INTAI Surgery Navigation System

{0}------------------------------------------------ September 20, 2019 Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Intai Technology Corporation Shih-Chang Chuang Manager No. 9 Jingke Rd., Nantun Dist., Taichung City, 40852 TW Re: K180523 Trade/Device Name: INTAI Surgery Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 21, 2019 Received: August 23, 2019 Dear Shih-Chang Chuang: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180523 Device Name INTAI Surgery Navigation System #### Indications for Use (Describe) The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. ### 5.1. Submitter's information | Applicant name | INTAI Technology Corporation | |------------------|--------------------------------------------------------------------------| | Address | No. 9, JingKe Rd., Nantun Dist., Taichung City 40852, Taiwan<br>(R.O.C.) | | Telephone number | +886-4-2359-5336 | | Contact person | Teng-Kuan Tsai | | Date prepared | August 15, 2019 | #### 5.2. Device information | Device name | INTAI Surgery Navigation System | |---------------------|-------------------------------------------------------------------------------------------------------| | Trade name | INTAI Surgery Navigation System | | Common name | Surgery Navigation System for Spine | | Classification name | Orthopedic Stereotaxic Instrument | | Classification | Class II (21 CFR 882.4560) | | Product code | OLO | | Predicate device | Medtronic StealthStation System (K133444)<br>Primary product code: HAW<br>Secondary product code: OLO | ### 5.3. Device description The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation. The system is compatible with the following pedicle screw system and C-arm systems. {4}------------------------------------------------ | Compatible Systems | Device Name | 510(k) Number | |--------------------|--------------------------------|---------------| | Pedicle screw | Wiltrom spinal fixation system | K172548 | | C-arm | Siemens Arcadis Varic | K040066 | | C-arm | GE OEC Fluorostar | K043076 | | C-arm | Ziehm Imaging Ziehm Solo | K092438 | #### 5.4. Intended use/Indications for use The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region. - 5.5. Substantial equivalence comparison The subject device has the same intended use and technological characteristics as the predicate device. Below is a comparison of the indications for use and technological characteristics of subject device to the predicate device and an assessment of the equivalence of each characteristic. It is shown that technological differences in the subject device do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics. | | Subject Device | Predicate Device | Equivalence Assessment | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | INTAI Surgery Navigation System | Medtronic StealthStation System | N/A | | Submitter | INTAI Technology Co. | Medtronic Navigation, Inc. | N/A | | 510(k) number | TBD | K133444 | N/A | | Primary<br>product code | OLO | HAW | N/A | | Secondary<br>product code | N/A | OLO | N/A | | | Subject Device | Predicate Device | Equivalence Assessment | | Indications for<br>use | The INTAI Surgery Navigation<br>System is indicated for precise<br>positioning of surgical<br>instruments or spinal implants<br>during general spinal surgery<br>when reference to a rigid<br>anatomical structure, such as the<br>vertebra, can be identified<br>relative to a patient's<br>fluoroscopic or CT imagery. It is<br>intended as a planning and<br>intraoperative guidance system<br>to enable open or percutaneous<br>image guided surgery by means<br>of registering intraoperative 2D<br>fluoroscopic projections to<br>pre-operative 3D CT imagery.<br>Example procedures include but<br>are not limited to:<br>Posterior-approach spinal<br>implant procedures, such as<br>pedicle screw placement, within<br>the lumbar region. | The StealthStation System is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures, The StealthStation<br>System is indicated for any<br>medical condition in which the<br>use of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the skull, a<br>long bone, or vertebra, can be<br>identified relative to a CT or MR<br>based model, fluoroscopy<br>images, or digitized landmarks of<br>the anatomy. | Equivalent<br>The scope of indications for use<br>of subject device is entirely<br>contained within that of<br>predicate device. The subject<br>device does not have any new<br>indications for use. | | Operating<br>principle | The subject device creates a<br>relative position between the<br>patient and 2D C-arm images by<br>means of capturing<br>intra-operative 2D C-arm images<br>of the patient. The relative<br>position between the patient and<br>3D CT images is established<br>through the registration of<br>intra-operative 2D C-arm images<br>to pre-operative 3D CT images.<br>Subsequently, the subject device<br>can continuously display the<br>relative position of a tracked<br>instrument to a representation of<br>the patient's anatomy. The<br>surgeon can utilize this<br>information as a guide to<br>perform either open or<br>percutaneous spine surgery. | The navigation system creates a<br>translation map between points<br>in the patient anatomy and the<br>corresponding points on<br>radiologic images of the patient.<br>Once this map is established<br>through a process called<br>registration), the software can<br>display the relative position of a<br>tracked instrument to a<br>representation of the patient's<br>anatomy.<br>During surgery, the system tracks<br>the position of specialized<br>surgical instruments in or on the<br>patient anatomy and<br>continuously updates the<br>instrument position on these<br>images either by optical tracking<br>or electromagnetic tracking. | Equivalent<br>Both subject device and<br>predicate device are intended to<br>establish the relative position<br>between the tracked instrument<br>and patient's anatomy. The<br>subject device utilizes the same<br>optical tracking system as the<br>predicate device. | | Main system<br>components | Optical tracker<br>Navigation cart, including optical<br>tracker, medical panel PC and<br>articulating arms | Optical and electromagnetic<br>(AXIEM)<br>localization system<br>Staff cart (optical system),<br>including camera and articulating<br>arms, and surgeon cart, including<br>surgeon monitor and articulating<br>arms | Equivalent<br>The function of optical tracker,<br>i.e. optical tracking, is equivalent<br>to that of optical localization<br>system. The subject device does<br>not have electromagnetic<br>localization system.<br>Equivalent<br>The subject device integrates<br>optical tracker and medical panel<br>PC into a cart. The function of<br>navigation cart is equivalent to<br>that of staff cart and surgeon<br>cart. | | | N/A | Keyboard and mouse | Equivalent | {5}------------------------------------------------ {6}------------------------------------------------ | | Subject Device | Predicate Device | Equivalence Assessment | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Main system<br>components | No touch reader | N/A | Equivalent<br>No touch reader is used to<br>automatically identify the<br>instruments. User shall manually<br>identify the instrument when<br>using the predicate device. | | Patient<br>tracking | Dynamic reference frame (DRF) | Dynamic referencing | Identical | | Operating<br>system | Windows 7 | Debian Linux | Equivalent<br>The function of navigation<br>software is successfully verified<br>on Windows' platform, which<br>does not affect its operation. | | Modes of<br>operation | Planning & Navigation Module<br>1. Procedure approach (next/last<br>buttons) software for guiding<br>surgical navigation<br>2. Display of 3D image and<br>multi-planar reconstruction<br>image<br>3. Localization of patient's<br>position by DRF<br>4. Anatomical images<br>"Instrument view" at different<br>depths from the viewpoint of<br>instrument tip<br>5. "Instrument navigation panel"<br>for trajectory planning | Planning & Navigation Module<br>1. Procedure guided software<br>(next/back buttons) with voice<br>prompt, instruction window<br>and task visualization<br>2. Advanced 3-D modeling<br>capabilities for multiple<br>models or plans<br>3. PatienTrak dynamic<br>referencing<br>4. User definable "Look-Ahead"<br>views and display setup<br>5. Display of the 3D accuracy<br>"Zone"<br>6. Linear measurement tools in<br>all planes for anatomical sizing<br>7. 3D guidance view with depth<br>display<br>8. Screen export as PC<br>compatible JPEG file on<br>CD-ROM | Equivalent<br>The subject device does not have<br>those modules incorporated in<br>the predicate device, i.e. module<br>5, 6 and 8. These modules<br>provide optional functions and<br>do not affect the overall<br>navigation procedure. | | Registration<br>1. C-arm/CT image registration<br>2. Minimally invasive surgery for<br>lumbar spine | | Advanced Contour Registration<br>1. Registration is achieved by<br>dragging probe across<br>vertebral body<br>2. For use in cervical, thoracic<br>and lumbar spine<br>3. Enabling technology for<br>minimal access spine surgery | Equivalent<br>Both subject device and<br>predicate device need<br>registration to establish spatial<br>coordinate transformation. | | Supported<br>image<br>modalities | CT | CT or MR | Equivalent<br>The subject device uses the same<br>CT image modality as the<br>predicate device. | #### 5.6. Non-clinical testing Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions. Below is a summary of all performance tests carried out on the subject device. It is demonstrated that the subject device performs as safely and effectively as the predicate device. {7}------------------------------------------------ | Test | Description | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cleaning | Cleaning of those reusable accessories is validated in<br>accordance with AAMI TIR30:2011/(R)2016, ASTM F3293-18<br>and FDA guidance for the “Reprocessing medical devices in<br>health care settings: Validation methods and labeling” issued on<br>March 17, 2015. | | Sterilization | Moist heat sterilization of those reusable accessories is<br>validated in accordance with ISO 17665-1:2006. | | Repeated<br>Reprocessing | Reliability of those reusable instruments after repeated<br>reprocessing is validated throughout their use-life. | | Biocompatibility | Biocompatibility of those accessories that come into contact<br>with patient is evaluated in accordance with FDA guidance for<br>the use of international standard ISO 10993-1, “Biological<br>evaluation of medical devices – Part 1: Evaluation and testing<br>within a risk management process” issued on June 16, 2016 and<br>ISO 10993-1:2009. | | Software | Software is verified and validated in accordance with FDA<br>guidance for the content of premarket submissions for software<br>contained in medical devices issued on May 11, 2005 and IEC<br>62304:2006 + A1:2015. | | Electrical Safety | Electrical safety of the system is complied with the<br>requirements of ANSI/AAMI ES60601-1:2005/(R)2012 and<br>A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. | | Electromagnetic<br>Compatibility | Electromagnetic compatibility of the system is complied with<br>the requirements of IEC 60601-1-2:2014. | | Usability | Usability of the system is validated in accordance with<br>ANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC<br>60601-1-6:2010 + A1:2013. | | Accuracy | Positional accuracy of the system is evaluated in accordance<br>with ASTM F2554-10. | | System<br>Performance<br>Validation | Clinical accuracy of the system is validated in cadaver against<br>the acceptance criteria of mean positional error $≤$ 3.0 mm and<br>mean trajectory angle error $≤$ 3.0 degrees. | | Risk Assessment | The effectiveness of all risk control measures is verified in<br>accordance with ISO 14971:2007 | {8}------------------------------------------------ | Test | Description | |------------------------|----------------------------------------------------------------------------| | Design<br>Verification | The design output fulfills all design input requirements. | | User Needs | The system meets the needs of the end user under simulated use conditions. | #### 5.7. Clinical testing No clinical testing has been conducted. #### 5.8. Conclusions The results of all non-clinical tests demonstrate that the INTAI Surgery Navigation System performs as safely and effectively as the legally marketed predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.