(91 days)
"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.
"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.
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.
The provided document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the "POINT" Kinguide Agile Hybrid Navigation System to previously cleared devices. It outlines the device's indications for use, a comparison to predicate devices, and lists various performance tests and compliance with standards.
However, the document does not contain the specific acceptance criteria for system performance beyond general accuracy expectations, nor does it detail the methodology or results of a study that directly proves the device meets these criteria. It refers to verification and validation results and reports overall accuracy figures, but the granular details expected for a comprehensive study description are absent.
Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is an attempt to address your request based on the available information from the document, with clear indications where the information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document states a system accuracy requirement and reports the performance. While it doesn't explicitly frame these as "acceptance criteria" for a specific study, these are the performance targets the device demonstrated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mean positional error $\leq$ 2.0 mm | Mean positional error of $\leq$ 2.0 mm (Stated as demonstrated performance) |
| Mean trajectory error $\leq$ 2 degrees | Mean trajectory error of $\leq$ 2 degrees (Stated as demonstrated performance) |
| (For pedicle screw entry point alignment and angular orientation in T12 to S1 vertebrae) | Mean accuracy of $\leq$ 2.0 mm for location error and $\leq$ 2.0° for trajectory angle error. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "verification and validation results" and "Non-clinical Performance (Accuracy)" and "Cadaveric Validation Report," but it does not provide the sample size (e.g., number of cases, number of anatomical structures, number of screws tested) for these studies.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified. The document does not provide details on the origin of the data or the study design (retrospective or prospective). The company's address is in New Taipei City, Taiwan, suggesting the studies might have been conducted there, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not mention the use of experts for establishing ground truth in the context of these performance tests. The performance assessments appear to be based on physical measurements and system capabilities rather than human expert assessment of images.
4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)
- Adjudication Method: Not applicable/Not specified. The tests described (positional and trajectory accuracy) are objective engineering and performance measurements, not typically requiring human adjudication in the way medical image interpretation might. The document does not mention any form of adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- MRMC Study: No, a MRMC comparative effectiveness study was not done or described. This device is a surgical navigation system, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Its "performance" relates to its ability to accurately track and guide surgical instruments.
- Effect Size of Human Reader Improvement: Not applicable. As no MRMC study was done, this information is not provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, implicitly. The reported "System Accuracy Requirement" and "Non-clinical Performance (Accuracy)" (mean accuracy of $\leq$ 2.0 mm for location error and $\leq$ 2.0° for trajectory angle error) appear to be measurements of the device's inherent accuracy, likely in a controlled, non-human-in-the-loop setting (e.g., phantom studies, cadaveric studies without surgical intervention by humans as the primary variable). The "Cadaveric Validation Report" and "Compatibility and Measuring Accuracy Verification Report" suggest standalone performance testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for positional and trajectory accuracy would primarily be established through physical measurements against known standards or reference points (e.g., using a precisely calibrated phantom or a CMM - coordinate measuring machine). The "Cadaveric Validation Report" implies real anatomical structures were used, where the "ground truth" for screw placement or trajectory would be derived from post-procedure imaging (e.g., CT scans) analyzed against planned trajectories and positions. It does not mention expert consensus readings or pathology.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. The document describes a navigation system, not a machine learning or AI model that requires a "training set" in the conventional sense of image data for model learning. The navigation algorithm uses transformation matrices, which are mathematical calculations based on tracking data, not a learned model from a large dataset.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As explained above, there is no "training set" for a machine learning model, and thus no ground truth establishment for such a set. The accuracy of the system's underlying mathematical algorithms and optical tracking mechanism is verified through engineering tests.
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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 (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Company Name | Point Robotics MedTech Inc. |
|---|---|
| Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,New Taipei City 231, Taiwan |
| Primary Contact | |
| Contact Person | Mrs. Sandy Lin |
| Phone | 866-2-29130272#2612 |
| sandy.lin@pointroboticsinc.com | |
| Alternate Contact | |
| Contact Person | Mr. Wayne Kao |
| Phone | 866-2-29130272#2610 |
| us.qra@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
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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" KinguideAgile HybridNavigation System | "POINT" KinguideAgile HybridNavigation System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | |||
| K number | N/A | K230087 | K201189 | K162309 | ||
| Product Code | OLO | OLO | OLO | HAW, OLO, PGW | ||
| Intended Use& Indicationsfor Use | "POINT" Kinguide AgileHybrid Navigation Systemis intended as an aid forprecisely locatinganatomical structures ineither open or percutaneousneurosurgical andorthopedic procedures.The device is indicated forpedicle screw entry pointalignment and angularorientation when using aposterior approach into T12to S1 vertebrae, and wherereference to the rigidanatomical structure can beidentified by intraoperative | "POINT" Kinguide AgileHybrid Navigation Systemis intended as an aid forprecisely locatinganatomical structures ineither open or percutaneousneurosurgical andorthopedic procedures.The device is indicated forpedicle screw entry pointalignment and angularorientation when using aposterior approach into T12and L1 vertebrae, and wherereference to the rigidanatomical structure can beidentified by intraoperative | The StealthStation™System, with StealthStationSpine Software, is intendedas an aid for preciselylocating anatomicalstructures in either open orpercutaneous neurosurgicaland orthopedic procedures.Their use is indicated forany medical condition inwhich the use of stereotacticsurgery may be appropriate,and where reference to arigid anatomical structure,such as the spine or pelvis,can be identified relative toimages of the anatomy. This | The StealthStation™System, with StealthStationCranial software, is intendedas an aid for preciselylocating anatomicalstructures in either open orpercutaneous surgicalprocedures. TheStealthStation™ System isindicated for any medicalcondition in which the useof stereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, such asthe skull, a long bone, orvertebra, can be identified | ||
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |||
| Item | "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideAgile HybridNavigation System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | ||
| 3D reconstruction images. | 3D reconstruction images. | can include, but is notlimited to, the followingprocedures:• Pedicle Screw Placement• Iliosacral Screw Placement• Interbody DevicePlacement | relative to a CT or MRbased model, fluoroscopyimages, or digitizedlandmarks of the anatomy. | |||
| SystemAccuracyRequirement | According to verificationand validation results,Kinguide Agile hasdemonstratedperformance in 3Dpositional accuracy witha mean positional error of$\leq$ 2.0 mm and meantrajectory error of $\leq$ 2degrees. | According to verificationand validation results,Kinguide Agile hasdemonstratedperformance in 3Dpositional accuracy witha mean positional error of$\leq$ 2.0 mm and meantrajectory error of $\leq$ 2degrees. | Under representativeworst-case configuration,the StealthStation S8Spine software v1.3.0,has demonstratedperformance in 3Dpositional accuracy witha mean positional error of$\leq$ 2.0 mm and meantrajectory error of $\leq$ 2degrees.Mean Accuracy Values(StealthAiR Spine):Positional Error - 1.01 | Under representativeworst-case configuration,the StealthStation S8System withStealthStation Cranialv1.0.0 Software, hasdemonstratedperformance in 3Dpositional accuracy witha mean error $\leq$ 2.0 mmand in trajectory angleaccuracy with a meanerror $\leq$ 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 | |||||
| mmTrajectory Error - 0.37degreesMean Accuracy Values(Overlapping Slices):Positional Error - 0.51mmTrajectory Error -0.41degrees | ||||||
| Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray based, MR basedNuclear Medicine based | ||
| Modalities | ||||||
| RigidAnatomicalPositioningMethods | Fiducial Frame Lock is aset of optical markersmounted on adynamic reference frame | Fiducial Frame Lock is aset of optical markersmounted on adynamic reference frame | N/A | Patient reference frame isa set of optical markersmounted on ametal frame which allows | ||
| which allows user toregister and track theanatomy. The Schanz | which allows user toregister and track theanatomy. The Schanz | user to register and trackthe anatomy. The | ||||
| Screw (reference pin) isdock on the iliac crest | Screw (reference pin) isdock on the iliac crest | reference pin docks onthe bone and combines | ||||
| with reference frame. | ||||||
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |||
| Item | "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideAgile HybridNavigation System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | ||
| and combines with theFiducial Frame Lock. | and combines with theFiducial Frame Lock. | |||||
| RegistrationFeatures | Skin Marker Registration(Referred to as AutomaticImage Registration (AIR)of predicate devices) | Skin Marker Registration(Referred to as AutomaticImage Registration (AIR)of predicate devices) | PointMerge RegistrationSurfaceMergeRegistrationFluoroMergeRegistrationAutomatic 2D ImageRegistrationAutomatic 3D ImageRegistrationStealthAiR SpineAutomaticRegistration | PointMerge® registration(referred to as Landmarkregistrations)Tracer™ registrationTouch registration(previously Touch-N-Go™)StealthAiR® registration,O-arm® registration,Mechanical basedregistrations (StereotacticLocalizer Registrationand StarFix™ BoneAnchor Registration) | ||
| PlanningFeatures | Plan Entry and TargetSelection3D Model Building | Plan Entry and TargetSelection3D Model Building | Plan Entry and TargetSelection3D Model Building | Plan Entry and Targetselection3D 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 | Navigation System | |||||
| Deformity Planning | Advanced Visualization | |||||
| MedicalDeviceInterfaces | Philips XperCT | Philips XperCT | O-arm Imaging System | Microscope Navigation: | ||
| Siemens Artis Pheno | Siemens Artis Pheno | Ziehm Vision FD Vario | Zeiss, Leica | |||
| Siemens Artis Zeego | Siemens Artis Zeego | 3D C-Arm | Ultrasound Navigation: | |||
| Siemens SOMATOMDefinition AS | Siemens SOMATOMDefinition AS | ISO-C 3D C-Arm | Aloka and Sonosite | |||
| Siemens Arcadis Orbic3D | Siemens Arcadis Orbic3D | Ziehm Vision RFD 3D C-arm | Medtronic O-arm® | |||
| GE Discovery IGS 730 | GE Discovery IGS 730 | Stealth-Midas MR8 | Stereotactic FrameSystems: Fischer ZD, | |||
| GE Discovery IGS 7 OR | GE Discovery IGS 7 OR | Orbic 3D C-Arm | Fischer RM, Integra | |||
| Ziehm Vision RFD 3D | CRW and Elekta Leksell | |||||
| Nexframe® StereotacticSystem | ||||||
| STarFix™PlatformSystem | ||||||
| View/DisplayFeatures | Look Sideways | Look Sideways | Look Sideways | Ultrasound Video In, | ||
| 3D View | 3D View | 3D | Ultrasound Overlay, | |||
| Anatomic Orthogonal | Anatomic Orthogonal | Anatomic Orthogonal | 3D, 2D Anatomic | |||
| Trajectory 1 and 2 | Trajectory 1 and 2 | Trajectory 1 and 2 | Orthogonal, | |||
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |||
| Item | "POINT" Kinguide | "POINT" Kinguide | Stealthstation™ S8 | StealthStation™ S8 | ||
| Agile HybridNavigation System | Agile HybridNavigation System | Spine Software v1.3.0 | System | |||
| Trajectory Guidance | Trajectory Guidance | Trajectory Guidance | Trajectory 1 and 2, Target | |||
| Probe's Eye | Probe's Eye | Look Ahead | Guidance, Trajectory | |||
| AP and Lateral | AP and Lateral | Probe's Eye | Guidance, Probes Eye, | |||
| Maximum Intensity | Maximum Intensity | AP and Lateral | Look Ahead, Microscope | |||
| Projection | Projection | Synthetic AP and Lateral | Injection, Video Input, | |||
| Maximum Intensity | Endoscopic | |||||
| Projection | ||||||
| Video Input | ||||||
| User friendly interfacewith procedure taskoverview at home page.System tools for imageadjustment, surgicalplanning and instrumentmanagement arecontained in a left-sidebar. The systeminformation is shown onthe right-side bar. | User friendly interfacewith procedure taskoverview at home page.System tools for imageadjustment, surgicalplanning and instrumentmanagement arecontained in a left-sidebar. The systeminformation is shown onthe right-side bar. | Black and gray style withprocedure task overviewin left menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right-side bar. | Black and gray style withprocedure task overviewin left menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right-side bar. | |||
| SoftwareInterface(GUI) | ||||||
| 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 | |||
| NavigationAlgorithm | Using the algorithm oftransformation matricesfor real-time visualization& navigation ofinstruments relative topatient image sets | Using the algorithm oftransformation matricesfor real-time visualization& navigation ofinstruments relative topatient image sets | Not applicable | Not applicable | ||
| ProgrammingLanguage | C++ | C++ | C++ | C++ | ||
| ScannerInterfaceTechnology(to imagingdevices) | CD, DVD, USBDICOM Import | CD, DVD, USBDICOM Import | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | ||
| LocalizationTechnology | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | ||
| ComputerPlatform | Intel-based PC | Intel-based PC | Intel-based PC | Intel-based PC |
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6.1. Brief Substantial Equivalence Discussion
Kinguide Agile and the predicates "POINT" Kinguide Agile Hybrid Navigation System (K230087) 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
- V Programming Language
-
Scanner Interface Technology
-
Localization Technology
- Computer Platform >
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7. 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.
| Verification/Validation | Description |
|---|---|
| General DesignRequirements | The design control process follows 21 CFR 820 |
| Risk Management | In compliance with ISO 14971 |
| Human Factors &Usability Engineering | Usability of the system is validated in accordancewith FDA guidance of applying Human Factors andUsability Engineering to Medical Devices and IEC62366-1. |
| Product Safety | Compliance with standards requirements, including:- IEC 60601-1- IEC 60601-1-2- IEC 60601-1-8 |
| Positional Accuracy | Compliance with ASTM F2554-18 and ASTMF3107-14 |
| Biocompatibility | Biocompatibility of those accessories that havingcontact with patients is evaluated in accordance withFDA guidance for the use of international standardISO 10993-1. |
| Software | System software is validated in accordance with:- FDA guidance for the Content of PremarketSubmissions for Device Software Functions,2023- IEC 62304. |
| Reprocessing | Reusable accessories are validated in accordancewith:- FDA guidance for the Reprocessing medical |
| Verification/Validation | Description |
| Verification/Validation | devices in health care settings: Validationmethods and labeling, 2015.- AAMI TIR12:2020- ANSI/AAMI ST79 |
| Sterilization | Compliance with FDA guidance for Submission andReview of Sterility Information in PremarketNotification (510(k)) Submissions for DevicesLabeled as Sterile, 2024 |
| Stability & Reliability | Stability & Reliability evaluation includes:- Standard Practice for Climatic Stressing ofPackaging Systems acc. ASTM F2825-18- Standard Practice for Performance Testing ofShipping Containers and Systems acc. ASTMD4169-22- Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devicesacc. ASTM F1980-21 |
| Non-clinicalPerformance (Accuracy) | The system has a mean accuracy of ≤2.0 mm forlocation error and ≤2.0° for trajectory angle error.The following verification and validation areperformed in support of our performance study:- Performance and Accuracy Verification Report- Cadaveric Validation Report- Compatibility and Measuring AccuracyVerification Report |
| Clinical Performance | The system has a mean accuracy of ≤2.0 mm forlocation error and ≤2.0° for trajectory angle error forpedicle screw entry point alignment and angularorientation.The following clinical data supports the Indicationsfor Use:- Clinical Evaluation Report |
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8. Conclusion
Based on the supporting evidence provided in this premarket notification, Point Robotics believes that the subject device, "POINT" Kinguide Agile Hybrid Navigation System, is substantially equivalent to the predicate devices.
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).