Who is the manufacturer of “POINT” Kinguide Agile Hybrid Navigation System?

Point Robotics MedTech, Inc. filed the 510(k) submission for “POINT” Kinguide Agile Hybrid Navigation System (K230087).

What is the FDA product code for “POINT” Kinguide Agile Hybrid Navigation System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for “POINT” Kinguide Agile Hybrid Navigation System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for “POINT” Kinguide Agile Hybrid Navigation System?

POINT Kinguide Robotic-Assisted Surgical System (K220241); Stealthstation S8 Spine Software v1.3.0 (K201189); StealthStation S8 System Platforms and StealthStation Cranial Software (K162309).

Who can help prepare an FDA 510(k) submission like “POINT” Kinguide Agile Hybrid Navigation System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

“POINT” Kinguide Agile Hybrid Navigation System

K230087 · Point Robotics MedTech, Inc. · OLO · Jul 17, 2023 · Neurology

Device Facts

Record ID	K230087
Device Name	“POINT” Kinguide Agile Hybrid Navigation System
Applicant	Point Robotics MedTech, Inc.
Product Code	OLO · Neurology
Decision Date	Jul 17, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

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.

Device Story

Image-guided system (IGS) for neurosurgical/orthopedic procedures; tracks surgical instruments relative to patient anatomy. Inputs: intraoperative 3D images (C-arm/CT) and optical tracking data from infrared camera. Operation: user loads software to plan procedure; registers patient anatomy using dynamic reference frames (DRFs) and fiducial frame locks (Schanz screw reference pins). System uses transformation matrices to map instrument position in real-time on imaging display. Used in OR by surgeons. Output: real-time visual navigation map on workstation monitor. Benefits: assists in precise anatomical localization for pedicle screw placement; improves surgical accuracy.

Clinical Evidence

Bench testing only. Performance validated via non-clinical accuracy verification, cadaveric studies, and compatibility testing. System demonstrated mean positional accuracy ≤ 2.0 mm and mean trajectory angle error ≤ 2.0°. Compliance with IEC 60601-1, IEC 62366-1, ISO 14971, and ASTM F2554-18/F3107-14 standards confirmed.

Technological Characteristics

Optical (infrared) navigation system using Northern Digital Vega localizer. Intel-based PC workstation. Connectivity via DICOM import (CD/DVD/USB). Software written in C++. Patient registration via fiducial frame lock/Schanz screw. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ASTM F2554-18/F3107-14 (positional accuracy).

Indications for Use

Indicated for pedicle screw entry point alignment and angular orientation in posterior approach T12 and L1 vertebral procedures, using intraoperative 3D reconstruction images for anatomical reference.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

POINT Kinguide Robotic-Assisted Surgical System (K220241)
Stealthstation S8 Spine Software v1.3.0 (K201189)
StealthStation S8 System Platforms and StealthStation Cranial Software (K162309)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. July 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. {1}------------------------------------------------ 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 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 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 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-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. Image /page/1/Picture/6 description: The image shows the text "Tejen D. Soni -5" on a white background. The text is black, and the font is simple and sans-serif. To the left of the text is a faded FDA logo. The logo is light blue and is partially transparent. 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K230087 Device Name "POINT" Kinguide Agile Hybrid Navigation System 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> 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}------------------------------------------------ #### 510(k) Summary June 21, 2023 | Company Name | Point Robotics MedTech Inc. | |--------------------------|-------------------------------------------------------------------------------| | Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist., New Taipei City 231, Taiwan | | Contact Person (Primary) | Mr. Wayne Kao | | Phone | 866-2-29130272#2610 | | Email | wayne.kao@pointroboticsinc.com | #### 1. Submitter's Information ### 2. Subject Device Information | Proprietary/Trade Name | "POINT" Kinguide Agile Hybrid Navigation System | |------------------------|-------------------------------------------------| | Regulation Name | Stereotaxic Instrument | | Regulation Number | 882.4560 | | Product Code | OLO | | Device Classification | II | | Review Panel | 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. {4}------------------------------------------------ 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 - Stealthstation™ S8 Spine Software v1.3.0 K162309 - Stealthstation™ S8 System Platforms and StealthStation Cranial Software {5}------------------------------------------------ ## 6. Comparison to the Predicate Device | Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | "POINT" Kinguide Agile Hybrid Navigation System | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | K number | N/A | K220241 | K201189 | K162309 | | Product Code | OLO | OLO | OLO | HAW, OLO, PGW | | Intended Use & 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 | "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 | The StealthStation™ 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, | The StealthStation™ System, with StealthStation Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStation™ 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, | | | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | Item | “POINT” Kinguide Agile Hybrid Navigation System | “POINT” Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | can be identified by intraoperative 3D reconstruction images. | 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). | 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 | such as the skull, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | | | 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 | 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 | 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 | | Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | | "POINT" Kinguide Agile Hybrid Navigation System | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | degrees. | trajectory error of ≤ 2 degrees. | 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 | a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees. | | Imaging Modalities | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray based, MR based Nuclear Medicine based | | Rigid Anatomical Positioning Methods | Fiducial Frame Lock is a set of optical markers mounted on a dynamic reference frame | Fiducial Frame Lock is a set of optical markers mounted on a dynamic reference frame | N/A | Patient reference frame is a set of optical markers mounted on a metal frame which allows | | | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | Item | "POINT" Kinguide Agile Hybrid Navigation System | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 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. | 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. | | user to register and track the anatomy. The reference pin docks on the bone and combines with reference frame. | | | Skin Marker Registration (Referred to as Automatic Image Registration (AIR) of predicate devices) | Surface Matching Registration Image Landmark Registration Precise Surface Registration Image Registration | PointMerge Registration SurfaceMerge Registration FluoroMerge Registration Automatic 2D Image Registration Automatic 3D Image Registration StealthAiR Spine Automatic Registration | PointMerge® registration (referred to as Landmark registrations) Tracer™ registration Touch registration (previously Touch-N- Go™) StealthAiR® registration, O-arm® registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFix™ Bone Anchor Registration) | | Registration Features | | | | | | Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | | "POINT" Kinguide Agile Hybrid Navigation System | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | Planning Features | Plan Entry and Target Selection 3D Model Building | Plan Entry and Target Selection 3D Model Building | Plan Entry and Target Selection 3D Model Building Deformity Planning | | | 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 | Siemens Arcadis Varic C- Arm Siemens Arcadis Orbic C-Arm | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm ISO-C 3D C-Arm Ziehm Vision RFD 3D C- arm Stealth-Midas MR8 Orbic 3D C-Arm | | | | View/Display Features | Look Sideways 3D View Anatomic Orthogonal Trajectory 1 and 2 | Look Sideways 3D View Anatomic Orthogonal Trajectory 1 and 2 | | | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | Item | “POINT” Kinguide Agile Hybrid Navigation System | “POINT” Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | Trajectory Guidance Probe's Eye AP and Lateral Maximum Intensity Projection | Trajectory Guidance Probe's Eye AP and Lateral Maximum Intensity Projection | Trajectory Guidance Look Ahead Probe's Eye AP and Lateral Synthetic AP and Lateral Maximum Intensity Projection Video Input | Trajectory 1 and 2, Target Guidance, Trajectory Guidance, Probes Eye, Look Ahead, Microscope Injection, Video Input, Endoscopic | | 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. | 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. | 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 right-side bar. | 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 right-side bar. | | Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | | "POINT" Kinguide Agile Hybrid Navigation System | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | Using the algorithm of transformation matrices for real-time visualization & navigation of instruments relative to patient image sets | Using the algorithm of transformation matrices for real-time visualization & navigation of instruments relative to patient image sets | Not applicable | Not applicable | | Navigation Algorithm | | | | | | Programming Language | C++ | C++ | C++ | C++ | | Scanner Interface Technology (to imaging devices) | CD, DVD, USB DICOM Import | CD, DVD, USB DICOM Import | Network Connectivity CD, DVD, USB DICOM Import DICOM Export | Network Connectivity CD, DVD, USB DICOM Import DICOM Export | | | | | | | | Localization Technology | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | | | | | | | | Computer Platform | Intel-based PC | Intel-based PC | Intel-based PC | Intel-based PC…

“POINT” Kinguide Agile Hybrid Navigation System

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“POINT” Kinguide Agile Hybrid Navigation System

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Device Story

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Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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