(186 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 and L1 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 "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. Specifically, it 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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean Positional Error ≤ 2.0 mm | Mean Positional Error ≤ 2.0 mm |
| Mean Trajectory Error ≤ 2.0° | Mean Trajectory Error ≤ 2.0° |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the test set for the accuracy verification. It mentions a "Cadaveric Validation Report," suggesting that testing was performed on cadaveric specimens, which would be retrospective data. The provenance (country of origin) of this data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device is a "Kinguide Agile Hybrid Navigation System," which is an image-guided system for surgical navigation, not an AI-assisted diagnostic tool that would typically involve human reader studies for comparative effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation of the device's accuracy was conducted. The "Non-clinical Performance (Accuracy)" section specifically states: "The system has a mean accuracy of ≤ 2.0 mm for location error and ≤ 2.0° for trajectory angle error." This refers to the intrinsic accuracy of the navigation system itself, independent of human interaction during the measurement process, aside from the initial setup and data acquisition.
7. The Type of Ground Truth Used:
The ground truth for the positional and trajectory accuracy would have been established through precise measurements using a highly accurate reference system (e.g., a calibrated measurement device or a pre-defined anatomical landmark with known coordinates) during the "Performance and Accuracy Verification Report" and "Cadaveric Validation Report." This is typically a technical ground truth rather than expert consensus or pathology.
8. The Sample Size for the Training Set:
The document describes the device as an image-guided navigation system and does not explicitly mention "training set" in the context of machine learning or AI models with distinct training phases. Therefore, no information is provided regarding the sample size for a training set.
9. How the Ground Truth for the Training Set Was Established:
As the document does not discuss a training set in the context of machine learning, it also does not elaborate on how ground truth for such a set would have been established. The core technology lies in optical positioning and image-to-patient registration, not typically in a machine learning model that requires a distinct training phase in the same way a diagnostic AI would.
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July 17, 2023
Point Robotics Medtech Inc. Wayne Kao Director, Quality Management Division 7F. No. 219, Sec. 3, Beixin Rd. Xindian Dist. New Taipei City, 231 Taiwan
Re: K230087
Trade/Device Name: "POINT" Kinguide Agile Hybrid Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 21, 2023 Received: June 21, 2023
Dear Wayne Kao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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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510(k) Summary
June 21, 2023
| Company Name | Point Robotics MedTech Inc. |
|---|---|
| Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,New Taipei City 231, Taiwan |
| Contact Person (Primary) | Mr. Wayne Kao |
| Phone | 866-2-29130272#2610 |
| wayne.kao@pointroboticsinc.com |
1. Submitter's Information
2. Subject Device Information
| Proprietary/Trade Name | "POINT" Kinguide Agile Hybrid Navigation System |
|---|---|
| Regulation Name | Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | OLO |
| Device Classification | II |
| Review Panel | Orthopedic |
3. Device Description
"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.
Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.
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The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.
*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.
4. Indications for Use
"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
5. Identification of Legally Marketing Devices
K220241 - "POINT" Kinguide Robotic-Assisted Surgical System K201189 - Stealthstation™ S8 Spine Software v1.3.0 K162309 - Stealthstation™ S8 System Platforms and StealthStation Cranial Software
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6. Comparison to the Predicate Device
| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate |
|---|---|---|---|---|
| "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | |
| K number | N/A | K220241 | 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 orpercutaneousneurosurgical andorthopedic procedures.The device is indicated forpedicle screw entry pointalignment and angularorientation when using aposterior approach intoT12 and L1 vertebrae, andwhere reference to therigid anatomical structure | "POINT" KinguideRobotic-Assisted SurgicalSystem is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneousneurosurgical andorthopedic procedures.The device is indicatedfor any medical conditionin which the use ofstereotactic spinal surgerymay be appropriate, andwhere reference to a rigidanatomical structure canbe identified relative to | The StealthStation™System, withStealthStation SpineSoftware, is intended asan aid for preciselylocating anatomicalstructures in either openor percutaneousneurosurgical andorthopedic procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, | The StealthStation™System, withStealthStation Cranialsoftware, is intended asan aid for preciselylocating anatomicalstructures in either openor percutaneous surgicalprocedures. TheStealthStation™ Systemis indicated for anymedical condition inwhich the use ofstereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, |
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |
| Item | “POINT” KinguideAgile HybridNavigation System | “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System |
| can be identified byintraoperative 3Dreconstruction images. | images of the anatomy.The indications includeall medical procedures inwhich pedicle screws areimplanted posteriorly intolumbar vertebrae (L1-L5)or sacral vertebrae (S1). | such as the spine, can beidentified relative toimages of the anatomy.This can include, but isnot limited to, thefollowing procedures:• Pedicle ScrewPlacement• Iliosacral ScrewPlacement• Interbody DevicePlacement | such as the skull, can beidentified relative to a CTor MR based model,fluoroscopy images, ordigitized landmarks ofthe anatomy. | |
| SystemAccuracyRequirement | According to verificationand validation results,Kinguide Agile hasdemonstratedperformance in 3Dpositional accuracy witha mean positional error of$≤$ 2.0 mm and meantrajectory error of $≤$ 2 | According to verificationand validation results,“POINT” KinguideRobotic-Assisted SurgicalSystem has demonstratedperformance in 3Dpositional accuracy witha mean positional error of$≤$ 2.0 mm and mean | Under representativeworst-case configuration,the StealthStation S8Spine software v1.3.0,has demonstratedperformance in 3Dpositional accuracy witha mean positional error of$≤$ 2.0 mm and mean | |
| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate |
| "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | |
| degrees. | trajectory error of ≤ 2degrees. | trajectory error of ≤ 2degrees.Mean Accuracy Values(StealthAiR Spine):Positional Error – 1.01 mmTrajectory Error – 0.37 degreesMean Accuracy Values(Overlapping Slices):Positional Error – 0.51 mmTrajectory Error -0.41 degrees | a mean error ≤ 2.0 mmand in trajectory angleaccuracy with a meanerror ≤ 2.0 degrees. | |
| ImagingModalities | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray based, MR basedNuclear Medicine based |
| 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 |
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |
| Item | "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System |
| which allows user toregister and track theanatomy. The SchanzScrew (reference pin) isdock on the iliac crestand combines with theFiducial Frame Lock. | which allows user toregister and track theanatomy. The SchanzScrew (reference pin) isdock on the iliac crestand combines with theFiducial Frame Lock. | user to register and trackthe anatomy. Thereference pin docks onthe bone and combineswith reference frame. | ||
| Skin Marker Registration(Referred to as AutomaticImage Registration (AIR)of predicate devices) | Surface MatchingRegistrationImage LandmarkRegistrationPrecise SurfaceRegistrationImage Registration | PointMerge RegistrationSurfaceMergeRegistrationFluoroMerge RegistrationAutomatic 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) | |
| RegistrationFeatures | ||||
| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate |
| "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | |
| PlanningFeatures | Plan Entry and TargetSelection3D Model Building | Plan Entry and TargetSelection3D Model Building | Plan Entry and TargetSelection3D Model BuildingDeformity Planning | |
| MedicalDeviceInterfaces | Philips XperCTSiemens Artis PhenoSiemens Artis ZeegoSiemens SOMATOMDefinition ASSiemens Arcadis Orbic3DGE Discovery IGS 730GE Discovery IGS 7 OR | Siemens Arcadis Varic C-ArmSiemens Arcadis OrbicC-Arm | O-arm Imaging SystemZiehm Vision FD Vario3D C-ArmISO-C 3D C-ArmZiehm Vision RFD 3D C-armStealth-Midas MR8Orbic 3D C-Arm | |
| View/DisplayFeatures | Look Sideways3D ViewAnatomic OrthogonalTrajectory 1 and 2 | Look Sideways3D ViewAnatomic OrthogonalTrajectory 1 and 2 | ||
| Subject Device | Primary Predicate | Software Predicate | Platform Predicate | |
| Item | “POINT” KinguideAgile HybridNavigation System | “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System |
| Trajectory GuidanceProbe's EyeAP and LateralMaximum IntensityProjection | Trajectory GuidanceProbe's EyeAP and LateralMaximum IntensityProjection | Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum IntensityProjectionVideo Input | Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probes Eye,Look Ahead, MicroscopeInjection, Video Input,Endoscopic | |
| SoftwareInterface(GUI) | 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. |
| Item | Subject Device | Primary Predicate | Software Predicate | Platform Predicate |
| "POINT" KinguideAgile HybridNavigation System | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8Spine Software v1.3.0 | StealthStation™ S8System | |
| 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 | |
| NavigationAlgorithm | ||||
| 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 Robotic-Assisted System (K20241) 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 | Compliance with ISO 14971:2019 |
| Human Factors &Usability Engineering | Usability of the system is validated in accordancewith FDA guidance of applying Human Factors andUsability Engineering to Medical Devices and IEC62366-1:2015. |
| 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 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 Software contained inMedical Devices, 2005- IEC 62304:2006 + A1:2015. |
| Reprocessing | Reusable accessories are validated in accordance |
| Verification/Validation | Description |
| with: | |
| - FDA guidance for the Reprocessing medicaldevices in health care settings: Validationmethods and labeling, 2015. | |
| - AAMI TIR30:2011/(R)2016 | |
| - AAMI TIR12:2020 | |
| Sterilization | Compliance with FDA guidance for Submission andReview of Sterility Information in PremarketNotification (510(k)) Submissions for DevicesLabeled as Sterile, 2016 |
| 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. ASTMD4169-16 | |
| Stability & Reliability | - Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devicesacc. ASTM F1980-16 |
| The system has a mean accuracy of $\leq$ 2.0 mm forlocation error and $\leq$ 2.0° for trajectory angle error. | |
| The following verification and validation areperformed in support of our performance study: | |
| Non-clinicalPerformance (Accuracy) | - Performance and Accuracy VerificationReport |
| - Cadaveric Validation Report | |
| - Compatibility and Measuring AccuracyVerification 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).