NAVIPLAN - CT Planning Software for Total Hip Replacement

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Naviswiss AG % Stefano Adami Senior Consultant confinis AG Allee 1b Sursee. 6210 SWITZERLAND October 5, 2021 #### Re: K211429 Trade/Device Name: NAVIPLAN - CT Planning Software for Total Hip Replacement Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 26, 2021 Received: August 30, 2021 Dear Stefano Adami: 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). 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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K211429 Device Name NAVIPLAN - CT Planning Software for Total Hip Replacement Indications for Use (Describe) Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants) | Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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This predicate has not been subject to a design-related recall. #### Device Description: NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography). The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export {4}------------------------------------------------ the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose. #### Indications for Use: Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants). #### Comparison of Technological Characteristics: Table 05-1 provides a comparison of the predominant technical characteristics of the subject device and the legally marketed predicate device. A more detailed comparison of the devices is presented in Section 12. | Description | Subject Device | Predicate Device | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Naviplan | ZedView (ZedHip) | | 510(k) Number | To be assigned | K133022 | | Manufacturer | Naviswiss AG | Lexi Co., Ltd. | | Prescription device | Yes | Yes | | Intended Use | Naviplan is intended to be used<br>by a suitably licensed and quali-<br>fied healthcare professional to ac-<br>cess medical images with the in-<br>tention of using such images, in<br>conjunction with templates for<br>prosthetic devices, for the pur-<br>poses to assist qualified<br>healthcare professional in choos-<br>ing the nature and characteristics<br>of the prosthetic device to be<br>used when planning a potential<br>surgical hip procedure.<br>The software is basically intended<br>to be standalone, however the<br>planning data can be imported<br>into the "Naviswiss System" (navi-<br>gation system) for intra-operative<br>use. | ZedView is intended to be used to<br>assist qualified medical profession-<br>als to perform fast and effective pre-<br>operative planning for various surgi-<br>cal procedures related to hip and<br>knee by using 2D image data. The<br>software is basically intended to be<br>standalone, however some part of<br>the software provides features for<br>communicating with PACS servers<br>to acquire the CT data of various pa-<br>tients or to upload planned projects,<br>images or<br>reports to the servers.<br>ZedHip is the specific 3-Dimensional<br>Pre-Op. Planning software for Total<br>Hip Arthroplasty with CT images. | | Indications for use | Naviplan is indicated for pre-oper-<br>ative planning for surgical proce-<br>dures related to hip, such as artifi-<br>cial joint replacement (3D tem-<br>plating of implants). | Zed View is indicated for pre-opera-<br>tive planning for various surgical pro-<br>cedures related to hip and knee,<br>such as artificial joint replacement<br>(3D templating of implants) and os-<br>teotomy. | | Principles of Oper-<br>ations | The user can manage a database<br>of patients data and perform a<br>pre-operative planning per pa-<br>tient. For each patient a hip DI-<br>COM series of a CT scan can be | The software primarily provides im-<br>port and storage of CT images of<br>various patients in DICOM or other<br>formats which are automatically seg-<br>mented by the software. ZedView | | Description | Subject Device | Predicate Device | | | loaded and automatically seg-<br>mented. When the segmentation,<br>which is done on the local com-<br>puter, is completed, the user can<br>edit the initialized case.<br>While planning the user can try<br>different configurations of im-<br>plant types, sizes, positions, orien-<br>tations and more. The planning<br>view shows the user useful met-<br>rics such as resulting leg length,<br>lateral offset, acetabular orienta-<br>tion, CCD-angle, femoral offset<br>and femur antetorsion. The pre-<br>operative planning can be ex-<br>ported in PDF format for printing<br>or in the Naviswiss Hip Naviga-<br>tion System as a binary format for<br>intra-operative use. | provides a means of 3D templating<br>of implants and positioning of fixa-<br>tion devices by calculating surgical<br>parameters in simulated environ-<br>ments and performing 3D measure-<br>ments on each pre-operative patient<br>data using 2D image viewing and<br>manipulations, 3D visualizations and<br>various MPR (Multi-Planar Recon-<br>struction) functions.<br><br>ZedHip is the software that supports<br>pre-operative planning of hip arthro-<br>plasty from 2D digital X-ray images<br>obtained with the EOS imaging and<br>CT images. | | Operating system | Windows or OS X | Windows | | Availability of de-<br>vice | Can be configured to be launched<br>from within a workstation environ-<br>ment or as a standalone PC appli-<br>cation for planning orthopedic<br>procedures. | Can be configured to be launched<br>from within a workstation environ-<br>ment or as a standalone PC applica-<br>tion for planning orthopedic proce-<br>dures. | | Source of images | Receive digital images from the<br>computer or via USB stick | Receive digital images from various<br>sources (including PACS system) | | Processing of im-<br>ages | The software processes data in<br>order to provide an overlap and di-<br>mensioning of digital representa-<br>tions of the prosthetic material | Scaling of image facility | | Superimposing<br>digital Prosthetic<br>Templates | Allows the overlap of models and<br>the intersection of the models | Permits overlay of templates | | Interactive posi-<br>tioning of template | Yes | Yes | | Interactive sizing<br>of template | Yes | Yes | | Permits template<br>rotation | Yes | Yes | | Provides templat-<br>ing support from<br>prosthetic manu-<br>facturers. | Yes | Yes | | Permits automatic<br>scaling | Yes | Semi-automatic measurements | | Pre-operative plan-<br>ning | Yes | Yes | | Description | Subject Device | Predicate Device | | Patient contact | None | None | | Control of life sus-<br>taining devices | None | None | | Human interven-<br>tion for interpreta-<br>tion of images | Required | Required | | Ability to add addi-<br>tional modules<br>when available | Yes | Yes | | Operating system | Windows or OS X | Windows | {5}------------------------------------------------ {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for NAVISWISS. The logo consists of a square with a design inside of it, followed by the word "NAVISWISS". The "NAVI" portion of the word is in black, while the "SWISS" portion is in red. The technological principle for both the subject and predicate devices is to use DICOM image standards that are automatically segmented, and the software provides anatomical landmarks and an initial proposed planning that can be edited by the surgeon to find the best implant configuration and positioning. Both software can be configured to be launched from within a workstation environment or as a standalone PC application for planning orthopedic procedures related to the hip joint. Both software can manaqe a database of patient's data and perform a pre-operative planning per patient based on DICOM series of a CT scan and allow different configurations of implant types, sizes, positions, orientations and more and show the user useful metrics such as resulting leg length, lateral offset, acetabular orientation, CCD-angle, femoral offset and femur antetorsion. Naviplan has an additional feature that allows export of planning data to be used in the Naviswiss Hip Navigation system (K193034). This difference does not represent a substantial difference since it is just an export feature to allow visualization of the planned positioning of the orthopedic implant to the intraoperative navigation. #### Summary of Testing: The relevant requirements set forth in standards listed in Section 9 by the manufacturer are sufficient to assure a safe and effective functioning of the NAVIPLAN - CT Planning Software for Total Hip Replacement. The device has fulfilled the requirements detailed above. The results of the bench and performance testing are summarized in the verification and validation plan and report enclosed. The following performance data were provided in support of the substantial equivalence determination. #### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This {7}------------------------------------------------ ## ള NAVISWISS software is considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning. #### Conclusion: Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022).