FDA K230087 Point Kinguide Agile Hybrid Navigation System Instructions

FDA K230087 Point Kinguide Agile Hybrid Navigation System

Product Information

Specifications

• Trade/Device Name: POINT Kinguide Agile Hybrid Navigation
  System

• Regulation Number: 21 CFR 882.4560

• Regulatory Class: Class II

• Product Code: OLO

Product Usage Instructions

Indications for Use

The 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. It is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

Type of Use

This device is for Prescription Use (Part 21 CFR 801 Subpart D).

How to Use the POINT Kinguide Agile Hybrid Navigation System

Step 1: Preparing the Device

Ensure the device is properly sterilized before each use according to the manufacturer’s instructions.

Step 2: Positioning the Device

Place the device in the desired location for navigation, ensuring proper alignment with the patient’s anatomy.

Step 3: Operating the Device

Follow the on-screen instructions to navigate and locate anatomical structures accurately during the surgical procedure.

Step 4: Post-Procedure Care

After use, clean and sterilize the device again following recommended procedures to ensure safe reuse or proper disposal.

Frequently Asked Questions

Q: How often should the device be calibrated?

A: The device should be calibrated according to the manufacturer’s recommendations, typically before each use or as specified in the user manual.

Q: Can the system be used for procedures other than neurosurgical and orthopedic?

A: The system is specifically designed and indicated for neurosurgical and orthopedic procedures as described in the user manual. Its use for other procedures should be verified with medical professionals.

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

K230087 – Wayne Kao

• 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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-regulatory-assistance/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. SoniFor
  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

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)

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Point Robotics MedTech Inc. 510(k) Notification

Kinguide Agile
510(k) Number: K230087

510(k) Summary

June 21, 2023

Submitter’s Information

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

Subject Device Information

Device Description

“POINT” Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an image- guided 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.

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.

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.

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

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
| “POINT” Kinguide Agile| “POINT” Kinguide| The StealthStation™| The StealthStation™
| Hybrid Navigation System| Robotic-Assisted Surgical| System, with| System, with
| is intended as an aid for| System is intended as an| StealthStation Spine| StealthStation Cranial
| precisely locating| aid for precisely locating| Software, is intended as| software, is intended as
| anatomical structures in| anatomical structures in| an aid for precisely| an aid for precisely
| either open or| either open or| locating anatomical| locating anatomical
| percutaneous| percutaneous| structures in either open| structures in either open
Intended Use| neurosurgical and| neurosurgical and| or percutaneous| or percutaneous surgical
& Indications| orthopedic procedures.| orthopedic procedures.| neurosurgical and| procedures. The
for Use| The device is indicated for| The device is indicated| orthopedic procedures.| StealthStationTM System
| pedicle screw entry point| for any medical condition| Their use is indicated for| is indicated for any
| alignment and angular| in which the use of| any medical condition in| medical condition in
| orientation when using a| stereotactic spinal surgery| which the use of| which the use of
| posterior approach into| may be appropriate, and| stereotactic surgery may| stereotactic surgery may
| T12 and L1 vertebrae, and| where reference to a rigid| be appropriate, and where| be appropriate, and where
| where reference to the| anatomical structure can| reference to a rigid| reference to a rigid
| rigid anatomical structure| be identified relative to| anatomical structure,| anatomical structure,

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
| can be identified by| images of the anatomy.| such as the spine, can be| such as the skull, can be
intraoperative 3D| The indications include| identified relative to| identified relative to a CT
reconstruction images.| all medical procedures in| images of the anatomy.| or MR based model,
| which pedicle screws are| This can include, but is| fluoroscopy images, or
| implanted posteriorly into| not limited to, the| digitized landmarks of
| lumbar vertebrae (L1-L5)| following procedures:| the anatomy.
| or sacral vertebrae (S1).| •  Pedicle Screw|
| | Placement|
| | •  Iliosacral Screw|
| | Placement|
| | •  Interbody Device|
| | Placement|
| According to verification| According to verification| Under representative| Under representative
| and validation results,| and validation results,| worst-case configuration,| worst-case configuration,
| Kinguide Agile has| “POINT” Kinguide| the StealthStation S8| the StealthStation S8
System| demonstrated| Robotic-Assisted Surgical| Spine software v1.3.0,| System with
Accuracy| performance in 3D| System has demonstrated| has demonstrated| StealthStation Cranial
Requirement| positional accuracy with| performance in 3D| performance in 3D| v1.0.0 Software, has
| a mean positional error of| positional accuracy with| positional accuracy with| demonstrated
| ≤ 2.0 mm and mean| a mean positional error of| a mean positional error of| performance in 3D
| trajectory error of ≤ 2| ≤ 2.0 mm and mean| ≤ 2.0 mm and mean| positional accuracy with

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

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
| 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.

Registration Features

| 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)

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
| 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.

Registration Features

| 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)

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
| 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

Navigation Algorithm

| 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
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

Brief Substantial Equivalence Discussion

Kinguide Agile and the predicates- “POINT” Kinguide Robotic-Assisted Surgical System (K220241) and StealthStation™ 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

Performance Testing

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.

The design control process follows 21 CFR 820.

Risk Management| Compliance with ISO 14971:2019

Human Factors & Usability Engineering

| 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.

Product Safety

| 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

Positional Accuracy| Compliance with ASTM F2554-18 and ASTM

F3107-14

Biocompatibility

| 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.

Software

| 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.

Reprocessing| Reusable accessories are validated in accordance
Verification/Validation| 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

Sterilization

| 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

| 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

Non-clinical Performance (Accuracy)

| 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

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.

References

• HHS Accessibility & Section 508 | HHS.gov
• U.S. Food and Drug Administration
• U.S. Food and Drug Administration
• 510(k) Premarket Notification
• Postmarketing Safety Reporting for Combination Products | FDA
• Device Advice: Comprehensive Regulatory Assistance | FDA
• Contact Us – Division of Industry and Consumer Education (DICE) | FDA
• Medical Device Reporting (MDR): How to Report Medical Device Problems | FDA

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