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U.S. Food and Drug Administration
Instructions for FDA models including: K230087 Point Kinguide Agile Hybrid Navigation System, K230087, Point Kinguide Agile Hybrid Navigation System, Agile Hybrid Navigation System, Hybrid Navigation System, Navigation System
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DocumentDocumentJuly 17, 2023 Point Robotics Medtech Inc. Wayne Kao Director, Quality Management Division 7F. No. 219, Sec. 3, Beixin Rd. Xindian Dist. New Taipei City, 231 Taiwan Re: K230087 Trade/Device Name: "POINT" Kinguide Agile Hybrid Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 21, 2023 Received: June 21, 2023 Dear Wayne Kao: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Doc ID# 04017.06.03 K230087 - Wayne Kao Page 2 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) 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 (QS) 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 531542 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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-devices/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, Tejen D. Soni -S For 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K230087 Device Name "POINT" Kinguide Agile Hybrid Navigation System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Indications for Use (Describe) "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. 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. 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." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF Point Robotics MedTech Inc. 510(k) Notification 510(k) Summary June 21, 2023 Kinguide Agile 510(k) Number: K230087 1. Submitter's Information Company Name Address Contact Person (Primary) Phone Email Point Robotics MedTech Inc. 7F., No.219, Sec.3, Beixin Rd., Xindian Dist., New Taipei City 231, Taiwan Mr. Wayne Kao 866-2-29130272#2610 wayne.kao@pointroboticsinc.com 2. Subject Device Information Proprietary/Trade Name Regulation Name Regulation Number Product Code Device Classification Review Panel "POINT" Kinguide Agile Hybrid Navigation System Stereotaxic Instrument 882.4560 OLO II Orthopedic 3. Device Description "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification. Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time. Page 1 of 12 Point Robotics MedTech Inc. 510(k) Notification Kinguide Agile 510(k) Number: K230087 The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking. *CT image DICOM file reconstructed from the 3D C-arm or the same function equipment. 4. Indications for Use "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. 5. Identification of Legally Marketing Devices K220241 - "POINT" Kinguide Robotic-Assisted Surgical System K201189 - StealthstationTM S8 Spine Software v1.3.0 K162309 - StealthstationTM S8 System Platforms and StealthStation Cranial Software Page 2 of 12 Point Robotics MedTech Inc. 510(k) Notification 6. Comparison to the Predicate Device Item K number Product Code Intended Use & Indications for Use Subject Device "POINT" Kinguide Agile Hybrid Navigation System N/A OLO "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System K220241 OLO "POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to Page 3 of 12 Software Predicate StealthstationTM S8 Spine Software v1.3.0 K201189 OLO The StealthStationTM System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System K162309 HAW, OLO, PGW The StealthStationTM System, with StealthStation Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStationTM System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, Point Robotics MedTech Inc. 510(k) Notification Item Subject Device "POINT" Kinguide Agile Hybrid Navigation System can be identified by intraoperative 3D reconstruction images. System Accuracy Requirement According to verification and validation results, Kinguide Agile has demonstrated performance in 3D positional accuracy with a mean positional error of 2.0 mm and mean trajectory error of 2 Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System images of the anatomy. The indications include all medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1). According to verification and validation results, "POINT" Kinguide Robotic-Assisted Surgical System has demonstrated performance in 3D positional accuracy with a mean positional error of 2.0 mm and mean Page 4 of 12 Software Predicate StealthstationTM S8 Spine Software v1.3.0 such as the spine, can be identified relative to images of the anatomy. This can include, but is not limited to, the following procedures: · Pedicle Screw Placement · Iliosacral Screw Placement · Interbody Device Placement Under representative worst-case configuration, the StealthStation S8 Spine software v1.3.0, has demonstrated performance in 3D positional accuracy with a mean positional error of 2.0 mm and mean Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System such as the skull, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial v1.0.0 Software, has demonstrated performance in 3D positional accuracy with Point Robotics MedTech Inc. 510(k) Notification Item Subject Device "POINT" Kinguide Agile Hybrid Navigation System degrees. Imaging Modalities Rigid Anatomical Positioning Methods X-Ray Based Imaging Fiducial Frame Lock is a set of optical markers mounted on a dynamic reference frame Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System trajectory error of 2 degrees. X-Ray Based Imaging Software Predicate StealthstationTM S8 Spine Software v1.3.0 trajectory error of 2 degrees. Mean Accuracy Values (StealthAiR Spine): Positional Error 1.01 mm Trajectory Error 0.37 degrees Mean Accuracy Values (Overlapping Slices): Positional Error 0.51 mm Trajectory Error 0.41 degrees X-Ray Based Imaging Fiducial Frame Lock is a N/A set of optical markers mounted on a dynamic reference frame Page 6 of 13 Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System a mean error 2.0 mm and in trajectory angle accuracy with a mean error 2.0 degrees. X-Ray based, MR based Nuclear Medicine based Patient reference frame is a set of optical markers mounted on a metal frame which allows Point Robotics MedTech Inc. 510(k) Notification Item Subject Device "POINT" Kinguide Agile Hybrid Navigation System which allows user to register and track the anatomy. The Schanz Screw (reference pin) is dock on the iliac crest and combines with the Fiducial Frame Lock. Skin Marker Registration (Referred to as Automatic Image Registration (AIR) of predicate devices) Registration Features Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System which allows user to register and track the anatomy. The Schanz Screw (reference pin) is dock on the iliac crest and combines with the Fiducial Frame Lock. Surface Matching Registration Image Landmark Registration Precise Surface Registration Image Registration Software Predicate StealthstationTM S8 Spine Software v1.3.0 PointMerge Registration SurfaceMerge Registration FluoroMerge Registration Automatic 2D Image Registration Automatic 3D Image Registration StealthAiR Spine Automatic Registration Page 6 of 12 Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System user to register and track the anatomy. The reference pin docks on the bone and combines with reference frame. PointMerge® registration (referred to as Landmark registrations) TracerTM registration Touch registration (previously Touch-NGoTM) StealthAiR® registration, O-arm® registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFixTM Bone Anchor Registration) Point Robotics MedTech Inc. 510(k) Notification Item Planning Features Subject Device "POINT" Kinguide Agile Hybrid Navigation System Plan Entry and Target Selection 3D Model Building Medical Device Interfaces Philips XperCT Siemens Artis Pheno Siemens Artis Zeego Siemens SOMATOM Definition AS Siemens Arcadis Orbic 3D GE Discovery IGS 730 GE Discovery IGS 7 OR View/Display Features Look Sideways 3D View Anatomic Orthogonal Trajectory 1 and 2 Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System Plan Entry and Target Selection 3D Model Building Siemens Arcadis Varic CArm Siemens Arcadis Orbic C-Arm Software Predicate StealthstationTM S8 Spine Software v1.3.0 Plan Entry and Target Selection 3D Model Building Deformity Planning O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm ISO-C 3D C-Arm Ziehm Vision RFD 3D Carm Stealth-Midas MR8 Orbic 3D C-Arm Look Sideways 3D View Anatomic Orthogonal Trajectory 1 and 2 Page 7 of 12 Look Sideways 3D Anatomic Orthogonal Trajectory 1 and 2 Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System Plan Entry and Target selection 3D Model Building Advanced Visualization Microscope Navigation: Zeiss, Leica Ultrasound Navigation: Aloka and Sonosite Medtronic O-arm® Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell Nexframe® Stereotactic System STarFixTMPlatform System Ultrasound Video In, Ultrasound Overlay, 3D, 2D Anatomic Orthogonal, Point Robotics MedTech Inc. 510(k) Notification Item Subject Device "POINT" Kinguide Agile Hybrid Navigation System Trajectory Guidance Probe's Eye AP and Lateral Maximum Intensity Projection Software Interface (GUI) User friendly interface with procedure task overview at home page. System tools for image adjustment, surgical planning and instrument management are contained in a left-side bar. The system information is shown on the right-side bar. Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System Trajectory Guidance Probe's Eye AP and Lateral Maximum Intensity Projection User friendly interface with procedure task overview at home page. System tools for image adjustment, surgical planning and instrument management are contained in a left-side bar. The system information is shown on the right-side bar. Software Predicate StealthstationTM S8 Spine Software v1.3.0 Trajectory Guidance Look Ahead Probe's Eye AP and Lateral Synthetic AP and Lateral Maximum Intensity Projection Video Input Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a rightside bar. Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System Trajectory 1 and 2, Target Guidance, Trajectory Guidance, Probes Eye, Look Ahead, Microscope Injection, Video Input, Endoscopic Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a rightside bar. Page 8 of 12 Point Robotics MedTech Inc. 510(k) Notification Item Navigation Algorithm Programming Language Scanner Interface Technology (to imaging devices) Localization Technology Computer Platform Subject Device "POINT" Kinguide Agile Hybrid Navigation System Using the algorithm of transformation matrices for real-time visualization & navigation of instruments relative to patient image sets C++ CD, DVD, USB DICOM Import Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega Intel-based PC Primary Predicate "POINT" Kinguide Robotic-Assisted Surgical System Using the algorithm of transformation matrices for real-time visualization & navigation of instruments relative to patient image sets C++ CD, DVD, USB DICOM Import Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega Intel-based PC Software Predicate StealthstationTM S8 Spine Software v1.3.0 Not applicable C++ Network Connectivity CD, DVD, USB DICOM Import DICOM Export Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega Intel-based PC Kinguide Agile 510(k) Number: K230087 Platform Predicate StealthStationTM S8 System Not applicable C++ Network Connectivity CD, DVD, USB DICOM Import DICOM Export Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega Intel-based PC Page 9 of 12 Point Robotics MedTech Inc. 510(k) Notification Kinguide Agile 510(k) Number: K230087 6.1. Brief Substantial Equivalence Discussion Kinguide Agile and the predicates- "POINT" Kinguide Robotic-Assisted Surgical System (K220241) and StealthStationTM System (K201189 and K162309) are based on the following same technological elements: Intended Use & Indications for Use System Accuracy Requirement Imaging Modalities Rigid Anatomical Positioning Methods Registration Features Planning Features Medical Device Interfaces View/Display Features Software Interface (GUI) Navigation Algorithm Programming Language Scanner Interface Technology Localization Technology Computer Platform Page 10 of 12 Point Robotics MedTech Inc. 510(k) Notification 7. Performance Testing Kinguide Agile 510(k) Number: K230087 The performance data, including required verification/validation, of Kinguide Agile has been carried out thoroughly both at the top level and on underlying SW/HW modules according to international standards and following U.S. FDA guidance. Verification has been conducted to demonstrate that the design specifications and the safety requirements are all met. Verification/Validation General Design Requirements Risk Management Human Factors & Usability Engineering Product Safety Positional Accuracy Biocompatibility Software Reprocessing Description The design control process follows 21 CFR 820. Compliance with ISO 14971:2019 Usability of the system is validated in accordance with FDA guidance of applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015. Compliance with standards requirements, including: - IEC 60601-1:2005/CORR.1(2006)+ CORR.2(2007)+AM1(2012) - IEC 60601-1: 2012 - IEC 60601-1-2:2014 - IEC 60601-1-8:2006+AMD1:2012 Compliance with ASTM F2554-18 and ASTM F3107-14 Biocompatibility of those accessories that having contact with patients is evaluated in accordance with FDA guidance for the use of international standard ISO 10993-1. System software is validated in accordance with: - FDA guidance for the Content of Premarket Submissions for Software contained in Medical Devices, 2005 - IEC 62304:2006 + A1:2015. Reusable accessories are validated in accordance Page 11 of 12 Point Robotics MedTech Inc. 510(k) Notification Verification/Validation Sterilization Stability & Reliability Non-clinical Performance (Accuracy) Kinguide Agile 510(k) Number: K230087 Description with: - FDA guidance for the Reprocessing medical devices in health care settings: Validation methods and labeling, 2015. - AAMI TIR30:2011/(R)2016 - AAMI TIR12:2020 Compliance with FDA guidance for Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, 2016 Stability & Reliability evaluation includes: - Standard Practice for Climatic Stressing of Packaging Systems acc. ASTM F2825-18 - Standard Practice for Performance Testing of Shipping Containers and Systems acc. ASTM D4169-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices acc. ASTM F1980-16 The system has a mean accuracy of 2.0 mm for location error and 2.0° for trajectory angle error. The following verification and validation are performed in support of our performance study: - Performance and Accuracy Verification Report - Cadaveric Validation Report - Compatibility and Measuring Accuracy Verification Report 8. Conclusion Based on the supporting evidence provided in this premarket notification, Point Robotics believes that the subject device, "POINT" Kinguide Agile Hybrid Navigation System, is substantially equivalent to the predicate devices. Page 12 of 12