testing (System verification) | |
| • Performance testing (Verification) | |
| • Safety testing (Verification) |
Summary of Clinical Tests:
A clinical reader study has been performed and has shown that
the image quality of V-Preview of SenoIris is either better or
equivalent to the image quality of V-Preview of the predicate
device MammoWorkstation. |
| Conclusion: | GE Healthcare considers the SenoIris to be as safe, as
effective, and performance is substantially equivalent to the
predicate device. |
| | Dedicated keypads are accessories to the SenoIris. The keypads
operate like standard keyboard and mouse and emit shortcuts
similar to that of the standard keyboard or mouse wheel. There is
also some flexibility of the configuration of the buttons of the
keypads that can be done by the end user and described within the
operator manual. |
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters and the circle's outline are in a lighter shade of blue, creating a contrast with the darker blue background of the circle.
GE Healthcare
fication Submission
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has a white border with decorative swirls, giving it a classic and recognizable appearance.
GE Healthcare
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Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The blue color is a vibrant and eye-catching shade.
GE Healthcare 510(k) Premarket Notification Submission