MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)

{0}------------------------------------------------ CAD K132684 MAY 23 2014 ## 510(k) Summary of Safety and Effectiveness ## MEDWS Product Name: MEDWS (variants MEDVIEW, MEDDIAG, MEDMAMMO) Product Classification Name: Picture, Archive and Communications System Product Code: LLZ CFR Section: 892.2050 Classification Panel: Radiology device Class: II Date prepared: May 21st, 2014 ### Submitter's information (21 CFR 807.92(a)(1)): MEDECOM SARL 9 bis rue de Kerbrat 29 470 PLOUGASTEL DAOULAS FRANCE Phone: +33 298 465 248 Fax: +33 298 247 193 Email: mathieu.reinaud@medecom.fr ### Name, title and phone number of contact (21 CFR 807.92(a)(1)): Mrs Cynthia Cottereau, Consultant. TWOKSA SAS 2 bis rue des Vauzelles 16 100 CHATEAUBERNARD FRANCE Phone: +33 545 321 884 Fax: +33 963 294 139 Email: cynthia.cottereau@twoksa.com ### Predicate Device (21 CFR 807.92(a)(3)): 510k number: K103385 Regulation number: 892.2050 Device name: SecurView DX Applicant: Hologic, Inc, 35 Crosby Drive, Bedford, MA 01730, USA Classification product code: LLZ {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Medecom, a company that specializes in communicating imaging. The logo features a stylized handwritten font for the word "Medecom", with the tagline "Communicating Imaging" printed in a simple, bold font below. The logo also includes a geometric design element to the left of the company name. Device classification name: System, image processing, radiological Class: II Panel: Radiology Device ### Device Description (21 CFR 807.92(a)(4)): The MEDWS software range offers solutions for managing radiology images and reviewing them for diagnostic purposes. They are used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ). A solution from the MEDWS software range is installed on a computer connected to the imaging network. The radiology table (modality) manages image acquisition and sends images over the local network to a console from the MEDWS range. ### Intended Use (21 CFR 807.92(a)(5)): The MEDWS Software (MEDVIEW, MEDDIAG, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Lossy compressed mammographic image are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used. The MEDWS Software (MEDVIEW, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants. ### Technological Characteristics (21 CFR 807.92(a)(6)): MEDWS is a software product used to manipulated digital medical images for diagnosis purpose. The device does not contact the patient, nor does it control any life sustaining devices. MEDWS software runs under Windows XP Professional SP3 or Windows 7 operating systems for Pcs (as minimum and depending upon system configuration). The requirements on hardware are quite ordinary for a system for displaying images. MEDWS has the same main technological characteristics as its predicate device. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The "M" is a handwritten-style letter, and the rest of the letters are in a sans-serif font. There is a geometric shape to the left of the word "Medecom". The word "om" is at the end of the word. ### Non-clinical performance The subject device is designed in conformance with: - ACR/NEMA Digital Imaging Communication in Medicine (DICOM) . Version 3.1 - ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements - ISO 14971:2007 Medical devices Application of risk management to medical devices - IEC 62304:2006 Medical device software Software life-cycle . processes - IEC 62366:2007 Medical devices Application of usability . engineering to medical devices Every specification of the MEDWS software is validated by a bench test before release. Bench testing includes: - The installation of the software . - The configuration of the software - The management of the patient information - The acquisition and integration of new data . - The manipulation of the data . - The DICOM conversion . - The DICOM connectivity . - The export and distribution of data . ### Substantial Equivalence The design, fundamental technology, functionalities ,intended use and performances of the MEDWS software are similar and therefore substantially equivalent to its predicate like it is demonstrated in the table below. | | Predicate<br>Device | Subject Device | | If different, | |---------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | | | MEDVIEW<br>MEDDIAG | MED-MAMMO | impact on safety<br>or efficacy | | | Hardware requirements | | | | | Operating system | Windows XP,<br>Windows 7 | Windows XP Professional SP3 or<br>Windows 7 | | No difference | | Memory | 2.0 GB RAM | 1.0 GB RAM | 4.0 GB RAM | No impact : RAM<br>needed is different<br>in order to insure<br>same efficacy | | Processor | Dual | Pentium Core 2 | Xeon Quad Core | No impact : | | | Predicate<br>Device | Subject Device | | If different,<br>impact on safety<br>or efficacy | | | | MEDVIEW<br>MEDDIAG | MED-MAMMO | | | | Processor Intel<br>CPU with<br>clock rate of<br>2.0 GHz or<br>higher | | 3 GHz | Processor needed<br>is different in<br>order to insure<br>same efficacy | | Free disc space | Unknown | 150 Mb for the software | | No impact | | Graphic Card | Unknown | OpenGL 2.0<br>compatible<br>graphic<br>controller<br>(Chipset or<br>graphic card) | 256 Mo, OpenGL<br>3.0 compatible<br>graphic card | No impact | | Networking | Network<br>Interface Card<br>(NIC) 10/100<br>Base-T | 100 Mbps<br>TCP/IP network<br>card | 1 Gbps TCP/IP<br>network card | No impact | | Support<br>conventional<br>screen for<br>multimodality<br>image review | Yes | Yes | Yes | No difference | | Support specific<br>screen for<br>mammography<br>image review<br>cleared by FDA | Yes | No | Yes | No difference | | Support Tactile<br>screen | Unknown | No | Yes | Tactile screen<br>does not add any<br>safety risks<br>because it permits<br>better control by<br>the user.<br>There is no impact<br>on efficacy. | | Support Several<br>screens at the<br>same time | Yes | MEDVIEW : No<br>MEDDIAG : Yes | Yes | No difference<br>If needed, support<br>of several screens<br>is available in<br>MEDDIAG or<br>MEDMAMMO<br>variants | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the word "Medecom" written in a stylized font. The "M" is a large, cursive letter, while the rest of the word is in a sans-serif font with a slightly rounded appearance. There are also some geometric shapes to the left of the word, including a rectangle and a square. Communicating Imaging {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "Medecom". The logo consists of a stylized letter "M" followed by the letters "edecom" in a unique font. There are also some geometric shapes to the left of the "M". | | Predicate<br>Device | Subject Device | | If different,<br>impact on safety<br>or efficacy | |-----------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | MEDVIEW<br>MEDDIAG | MED-MAMMO | | | Support<br>conventional<br>Keyboard | | Yes | Yes | | | Support specific<br>keyboard for<br>mammography<br>image review | Yes | No | Yes | No difference | | Printing on<br>DICOM printer | Yes | Yes | Yes | No difference | | Printing on<br>standard printer | Unknown | | Yes | This functionality<br>does not add risks<br>and permit to user<br>to keep some<br>images in the<br>paper patient file.<br>There is no impact<br>on safety. | | Administration Setting | | | | | | Account user<br>administration | Yes | | Yes | No difference | | Patients list<br>administration | Yes | | Yes | No difference | | User preference<br>setting | Yes | | Yes | No difference | | User workflow<br>setting | Yes | | Yes | No difference | | DICOM Features | | | | | | Modalities<br>supported | MG, MR, US,<br>CT, SC, CR,<br>PET, DR and<br>multiframe<br>mammography<br>images | | MG, MR, US, CT, SC, CR, PET,<br>DR, ES, NM, PX, RF, XA and<br>multiframe mammography images | The subject device<br>support more<br>modalities than<br>the predicate<br>device (ES, NM,<br>PX, RF, XA).<br>This has no<br>impact on the<br>safety of the<br>device and<br>permits to the<br>device to be used<br>for more patients. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Medecom" in a stylized font. The word is written in black ink on a white background. There are some abstract shapes to the left of the word. The shapes are also in black ink. Communicating Imaging | | Predicate<br>Device | Subject Device | | If different, impact on safety or efficacy | |---------------------------------------------------|---------------------|--------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | MEDVIEW<br>MEDDIAG | MED-MAMMO | | | DICOM Objects transfer & communication | Yes | Yes | Yes | No difference | | Query / retrieve DICOM Operation | Yes | Yes | Yes | No difference | | Viewing DICOM Images | Yes | Yes | Yes | No difference | | Viewing DICOM Reports | Yes | Yes | Yes | No difference | | Send GSPS[1] or SC[2] images to other DICOM nodes | Yes | No, only SC images | | GSPC is a file which contains parameters to apply to an image. The subject device could send the SC image, that is to say the image with the parameters applied. This difference has no impact on safety or efficacy of the device. | | Exporting DICOM image | Yes | Yes | Yes | No difference | | Exporting anonymised DICOM image | Yes | Yes | Yes | No difference | | Exporting anonymised TIFF image | Yes | Yes | Yes | No difference | | Application Synchronization and Data Exchange | Yes | Yes | Yes | No difference | | Windows / Level | Yes | Yes | Yes | No difference | | Magnification Window | Yes | Yes | Yes | No difference | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The word is written in lowercase letters, with the "M" having a unique, flowing design. To the left of the word is a geometric shape composed of two rectangles stacked vertically, with the top rectangle being smaller than the bottom one. The logo appears to be simple and modern. | | Predicate<br>Device | Subject Device | If different,<br>impact on safety<br>or efficacy | |--------------------------------------------------------------------------------------|---------------------|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | MEDVIEW<br>MEDDIAG<br>MED-MAMMO | | | Display at<br>variable<br>resolution | Yes | Yes | No difference | | Rotation | Yes | Yes | No difference | | Mirroring | Yes | Yes | No difference | | Image inversion | Yes | Yes | No difference | | Display of CAD<br>results | Yes | No | Medical<br>users are<br>informed<br>about this<br>fact, and<br>not all users<br>use CAD, so<br>this point<br>does not<br>add new<br>risk. | | Display of patient<br>demographic<br>information | Yes | Yes | No difference | | Multiframe<br>images breast<br>MR CAD analysis<br>And breast MR<br>motion correction | Yes | No | The fact that<br>MEDWS cannot<br>perform MR CAD<br>analysis and<br>breast MR motion<br>correction does<br>not add new risks.<br>Medical users are<br>informed about<br>this fact. Not all<br>users use CAD<br>nor display MR<br>images. | | Free hand<br>drawing | Yes | Yes | No difference | | Ellipse drawing | Yes | Yes | No difference | | Ability to add<br>textual<br>annotation | Yes | Yes | No difference | | Ability to | Yes | Yes | No difference | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The "M" is a large, cursive letter with a textured fill, while the rest of the letters are in a simpler, sans-serif font. To the left of the word is a geometric design consisting of two rectangles, one larger than the other, connected by a vertical line. | | Predicate<br>Device | Subject Device | | If different,<br>impact on safety<br>or efficacy | |----------------------------------------------------------------------------------------------------|---------------------|--------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | MEDVIEW<br>MEDDIAG | MED-MAMMO | | | measure features | | | | | | Other functions | | | | | | Image storage for<br>short duration | Yes | Yes | Yes | No difference | | Full conformance<br>to IHE<br>Mammography<br>image profile | Yes | No | | The transactions<br>from IHE<br>Mammography<br>image profile not<br>supported by<br>MEDWS concern<br>Evidence<br>Documents, i.e.<br>CAD results.<br>Medical users are<br>informed about<br>this fact, and not<br>all users use CAD,<br>so this point does<br>not add new risk. | | Standardized<br>display of<br>mammography<br>images for all<br>FFDM vendors | Yes | No | Yes | No difference | | Intelligent<br>roaming | Yes | Yes | | No difference | | Can display<br>tomosynthesis<br>images | Yes | Yes | Yes | No difference | | Usability | | | | | | Single click<br>navigation | Yes | Yes | | No difference | | Allow instant<br>access to images<br>and shared<br>patient data<br>across multiple<br>workstations | Yes | Yes | Yes | No difference | ## Conclusion {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with a stylized design. The logo includes a geometric shape on the left side, consisting of two rectangles connected by a vertical line. To the right of the geometric shape is the text "Medecom" in a stylized font, with the "M" appearing as a flowing, cursive letter. The MEDWS Software is substantially equivalent to the predicate software in terms or intended use, indications for use and conformance to the DICOM standard. The MEDWS software has successfully undergone every bench testing designed to simulate clinical use. Based on the information supplied in this 510(k), MEDECOM SARL concludes that MEDWS is substantially equivalent to the predicate device and is safe and effective. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 23, 2014 MEDECOM SARL % Ms. Cynthia Cottereau Consultant TWOKSA 2 rue Quenot JARNAC, 16 200 FRANCE Re: K132684 Trade/Device Name: MEDWS Software (Variants MEDVIEW, MEDDIAG, MEDMAMMO) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ Dated: April 22, 2014 Received: April 30, 2014 Dear Ms. Cottereau: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your cover mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 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). and Cosmetic Act (71cc) that as not request to the general controls provisions of the Act. The 1 ou may, mercrore, manel of the Act include requirements for annual registration, listing of general controls provisions or actice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Theast note: ODNY Book 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), if your device is elassified tools and 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 I lease oc advised that 1 Dris issuance evour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I edital statutes and regalations and 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 {10}------------------------------------------------ Page 2-Ms. Cottereau 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. 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/ResourcesforYou/Industry/default.htm. 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 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,  for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. ### 510(k) Number (if known) K 132684 #### Device Name MEDWS software (variants MEDVIEW, MEDDIAG, MEDMAMMO) #### Indications for Use (Describe) The MEDWS Software (MEDVIEWS, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards. Lossy compressed mammographic image are not intended for diagnostic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used. The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants. Type of Use (Select one or both, as applicable) [図] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {12}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the lime to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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