(91 days)
No
The description focuses on optical tracking and navigation using reflective spheres and a camera system, with no mention of AI or ML algorithms for image processing, decision support, or other functions.
No
The devices (NavLock Trackers and Robotic Reference Frame) are described as enabling navigation and tracking the position of surgical instruments for the MAZOR X Stealth™ Edition system during spinal procedures. They do not directly treat, diagnose, cure, mitigate, or prevent disease. They are accessories that assist in the surgical procedure.
No
The provided text explicitly states that the NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation during spinal fusion and interbody procedures. There is no mention of the device being used to diagnose a medical condition or ailment. It assists in surgical procedures by tracking instrument position.
No
The device description explicitly mentions physical components like "posts to affix reflective spheres" and describes how these components are used for optical tracking, indicating a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for enabling navigation of surgical instruments during spinal fusion and interbody procedures. This is a surgical guidance and tracking system, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on how the devices attach to surgical instruments and are tracked by a camera for navigation. This aligns with surgical navigation technology, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The devices described are accessories for a surgical navigation system (MAZOR X Stealth™ Edition system) used to assist surgeons during procedures.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Navigational Accuracy Analysis: Provides confirmation that the subject devices satisfy the necessary navigational accuracy requirements.
Accelerated Life Functionality: Tested functionality after multiple reprocessing cycles (cleaning and sterilization) and repeated use. Provides confirmation that the product remains functional throughout its intended useful life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
Page
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ 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
"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."
3
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 PRAStaff@fda.hhs.gov
"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."
4
K182104
510(k) Summary
July 31, 2018
- I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Jainam Shah Regulatory Affairs Specialist Telephone Number: (720) 890-2595 Fax: (720) 890-3500 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.
5
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
Trackers and Robotic
Reference Frame) | NavLock Trackers, K171267, S.E.
07/03/2017 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | OLO | OLO |
| Operating
Principle
(Tracking
Method) | Optical (infra-red) | Optical (infra-red) |
| Intended
Use | The subject devices are
intended to enable navigation
during stereotactic spinal
procedures that utilize the
MAZOR X StealthTM Edition
system. | The NavLock trackers are intended to
enable navigation of Medtronic
instrumentation during stereotactic
spinal procedures that utilize the
Medtronic StealthStation surgical
navigation system. |
| 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 StealthTM Edition
system. The NavLockTM
Trackers should only be used
with Medtronic instruments
on the Medtronic MAZOR X
StealthTM Edition system. | The NavLock Trackers are intended to
enable navigation of Medtronic
instrumentation used during spinal
fusion and interbody procedures with
the Medtronic StealthStation surgical
navigation system. The NavLock
Trackers should only be used with
Medtronic instruments. |
6
| Feature | Subject Devices (NavLock
Trackers and Robotic
Reference Frame) | NavLock Trackers, K171267, S.E.
07/03/2017 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | The Robotic Reference Frame
is an accessory to the
MAZOR X StealthTM Edition
system and it is intended to
enable navigation during
spinal fusion and interbody
procedures that utilize the
MAZOR X StealthTM Edition
system. | |
| Sterilization
Method | Non-Sterile, Reusable, Steam
Sterilized | Non-Sterile, Reusable, Steam
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 | |
| Accuracy Analysis | Provides confirmation that the subject devices satisfy the |
| necessary navigational accuracy requirements. | |
| Accelerated Life | |
| Functionality | Tested functionality after multiple reprocessing cycles |
| (cleaning and sterilization) and repeated use. Provides | |
| confirmation that the product remains functional throughout | |
| its intended useful life. |
XII. Conclusions
The subject devices have shown through comparison to be substantially equivalent to the identified predicate device.