(30 days)
No
The description focuses on optical tracking of instruments using reflective spheres and does not mention any AI/ML components for image processing, decision support, or other functions.
No
The device is used for navigation of surgical instruments and tracks their position during spinal fusion and interbody procedures, but it does not directly treat or diagnose a disease or condition.
No
The device is used for navigation of surgical instruments and tracking their position, not for diagnosing medical conditions. It aids in surgical procedures rather than identifying a disease or condition.
No
The device description explicitly states that the NavLock™ Trackers are physical components with posts to affix reflective spheres, which are visible to a camera for tracking. This indicates a hardware component, not a software-only device.
Based on the provided information, the NavLock™ Trackers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the NavLock™ Trackers are used to enable navigation of surgical instruments during spinal fusion and interbody procedures. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description details how the trackers work with a camera system to track the position of surgical instruments during surgery. This further reinforces its use in a surgical setting.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. The NavLock™ Trackers do not perform any such function.
Therefore, the NavLock™ Trackers are a surgical navigation accessory used during procedures, not an IVD device.
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 Medtronic systems utilizing STEALTH™ Technology. The NavLock™ Trackers should only be used with Medtronic instruments on Medtronic systems utilizing STEALTH™ Technology.
Product codes
OLO
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.
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
Not Found
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)
System level accuracy testing was demonstrated on the Navlock™ Trackers for use with StealthStation™ Systems (K171267) and MAZOR X Stealth™ Edition (K182104). Worst-case test configurations using StealthStation™ Software met the criteria of ≤2.0 mm positional error and ≤2.0° trajectory error. Rationale has been provided for the subject Navlock™ Black and Blue Trackers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positional error: ≤2.0 mm, Trajectory error: ≤2.0°
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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:
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.
4
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 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | OLO | OLO | OLO |
| Operating
Principle
(Tracking
Method) | Optical (infra-red) | Optical (infra-red) | Optical (infra-red) |
| Intended
Use | The subject devices
are intended to enable
navigation during
stereotactic spinal
procedures that utilize
STEALTH™
Technology. | The subject devices
are intended to
enable navigation
during stereotactic
spinal procedures
that utilize the
MAZOR X
Stealth™ 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
Medtronic systems
utilizing STEALTH™
Technology. The
NavLock™ Trackers
should only be used
with Medtronic
instruments on
Medtronic systems
utilizing STEALTH™
Technology. | 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
Medtronic MAZOR
X Stealth™ 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. |
| Feature | Subject Device,
NavLock™ Trackers | NavLock™
Trackers, K182104 | NavLock™
Trackers, K171267 |
| Navigational
System
Accuracy
Analysis | System level accuracy
testing was
demonstrated on the
Navlock™ Trackers
for use with
StealthStation™
Systems (K171267)
and MAZOR X
Stealth™ Edition
(K182104). Worst-
case test
configurations using
StealthStation™
Software met the
criteria of ≤2.0 mm
positional error and
≤2.0° trajectory error.
Rationale has been
provided for the
subject Navlock™
Black and Blue
Trackers. | Utilizing worst-case
test configurations,
subject NavLock™
Tracker
(NavLock™ Blue)
and the Robotic
Reference Frame
were tested with the
MAZOR X
Stealth™ Edition
software application
and the overall test
results met the
criteria of ≤2.0 mm
positional error and
≤2.0° trajectory
error. | Utilizing worst-case
test configurations,
predicate
NavLock™ Tracker
(NavLock™
Orange)** was
tested with
StealthStation™ S8
Spine Software
application and the
overall test results
met the criteria of
≤2.0 mm positional
error and ≤2.0°
trajectory error. |
| Sterilization
Method | Non-Sterile, Reusable,
Steam Sterilized | Non-Sterile,
Reusable, Steam
Sterilized | Non-Sterile,
Reusable, Steam
Sterilized |
5
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.