HipCheck

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. December 13, 2018 Stryker Corp. Cara Mellits Sr. Regulatory Affairs Specialist 5900 Optical Ct SAN JOSE, CA 95138 Re: K182359 Trade/Device Name: HipCheck Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 12, 2018 Received: November 14, 2018 Dear Cara Mellits: 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. 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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182359 Device Name HipCheck Indications for Use (Describe) HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures. 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) ... ... ...................................................................................................................................................................... ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER Stryker Corp. 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2367 Email: cara.mellits@stryker.com Contact Person: Cara Mellits Date Prepared: August 28, 2018 #### II. DEVICE Name of Device: HipCheck Common or Usual Name: HipCheck Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ #### III. PREDICATE DEVICES Primary Predicate: Dyonics Plan Hip Impingement Planning Software, K132636 Secondary Predicate: FluoroMap Computer Assisted Surgery System, K103400 Neither predicate has been subject to a design-related recall. ### IV. DEVICE DESCRIPTION HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility. Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making. {4}------------------------------------------------ HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field. The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400). #### V. INTENDED USE HipCheck provides static localization information derived from image processing of intraoperatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. #### VI. INDICATIONS FOR USE HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the alphanumeric string 'K182359' in a simple, sans-serif font. The characters are uniformly sized and spaced, creating a clear and legible sequence. The text is presented in black against a plain white background, ensuring high contrast and readability. | Characteristic | Subject Device | Primary Predicate Device<br>Dyonics Plan Hip Impingement<br>Planning Software | Secondary Predicate Device<br>FluoroMap Computer Assisted Surgery<br>System | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | HipCheck provides static<br>localization information derived<br>from image processing of intra-<br>operatively acquired X-ray images,<br>by superposition of virtual<br>measurement tools onto those X-<br>ray images. | The DYONICS PLAN is intended as<br>pre-operative or post-operative<br>software for simulating/evaluating<br>hip preservation surgical treatment<br>options and historical case review,<br>respectively. | FluoroMap is a computer controlled<br>stereotaxic image guided surgery<br>system.<br>It provides static localization<br>information derived from image<br>processing of intra-operatively<br>acquired X-ray images, by<br>superposition of virtual implants and<br>instruments onto those X-ray images. | | Indications for Use<br>Statement | HipCheck assists the surgeon to<br>determine quantitative<br>measurements during<br>femoroacetabular impingement<br>procedures. | The DYONICS PLAN Hip<br>Impingement Planning System<br>software is intended for use as a<br>software interface and image<br>segmentation system for the<br>transfer of imaging information<br>from a medical scanner such as a CT<br>scanner to an output file. It is also<br>intended as pre-operative or post-<br>operative software for<br>simulating/evaluating hip<br>preservation surgical treatment<br>options and historical case review,<br>respectively. | FluoroMap assists the surgeon to<br>determine the needed size and<br>position of orthopedic implants<br>during proximal femur fracture<br>surgery using the Stryker Gamma3<br>Nail system.<br>The system should be operated only<br>by trained personnel such as<br>surgeons and clinical staff. | | Product Code(s) | Same as predicate. | LLZ | OLO, LLZ | | Regulation Number | Same as predicate. | 892.2050 | 882.4560 | | Intended Patient<br>Population | Same as predicate. | Patients undergoing orthopedic<br>surgery. | Patients undergoing orthopedic<br>surgery. | | Surgical Approach | Orthopedic surgery, specifically<br>femoroacetabular impingement. | Orthopedic surgery, specifically hip<br>preservation treatment options. | Orthopedic surgery, specifically at the<br>proximal femur. | | Intended Users | Same as predicate. | Orthopedic surgeons and other<br>healthcare professionals. | Surgeons and clinical staff. | | Operational<br>Environment | Surgical suite.<br>Postoperative case review. | Preoperative planning.<br>Postoperative case review. | Surgical suite. | | Primary Device<br>Function | Locate the femoral head and neck<br>to determine the alpha angle using<br>intra-operative X-ray images. | Visualization and assessment of hip<br>preservation surgical treatment<br>options using CT images. | Assistance in planning and<br>positioning of orthopedic implants<br>using intra-operative X-ray images. | | Main System<br>Components | Same as predicate. | - Software | - Software<br>- Reference device for C-arm<br>- Reference device for<br>instrumentation | | User Interface | Tablet. | Personal Computer (PC). | Computer and monitor. | | Body Contact and Use | Same as predicate. | N/A – Device does not have any<br>patient contact. | Reference device for instrumentation<br>(closed tube clip) has patient contact. | | Sterile, Single-use | Same as predicate. | N/A – Device is not provided sterile<br>or as a single use product. | Reference device for instrumentation<br>(closed tube clip) is delivered sterile<br>and as a single use product. | | Design | - Workstation for viewing software<br>- Dedicated software for image<br>processing and display of virtual<br>measurement tools | - Installed and run locally on a PC<br>- Software for image processing<br>- Provides virtual measurement<br>tools, surgical simulation and<br>planning tools | - Reference frames containing metal<br>marker spheres<br>- Reference frames are attached to the<br>implant system and to the C-arm<br>- Workstation for viewing software<br>- Dedicated software for image<br>processing and display of positional<br>information | | Principles of Operation | Acquire intra-operative X-ray<br>images, process the images and | Stand-alone software for computer<br>assisted surgical planning, via | Acquire intra-operative X-ray images,<br>register the images through metal | | | display the virtual measurement<br>tools onto images. | import of CT scans in DICOM format,<br>provides image processing and<br>measurement tools. | marker detection and display the<br>actual position of instruments and<br>implants onto images. | | Function | Display on a tablet screen virtual<br>measurement tools in relationship<br>to X-ray images. | Display on a computer screen<br>virtual measurement and surgical<br>planning tools in relationship to 2D<br>views and 3D renderings generated<br>from CT scans. | Display on a computer screen<br>navigated instruments and implants<br>in relationship to X-ray images. | | Image Processing | - Transfer X-ray images from C-arm<br>to computer platform<br><br>- Overlay virtual measurement<br>tools onto images | - Import DICOM images from CT<br>scans to computer platform.<br><br>- Process images to display various<br>2D views and 3D renderings.<br><br>- Provide virtual measurement<br>tools, surgical simulation and<br>planning tools. | - Transfer X-ray images from C-arm to<br>computer platform<br><br>- Remove image distortions<br><br>- Register images to patient space<br><br>- Overlay instruments and implants<br>onto images | | Energy Source | Same as predicate. | No energy applied to the patient or<br>operating staff. | No energy applied to the patient or<br>operating staff. | ### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the alphanumeric string "K182359" in a simple, sans-serif font. The characters are black against a white background, providing high contrast and readability. The string appears to be a code or identifier, possibly a serial number or product key. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the alphanumeric string "K182359" in a simple, sans-serif font. The characters are black against a white background, providing high contrast and readability. The string appears to be a code or identifier, possibly a serial number or product key. {8}------------------------------------------------ ### Discussion of Similarities and Differences Primary Predicate (Dyonics Plan, K132636): Dyonics Plan is a surgical planning tool, in that its operational environment is primarily pre-operative, thereby outside the surgical suite. However, the software allows for the export of the plan in PDF or HTML format, which can be referenced intraoperatively. As such, the Dyonics Plan utilizes CT preoperative imaging for displaying 2D views and 3D renderings and provides virtual measurement tools for visualization and analysis of hip preservation treatment options. HipCheck's operational environment is primarily intraoperative, within the surgical suite. Since HipCheck is primarily used intraoperatively, it displays intraoperatively collected X-ray images, likewise providing virtual measurement tools for visualization purposes during femoroacetabular impingement procedures. While the operational environment may differ, the intended use is the same. Dyonics Plan utilizes image processing of preoperative CT images and virtual measurement tools to visualize hip anatomy and plan preservation procedures. HipCheck utilizes image processing of intraoperatively collected X-ray images and virtual measurement tools to visualize hip anatomy during femoroacetabular impingement procedures. The Dyonics Plan and HipCheck have the same intended use, as defined in their shared regulation 21 CFR 892.2050. Though their indications for use statements differ, both are used in the treatment of femoroacetabular impingement. Secondary Predicate (FluoroMap, K103400): In addition to its clearance as an orthopedic stereotaxic instrument (OLO; 21 CFR 882.4560), FluoroMap is also cleared as a picture archiving and communications system (LLZ; 21 CFR 892.2050). This is due to the core functionality of FluoroMap's software that supports the acceptance, display, and digital processing of X-ray images in order for FluoroMap to function as intended. FluoroMap software facilitates image manipulation and quantification in order to achieve visualization of the placement of virtual implants and instruments. Similarly, HipCheck shares this core functionality to achieve visualization of the placement of virtual measurement tools for the determination of alpha angle. HipCheck's Alpha Angle algorithm is built directly on the Femoral Head Detector algorithm within the FluoroMap software (K103400). HipCheck leverages the Femoral Head Detector algorithm from FluoroMap for its same intended purpose, simply in a different application. While the primary function of FluoroMap is as a navigated surgical system for placing orthopedic implants, the how behind the device's ability to achieve its intended purpose is important in the substantial equivalence discussion for HipCheck. {9}------------------------------------------------ #### VIII. PERFRMANCE DATA/NON-CLINICAL TESTING Design verification testing was performed on HipCheck as a result of the risk analysis and product requirements. Testing included software and bench verification testing, as well as design validation. Design validation testing was conducted in a simulated-use environment by surgeon and nurse users. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools. ### Software testing Software testing was 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." The software for this device was considered to be of "moderate" level of concern since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator. ### Alpha Angle Performance Testing Alpha angle performance was evaluated in both verification and validation testing performed for HipCheck. Verification testing was conducted based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm. Additionally, validation testing was conducted to ensure applicable user needs were met for generating, manipulating, and using the overlay to determine the alpha angle. All testing had overall passing results. ### Mechanical testing Mechanical functionality testing included the following to ensure the device design meets user needs in the environment of use: - Battery life - - -Tablet weight - -Tablet securement and attachment force to evaluate the connection between the tablet and its docking interface on the compatible operating table mounting arm - -User interface temperature and functionality at operating temperatures - RF ablation interference - - -Mounting arm staying force - Simulated-use testing - ### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing was conducted on the compatible touchscreen tablet that the HipCheck software is provided pre-installed on. The tablet complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and connected, giving the word a modern and unified appearance. The color of the text is black, contrasting with the white background. ## Animal Study No animal testing was conducted to determine the safety and effectiveness of HipCheck. ## Clinical Studies No human clinical testing was conducted to determine the safety and effectiveness of HipCheck. #### IX. CONCLUSIONS Based on the shared technological characteristics and intended use, HipCheck is substantially equivalent to the primary predicate, Dyonics Plan Hip Impingement Planning Software (K132636), and the secondary predicate, FluoroMap Computer Assisted Surgery System (K103400). Differences between the subject and predicate devices' technological characteristics do not raise different questions of safety and effectiveness of HipCheck. The results of the non-clinical testing conducted supports the safety of the device and demonstrates that HipCheck performs as intended in the specified use conditions.