The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with Medtronic systems utilizing STEALTH™ Technology. The NavLock™ Trackers should only be used with Medtronic instruments on Medtronic systems utilizing STEALTH™ Technology.

Device Description

The NavLock™ Trackers are compatible with StealthStation™ Systems and Mazor X STEALTH™ Edition and are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock™ Trackers for optical navigation. The NavLock™ Trackers have posts to affix reflective spheres, which are visible to the StealthStation camera as a means of tracking the position of the attached surgical instrument.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Medtronic Navigation's NavLock Trackers. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or not provided in the given document.

However, based on the information available, here's a reconstructed answer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Positional Error ≤ 2.0 mm	≤ 2.0 mm positional error
Trajectory Error ≤ 2.0°	≤ 2.0° trajectory error
Substantial Equivalence to predicate devices	Demonstrated through comparison to K182104 and K171267

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the provided text for the current submission (K201327). The document indicates "worst-case test configurations" were used in previous clearances (K182104 and K171267).
Data Provenance: The document does not specify the country of origin. The previous studies were "system-level accuracy testing." It's retrospective in the sense that the current submission relies on previous clearances and states "There have been no significant design changes to the NavLock™ Trackers since clearance in K182104. Therefore, performance testing is not needed to demonstrate substantial equivalence in the current submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. The performance testing was for device accuracy (positional and trajectory error), which typically relies on metrological measurements rather than expert human interpretation to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this device's accuracy testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device (trackers for navigation systems), not an AI diagnostic algorithm that assists human readers.

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

The performance testing cited (positional and trajectory error) represents the "standalone" accuracy of the navigation system when using the trackers. The device itself (NavLock Trackers) is a component of a navigation system, and its performance contributes to the overall system's accuracy. The stated accuracies (≤2.0 mm positional error and ≤2.0° trajectory error) can be considered the standalone performance based on the system's measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the accuracy testing, the ground truth would have been established by precise measurement systems (e.g., optical metrology systems) used to determine the true position and trajectory, against which the device's measurements were compared. The text mentions "system level accuracy testing."

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical design and optical tracking principles.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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June 18, 2020

Medtronic Navigation Taylor West Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, California 80027

Re: K201327

Trade/Device Name: NavLock Trackers Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 18, 2020 Received: May 19, 2020

Dear Taylor West:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201327

Device Name NavLock™ Trackers

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)

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K201327 Page 1

510(k) Summary

Mav 18, 2020

I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Taylor Gold West, MBA (Primary) Contact: Senior Regulatory Affairs Specialist Telephone Number: (720) 890-2322 Email: taylor.c.goldwest@medtronic.com

Rishi Sinha (Alternate) Senior Regulatory Affairs Manager Telephone: (720) 890-2485 Email: rishi.k.sinha@medtronic.com

Proprietary Trade Name: NavLockTM Trackers II.
III. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II V.
VI. Product Code: OLO
Primary Predicate: Navlock™ Trackers, K182104 VII. Additional Predicate: Navlock™ Trackers, K171267

VIII. Product Description:

IX. Indications for Use:

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X. Comparison of the Technological Characteristics:

There have been no changes to the technological characteristics of the NavLock™ Trackers since the clearance of the Medtronic NavLock™ Trackers in K182104.

Feature	Subject Device,NavLock™ Trackers	NavLock™Trackers, K182104	NavLock™Trackers, K171267
ProductCode	OLO	OLO	OLO
OperatingPrinciple(TrackingMethod)	Optical (infra-red)	Optical (infra-red)	Optical (infra-red)
IntendedUse	The subject devicesare intended to enablenavigation duringstereotactic spinalprocedures that utilizeSTEALTH™Technology.	The subject devicesare intended toenable navigationduring stereotacticspinal proceduresthat utilize theMAZOR XStealth™ Editionsystem.	The NavLocktrackers are intendedto enable navigationof Medtronicinstrumentationduring stereotacticspinal proceduresthat utilize theMedtronicStealthStation™surgical navigationsystem.
Indicationsfor Use	The NavLock™Trackers are intendedto enable navigationof Medtronicinstrumentation usedduring spinal fusionand interbodyprocedures withMedtronic systemsutilizing STEALTH™Technology. TheNavLock™ Trackersshould only be usedwith Medtronicinstruments onMedtronic systemsutilizing STEALTH™Technology.	The NavLock™Trackers areintended to enablenavigation ofMedtronicinstrumentationused during spinalfusion andinterbodyprocedures with theMAZOR XStealth™ Editionsystem. TheNavLock™Trackers shouldonly be used withMedtronicinstruments on theMedtronic MAZORX Stealth™ Editionsystem.	The NavLock™Trackers areintended to enablenavigation ofMedtronicinstrumentation usedduring spinal fusionand interbodyprocedures with theMedtronicStealthStation™surgical navigationsystem. TheNavLock™Trackers shouldonly be used withMedtronicinstruments.
Feature	Subject Device,NavLock™ Trackers	NavLock™Trackers, K182104	NavLock™Trackers, K171267
NavigationalSystemAccuracyAnalysis	System level accuracytesting wasdemonstrated on theNavlock™ Trackersfor use withStealthStation™Systems (K171267)and MAZOR XStealth™ Edition(K182104). Worst-case testconfigurations usingStealthStation™Software met thecriteria of ≤2.0 mmpositional error and≤2.0° trajectory error.Rationale has beenprovided for thesubject Navlock™Black and BlueTrackers.	Utilizing worst-casetest configurations,subject NavLock™Tracker(NavLock™ Blue)and the RoboticReference Framewere tested with theMAZOR XStealth™ Editionsoftware applicationand the overall testresults met thecriteria of ≤2.0 mmpositional error and≤2.0° trajectoryerror.	Utilizing worst-casetest configurations,predicateNavLock™ Tracker(NavLock™Orange)** wastested withStealthStation™ S8Spine Softwareapplication and theoverall test resultsmet the criteria of≤2.0 mm positionalerror and ≤2.0°trajectory error.
SterilizationMethod	Non-Sterile, Reusable,Steam Sterilized	Non-Sterile,Reusable, SteamSterilized	Non-Sterile,Reusable, SteamSterilized

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XI. Discussion of the Performance Testing:

There have been no significant design changes to the NavLock™ Trackers since clearance in K182104. Therefore, performance testing is not needed to demonstrate substantial equivalence in the current submission.

XII. Conclusions

The NavLock™ Black and Blue Trackers have shown through comparison to be substantially equivalent to the identified predicate devices.

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).