(90 days)
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic guidance features: freehand navigation and robotic guidance.
The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.
The robotic guidance feature utilizes the same principle of optical position determination technology. The system componentss include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the SURGIVISIO Device:
Note: The provided text is an FDA 510(k) summary, which often focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing the design and execution of individual performance studies, especially clinical ones. As such, some of the requested information (like specific sample sizes for test/training sets, detailed expert qualifications, adjudication methods, and MRMC study details) is not explicitly present or fully elaborated in this type of document. I will extract what is directly stated and highlight where information is absent.
Acceptance Criteria and Device Performance
The acceptance criteria for the SURGIVISIO Device are implicitly defined by its comparison to the predicate devices, specifically regarding "System accuracy" and "Device accuracy." The device claims to meet these criteria.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate) | Reported Device Performance (SURGIVISIO Device) |
|---|---|---|
| Freehand Navigation Feature | ||
| Mean navigation accuracy | ± 2mm point (tip) displacement and ± 2° angular axis displacement | Mean navigation accuracy of ± 2mm point (tip) displacement and ± 2° angular axis displacement |
| Robotic Guidance Feature | ||
| Device accuracy | <2 mm | <2 mm |
| Angular error | <2 degrees | <2 degrees |
Study Details
The document states that no clinical tests were conducted to demonstrate substantial equivalence. The performance was assessed through nonclinical tests.
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated. The nonclinical tests included "Design verification tests," "Software development and testing," "Biocompatibility evaluation," "Electrical safety and electromagnetic compatibility (EMC) testing," and "validated with intended users in cadaver labs and simulated use testing." The sample sizes for these various nonclinical tests are not provided.
- Data Provenance: The document implies these were internal nonclinical tests conducted by the manufacturer (eCential Robotics, France). There is no mention of country of origin for specific data or whether it was retrospective or prospective, as these are typically clinical study terms.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not explicitly stated. While "validated with intended users in cadaver labs and simulated use testing" suggests experts (surgeons, medical professionals) were involved, the number of such individuals is not provided.
- Qualifications of Experts: Not explicitly stated. The term "intended users" implies relevant medical professionals, but specific qualifications (e.g., years of experience, specialty) are not detailed.
-
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. Given that performance was assessed via non-clinical tests and simulated use, formal expert adjudication methods like 2+1 or 3+1 typically used in clinical imaging studies would not apply in the same way. The validation would likely involve confirmation by engineering/QA teams based on pre-defined test protocols and possibly feedback from the "intended users" during cadaver/simulated labs.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:
- MRMC Study: No. The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, no MRMC study was performed.
- Effect Size: Not applicable, as no MRMC study was conducted.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not explicitly separated as a "standalone" study in the context of AI algorithms. The device itself is an intraoperative guidance system intended for human-in-the-loop use. The "Design verification tests," "Software development and testing," "Biocompatibility," "Electrical safety and EMC" are all tests of the device's components and system performance in a non-human environment or against engineering standards. The accuracy metrics mentioned (e.g., "Device accuracy: <2 mm") can be considered a form of standalone performance measurement of the system's precision, separate from the clinical outcome.
-
The type of ground truth used:
- Ground Truth: For the nonclinical performance evaluations (accuracy, safety, etc.), the ground truth would be based on engineering measurements, reference standards, and predetermined design specifications. For example, device accuracy (positional and angular) would be measured against highly precise metrology systems. In the "cadaver labs and simulated use testing," the "ground truth" would likely be the desired surgical outcome or precise instrument placement as verified by imaging or other means, in a controlled environment.
-
The sample size for the training set:
- Training Set Sample Size: Not applicable or not provided. The SURGIVISIO Device is described as using "established computer-assisted orthopedic surgery technologies" and "optical localization technology," implying a more deterministic or rule-based system or one pre-trained on generic data, rather than a machine learning model that requires a specific training set to be described in this context. If there are AI components that rely on a training set, the size and nature of that set are not mentioned in this summary.
-
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable or not provided, for the same reasons as point 7.
{0}------------------------------------------------
July 6, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an eagle with outstretched wings, while the FDA part has the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Ecential Robotics Sarah Lefevre-Billard Zone Mayencin II, Parc Equation - Bâtiment 1, 2 avenue de Vignate Gieres. 38610 France
Re: K221028
Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 4, 2022 Received: April 7, 2022
Dear Sarah Lefevre-Billard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
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 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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221028
Device Name SURGIVISIO Device
Indications for Use (Describe)
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Submitter Information
| Submitter: | ECENTIAL ROBOTICS2 avenue de VignateZone Mayencin II, Parc Equation – Bâtiment 138610 GièresFrance |
|---|---|
| Contact Person: | Mathilde SAULPICQuality and Regulatory Affairs EngineerPhone: +33 4 58 00 57 21Email: mathilde.saulpic@ecential-robotics.com |
| Date Summary Prepared: | April 4th, 2022 |
| Device Information | |
| Trade or proprietary name: | SURGIVISIO Device |
| Common or usual name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Regulatory class: | II |
| Primary product code: | OLO |
| Legally marketed device to which equivalence is claimed: | K141941 Stryker SpineMap® 3D Navigation System(available with SpineMask™ tracking device) by StrykerLeibinger GmbH & Co for the free hand navigation feature of the SURGIVISIO Device [Primary], andK182848 ROSA® ONE Spine application by MedtechS.A.(Zimmer Biomet) for the robotic guidance feature of the SURGIVISIO Device. |
| Device Description: | The SURGIVISIO Device is a medical device thatprovides 2D/3D medical imaging and stereotaxicguidance. The subject device offers two stereotaxicguidance features: freehand navigation and roboticguidance.The freehand navigation feature is based on the standardand established technique of navigation systems utilizingoptical position determination technology. Like currentlymarketed optical tracking navigation systems, theoperating principle of the freehand navigation feature isbased upon the use of a stereoscopic camera emittinginfrared light which can determine a 3D position ofreflective marker spheres. This allows for real-timetracking of the marker spheres. The system components |
| Traditional 510(k)Section 05 – 510(k) Summary | SURGIVISIODevice |
| include a stereoscopic camera (SURGIVISIO CameraPole), a computer platform with monitors (SURGIVISIOStation) and navigation software (3D Spine UniversalWorkflow software application) and instruments equippedwith marker spheres to enable an exact localization inspace.The robotic guidance feature utilizes the same principleof optical position determination technology. The systemcomponentss include a stereoscopic camera(SURGIVISIO Camera Pole), a computer platform withmonitors (SURGIVISIO Station) and a navigationsoftware (3D Spine Robotic Workflow softwareapplication), a robotic arm (CoBot), and instrumentsequipped with marker spheres to enable an exactlocalization in space. | |
| Indications for use: | The SURGIVISIO Device is intended to be used duringsurgical procedures in which the physician would benefitfrom the visualization of 2D medical imaging and/orintraoperatively generated 3D medical imaging ofanatomical structures or objects with high x-rayattenuation such as bony anatomy or metallic objects.Such procedures include procedures during which thespine, pelvis, or articulation structures are visualizedThe SURGIVISIO Device through its freehand navigationfeature is intended as an intraoperative guidance systemto enable open or percutaneous computer-assistedsurgery. It is indicated for conditions of the spine in whichthe use of stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical bony structure canbe identified relative to the intraoperatively generated 3Dimage of the anatomy provided by the SURGIVISIODevice. It is indicated to precisely position the NavigatedTargeting Needle SPX1 during general spinal procedureswith a posterior approach.The SURGIVISIO Device through its robotic guidancefeature is intended for the positioning of instrumentholders or tool guides to be used by surgeons to guidethe Spine CoBot instruments during general spinalsurgery.Guidance is based on an intra-operative plan developedwith three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIODevice. It is indicated for positioning of surgicalinstruments in vertebrae with a posterior approach in thethoracolumbar region.The SPX1 instruments and Spine CoBot instruments areintended to be used with the SURGIVISIO Device. |
{4}------------------------------------------------
{5}------------------------------------------------
Summary of Technological Characteristics and Comparison to Predicate Device
There are no new technological characteristics in the SURGIVISIO Device as compared to the predicate device. A comparison of the technological characteristics of the SURGIVISIO Device freehand navigation feature to the predicate, the Stryker SpineMap® 3D Navigation System (available with the SpineMask™ tracking device) is provided below:
| Characteristics | Free Hand Navigation Feature ofthe SURGIVISIO Device | The Stryker SpineMap® 3DNavigation System withSpineMask™ tracking device(K141941) |
|---|---|---|
| (Subject device) | (Predicate device) | |
| Intended use | The SURGIVISIO Device through itsfreehand navigation feature isintended as an intraoperativeguidance system to enable open orpercutaneous computer-assistedsurgery.It is indicated for conditions of the | The Stryker SpineMap® 3D NavigationSystem, when used with a Strykercomputer workstation, is intended as aplanning and intraoperative guidancesystem to enable open or percutaneouscomputer-assisted surgery.The system is indicated for any medical |
| spine in which the use of stereotacticsurgery may be appropriate, andwhere reference to a rigid anatomicalbony structure can be identifiedrelative to the intraoperativelygenerated 3D image of the anatomyprovided by the SURGIVISIO Device.It is indicated to precisely position theNavigated Targeting Needle SPX1during general spinal procedures witha posterior approach. | condition in which the use of computer-assisted planning and surgery may beappropriate. The system can be usedfor intraoperative guidance where areference to a rigid anatomical structurecan be identified.The Stryker SpineMap® 3D NavigationSystem assists in the precisepositioning of instruments forprocedures on the spine, including:• Pedicle screw placementStryker SpineMask™ TrackerIndications for UseThe Stryker SpineMask™ Tracker isintended to be used as an accessory tothe Stryker SpineMap® 3D NavigationSystem. It is placed onto the patient'sskin dorsal to the spine.• In combination withintraoperative imaging devices, itenables automatic patient registration | |
| Device | ||
| for open or percutaneous computer-assisted surgery.• When used for patient tracking,the Stryker SpineMask™ Trackersupports minimally invasive procedureson the lumbar and thoracic spine | ||
| Principle ofoperation | Uses established computer-assistedorthopedic surgery technologies tonavigate targeting needles. | Uses established computer-assistedorthopedic surgery technologies tonavigate targeting needles. |
| Optical localization technology is usedto collect intraoperative data and trackthe relative position of the navigatedtargeting needle during surgery | Optical localization technology is usedto collect intraoperative data and trackthe relative position of the navigatedtargeting needle during surgery | |
| Uses infrared optical passive sensingtechnology to collect intraoperativedata and track the relative position ofthe navigated targeting needle duringsurgery | Uses infrared optical active sensingtechnology to collect intraoperativedata and track the relative position ofthe navigated targeting needle duringsurgery | |
| Uses Automatic IntraoperativeRegistration | Uses Automatic intraoperativeregistration or anatomical registrationor 3D C-Arm registration | |
| If the computer unit or camera fails,the user reverts to conventionalmanual | If the computer unit or camera fails, theuser reverts to conventional manual | |
| SystemaccuracyStatement | Mean navigation accuracy of ± 2mmpoint (tip) displacement and ± 2°angular axis displacement | Mean navigation accuracy of ± 2mmpoint (tip) displacement and ± 2°angular axis displacement |
| DedicatedSoftware | Dedicated freehand spine navigationapplication software | Dedicated freehand spine navigationapplication software |
| Characteristics | Robotic guidance feature of theSurgivisio Device(Spine CoBot Solution)(Subject device) | ROSA One Spine application(K182848)(Predicate device) |
| Intended use | The SURGIVISIO Device through itsrobotic guidance feature is intendedfor the positioning of instrumentholders or tool guides to be used bysurgeons to guide the Spine CoBotinstruments during general spinalsurgery.Guidance is based on an intra-operative plan developed with three-dimensional imaging software basedon intra-operative 3D images providedby the SURGIVISIO Device.It is indicated for positioning of surgicalinstruments in vertebrae with aposterior approach in thethoracolumbar region.The SPX1 instruments and SpineCoBot instruments are intended to beused with the SURGIVISIO Device. | The ROSA one spine application isintended for the spatial positioning andorientation of instrument holders or toolguides to be used by surgeons to guidestandard surgical instruments duringspine surgeries. Guidance is based onan intraoperative plan developed withthree-dimensional imaging softwareprovided that the required fiducialmarkers and rigid patient anatomy canbe identified on 3D CT scans. Thedevice is intended for the placement ofpedicle screws in vertebrae with aposterior approach in thethoracolumbar region |
| General devicetechnologydescription | Computer-controlledelectromechanical arm guidingneurosurgical instruments | Computer-controlledelectromechanical arm guidingneurosurgical instruments |
| Global systemfunctionalprincipal | Stereotactic robotic navigationguidance of spine surgical instrumentbased on an intra-operative plandeveloped with three-dimensionalimaging software which is based onintraoperative 3D images using anoptical system (infrared camera) | Stereotactic robotic navigationguidance of spine surgical instrumentbased on an intra-operative plandeveloped with three-dimensionalimaging software which is based onintraoperative 3D images using anoptical system (infrared camera) |
| Deviceaccuracy | - Device accuracy: <2 mm- Angular error <2 degrees | - Device accuracy: <2 mm- Angular error <2 degrees |
| Software | Dedicated Spine application Software | Dedicated Spine application Software |
| Nonclinicaltests: | The following nonclinical tests were performed on the SURGIVISIO Device todemonstrate substantial equivalence of safety and effectiveness with thepredicate devices:- Design verification tests were performed based on risk managementactivities and product requirements.- Software development and testing activites were conducted inaccordance with IEC 62304 Medical device software – Life cycleprocesses and FDA guidance.- Biocompatibility was evaluated and testing in accordance with ISO10993 Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process..- Electrical safety and electromagnetic compatibility (EMC) testing wereconducted in accordance with IEC 60601-1 Medical electrical equipment– Part 1: General requirements for basic safety and essentialperformance and IEC 60601-1-1 Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safetyrequirements for medical electrical systems.- The SURGIVISIO Device was validated with intended users in cadaverlabs and simulated use testing to ensure the users' needs and intendeduse requirements were met.All test requirements were met, no new issues of safety or effectiveness wereraised, and substantial equivalence was demonstrated. | |
| Clinical tests: | No clinical tests were conducted to demonstrate substantial equivalence. |
{6}------------------------------------------------
There are no new technological characteristics in the SURGIVISIO Device as compared to the predicate device. A comparison of the technological characteristics or the SURGIVISIO Device robotic guidance feature to the predicate, the Medtech S.A.(Zimmer Biomet) ROSA® ONE Spine application is provided below:
{7}------------------------------------------------
{8}------------------------------------------------
Performance Data
Conclusions drawn from Performance Data
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR 807, and based upon the information and scientifically valid data provided in this premarket notification, eCential Robotics concludes that the subject device, the SURGIVISIO Device, is as safe and effective and performs as well as the predicate devices, the SpineMap® 3D Navigation System with SpineMask™ tracking device and to the ROSA® ONE Spine application. Substantial equivalence was established in terms of design features, technological characteristics, intended use and performance as compared to the two 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).