NavLock Trackers, Robotic Reference Frame

K182104 · Medtronic Navigation · OLO · Nov 2, 2018 · Neurology

Device Facts

• Record ID: K182104
• Device Name: NavLock Trackers, Robotic Reference Frame
• Applicant: Medtronic Navigation
• Product Code: OLO · Neurology
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Traditional
• 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 the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system. The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system.

Device Story

NavLock Trackers and Robotic Reference Frame are optical navigation accessories for the MAZOR X Stealth Edition system. Devices feature posts to affix reflective spheres, which are tracked by the MAZOR X Navigation camera. NavLock Trackers attach to Medtronic surgical instruments; Robotic Reference Frame serves as a system accessory. Used in spinal fusion and interbody procedures; operated by surgeons in clinical settings. Optical tracking data enables real-time visualization of instrument position relative to patient anatomy, assisting in surgical guidance and precision. Devices are reusable and steam-sterilized.

Clinical Evidence

Bench testing only. Navigational accuracy analysis confirmed requirements; accelerated life functionality testing confirmed performance after multiple reprocessing and use cycles.

Technological Characteristics

Stereotaxic instruments; optical (infra-red) tracking principle; non-sterile, reusable, steam-sterilized. Components include posts for reflective spheres. Compatible with MAZOR X Stealth™ Edition system.

Indications for Use

Indicated for patients undergoing spinal fusion and interbody procedures requiring navigation via the MAZOR X Stealth™ Edition system. Used with Medtronic instrumentation.

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 (K171267)

Reference Devices

• SteathStation® S8 Spine Software v1.0.0 (K170011)
• SteathStation® S8 System (K162309)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Medtronic Navigation Jainam Shah Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

November 2, 2018

Re: K182104

Trade/Device Name: NavLock Trackers, Robotic Reference Frame Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 2, 2018 Received: August 3, 2018

Dear Jainam Shah:

This letter corrects our substantially equivalent letter of November 2, 2018

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digital signature. The name "Jesse Muir -S" is prominently displayed on the left side of the image. To the right of the name, the text "Digitally signed by Jesse Muir -S Date: 2018.11.02 15:53:43 -04'00'" is displayed.

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

## K182104

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 the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system

| 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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## Indications for Use

510(k) Number (if known) K182104

Device Name Robotic Reference Frame

Indications for Use (Describe)

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system and it is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth™ Edition system.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## K182104

## 510(k) Summary

## July 31, 2018

- I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: [phone]
- Contact: Jainam Shah Regulatory Affairs Specialist Telephone Number: [phone] Fax: [phone] Email: jainam.shah(@medtronic.com
- II. Proprietary Trade Name: NavLock™ Trackers; Robotic Reference Frame
- III. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
- VI. Product Code: OLO

#### VII. Product Description:

The NavLock trackers are compatible with the MAZOR X Stealth™ Edition system. The NavLock Trackers 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 subject NavLock Trackers have posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera as a means of tracking the position of the attached surgical instrument.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system. The Robotic Reference Frame has posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera for tracking location during navigated procedures.

#### VIII. Indications for Use:

The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

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The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth™ Edition system.

#### IX. Identification of Legally Marketed Devices (Predicate Devices):

NavLock Trackers (K171267, S.E. 07/03/2017). This predicate has not been subject to any recall. This predicate is the primary predicate for this submission.

The following devices have been added as reference devices in this submission:

- SteathStation® S8 Spine Software v1.0.0 (K170011, S.E. 05/01/2017) ●
- SteathStation® S8 System (K162309, S.E. 03/31/2017). ●

#### X. Comparison of the Technological Characteristics:

The subject devices under this submission consist of the NavLock trackers and the Robotic Reference Frame. Both the subject devices are stereotaxic instruments intended to enable navigation during stereotactic spinal procedures that utilize the MAZOR X Stealth™ Edition system. A comparison of the technological characteristics is provided below:

| Feature | Subject Devices (NavLock<br>Trackers and Robotic<br>Reference Frame) | NavLock Trackers, K171267, S.E.<br>07/03/2017 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | OLO | OLO |
| Operating<br>Principle<br>(Tracking<br>Method) | Optical (infra-red) | Optical (infra-red) |
| Intended<br>Use | The subject devices are<br>intended to enable navigation<br>during stereotactic spinal<br>procedures that utilize the<br>MAZOR X StealthTM Edition<br>system. | The NavLock trackers are intended to<br>enable navigation of Medtronic<br>instrumentation during stereotactic<br>spinal procedures that utilize the<br>Medtronic StealthStation surgical<br>navigation system. |
| Indications<br>for Use | The NavLock Trackers are<br>intended to enable navigation<br>of Medtronic instrumentation<br>used during spinal fusion and<br>interbody procedures with the<br>MAZOR X StealthTM Edition<br>system. The NavLockTM<br>Trackers should only be used<br>with Medtronic instruments<br>on the Medtronic MAZOR X<br>StealthTM Edition system. | The NavLock Trackers are intended to<br>enable navigation of Medtronic<br>instrumentation used during spinal<br>fusion and interbody procedures with<br>the Medtronic StealthStation surgical<br>navigation system. The NavLock<br>Trackers should only be used with<br>Medtronic instruments. |

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| Feature | Subject Devices (NavLock<br>Trackers and Robotic<br>Reference Frame) | NavLock Trackers, K171267, S.E.<br>07/03/2017 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | The Robotic Reference Frame<br>is an accessory to the<br>MAZOR X StealthTM Edition<br>system and it is intended to<br>enable navigation during<br>spinal fusion and interbody<br>procedures that utilize the<br>MAZOR X StealthTM Edition<br>system. | |
| Sterilization<br>Method | Non-Sterile, Reusable, Steam<br>Sterilized | Non-Sterile, Reusable, Steam<br>Sterilized |

The difference in the indications for use between the subject devices and the predicate device is that the subject devices are compatible with the MAZOR X Stealth™ Edition system. The test data included with this submission supports the compatibility of the subject devices with the MAZOR X Stealth™ Edition system.

### XI. Discussion of the Performance Testing:

Testing conducted to demonstrate equivalency of the subject device to the predicate device is summarized as follows:

| Test | Description |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Navigational<br>Accuracy Analysis | Provides confirmation that the subject devices satisfy the<br>necessary navigational accuracy requirements. |
| Accelerated Life<br>Functionality | Tested functionality after multiple reprocessing cycles<br>(cleaning and sterilization) and repeated use. Provides<br>confirmation that the product remains functional throughout<br>its intended useful life. |

### XII. Conclusions

The subject devices have shown through comparison to be substantially equivalent to the identified predicate device.