“POINT” Kinguide Robotic-Assisted Surgical System
Device Facts
| Record ID | K220241 |
|---|---|
| Device Name | “POINT” Kinguide Robotic-Assisted Surgical System |
| Applicant | Point Robotics MedTech, Inc. |
| Product Code | OLO · Neurology |
| Decision Date | Aug 9, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Indications for Use
“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 images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
Device Story
Kinguide Robotic-Assisted Surgical System is an orthopedic stereotaxic device; consists of hand-held robot, passive arm, workstation, infrared navigation camera, navigation software, C-arm ring calibrator, and surgical accessories. Input: patient images (CT) and real-time spatial positioning data from infrared camera tracking Dynamic Reference Frames (DRFs) on patient and tools. Workstation processes data to register patient anatomy to images; establishes surgical navigation map. Surgeon uses hand-held robot, supported by passive arm, to find surgical trajectories; robot provides high-precision positioning for instruments. Used in OR; operated by surgeons. Output: visual navigation map on workstation display; physical guidance for instrument placement. Benefits: increased precision in locating anatomical structures; stable movement; prevention of unexpected instrument drops.
Clinical Evidence
No clinical data. Evidence based on bench testing and cadaveric validation. Performance testing included positional accuracy verification (mean positional error ≤2.0 mm, mean trajectory error ≤2°), human factors/usability engineering (IEC 62366-1), product safety (IEC 60601 series), biocompatibility (ISO 10993-1), and environmental/mechanical stress testing (ASTM/IEC standards).
Technological Characteristics
Orthopedic stereotaxic system. Components: hand-held robot, passive arm, workstation (Intel-based PC), infrared navigation camera (Northern Digital Vega). Connectivity: DICOM import via CD/DVD/USB. Software: C++ based. Accuracy: ≤2.0 mm positional, ≤2° trajectory. Sterilization: Reusable accessories validated per AAMI TIR30/TIR12. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-77, ASTM F2554-18, ASTM F3107-14.
Indications for Use
Indicated for patients requiring stereotactic spinal surgery where rigid anatomical structures can be identified via imaging. Specifically indicated for posterior pedicle screw implantation in lumbar (L1-L5) or sacral (S1) vertebrae.
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
- Stealthstation™ S8 Spine Software v1.3.0 (K201189)
- StealthStation™ S8 System (K162309)
- Stealth-Midas System (K160713)
Submission Summary (Full Text)
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August 9, 2022
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.
Point Robotics MedTech Inc. Wayne Kao, Director 7F., No.219, Sec.3, Beixin Rd., Xindian Dist. New Taipei City, 231 Taiwan
### Re: K220241
Trade/Device Name: "POINT" Kinguide Robotic-Assisted Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 25, 2022 Received: d-
#### Dear Mr. 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.
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
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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,
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
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### Indications for Use
510(k) Number (if known) K220241
Device Name
"POINT" Kinguide Robotic-Assisted Surgical System
Indications for Use (Describe)
"POINT" Kinguide Robotic-Assisted 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 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 images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
Type of Use (*Select one or both, as applicable*):
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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### 510(k) Summary
January 13, 2022
### 1. Submitter's Information
#### Submission Submitter
| Company Name | Point Robotics MedTech Inc. |
|----------------|-------------------------------------------------------------------------------|
| Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,<br>New Taipei City 231, Taiwan |
| Contact Person | Mr. Wayne Kao |
| Phone | 866-2-29130272#165 |
| Email | wayne.kao@pointroboticsinc.com |
| Proprietary/Trade Name | “POINT” Kinguide Robotic-Assisted Surgical System |
|------------------------|---------------------------------------------------|
| Regulation Name | Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | OLO |
| Device Classification | II |
| Review Panel | Orthopedic |
### 2. Subject Device Information
# 3. Device Description
"POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation.
The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the
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patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools.
# 4. Indications for Use
"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 images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
# 5. Identification of Legally Marketing Devices
K201189 - StealthstationTM S8 Spine Software v1.3.0 K162309 - StealthstationTM S8 System Platforms and StealthStation Cranial Software K160713 - Stealth-Midas System
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# 6. Comparison to the Predicate Device
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | “POINT” Kinguide<br>Robotic-Assisted | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | Surgical System | | | |
| | | | | |
| K number | N/A | K201189 | K162309 | K160713 |
| Product Code | OLO | OLO | HAW, OLO, PGW | OLO |
| Intended Use &<br>Indications for<br>Use | “POINT” Kinguide<br>Robotic-Assisted<br>Surgical System is<br>intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or<br>percutaneous<br>neurosurgical and<br>orthopedic procedures.<br>The device is indicated<br>for any medical condition<br>in which the use of<br>stereotactic spinal<br>surgery may be<br>appropriate, and where | The StealthStation™<br>System, with<br>StealthStation Spine<br>Software, is intended as an<br>aid for precisely locating<br>anatomical structures in<br>either open or<br>percutaneous<br>neurosurgical and<br>orthopedic procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of<br>stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid | The StealthStation™<br>System, with<br>StealthStation Cranial<br>software, is intended as an<br>aid for precisely locating<br>anatomical structures in<br>either open or<br>percutaneous surgical<br>procedures. The<br>StealthStationTM System<br>is indicated for any<br>medical condition in which<br>the use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to a rigid | The Stealth-Midas System<br>is indicated for the<br>drilling, burring and<br>removal of hard tissue and<br>bone in spinal surgical<br>procedures. Computer-<br>assisted surgery and its<br>associated applications are<br>intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or<br>percutaneous procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of |
| | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| Item | "POINT" Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | reference to a rigid<br>anatomical structure can<br>be identified relative to<br>images of the anatomy.<br>The indications include<br>all medical procedures in<br>which pedicle screws are<br>implanted posteriorly<br>into lumbar vertebrae<br>(L1-L5) or sacral<br>vertebrae (S1). | anatomical structure, such<br>as the spine or pelvis, can<br>be identified relative to<br>images of the anatomy.<br>This can include, but is<br>not limited to, the<br>following procedures:<br>• Pedicle Screw Placement<br>• Iliosacral Screw<br>Placement<br>• Interbody Device<br>Placement | anatomical structure, such<br>as the skull, can be<br>identified relative to a CT<br>or MR based model,<br>fluoroscopy images, or<br>digitized landmarks of the<br>anatomy. | stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid<br>anatomical structure, such<br>as a long bone, or<br>vertebra, can be identified<br>relative to a CT- or MR-<br>based model, fluoroscopic<br>images, or digitized<br>landmarks of the anatomy. |
| | System<br>Accuracy<br>Requirement | According to verification<br>and validation results,<br>"POINT" Kinguide<br>Robotic-Assisted<br>Surgical System has<br>demonstrated<br>performance in 3D | Under representative<br>worst-case configuration,<br>the StealthStation S8<br>Spine software v1.3.0, has<br>demonstrated performance<br>in 3D positional accuracy<br>with a mean positional | Under representative<br>worst-case configuration,<br>the StealthStation S8<br>System with StealthStation<br>Cranial v1.0.0 Software,<br>has demonstrated<br>performance in 3D |
| | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| Item | "POINT" Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | positional accuracy with<br>a mean positional error of<br>$\leq$ 2.0 mm and mean<br>trajectory error of $\leq$ 2<br>degrees. | error of $\leq$ 2.0 mm and<br>mean trajectory error of $\leq$<br>2 degrees.<br>Mean Accuracy Values<br>(StealthAiR Spine):<br>Positional Error – 1.01<br>mm<br>Trajectory Error – 0.37<br>degrees<br>Mean Accuracy Values<br>(Overlapping Slices):<br>Positional Error - 0.51<br>mm<br>Trajectory Error -0.41<br>degrees | positional accuracy with a<br>mean error $\leq$ 2.0 mm and<br>in trajectory angle<br>accuracy with a mean error<br>$\leq$ 2.0 degrees. | |
| Imaging<br>Modalities | X-Ray based (CT) | X-Ray Based Imaging | X-Ray based, MR based<br>Nuclear Medicine based | Identified relative to a CT-<br>or MR-based model |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| | “POINT” Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | Surface Matching<br>Registration<br>Image Landmark<br>Registration<br>Precise Surface<br>Registration<br>Image Registration | PointMerge Registration<br>SurfaceMerge<br>Registration<br>FluoroMerge Registration<br>Automatic 2D Image<br>Registration<br>Automatic 3D Image<br>Registration<br>StealthAiR Spine<br>Automatic Registration | PointMerge® registration<br>(referred to as Landmark<br>registrations)<br>Tracer™ registration<br>Touch registration<br>(previously Touch-N-Go™)<br>StealthAiR® registration,<br>O-arm® registration,<br>Mechanical based<br>registrations (Stereotactic<br>Localizer Registration and<br>StarFix™ Bone Anchor<br>Registration) | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| | Registration<br>Features | | | |
| | | | | |
| Planning<br>Features | Plan Entry and Target<br>Selection<br>3D Model Building | Plan Entry and Target<br>Selection<br>3D Model Building<br>Deformity Planning | Plan Entry and Target<br>selection<br>3D Model Building<br>Advanced Visualization | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| Medical Device<br>Interfaces | “POINT” Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | Siemens Arcadis Varic C-<br>Arm<br>Siemens Arcadis Orbic<br>C-Arm | O-arm Imaging System<br>Ziehm Vision FD Vario<br>3D C-Arm<br>ISO-C 3D C-Arm<br>Ziehm Vision RFD 3D C-arm<br>Stealth-Midas MR8<br>Orbic 3D C-Arm | Microscope Navigation:<br>Zeiss, Leica<br>Ultrasound Navigation:<br>Aloka and Sonosite<br>Medtronic O-arm®<br>Stereotactic Frame<br>Systems: Fischer ZD,<br>Fischer RM, Integra CRW<br>and Elekta Leksell<br>Nexframe® Stereotactic<br>System<br>STarFix™Platform System | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| | View/Display<br>Features | Look Sideways<br>3D View<br>Anatomic Orthogonal<br>Trajectory 1 and 2<br>Trajectory Guidance<br>Probe's Eye<br>AP and Lateral | Look Sideways<br>3D<br>Anatomic Orthogonal<br>Trajectory 1 and 2<br>Trajectory Guidance<br>Look Ahead<br>Probe's Eye | Ultrasound Video In,<br>Ultrasound Overlay,<br>3D, 2D Anatomic<br>Orthogonal,<br>Trajectory 1 and 2, Target<br>Guidance, Trajectory<br>Guidance, Probes Eye, |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| “POINT” Kinguide<br>Robotic-Assisted<br>Surgical System | | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System |
| | Maximum Intensity<br>Projection | AP and Lateral<br>Synthetic AP and Lateral<br>Maximum Intensity<br>Projection<br>Video Input | Look Ahead, Microscope<br>Injection, Video Input,<br>Endoscopic | |
| Software<br>Interface (GUI) | User friendly interface<br>with procedure task<br>overview at home page.<br>System tools for image<br>adjustment, surgical<br>planning and instrument<br>management are<br>contained in a left-side<br>bar. The system<br>information is shown on<br>the right-side bar. | Black and gray style with<br>procedure task overview<br>in left menu option and<br>next/back task flow at<br>bottom of the screen.<br>Software controls for<br>images, planning and<br>instrument management<br>are contained in a right-<br>side bar. | Black and gray style with<br>procedure task overview in<br>left menu option and<br>next/back task flow at<br>bottom of the screen.<br>Software controls for<br>images, planning and<br>instrument management<br>are contained in a right-<br>side bar. | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| Programming<br>Language | C++ | C++ | C++ | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| | "POINT" Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | |
| | | | | navigation solutions. |
| Scanner<br>Interface<br>Technology<br>(to imaging<br>devices) | CD, DVD, USB<br>DICOM Import | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| Localization<br>Technology | Optical (infra-red)<br>Manufacturer: Northern<br>Digital<br>Localizer: Vega | Optical (infra-red)<br>Manufacturer: Northern<br>Digital<br>Localizer: Vega | Optical (infra-red)<br>Manufacturer: Northern<br>Digital<br>Localizer: Vega | Optical (infra-red)<br>Manufacturer: Northern<br>Digital<br>Localizer: Vega |
| Computer<br>Platform | Intel-based PC | Intel-based PC | Intel-based PC | Stealth-Midas integrates<br>seamlessly with<br>StealthStation surgical<br>navigation solutions. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| “POINT” Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0 | StealthStation™ S8<br>System | Stealth-Midas System | |
| Drill System | The Kinguide Surgical<br>System has a hand-held<br>robot. The hand-held<br>robot can be identified by<br>the infrared navigation<br>camera through the<br>Robotic Base Frame<br>(BF). It has high freedom<br>of operation and high-<br>precision positioning<br>ability. It is used to<br>position the surgical<br>instrument connected to<br>the end-effector of the<br>robot. | Not Applicable | Not Applicable | The Stealth-Midas™ is a<br>high-speed drill with a<br>permanently attached<br>tracker that allows for<br>intraoperative navigation<br>of spinal procedures using<br>the StealthStation™<br>surgical navigation<br>system. |
| Mechanical<br>Support | A passive arm of this<br>system is applied to<br>support the hand-held<br>robot during surgeries. It | Not Applicable | Not Applicable | A standard handpiece drill<br>with a permanently<br>attached tracker. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| | "POINT" Kinguide<br>Robotic-Assisted<br>Surgical System | Stealthstation™ S8 Spine<br>Software v1.3.0…
