“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

K241130 · Point Robotics MedTech, Inc. · OLO · Jul 24, 2024 · Neurology

Device Facts

• Record ID: K241130
• Device Name: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
• Applicant: Point Robotics MedTech, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jul 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

Device Story

Kinguide Agile is an image-guided system (IGS) for neurosurgical and orthopedic procedures. It utilizes an infrared navigation camera, workstation, and surgical instruments to track patient anatomy and instruments in real-time. Input data includes intraoperative 3D images (3D C-arm or CT). The system uses optical positioning via Dynamic Reference Frames (DRFs) and fiducial frame locks to register patient anatomy. Software creates a surgical navigation map, allowing surgeons to plan procedures and track instrument position relative to anatomy. Output is displayed on a workstation monitor, providing real-time trajectory guidance and anatomical visualization. Used in OR settings by surgeons; assists in precise pedicle screw placement. Benefits include improved accuracy in anatomical localization and trajectory alignment.

Clinical Evidence

Bench testing and cadaveric validation performed. System demonstrated mean positional accuracy ≤2.0 mm and mean trajectory angle error ≤2.0 degrees. Clinical evaluation report provided to support indications for use. No specific clinical trial metrics (sensitivity/specificity) reported; validation focused on technical accuracy and usability per FDA guidance.

Technological Characteristics

Optical (infrared) navigation system using Northern Digital Vega localizer. Components: infrared camera, workstation (Intel-based PC), navigation software, and surgical instruments. Materials evaluated per ISO 10993-1. Connectivity via DICOM import (CD/DVD/USB). Software programmed in C++. Accuracy verified per ASTM F2554-18 and ASTM F3107-14. Sterilization and reprocessing validated per FDA guidance.

Indications for Use

Indicated for pedicle screw entry point alignment and angular orientation in posterior approach T12-S1 vertebral procedures, using intraoperative 3D reconstruction for anatomical reference in neurosurgical and orthopedic patients.

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 Agile Hybrid Navigation System (K230087)
• Stealthstation S8 Spine Software v1.3.0 (K201189)
• StealthStation S8 System Platforms and StealthStation Cranial Software (K162309)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

July 24, 2024

Point Robotics MedTech Inc. Sandy Lin Regulatory Researcher 7F., No.219, Sec.3, Beixin Rd., Xindian Dist. New Taipei City, 231 Taiwan

Re: K241130

Trade/Device Name: "POINT" Kinguide Agile Hybrid Navigation System (PSHF01-000) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 24, 2024 Received: April 24, 2024

Dear Sandy Lin:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# Shumaya Ali -S

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

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#### Indications for Use

510(k) Number (if known) K241130

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 to S1 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) Summary

| Company Name | Point Robotics MedTech Inc. |
|-------------------|-------------------------------------------------------------------------------|
| Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,<br>New Taipei City 231, Taiwan |
| Primary Contact | |
| Contact Person | Mrs. Sandy Lin |
| Phone | 866-2-29130272#2612 |
| Email | [e-mail] |
| Alternate Contact | |
| Contact Person | Mr. Wayne Kao |
| Phone | 866-2-29130272#2610 |
| Email | [e-mail] |

#### 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

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(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.

#### 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 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

#### 5. Identification of Legally Marketing Devices

K230087 - "POINT" Kinguide Agile Hybrid Navigation System

K201189 - Stealthstation™ S8 Spine Software v1.3.0

K162309 - Stealthstation™ S8 System Platforms and StealthStation Cranial Software

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## 6. Comparison to the Predicate Device

| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | Stealthstation™ S8<br>Spine Software v1.3.0 | StealthStation™ S8<br>System | | |
| K number | N/A | K230087 | K201189 | K162309 | | |
| Product Code | OLO | OLO | OLO | HAW, OLO, PGW | | |
| Intended Use<br>& Indications<br>for Use | "POINT" Kinguide Agile<br>Hybrid Navigation System<br>is intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or percutaneous<br>neurosurgical and<br>orthopedic procedures.<br>The device is indicated for<br>pedicle screw entry point<br>alignment and angular<br>orientation when using a<br>posterior approach into T12<br>to S1 vertebrae, and where<br>reference to the rigid<br>anatomical structure can be<br>identified by intraoperative | "POINT" Kinguide Agile<br>Hybrid Navigation System<br>is intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or percutaneous<br>neurosurgical and<br>orthopedic procedures.<br>The device is indicated for<br>pedicle screw entry point<br>alignment and angular<br>orientation when using a<br>posterior approach into T12<br>and L1 vertebrae, and where<br>reference to the rigid<br>anatomical structure can be<br>identified by intraoperative | The StealthStation™<br>System, with StealthStation<br>Spine Software, is intended<br>as an aid for precisely<br>locating anatomical<br>structures in either open or<br>percutaneous neurosurgical<br>and orthopedic procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of stereotactic<br>surgery may be appropriate,<br>and where reference to a<br>rigid anatomical structure,<br>such as the spine or pelvis,<br>can be identified relative to<br>images of the anatomy. This | The StealthStation™<br>System, with StealthStation<br>Cranial software, is intended<br>as an aid for precisely<br>locating anatomical<br>structures in either open or<br>percutaneous surgical<br>procedures. The<br>StealthStation™ System is<br>indicated for any medical<br>condition in which the use<br>of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid<br>anatomical structure, such as<br>the skull, a long bone, or<br>vertebra, can be identified | | |
| | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | |
| Item | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | Stealthstation™ S8<br>Spine Software v1.3.0 | StealthStation™ S8<br>System | | |
| | 3D reconstruction images. | 3D reconstruction images. | can include, but is not<br>limited to, the following<br>procedures:<br>• Pedicle Screw Placement<br>• Iliosacral Screw Placement<br>• Interbody Device<br>Placement | relative to a CT or MR<br>based model, fluoroscopy<br>images, or digitized<br>landmarks of the anatomy. | | |
| | System<br>Accuracy<br>Requirement | According to verification<br>and validation results,<br>Kinguide Agile has<br>demonstrated<br>performance in 3D<br>positional accuracy with<br>a mean positional error of<br>$\leq$ 2.0 mm and mean<br>trajectory error of $\leq$ 2<br>degrees. | According to verification<br>and validation results,<br>Kinguide Agile has<br>demonstrated<br>performance in 3D<br>positional accuracy with<br>a mean positional error of<br>$\leq$ 2.0 mm and mean<br>trajectory error of $\leq$ 2<br>degrees. | Under representative<br>worst-case configuration,<br>the StealthStation S8<br>Spine software v1.3.0,<br>has demonstrated<br>performance in 3D<br>positional accuracy with<br>a mean positional error of<br>$\leq$ 2.0 mm and mean<br>trajectory error of $\leq$ 2<br>degrees.<br>Mean Accuracy Values<br>(StealthAiR Spine):<br>Positional Error - 1.01 | Under representative<br>worst-case configuration,<br>the StealthStation S8<br>System with<br>StealthStation Cranial<br>v1.0.0 Software, has<br>demonstrated<br>performance in 3D<br>positional accuracy with<br>a mean error $\leq$ 2.0 mm<br>and in trajectory angle<br>accuracy with a mean<br>error $\leq$ 2.0 degrees. | |
| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | |
| | "POINT" Kinguide | "POINT" Kinguide | Stealthstation™ S8 | StealthStation™ S8 | | |
| | Agile Hybrid | Agile Hybrid | Spine Software v1.3.0 | System | | |
| | Navigation System | Navigation System | | | | |
| | | | 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 | | | |
| Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray based, MR based<br>Nuclear Medicine based | | |
| Modalities | | | | | | |
| Rigid<br>Anatomical<br>Positioning<br>Methods | Fiducial Frame Lock is a<br>set of optical markers<br>mounted on a<br>dynamic reference frame | Fiducial Frame Lock is a<br>set of optical markers<br>mounted on a<br>dynamic reference frame | N/A | Patient reference frame is<br>a set of optical markers<br>mounted on a<br>metal frame which allows | | |
| | which allows user to<br>register and track the<br>anatomy. The Schanz | which allows user to<br>register and track the<br>anatomy. The Schanz | | user to register and track<br>the anatomy. The | | |
| | Screw (reference pin) is<br>dock on the iliac crest | Screw (reference pin) is<br>dock on the iliac crest | | reference pin docks on<br>the bone and combines | | |
| | | | | with reference frame. | | |
| | Subject Device | Primary Predicate | Software Predicate | Platform Predicate | | |
| Item | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | "POINT" Kinguide<br>Agile Hybrid<br>Navigation System | Stealthstation™ S8<br>Spine Software v1.3.0 | StealthStation™ S8<br>System | | |
| | and combines with the<br>Fiducial Frame Lock. | and combines with the<br>Fiducial Frame Lock. | | | | |
| Registration<br>Features | Skin Marker Registration<br>(Referred to as Automatic<br>Image Registration (AIR)<br>of predicate devices) | Skin Marker Registration<br>(Referred to as Automatic<br>Image Registration (AIR)<br>of predicate devices) | PointMerge Registration<br>SurfaceMerge<br>Registration<br>FluoroMerge<br>Registration<br>Automatic 2D Image<br>Registration<br>Automatic 3D Image<br>Registration<br>StealthAiR Spine<br>Automatic<br>Registration | PointMerge® registration<br>(referred to as Landmark<br>registrations)<br>Tracer™ registration<br>Touch registration<br>(previously Touch-N-<br>Go™)<br>StealthAiR® registration,<br>O-arm® registration,<br>Mechanical based<br>registrations (Stereotactic<br>Localizer Registration<br>and StarFix™ Bone<br>Anchor Registration) | | |
| | Planning<br>Features | Plan Entry and Target<br>Selection<br>3D Model Building | Plan Entry and Target<br>Selection<br>3D Model Building | Plan Entry and Target<br>Selection<br>3D Model Building | Plan Entry and Target<br>selection<br>3D Model Building | |
| | | Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate |
| | | | "POINT" Kinguide | "POINT" Kinguide | Stealthstation™ S8 | StealthStation™ S8 |
| | Agile Hybrid | | Agile Hybrid | Spine Software v1.3.0 | System | |
| | Navigation System…