MAMMOWORKSTATION

K123575 · Image Diagnost International GmbH · LLZ · Feb 19, 2013 · Radiology

Device Facts

• Record ID: K123575
• Device Name: MAMMOWORKSTATION
• Applicant: Image Diagnost International GmbH
• Product Code: LLZ · Radiology
• Decision Date: Feb 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Mammo Workstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images. It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. Mammo Workstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates. Mammo Workstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital. Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography. All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.

Device Story

MammoWorkstation is a medical image review software for diagnostic and screening mammography; enables primary diagnostic review of multi-modality softcopy images, including Digital Breast Tomosynthesis (DBT). Software operates on standard workstations equipped with at least three monitors (one control, high-resolution diagnostic monitors). Radiologists use the workstation to access, display, manipulate, analyze, and post-process images and CAD results retrieved from storage devices via DICOM interfaces. Supports structured reporting per DICOM breast imaging templates; facilitates teleradiology and teleconferencing. Output allows radiologists to perform clinical assessments and diagnostic interpretations. Benefits include improved access to images and structured reports across hospital locations.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including risk analysis, requirements reviews, design reviews, unit-level module verification, system-level integration testing, performance testing, safety testing, and simulated use validation.

Technological Characteristics

Software-only medical device; runs on Windows OS. Requires standard workstation hardware with minimum three-monitor configuration (including high-resolution monitors cleared for mammography). Connectivity via DICOM or similar standards for image storage and retrieval. Supports DICOM breast imaging report templates.

Indications for Use

Indicated for radiologists performing primary diagnostic review of diagnostic and screening mammography images. Supports multi-modality softcopy image review, analysis, and reporting. Contraindicated for primary diagnostic interpretation using lossy compressed mammographic images unless specifically approved for digital mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Mammo Workstation (version 3.3.2) K081630
• Hologic SecurView DX K103385

Submission Summary (Full Text)

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K.123575

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. There are decorative swirls or flourishes around the outer edge of the circle, adding a touch of elegance to the design. The logo is presented in black and white.

GE Healthcare

510(k) Premarket Notification Submission

FEB 1 9 2013

# Section 5: 510(k) Summary

MammoWorkstation

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are three small, decorative swirls or flourishes placed around the outer edge of the circle, evenly spaced. The logo is black and white.

# 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: | 13 November 2012 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, (Image Diagnost International GmbH)<br>Oskar-Schlemmer-Str. 11;<br>80807 München, Germany |
| Primary Contact Person: | Mounir Zaouali, RAC<br>Regulatory Affairs Leader<br>GE Healthcare, (GE Medical Systems, SCS)<br>283 RUE DE LA MINIERE<br>78530 BUC - FRANCE<br>Phone: + 33 1 30 70 45 39<br>Fax: + 33 1 30 70 41 40<br>[e-mail] |
| Secondary Contact<br>Person: | Steven Kachelmeyer, RAC<br>Regulatory Affairs Director - X-ray<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade Name: | Mammo Workstation |
| Common/Usual Name: | Medical imaging software |
| Classification Names: | Picture archiving and communication system<br>Class II CFR 892.2050 System, Image Processing,<br>Radiological, |
| Product Code: | LLZ |
| Predicate Device(s): | Mammo Workstation (version 3.3.2) K081630<br>Hologic SecurView DX K103385 |

5-2

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# GE Healthcare

510(k) Premarket Notification Submission

| Device Description: | The Mammo Workstation is a medical image review<br>workstation software for diagnostic and screening<br>mammography.<br><br>Mammoworkstation has the capability to review Digital<br>Breast Tomosynthesis (DBT) images that are compatible<br>with DICOM Breast Tomosynthesis Image Storage.<br><br>It is a software product. |
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| Intended Use: | Mammo Workstation is designed to assist radiologists<br>in conducting primary diagnostic review for diagnostic<br>and screening mammography through flexible and<br>interactive manipulation of multi-modality softcopy<br>images.<br><br>It provides image review, manipulation, analysis, post-<br>processing and printing capabilities that support image<br>management display needs in the medical environment.<br><br>Mammo Workstation is designed to give easy and<br>economic access to and display of multi-modality<br>softcopy images, structured reports, and CAD results<br>through interfaces to various image storage devices<br>using DICOM or similar interface standards. It<br>supports creation of structured reports according to the<br>DICOM breast imaging report templates.<br><br>Mammo Workstation supports teleradiology and<br>teleconferencing providing access to multi-modality<br>softcopy images and structured reports in multiple<br>locations within and outside the hospital.<br><br>Lossy compressed mammographic images must not be<br>used for primary diagnostic interpretation unless<br>approved for use in digital mammography.<br><br>Display monitors used for primary diagnostic<br>interpretation of mammographic images must be<br>approved for use in digital mammography." |

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes at four points around the circle, giving it a distinctive and recognizable appearance. The logo is in black and white.

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| | All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading. |
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| Technology: | MammoWorkstation is 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. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The Mammo Workstation 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:<br>Risk Analysis<br>Requirements Reviews<br>Design Reviews<br>Testing on unit level (Module verification)<br>Integration testing (System verification)<br>Performance testing (Verification)<br>Safety testing (Verification)<br>Simulated use testing (Validation)<br>Summary of Clinical Tests:<br>The subject of this premarket submission, MammoWorkstation, did not require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the Mammo Workstation to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |

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5-4

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### February 19, 2013

Image Diagnost International GmbH c/o Mounir Zaouali GE Healthcare, (GE Medical Systems, SCS) 283 RUE DE LA MINIERE BUC FRANCE 78530

Re: K123575

Trade/Device Name: MammoWorkstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 15, 2012 Received: November 20, 2012

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

FDA

for

Janine M. Morris 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 Form

510(k) Number (if known): K123575

Device Name: Mammo Workstation

Indications For Use:

MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images.

It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment.

Mammo Workstation is designed to give easy and economic access to and display of multimodality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates.

Mammo Workstation supports teleradiology and teleconferencing providing access to multimodality softcopy images and structured reports in multiple locations within and outside the hospital.

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography.

Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.

| Prescription Use_X____________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------|
| (Part 21 CFR 801 Subpart D) | | (Part 21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of (CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Sin Vis Jan 2

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123575

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