NavLock Trackers

K201327 · Medtronic Navigation · OLO · Jun 18, 2020 · Neurology

Device Facts

• Record ID: K201327
• Device Name: NavLock Trackers
• Applicant: Medtronic Navigation
• Product Code: OLO · Neurology
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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 Story

NavLock™ Trackers are reusable, non-sterile optical tracking devices used in spinal fusion and interbody procedures. They attach to the proximal end of Medtronic surgical instruments; feature posts for reflective spheres visible to StealthStation cameras. The system tracks the spatial position of the instrument in real-time during surgery. Used in OR settings by surgeons; provides visual feedback on navigation displays to guide instrument placement. Benefits include enhanced precision in spinal instrumentation. No changes to technological characteristics from predicate devices.

Clinical Evidence

No clinical data. Bench testing only; system-level accuracy previously demonstrated with positional error ≤2.0 mm and trajectory error ≤2.0°.

Technological Characteristics

Reusable, non-sterile, steam-sterilized optical trackers. Principle: infra-red optical tracking via reflective spheres. Connectivity: passive markers for optical camera systems. Form factor: instrument-mounted trackers with posts for reflective spheres.

Indications for Use

Indicated for patients undergoing spinal fusion and interbody procedures requiring navigation of Medtronic instrumentation via Medtronic STEALTH™ Technology systems.

Regulatory Classification

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.

Predicate Devices

• Navlock™ Trackers (K182104)
• Navlock™ Trackers (K171267)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]
- Taylor Gold West, MBA (Primary) Contact: Senior Regulatory Affairs Specialist Telephone Number: [phone] Email: [e-mail]

Rishi Sinha (Alternate) Senior Regulatory Affairs Manager Telephone: [phone] Email: [e-mail]

- 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:

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.

#### IX. Indications for Use:

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.

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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,<br>NavLock™ Trackers | NavLock™<br>Trackers, K182104 | NavLock™<br>Trackers, K171267 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | OLO | OLO | OLO |
| Operating<br>Principle<br>(Tracking<br>Method) | Optical (infra-red) | Optical (infra-red) | Optical (infra-red) |
| Intended<br>Use | The subject devices<br>are intended to enable<br>navigation during<br>stereotactic spinal<br>procedures that utilize<br>STEALTH™<br>Technology. | The subject devices<br>are intended to<br>enable navigation<br>during stereotactic<br>spinal procedures<br>that utilize the<br>MAZOR X<br>Stealth™ Edition<br>system. | The NavLock<br>trackers are intended<br>to enable navigation<br>of Medtronic<br>instrumentation<br>during stereotactic<br>spinal procedures<br>that utilize the<br>Medtronic<br>StealthStation™<br>surgical navigation<br>system. |
| Indications<br>for Use | The NavLock™<br>Trackers are intended<br>to enable navigation<br>of Medtronic<br>instrumentation used<br>during spinal fusion<br>and interbody<br>procedures with<br>Medtronic systems<br>utilizing STEALTH™<br>Technology. The<br>NavLock™ Trackers<br>should only be used<br>with Medtronic<br>instruments on<br>Medtronic systems<br>utilizing STEALTH™<br>Technology. | The NavLock™<br>Trackers are<br>intended to enable<br>navigation of<br>Medtronic<br>instrumentation<br>used during spinal<br>fusion and<br>interbody<br>procedures with the<br>MAZOR X<br>Stealth™ Edition<br>system. The<br>NavLock™<br>Trackers should<br>only be used with<br>Medtronic<br>instruments on the<br>Medtronic MAZOR<br>X Stealth™ Edition<br>system. | The NavLock™<br>Trackers are<br>intended to enable<br>navigation of<br>Medtronic<br>instrumentation used<br>during spinal fusion<br>and interbody<br>procedures with the<br>Medtronic<br>StealthStation™<br>surgical navigation<br>system. The<br>NavLock™<br>Trackers should<br>only be used with<br>Medtronic<br>instruments. |
| Feature | Subject Device,<br>NavLock™ Trackers | NavLock™<br>Trackers, K182104 | NavLock™<br>Trackers, K171267 |
| Navigational<br>System<br>Accuracy<br>Analysis | System level accuracy<br>testing was<br>demonstrated on the<br>Navlock™ Trackers<br>for use with<br>StealthStation™<br>Systems (K171267)<br>and MAZOR X<br>Stealth™ Edition<br>(K182104). Worst-<br>case test<br>configurations using<br>StealthStation™<br>Software met the<br>criteria of ≤2.0 mm<br>positional error and<br>≤2.0° trajectory error.<br>Rationale has been<br>provided for the<br>subject Navlock™<br>Black and Blue<br>Trackers. | Utilizing worst-case<br>test configurations,<br>subject NavLock™<br>Tracker<br>(NavLock™ Blue)<br>and the Robotic<br>Reference Frame<br>were tested with the<br>MAZOR X<br>Stealth™ Edition<br>software application<br>and the overall test<br>results met the<br>criteria of ≤2.0 mm<br>positional error and<br>≤2.0° trajectory<br>error. | Utilizing worst-case<br>test configurations,<br>predicate<br>NavLock™ Tracker<br>(NavLock™<br>Orange)** was<br>tested with<br>StealthStation™ S8<br>Spine Software<br>application and the<br>overall test results<br>met the criteria of<br>≤2.0 mm positional<br>error and ≤2.0°<br>trajectory error. |
| Sterilization<br>Method | Non-Sterile, Reusable,<br>Steam Sterilized | Non-Sterile,<br>Reusable, Steam<br>Sterilized | Non-Sterile,<br>Reusable, Steam<br>Sterilized |

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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.