The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Device Description

The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k).

The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized.

The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.

AI/ML Overview

The Stryker NAV3i Platform is a computer workstation intended to display patient-specific images/anatomical landmark information and track surgical instruments for stereotactic procedures when used with specific Stryker Navigation surgical software. The non-clinical testing conducted aimed to demonstrate that the device performs as safely and effectively as its predicate device, the Cart I Platform (Stryker Navigation System - ENT Module, K002732).

Here's an analysis of the acceptance criteria and study details provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
User Need Validation	All user needs for the NAV3i Platform under simulated use case situations are met, and the Indications For Use are validated.	Validation successful, all user needs met.
Human Factors Engineering (HFE)	Device is safe and effective with respect to use errors.	Validation successful, device safe and effective with respect to use errors.
Safety Test regarding risk analysis	All risk control measures specified in the NAV3i Platform risk analysis are effective and mitigate associated risks.	Risk Control measures are effective and mitigate the associated risks.
Product Safety Test regarding medical electrical equipment	Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 standards for medical electrical equipment (Part 1 & Part 1-2).	Compliance with standards' requirements demonstrated, no deviations.
Accuracy Test	All accuracy specifications are met.	All accuracy specifications met with statistical significance. (Following ASTM F2554-10)
Integration Tests with Stryker Navigation Software Applications	All specified Stryker Navigation Software Application Modules (SpineMap 3D, OrthoMap 3D, Versatile Hip, Express Knee, Precision Knee, Fluoro, FluoroMap, CranialMap) meet specifications on the NAV3i Platform, demonstrating compatibility.	All Application Modules meet specifications on NAV3i Platform as on previous platforms. (Tested under simulated clinical use conditions)
Startup Reliability	Device is electronically reliable over its specified lifetime, including Stryker Navigation Software Application Modules across multiple usages.	Device electronically reliable over the specified lifetime. (Number of test samples and runs determined using statistical methods)
Robustness for everyday use	Device is mechanically robust over its specified lifetime, considering transport inside hospital and intraoperative use.	Device mechanically robust over the specified lifetime. (Number of test samples and runs determined using statistical methods, simulating hospital transport and intraoperative use)
Shipment Test	Device is fully functional after shipment.	Device fully functional after shipment. (Performed according to ASTM D 4169-09 for transport conditions in transport cases)

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical testing for a medical device platform. Rather than a test set of patient data, the studies involved various engineering and simulated use tests.

Accuracy Test: While the document states "All accuracy specifications met with statistical significance," it does not specify the sample size for the accuracy test. It mentions following ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, which would define the methodology for determining accuracy.
Startup Reliability & Robustness: The document states that "The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods." However, specific sample sizes (number of devices, number of runs) are not provided.
Data Provenance: The studies are non-clinical, involving device testing rather than patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the traditional sense. These would be considered prospective laboratory/engineering tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since these are non-clinical engineering and usability tests, the concept of "ground truth established by experts" in the clinical imaging sense is not directly applicable.
User Need Validation and Human Factors Engineering (HFE) would involve user feedback and expert assessment (e.g., human factors engineers, clinical users like surgeons) to validate usability and user needs. However, the number and specific qualifications of any experts involved are not detailed in the summary. It broadly states "Validation successful, all user needs met" and "Validation successful, device safe and effective with respect to use errors."

4. Adjudication Method for the Test Set

Not applicable. The described tests are primarily performance and safety evaluations of the device's technological characteristics, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done.
The document explicitly states: "No clinical testing has been conducted."
This submission focuses on establishing substantial equivalence for a platform based on its technological characteristics and non-clinical performance, not on the clinical effectiveness of specific surgical software or human-AI interaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the testing described is primarily standalone device performance (without a human-in-the-loop clinical effectiveness study).
The "Accuracy Test" evaluates the Stryker Navigation System's (including NAV3i Platform, software, instruments) positional accuracy directly, without human interpretation as part of the primary measurement.
"Integration Tests" confirm compatibility and performance of the platform with various software modules in a simulated clinical use, essentially evaluating the combined system's functional integrity.

7. The Type of Ground Truth Used

For the non-clinical tests:

User Need Validation: Ground truth would be defined by the pre-established user requirements and intended uses of the device.
Human Factors Engineering: Ground truth relates to established human factors principles and identified potential use errors.
Safety Test regarding risk analysis: Ground truth is based on the identified risks and the defined effectiveness of risk mitigation measures.
Product Safety Test regarding medical electrical equipment: Ground truth is the compliance with specific international standards (AAMI/ANSI ES60601-1).
Accuracy Test: Ground truth for accuracy would be an objectively measured "true" positional reference, as defined by the ASTM F2554-10 standard. This standard outlines methods to measure positional accuracy, typically involving phantoms and known spatial references.
Integration Tests, Startup Reliability, Robustness, Shipment Test: Ground truth is the device meeting its predefined engineering specifications and functional requirements under various conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware platform for surgical navigation software. The document does not describe any machine learning or AI algorithms requiring a training set in the context of device clearance. The software that runs on the platform is cleared separately.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for machine learning/AI algorithms in this submission for the NAV3i Platform.

Summary

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K130874

stryker®

Navigation

SEP 2 7 2013

510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

Applicant Name:	Stryker Leibinger GmbH & Co. KG - Navigation
	Boetzinger Strasse 41
	D-79111 Freiburg, Germany
	Phone number: +49-761-4512117
	Fax number: +49-761-451249117
Registration No.:	3007582679
Name of Contact Person:	Lilian Eckert
	lilian.eckert@stryker.com
Date prepared:	24 September 2013

2. Device Name

Trade Name:	Stryker NAV3i Platform
Common Name:	Navigation System Platform
ClassificationName:	Product Code	Device	RegulationNumber	Class	Review Panel
	Primary Code:HAW	Neurologicstereotaxicinstrument	21 CFR§882.4560	II	Neurology
	SecondaryCode:OLO	Orthopedicstereotaxicinstrument	21 CFR§882.4560	II	Orthopedic

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3. Legally Marketed Predicate Device

The legally marketed predicate device is the Cart I Platform (trade name: Stryker Navigation Cart) as cleared in K002732 Stryker Navigation System - ENT Module.

510(k) Number	Product Code Trade Name		Manufacturer
K002732	HAW	Stryker Navigation Cart	Stryker Leibinger GmbH &Co. KGBoetzinger Strasse 41D-79111 Freiburg,Germany

4. Device Description

There are two reasons for the traditional 510(k) submission. Firstly, it is intended to "unbundle" the clearance of the platform from the Stryker Navigation System as a whole. The predicate device submission included the platform as a component of the Stryker Navigation System -ENT Module. Secondly, some design modifications have been introduced to increase the user's comfort, to provide a more modern industrial design and to offer state-of-the-art technology for computer interfaces and components.

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5. Indications for Use

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

6. Substantial Equivalence Comparison

The indications for use of the subject device Stryker NAV3i Platform are equivalent to the predicate device Cart I Platform for the Stryker Navigation System. Furthermore, the technological characteristics of the modified NAV3i Platform are substantially equivalent to the original Cart I Platform. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the NAV3i Platform is substantially equivalent to the predicate device.

The following table gives an overview of the substantial equivalence reflecting all modifications being made between the predicate device and the subject device.

Topic	Predicate Device	Subject Device	Equivalence assessment
LiveCam (USBVideo Camera)	LiveCam was not offered.	Built-in LiveCam allows foreasy positioning of theNavigation Camera.	Equivalent:This feature did not exist inthe predicate device butdoes not alter the operatingprinciple nor is it affectingthe essential performance.
Monitor	The main monitor used bythe surgeon:18 inch flat screen monitormounted on an articulatedarm.	The main monitor used bythe surgeon:32 inch flat screen monitormounted on an articulatedarm.	Equivalent:Changes do not affect thetechnology or the operatingprinciple of the platform.
IO-Tablet	Contained mouse andkeyboard.	Mouse and touch screenmonitor with implementedkeyboard functionality areintegrated in the IO-Tablet,IO-Tablet doubles asoperator's monitor for theOR staff.	Equivalent:Ergonomic improvementsby intuitive touchfunctionality and state-of-the-art technology for adata input device do notchange the performancespecification.
Topic	Predicate Device	Subject Device	Equivalence assessment
Computer	Windows PC based onIntel architecture.Configured Windows NToperating system.	Windows PC based onIntel state of the artarchitecture. ConfiguredWindows XP operatingsystem.	Equivalent:Performance specificationchanges due to additionalstate of the art PCinterfaces and a newversion of the operatingsystem.
RFID CardReader forlicensing andlogistic reasons	Not existing.	RFID Card Reader forsingle case licensingintegrated in the IO-Tablet.	Equivalent:The addition of the RFIDCard Reader does not addany performance featuresand has no effect on theessential performance ofthe NAV3i Platform.
Networkconnectivity	Connection type: StandardEthernet connection andmodem connection.	Connection type: StandardEthernet connection andWLAN connection.	Equivalent:The extended networkconnectivity does not addany performance featuresin regards to theindications for use of theNAV3i Platform.
RemoteServiceConnectivity	Remote service access byVirtual Network Computing(VNC) remote desktopservice over network ormodem connection.	Remote service access isoffered by a remote accessclient over Ethernet orWLAN.	Equivalent:This represents the sametechnology for the remoteservice access.
NavigationCamera	Active opticalmeasurement systemlocalizing infrared lightemitting diodes (LED)using three linear sensorsand a working space of1.00 meter in diameter.The system isencapsulated in twoseparate housings: thecamera and the localizercomputer.	Active opticalmeasurement systemlocalizing infrared lightemitting diodes (LED)using three linear sensorsand a working space of1.25 meter in diameter.The system isencapsulated in onehousing and is calledNavigation Camera.	Equivalent:The modified design of theNavigation Camera doesnot impact the operatingprinciple, controlmechanism, technology orenergy source. Therefore,the change does not affectthe essential performanceof the NAV3i Platform.
Topic	Predicate Device	Subject Device	Equivalence assessment
Power Supply	External power source:AC Power supply, 120V,50/60Hz including off-the-shelf uninterruptible powersupply (UPS) for powerinterruptions less than orequal to 10 minutes.	External power source:AC Power supply,100/240V, 50/60Hz.including off-the-shelfuninterruptible powersupply (UPS) for powerinterruptions less than orequal to 6 minutes.	Equivalent:The time difference doesnot alter the operatingprinciple and does notraise new safety oreffectiveness issues.
Articulatedarms	Weight balancedarticulated arms have themonitor and localizationcamera mounted.Approximately 1000 mmarms with three joints forcamera and monitormovement are offered.	Same mechanical principalof spring arms with thesame degrees of freedom.Change in arm lengths:monitor arm length is about900 mm, NavigationCamera arm length isabout 1300 mm.	Equivalent:Improved ergonomics foralignment and handling ofthe Navigation Camera andmonitor in the OR space.The operating principle ofthe Platform is not affected.
Cart Housing	The Cart I Platform isequipped with 4 castorswith brakes. The carthousing contains thecomputer, the computerinterfaces as well as thetwo articulated armscarrying the camera andthe monitor.	The NAV3i Platform isequipped with 4 castorswith brakes and additionalcable guards. The carthousing contains thecomputer, the computerinterfaces as well as thetwo articulated armscarrying the NavigationCamera and the monitor.	Equivalent:The industrial design ischanged but themechanical structure andfunctioning is similar. Theperformance of theplatform is not changedand no new safety andeffectiveness issues areraised.
DimensionalSpecifications	Outer dimensions:Length x Width x Height:762 x 762 x 1880 mmWeight: 249.5 kg	Outer dimensions:Length x Width x Height:960 x 720 x 1920 mmWeight: 250 kg	Equivalent:Only slight modificationswhich do not impact theperformance of the StrykerNavigation Platform and donot raise new safety andeffectiveness issues.

Table 1

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The following table gives an overview of all design features which remain the same between the predicate device and the subject device.

Table 2

Design features which remain the same
Controlmechanism	The Platform is controlled by a standard PC interface including mouse and keyboardinput functions and a display. In addition, the Stryker Navigation ApplicationSoftware can be remotely controlled by Stryker Smart Instruments over an infraredcommunication interface. During surgery, the software is controlled via StrykerSmart Instruments.
Operatingprinciple	The Platform runs Stryker Navigation Application Software on a Windows PC basedsystem. For patient data import and export, the Platform provides standard state-of-the-art storage media and network interfaces. For video import the system providesa standard state-of-the-art video interface to capture live video. The Platform offersan active optical localization device, i.e. the Navigation Camera. The NavigationCamera allows three-dimensional localization of the Stryker Smart Instrumentswhich are equipped with LEDs by detecting the position of the light center of eachinfrared LED.
Movability	The Platform is equipped with four castors and is movable within a hospital.
General design	Both devices have articulated arms to carry the monitor and the camera and have ahousing body to carry a Windows-based computer.
Microscopedata interface	Both platform models encompass a microscope data interface.

The modifications do not alter the basic technology, do not raise any new issues regarding safety and effectiveness and support substantial equivalence of the subject device.

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7. Non-clinical Testing

Validation activities, including usability testing, have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions. In addition, verification tests, such as electrical safety acc. to IEC 60601-1, have been performed to show that the device is safe and effective. The following table contains a complete list of all tests performed to support substantial equivalence, gives a basic description of the test procedure in the column "Basic description" and the conclusion or results obtained from the test in the column "Conclusion/Result".

Test	Basic description	Conclusion/Result
User NeedValidation	Scope of the test is to validate the Indications For Use and theuser needs of the NAV3i Platform under simulated use casesituations.	Validationsuccessful, all userneeds met
HumanFactorsEngineering(HFE)	This test is conducted to validate the NAV3i Platform withrespect to use errors following the FDA guidance paper DraftGuidance for Industry and Food and Drug Administration Staff.Applying Human Factors and Usability Engineering to OptimizeMedical Device Design.	Validationsuccessful, devicesafe and effectivewith respect to useerrors
Safety Testregardingrisk analysis	Implementation and effectiveness of all risk control measuresspecified in the NAV3i Platform risk analysis are tested andverified.	Risk Controlmeasures areeffective andmitigate theassociated risks
ProductSafety Testregardingmedicalelectricalequipment	Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 formedical electrical equipment is tested.Part 1: General requirements for basic safety and essentialperformancePart 1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests	Compliance withstandards'requirementsdemonstrated, nodeviations
AccuracyTest	The Stryker Navigation System's accuracy is tested using theNAV3i Platform, a Stryker Navigation Software Application,Smart Instruments and Accessories following the ASTMF2554-10 Standard Practice for Measurement of PositionalAccuracy of Computer Assisted Surgical Systems.	All accuracyspecifications metwith statisticalsignificance

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Test	Basic Description	Conclusion/ Result
IntegrationTests withStrykerNavigationSoftwareApplications	The NAV3i Platform is restricted to operation with StrykerNavigation Software Application Modules only. To demonstratecompatibility of the NAV3i Platform with existing ApplicationModules, integration tests have been performed. Theintegration of SpineMap 3D Navigation, OrthoMap 3DNavigation, Versatile Hip Navigation, Express KneeNavigation, Precision Knee Navigation, Fluoro Navigation,FluoroMap Navigation and CranialMap Navigation SoftwareApplication Modules has been tested with the NAV3i Platformaccording to Design Input requirements under simulatedclinical use conditions.	All ApplicationModules meetspecifications onNAV3i Platform ason previousplatforms
StartupReliability	Tested NAV3i Platform start up reliability over lifetime includingStryker Navigation Software Application Modules acrossmultiple usages. The number of test samples and test runsrequired to simulate reliability over lifetime was defined usingstatistical methods.	Device electronicallyreliable over thespecified lifetime
Robustnessfor every dayuse	Tested NAV3i Platform robustness by simulating transportinside hospital and intraoperative use over lifetime. Thenumber of test samples and test runs required to simulatereliability over lifetime was defined using statistical methods.	Device mechanicallyrobust over thespecified lifetime
ShipmentTest	Test of shipment conditions of the NAV3i Platform in transportcases was performed according to ASTM D 4169-09.	Device fullyfunctional aftershipment

All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.

8. Clinical Testing

No clinical testing has been conducted.

9. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the NAV3i Platform performs as safely and effectively as the legally marketed device identified in section 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the NAV3i Platform is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2013

Stryker Navigation Ms. Lilian Eckert Senior Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg. Baden-Wuerttemberg 79111 Germany

Rc: K130874

Trade/Device Name: NAV3i Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Neurologic Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: August 26, 2013 Received: August 28. 2013

Dear Ms. Eckert:

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. The general controls provisions of the Act include requirements for annual registration. Issing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 (sec above) into cither 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Eckert

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Styker NAV3i Platform

Indications For Use:

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S
-------------------

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K130874 510(k) Number __

Page 1 of 1

Regulation Number and Section

§ 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).