The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.

The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.

The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Stylet is indicated for use in the following procedures:

General ventricular catheter placement
Pediatric ventricular catheter placement
Tumor resections
Skull base procedures
Craniotomies/craniectomies
Transsphenoidal procedures

The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computerassisted surgery systems using electromagnetic navigation and cranial software.

The Touch-n-Go Pointer is indicated for use in registent anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medironic computer-assisted surgery systems using electromagnetic navigation and cranial software.

The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigation Pointer is indicated for use in the following procedures:

General tumor resections
Pediatric tumor resections
Skull base procedures
Craniotomies/craniectomies
Transsphenoidal procedures

Device Description

The AxiEM™ Instruments (Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer) and Trackers (Skull-Mount Patient Tracker. Non-Invasive Patient Tracker) are singleuse, sterile devices compatible with AxiEM™-enabled Medtronic computer assisted surgery systems. The instruments and trackers are electromagnetically navigated devices used for the purpose of localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures.

Each device incorporates a tracking system within the instrument or tracker. The mobile emitter of the navigation system generates a low-energy magnetic field that is detected by the tracking system within the device. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.

AI/ML Overview

The provided FDA 510(k) summary for the Medtronic Navigation, Inc. devices (Stylet, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker) details the acceptance criteria and the studies performed to demonstrate equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implicit from Predicate/Standard)	Reported Device Performance
System Accuracy	Mean positional error <2mm, Mean trajectory error <2 degrees (based on predicate)	Mean positional error <2mm, Mean trajectory error <2 degrees.
Simulated Environment Accuracy	Mean positional error <2mm, Mean trajectory error <2 degrees (matching System Accuracy)	Mean positional error <2mm, Mean trajectory error <2 degrees.
Skin Shift Test	Minimal shifting similar to existing methods.	Shifting of the NIPT during use is minimal and similar to existing methods.
Chemical Resistance	Adhesion maintained when exposed to common surgical chemical solutions.	Adhesion of the NIPT to the patient is maintained when exposed to common chemical solutions.
Electrical Safety	Conformance to IEC 60601-1 and IEC 60601-1-2.	Conforms to IEC 60601-1 and IEC 60601-1-2.
Shipping	Instruments and packaging functional and intact.	Functional and intact after simulated shipping conditions.
General Requirements & Performance	Conformance with identified design and performance specifications.	Conformance with identified design and performance specifications.
MRI Compatibility	MR Conditionally-Safe in 1.5T and 3T MRI scanners.	Demonstrated to be MR Conditionally-Safe in 1.5T and 3T MRI scanners.
Usability	Satisfies user's needs and product usability.	Satisfies the user's needs and product usability.
Accelerated Life Functionality	Maintains functionality after accelerated life exposures and user conditions for labeled shelf life.	Maintained functionality after exposure to accelerated life exposures and user conditions.
Tool Cards	Meets required interface needs of application software.	Met the required interface needs of the application software.
Biocompatibility - Cytotoxicity (MEM Elution)	No reactivity (Grade 0).	No reactivity (Grade 0).
Biocompatibility - Maximization Sensitization	No evidence of sensitization.	No evidence of sensitization.
Biocompatibility - Intracutaneous Irritation	No evidence of irritation.	No evidence of irritation.
Biocompatibility - Acute Systemic Toxicity	No mortality or toxicity.	No mortality or toxicity.
Biocompatibility - Pyrogenicity	No evidence of pyrogenicity.	No evidence of pyrogenicity.

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

The document does not explicitly state numerical sample sizes for each test. However, it indicates that "Testing was completed" and "The instruments tested demonstrate conformance," implying that a sufficient number of samples were used to obtain statistically relevant results according to Medtronic's internal testing protocols and relevant international standards (e.g., ISO, IEC).

The data provenance is from non-clinical testing performed by Medtronic Navigation, Inc. The document does not specify the country of origin of the data beyond the company's US address. It is retrospective in the sense that the studies were completed prior to this 510(k) submission.

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

This submission deals with the technical performance of medical devices (accuracy, safety, material properties, etc.) and not with clinical diagnostic performance that would typically require expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists for image reading) is not applicable here. The "ground truth" for these tests is based on objective measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is objective performance testing against defined metrics rather than interpretive assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (like AI algorithms for image interpretation) to compare the performance of human readers with and without AI assistance. The submitted devices are surgical instruments and patient trackers for navigation systems, which have objective physical performance metrics rather than interpretive diagnostic outcomes.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, standalone performance (algorithm only/device only performance) was done. The entire "Performance Data" section (Section VII) describes the standalone testing of the devices' accuracy, safety, mechanical properties, and biocompatibility. The reported accuracy of "<2mm positional error and <2 degrees trajectory error" is a direct measure of the device's inherent performance.

7. The Type of Ground Truth Used:

The ground truth used for these technical performance tests is primarily based on:

Physical measurements against known standards and specifications: For accuracy (e.g., using precision measurement tools to determine positional and trajectory error against a known target).
Compliance with international standards: For electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility (ISO 10993 series).
Simulated environmental conditions: For skin shift and chemical resistance, simulating real-world use conditions to assess performance.
User feedback/testing: For usability.

8. The Sample Size for the Training Set:

Not applicable. These devices are physical instruments and trackers; they are not machine learning or AI algorithms that require a "training set" in the traditional sense of data-driven model development. Their performance is inherent to their design, materials, and manufacturing, which are validated through testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for these devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in black and are arranged to create a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

March 25, 2015

Medtronic Navigation, Inc. Mr. Christopher Perman Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K141833

Trade/Device Name: Stylet, 23cm, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-n-Go Pointer, Navigation Pointer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 20, 2015 Received: February 23, 2015

Dear Mr. Perman,

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, 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 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education 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. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education 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,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K141833

Device Name Non-Invasive Patient Tracker

Indications for Use (Describe)

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)

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

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510(k) Number (if known) K141833

Device Name Skull-Mount Patient Tracker

Indications for Use (Describe)

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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K141833

Device Name Stylet, 23 cm

Indications for Use (Describe)

The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Stylet is indicated for use in the following procedures:

· General ventricular catheter placement
· Pediatric ventricular catheter placement
· Tumor resections
· Skull base procedures
· Craniotomies/craniectomies
· Transsphenoidal procedures

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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K141833

Device Name Tracer Pointer

Indications for Use (Describe)

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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K141833

Device Name Touch-n-Go Pointer

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{7}------------------------------------------------

510(k) Number (if known) K141833

Device Name Navigation Pointer

Indications for Use (Describe)

The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Navigation Pointer is indicated for use in the following procedures:

· General tumor resections
Pediatric tumor resections
· Skull base procedures
· Craniotomies/craniectomies
· Transsphenoidal procedures

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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

I. SUBMITTER

Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA

Telephone: 720-890-3200 Fax: 720-890-3500

Contact Person: Christopher Perman Date Prepared: March 24, 2015

II. DEVICE

Name of Device: Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker Common Name: Stereotaxic Instrument Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II (21 CFR 882.4560) Product Code: HAW

III. PREDICATE DEVICE

StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option, K001284 Catheter Introducer for the StealthStation® System, K022126 StealthStation® System Update, K050438

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

Stylet, 23cm

The Stylet is indicated for use in the following procedures:

General ventricular catheter placement ●
Pediatric ventricular catheter placement ●
Tumor resections
Skull base procedures ●
Craniotomies/craniectomies ●
Transsphenoidal procedures

Tracer® Pointer

The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

Touch-n-Go Pointer

The Touch-n-Go Pointer is indicated for use in registering patient anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

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Navigation Pointer

The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.

The Navigation Pointer is indicated for use in the following procedures:

General tumor resections
Pediatric tumor resections ●
Skull base procedures
Craniotomies/craniectomies ●
Transsphenoidal procedures ●

Skull-Mount Patient Tracker

Non-Invasive Patient Tracker

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Stylet, 23cm

Item	Subject Device(Stylet, 23cm)	Predicate Devices
Indicationsfor Use	The Stylet is indicated for use inprecisely locating anatomical structuresduring navigated cranial procedures. Itis indicated for use with Medtroniccomputer-assisted surgery systems usingelectromagnetic navigation and cranialsoftware.The Medtronic computer assisted surgerysystem and its associated applications areintended as an aid for precisely locatinganatomical structures in either open orpercutaneous procedures. Their use isindicated for any medical condition inwhich the use of stereotactic surgery maybe appropriate, and where reference to arigid anatomical structure, such as theskull, can be identified relative to a CT- based or MR-based model, fluoroscopyimages, or digitized landmarks of theanatomy.	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)The StealthStation® System is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. The StealthStation® System isindicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as the skull, a longbone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopyimages of the anatomy.Example procedures include, but are not limited to:Cranial Procedures:Cranial biopsiesTumor resectionsCraniotomies/CraniectomiesSkull base proceduresThalamotomies/PallidotomiesENT Procedures:Transphenoidal procedures
	The Stylet is indicated for use in thefollowing procedures:• General ventricular catheterplacement• Pediatric ventricular catheterplacement• Tumor resections• Skull base procedures• Craniotomies/craniectomies• Transsphenoidal procedures	Catheter Introducer for the StealthStation® System(K022126)The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.Example procedures include, but are not limited to:Cranial Procedures:Cranial BiopsiesPlacementTumor Resections

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Craniotomies/ CraniectomiesSkull Base proceduresThalamotomies/PallidotomiesPituitary Tumor RemovalCSF Leak RepairPediatric Catheter Shunt PlacementGeneral Catheter Shunt PlacementENT Procedures:Transphenoidal Procedures
StealthStation® System Update(K050438)
The StealthStation® System is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. The StealthStation® System isindicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as the skull, a longbone, or vertebra, can be identified relative to a CT based or MR-based model, fluoroscopyimages, or digitized landmarks of the anatomy.For the optical-based and EM-based system, example procedures include, but are notlimited to:Cranial Procedures:Cranial BiopsiesTumor ResectionsCraniotomies/ CraniectomiesSkull Base proceduresThalamotomies/PallidotomiesPituitary Tumor RemovalCSF Leak RepairPediatric Catheter Shunt PlacementGeneral Catheter Shunt Placement
ENT Procedures:Transphenoidal Procedures

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EstablishmentofStereotacticCoordinates(TrackingMethod)	Electromagnetic	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)ElectromagneticCatheter Introducer for the StealthStation® System(K022126)Electromagnetic or OpticalStealthStation® System Update(K050438)Electromagnetic or Optical
SystemAccuracy	The system has demonstrated accuracywith a mean positional error of <2mmand mean trajectory error of <2 degrees.	The system has demonstrated accuracy with a mean positional error of <2mm and meantrajectory error of <2 degrees.
Materials	-302 Spring Steel-PET-Loctite Adhesive	Catheter Introducer for the StealthStation® System(K022126)-302 Spring Steel-PET-Loctite Adhesive
Sterility	ETO Sterile/ Single Use	Catheter Introducer for the StealthStation® System(K022126)ETO Sterile/ Single Use
Item	Subject Device(Tracer Pointer)	Predicate Devices
Indicationsfor Use	The Tracer® Pointer is indicated for use inregistering patient anatomy and in preciselylocating anatomical structures during navigatedcranial procedures in adult and pediatric patients.It is indicated for use with Medtronic computer-assisted surgery systems using electromagneticnavigation and cranial software.The Medtronic computer assisted surgery systemand its associated applications are intended as anaid for precisely locating anatomical structures ineither open or percutaneous procedures. Their useis indicated for any medical condition in which theuse of stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical structure,such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, ordigitized landmarks of the anatomy.	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can be identifiedrelative to a CT or MR based model or fluoroscopy images of the anatomy.StealthStation® System Update(K050438)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can be identifiedrelative to a CT based or MR-based model, fluoroscopy images, or digitizedlandmarks of the anatomy.
EstablishmentofStereotacticCoordinates(TrackingMethod)	Electromagnetic	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)ElectromagneticStealthStation® System Update(K050438)Electromagnetic or Optical
SystemAccuracy	The system has demonstrated accuracy with amean positional error of <2mm and meantrajectory error of <2 degrees.	The system has demonstrated accuracy with a mean positional error of <2mmand mean trajectory error of <2 degrees.
Materials	-303 Stainless Steel-Lustran 348 (ABS Plastic)	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)-Medical Grade SS-Titanium-Plastic
Sterility	ETO Sterile/ Single Use	StealthStation® System Update(K050438)ETO Sterile/ Single Use

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Tracer Pointer

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Touch-n-Go Pointer

Item	Subject Device(Touch-n-Go Pointer)	Predicate Devices
Indicationsfor Use	The Touch-n-Go Pointer is indicated for use inregistering patient anatomy during navigated cranialprocedures in adult and pediatric patients. It isindicated for use with Medtronic computer-assistedsurgery systems using electromagnetic navigationand cranial software.The Medtronic computer assisted surgery systemand its associated applications are intended as an aidfor precisely locating anatomical structures in eitheropen or percutaneous procedures. Their use isindicated for any medical condition in which the useof stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical structure, suchas the skull, can be identified relative to a CT-basedor MR-based model, fluoroscopy images, ordigitized landmarks of the anatomy.	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can beidentified relative to a CT or MR based model or fluoroscopy images of theanatomy.StealthStation® System Update(K050438)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can beidentified relative to a CT based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
EstablishmentofStereotacticCoordinates(TrackingMethod)	ElectromagneticThe system has demonstrated accuracy with a meanpositional error of <2mm and mean trajectory errorof <2 degrees.	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)ElectromagneticStealthStation® System Update(K050438)Electromagnetic or OpticalThe system has demonstrated accuracy with a mean positional error of <2mm and mean trajectory error of <2 degrees.

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Materials	-303 Stainless Steel-Lustran 348 (ABS Plastic)	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)
		-Medical Grade SS-Titanium
		-Plastic
Sterility	ETO Sterile/ Single Use	StealthStation® System Update(K050438)
		ETO Sterile/ Single Use

Navigation Pointer

Item	Subject Device(Navigation Pointer)	Predicate Devices	Item	Subject Device(Skull-Mount Patient Tracker)	Predicate Devices
Indicationsfor Use	The Navigation Pointer is indicated foruse in precisely locating anatomicalstructures during navigated cranialprocedures. It is indicated for use withMedtronic computer-assisted surgerysystems using electromagneticnavigation and cranial software.The Medtronic computer assistedsurgery system and its associatedapplications are intended as an aid forprecisely locating anatomical structuresin either open or percutaneousprocedures. Their use is indicated forany medical condition in which the useof stereotactic surgery may beappropriate, and where reference to arigid anatomical structure, such as theskull, can be identified relative to a CT-based or MR-based model, fluoroscopyimages, or digitized landmarks of theanatomy.The Navigation Pointer is indicated foruse in the following procedures:• General tumor resections	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)The StealthStation® System is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. The StealthStation® System isindicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as the skull, a longbone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopyimages of the anatomy.Example procedures include, but are not limited to:Cranial Procedures:Cranial biopsiesTumor resectionsCraniotomies/CraniectomiesSkull base proceduresThalamotomies/PallidotomiesENT Procedures:Transphenoidal proceduresStealthStation® System Update(K050438)The StealthStation® System is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. The StealthStation® System isindicated for any medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as the skull, a long	Indicationsfor Use	The Skull-Mount Patient Tracker is indicated foruse as a stereotactic reference frame to track theposition of patient anatomy during navigatedcranial and ENT procedures. It is indicated for usewith Medtronic computer-assisted surgery systemsusing electromagnetic navigation and cranial andENT software.The Medtronic computer assisted surgery systemand its associated applications are intended as anaid for precisely locating anatomical structures ineither open or percutaneous procedures. Their useis indicated for any medical condition in which theuse of stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical structure,such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, ordigitized landmarks of the anatomy.	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can be identifiedrelative to a CT or MR based model or fluoroscopy images of the anatomy.StealthStation® System Update(K050438)The StealthStation® System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous procedures. TheStealthStation® System is indicated for any medical condition in which the useof stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the skull, a long bone, or vertebra, can be identifiedrelative to a CT based or MR-based model, fluoroscopy images, or digitizedlandmarks of the anatomy.
	Pediatric tumor resections Skull base procedures Craniotomies/craniectomies Transsphenoidal procedures	bone, or vertebra, can be identified relative to a CT based or MR-based model, fluoroscopyimages, or digitized landmarks of the anatomy.For the optical-based and EM-based system, example procedures include, but are not limitedto:Cranial Procedures:Cranial BiopsiesTumor ResectionsCraniotomies/ CraniectomiesSkull Base proceduresThalamotomies/PallidotomiesPituitary Tumor RemovalCSF Leak RepairPediatric Catheter Shunt PlacementGeneral Catheter Shunt PlacementENT Procedures:Transphenoidal Procedures	EstablishmentofStereotacticCoordinates(TrackingMethod)	Electromagnetic	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)ElectromagneticStealthStation® System Update(K050438)Electromagnetic or Optical
EstablishmentofStereotacticCoordinates(TrackingMethod)	Electromagnetic	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)ElectromagneticStealthStation® System Update(K050438)Electromagnetic or Optical	SystemAccuracy	The system has demonstrated accuracy with amean positional error of <2mm and meantrajectory error of <2 degrees.	The system has demonstrated accuracy with a mean positional error of <2mmand mean trajectory error of <2 degrees.
SystemAccuracy	The system has demonstrated accuracywith a mean positional error of <2mmand mean trajectory error of <2 degrees.	The system has demonstrated accuracy with a mean positional error of <2mm and meantrajectory error of <2 degrees.	Materials	--Lustran 348 (ABS Plastic)-Silicon 70-Titanium Alloy Bone Screw	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)-Medical Grade SS-PlasticStealthStation® System Update (K050438)
Materials	-304 Stainless Steel-Lustran 348 (ABS Plastic)	StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option(K001284)-Medical Grade SS-Titanium-Plastic	Sterility	ETO Sterile/ Single Use	ETO Sterile/ Single Use
Sterility	ETO Sterile/ Single Use	StealthStation® System Update(K050438)ETO Sterile/ Single Use

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Skull-Mount Patient Tracker

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Non-Invasive Patient Tracker

Item	Subject Device(Non-Invasive Patient Tracker)	Predicate Devices
Indicationsfor Use	The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.	StealthStation® System Update(K050438)The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Establishment ofStereotacticCoordinates(Tracking Method)	Electromagnetic	StealthStation® System Update(K050438)Electromagnetic or Optical
SystemAccuracy	The system has demonstrated accuracy with a mean positional error of <2mm and mean trajectory error of <2 degrees.	The system has demonstrated accuracy with a mean positional error of <2mm and mean trajectory error of <2 degrees.
Materials	-Pellethane 2363-3M 9917 Medical Tape-Santoprene-3M 9916 Tape-Loctite Epoxy	StealthStation® System Update(K050438)-3M 9874 Adhesive-ABS Plastic
Sterility	ETO Sterile/ Single Use	StealthStation® System Update(K050438)ETO Sterile/ Single Use

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VII. PERFORMANCE DATA

Testing was completed to ensure the functionality and compatibility with the identified Medtronic navigation systems. The following table summarizes the performance testing completed:

Test	Results	Conclusions
System Accuracy	The system has demonstrated accuracy with amean positional error of <2mm and meantrajectory error of <2 degrees.	Instruments are accurate fortheir intended use. Testingincluded predicate testing todemonstrate comparability.
Simulated EnvironmentAccuracy	The system has demonstrated accuracy with amean positional error of <2mm and meantrajectory error of <2 degrees.	Instruments are accurate fortheir intended use in the useenvironment
Skin Shift Test	Shifting of the NIPT during use is minimal andsimilar to existing methods of securing patienttrackers for navigation.	Instrument performs as designedfor its intended use.
Chemical Resistance	Adhesion of the NIPT to the patient is maintainedwhen exposed to common chemical solutionspresent in the surgical environment.	Instrument performs as designedfor its intended use.
Electrical Safety	The instruments conform to IEC 60601-1 and IEC60601-1-2, electrical safety and EMC standards.	Instruments meet electricalsafety and EMC requirements.
Shipping	The instruments and packaging are functional andintact after simulated shipping conditions.	The instruments in the designedpackage can be safely shipped.
General Requirementsand Performance	The instruments tested demonstrate conformancewith identified design and performancespecifications.	The instruments perform asdesigned for their intended use.
MRI Compatibility	The patient trackers were demonstrated to be MRConditionally-Safe in 1.5T and 3T MRI scanners.	The patient trackers can be usedsafely with MR scanners underthe labeled conditions.
Usability	The instruments satisfy the user's needs andproduct usability.	The instruments can be usedcorrectly by the defined users.
Accelerated LifeFunctionality	The instruments maintained functionality afterexposure to accelerated life exposures and userconditions.	The instruments can beeffectively used for their labeledshelf life.
Tool Cards	The instrument tools package has met the requiredinterface needs of the application software.	The NIPT can be correctlyselected as an instrument usingthe application software.
Biocompatibility
Cytotoxicity - MEMElution	Cell culture treated with test sample exhibited noreactivity (Grade 0)	Non-cytotoxic
MaximizationSensitization –ISO 10993-10	Intradermal injection of test sample showed noevidence of sensitization.	Non-sensitizer
Intracutaneous Irritation–ISO 10993-10	Intracutaneous injection of test sample showed noevidence of irritation.	Non-irritant
Acute SystemicToxicity-ISO 10993-11	Systemic injection of test sample showed nomortality or toxicity.	Non-toxic
Pyrogenicity - USP	Intravenous injection of test sample showed noevidence of pyrogenicity.	Non-pyrogenic

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VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker devices should perform as intended in the specified use conditions. The non-clinical data demonstrate that the Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker devices perform comparably to the predicate device that is currently marketed for the same intended use.

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).