ZEDVIEW

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word LEXI in bold, black letters. To the left of the word is a blue square design with several squares inside of each other. There is a blue line on either side of the word and design. ## ''510(k) SUMMARY'' AS REQUIRED BY SECTION 807.92(c) ## 510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared. Lexi Co., Ltd. Kyodo-Keikaku Bldg. 9F 3-36-6 Sugamo, Toshima-ku, Tokyo 170-0002, JAPAN Phone: +81 (0)3 5394 4833 Fax: + 81 (0)3 5394 4834 E-mail: admin@lexi.co.jp Website: http://www.lexi.co.jp/ Contact Person: Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for Lexi Co., Ltd. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124 Date Prepared: September 8, 2013 ## Name of Device - Trade Name: ZedView ● - Common Name: Image Management Software - Classification Name: Medical Image Management System, Product Code LLZ #### Predicate Device ZedView is substantially equivalent to the Meridian Technique Ltd. Orthoview™ (510(k) Accession Numbers: K032401 and K063327). | Volume Number | |---------------| | 8 | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with multiple squares nested inside each other. There are also short blue lines on either side of the word "LEXI". ## Device Description: ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative hip and knee surgical procedures. The software is composed of various modules as shown in Figure 1, below. Image /page/1/Figure/4 description: The image is a flowchart that shows the architecture of the ZedView software. The top-level component is ZedView, which is composed of ZedViewDB, ZedView3D, and ZedReport. ZedViewDB is responsible for 2D slice image data management, ZedView3D is responsible for 3D visualization, measurement, and simulations, and ZedReport is responsible for screenshot report generation, editing, and transmission. The ZedViewDB and ZedReport components are connected to ZedEdit, ZedHip, ZedKnee/JIGEN, ZedHip-EOS, ZedKnee-EOS, and ZedOsteotomy. Image /page/1/Figure/5 description: The image shows the text "FIGURE 1" in a bold, sans-serif font. The text is underlined. The words are stacked on a single line. ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers. The software primarily provides import and storage of CT images of various patients in DICOM or other formats. Also, it provides a means of 3D templating of implants and positioning of fixation devices by calculating surgical parameters in simulated environments and performing 3D measurements on each pre-operative patient data, using 2D image viewing and manipulations, 3D visualizations and various MPR (Multi-Planar Reconstruction) functions. The software also provides separate modules that support pre-operative planning of hip and knee arthroplasty for 2D digital X-rav images obtained with the EOS imaging system by providing quasi-3D templating, 3D measurement, etc. Besides the functional modules for artificial joint replacement surgeries, the software also provides a module that incorporates planning and evaluations for osteotomy (Curved Periacetabular Osteotomy etc.). {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a blue line on either side of the word and the square design. The word is the main focus of the image. #### Intended Use ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers. #### Predicate Device Comparison The ZedView software is substantially equivalent to the Meridian Technique Ltd. Orthoview™ Software (K032401 and K063327). (See Page 11-1 for the comparative analysis). #### Performance Data: (Non-clinical Testing) The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data. Verification and validation results confirm that the ZedView Software meets its requirements for intended use and its performance requirements. #### Conclusions of non-clinical tests The results of the non-clinical tests confirm that ZedView is as safe, as effective, and performs as well as or better than the predicates. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with several squares nested inside of each other. There is a short blue line on either side of the word and the square design. # ZedView/OrthoView Comparative Analysis | Characteristic | Meridian Technique<br>OrthoView (K032401) | Meridian Technique<br>OrthoView (K063327) | Lexi ZedView | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------| | Computer | PC Workstation | Personal computer or<br>Workstation/Server | Personal computer or<br>Workstation | | Operating<br>System | Windows | Windows | Same | | Availability of<br>Device | Can be configured to be<br>launched from within a<br>workstation environment or<br>as a standalone PC<br>application for planning<br>orthopedic procedures. | Same | Same | | Source of<br>images | Receive digital images<br>from various sources<br>(including PACS system) | Same | Same | | Processing of<br>data | Scaling of image facility | Same | Same | | Superimposing<br>digital<br>Prosthetic<br>Templates | Permits overlay of<br>templates | Same | Same | | Interactive<br>positioning of<br>template | Yes | Same | Same | | Interactive<br>sizing of<br>template | Yes | Same | Same | | Permits template<br>rotation | Yes | Same | Same | | Provides<br>templating<br>support from<br>prosthetic<br>manufacturers. | Yes | Same | Same | | Permits<br>automatic<br>scaling | Yes | Same | Semi-automatic<br>measurements | | Pre-operative<br>planning | Allowed | Same | Same | | Osteotomy<br>module | No | Yes | Yes | | Patient contact | None | Same | Same | | Control of life-<br>sustaining<br>devices | None | Same | Same | | Human<br>intervention for<br>interpretation of | Required | Same | Same | Volume Number Page Number {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a blue dash on either side of the word and the square design. | Characteristic | Meridian Technique<br>OrthoView (K032401) | Meridian Technique<br>OrthoView (K063327) | Lexi ZedView | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | images | | | | | Ability to add<br>additional<br>modules when<br>available | Yes | Same | Same | | Intended use | The OrthoviewTM system<br>is designed with the<br>intention that licensed<br>medical professionals can<br>access digitised medical X-<br>Ray images in DICOM or<br>other formats obtained<br>from a variety of<br>modalities such as PACS<br>systems, X-Ray digitisers<br>etc.<br>This permits the review of<br>such images and allows the<br>overlay of digitised images<br>of templates for prosthetic<br>devices thereby providing<br>an alternative to traditional<br>means of optically viewing<br>processed X-Ray films<br>overlaid with the acetate<br>templates of such<br>prostheses supplied by the<br>prosthetic manufacturer.<br>OrthoviewTM provides the<br>means of recording, storing<br>and retrieving the<br>templating process steps<br>performed by the licensed<br>medical professional when<br>assessing the<br>optimum prosthetic device<br>for a particular patient.<br>The OrthoviewTM system<br>does not have any function<br>such as image acquisition,<br>image storage etc, this is<br>the responsibility of the<br>systems alongside which<br>OrthoviewTM operates.<br>The OrthoviewTM system<br>does not specify the<br>requirements for the<br>prosthetic template - this is<br>the responsibility of the<br>prosthetic manufacturer. | OrthoviewTM intended use is to<br>enable a suitably licensed and<br>qualified healthcare<br>professional access to medical<br>images with the intention of<br>using such images, in conjunction<br>with templates for prosthetic and<br>fixation devices, for the purposes<br>of choosing the nature and<br>characteristics of the<br>prosthetic/fixation device to be<br>used when<br>planning a potential surgical<br>procedure. In addition, Trauma<br>and Osteotomy modules and<br>Trauma Templates are included<br>to extend the range of<br>functionality available to the<br>healthcare professional. | ZedView is intended to be<br>used to assist qualified<br>medical professionals to<br>perform fast and effective pre-<br>operative planning for various<br>surgical procedures related to<br>hip and knee by using 2D<br>image data. The software is<br>basically intended to be<br>standalone, however some<br>part of the software provides<br>features for communicating<br>with PACS servers to acquire<br>the CT data of various<br>patients or to upload planned<br>projects, images or reports to<br>the servers.<br>The software primarily<br>provides import and storage<br>of CT images of various<br>patients in DICOM or other<br>formats and provides a means<br>of 3D templating of implants<br>and positioning of fixation<br>devices by calculating<br>surgical parameters in<br>simulated environments and<br>performing 3D measurements<br>on each pre-operative patient<br>data using 2D image viewing<br>and manipulations, 3D<br>visualizations and various<br>MPR (Multi-Planar<br>Reconstruction) functions.<br>The software also provides<br>separate modules that support<br>pre-operative planning of hip<br>and knee arthroplasty for 2D<br>digital X-ray images obtained<br>with the EOS imaging system<br>by providing quasi-3D<br>templating, 3D measurement,<br>etc.<br>Besides the functional<br>modules for artificial joint<br>replacement surgeries, the<br>software also provides a | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "LEXI" in black, bold letters. To the left of the word is a blue square design with several squares nested inside each other. There is a short blue line on either side of the word and square design. | Characteristic | Meridian Technique<br>OrthoView (K032401) | Meridian Technique<br>OrthoView (K063327) | Lexi ZedView | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | module that incorporates<br>planning and evaluations for<br>osteotomy (Curved<br>Periacetabular Osteotomy<br>etc.). | | Indications for<br>use | OrthoviewTM is indicated<br>for use when a suitably<br>licensed and qualified<br>healthcare professional<br>requires access to medical<br>images with the intention<br>of using such images, in<br>conjunction with templates<br>for prosthetic devices, for<br>the purposes of choosing<br>the nature and<br>characteristics of the<br>prosthetic device to be used<br>when planning a potential<br>surgical procedure. | OrthoviewTM is indicated for use<br>when a suitably licensed and<br>qualified healthcare professional<br>requires access to medical images<br>with the intention of using such<br>images, in conjunction with<br>templates for prosthetic and<br>fixation devices, for the purposes<br>of choosing the nature and<br>characteristics of the<br>prosthetic/fixation device to be<br>used when planning a potential<br>surgical procedure. In addition,<br>Trauma and Osteotomy modules<br>and Trauma Templates are<br>provided to extend the range of<br>functionality available to<br>healthcare professionals. | Pre-operative planning for<br>various surgical procedures<br>related to hip and knee like<br>artificial joint replacement<br>(3D templating of implants),<br>osteotomy. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "ZedView" in a serif font. The text is black and the background is white. The word is written in a slightly italicized style. Image /page/6/Picture/1 description: The image shows the word "LEXI" in bold, black letters. To the left of the word is a blue square with a series of smaller squares inside, creating a tunnel-like effect. A short blue line is on either side of the word, connecting it to the square. ## Discussion of Differences ## Important Differences ## 1. Image format OrthoView uses digital X-ray image data, ZedView provides pre-operative planning from CT sliced image data. ## Discussion: The CT image data provides more relevant information than the X-ray images, thus offers a better and precise pre-operative planning, while the intended use and the indications for use remain the same. Besides, ZedView also contains separate operational modules (ZedHip-EOS, ZedKnee-EOS) for providing pre-operative planning for hip and knee using the digital X-ray (DX modality) images from the EOS imaging systems. ## 2. Templating system In contrast to the conventional 2D templating of OrthoView. ZedView provides CTbased 3D templating system. In addition to the template overlays in 2D cross-sectional images, the software allows user to place and register the 3D imported models of implants or fixation devices over the 3D reconstructed bone models and also provides 3D movement (translation, rotation) of the implants. In addition. ZedView offers visualization of bone models in various simulated post-operative positions and calculation of surgical parameters with respect to various coordinate systems. ## Discussion: The 3D templating system provides flexibility and extension of functionality by providing additional information (surgical parameters, range of motion analysis, etc.) for pre-operative planning than the 2D templating systems. Moreover, the 3D visualizations of bone and implant models help visualize elements that cannot be visualized in 2D, thus allowing for intuitive, effective and more accurate and precise planning. ## 3. Osteotomy operational module In addition to the joint replacement modules, the Osteotomy module in ZedView also offers simulations, measurements, surgical parameters calculations, etc. in 3D. ## Discussion: Similar to the discussion in section 2 above, the extra information and the 3D visualization of simulated bone models allow for intuitive, effective and more accurate and precise planning. ## Conclusion While there are some differences between ZedView and its predicates, these differences are minor and do not affect device substantial equivalence. It has the same basic operational principles and technical characteristics as its predicates and it functions in the same manner. Additionally, it has the indications for use and intended function and | Volume Number | Page Number | |---------------|-------------| | 8 | 8-7 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a short blue line on either side of the word and design. use and performs as well as or better than its predicates. Therefore, Lexi believes that ZedView is substantially equivalent to the predicate devices cited within this submission. | Volume Number | Page Number | |---------------|-------------| | 8 | 8-8 | {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 March 6, 2014 LEXI Co., Ltd. % Mr. Edward Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141 Re: K133022 Trade/Device Name: ZedView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2014 Received: February 21, 2014 Dear Mr. Kroll: 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 11 (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. {9}------------------------------------------------ Page 2-Mr. Kroll If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Smh.7) for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K133022 Device Name ZedView Indications for Use (Describe) ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy. Type of Use (Select one or both, as applicable) 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) Sm.h.7) 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 f the 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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