K Number
K183381
Device Name
Navigation Enabled Instruments
Manufacturer
Date Cleared
2019-05-17

(162 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medironic System, which is indicated for anv medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model. fluoroscopy images, or digitized landmarks of the anatomy. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE System.
Device Description
Navigation Enabled Instruments are nonsterile, reusable instruments, including taps which are operated manually and drivers that can be manually operated or operated with the Medtronic IPC POWEREASE System. These instruments are intended to be used with the Medtronic StealthStation system.
More Information

Globus Navigation Instruments (K153203), Medtronic Navigated Instruments (K143628, K143375, K140454, K180690)

Not Found

No
The summary describes navigation-enabled instruments used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on stereotactic surgery and image-based navigation, not AI/ML algorithms.

No.
The device is described as "Navigation Enabled Instruments" intended to assist surgeons in precisely locating anatomical structures during spinal surgery by enabling navigation. It does not directly treat or cure a disease; it is a tool for surgical guidance.

No

The device is an instrument used to assist surgeons in locating anatomical structures during spinal surgery. It helps with the physical placement of screws, rather than diagnosing a condition.

No

The device description explicitly states that the Navigation Enabled Instruments are "nonsterile, reusable instruments, including taps which are operated manually and drivers that can be manually operated or operated with the Medtronic IPC POWEREASE System." This indicates the device includes physical hardware components, not just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is used during spinal surgery to assist the surgeon in precisely locating anatomical structures. This is an in-vivo (within the living body) application.
  • Device Description: The description confirms these are surgical instruments (taps and drivers) used in a surgical setting.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such analysis on specimens.

The device is a surgical navigation tool used to guide the placement of screws during surgery, which is a completely different category from IVD devices.

N/A

Intended Use / Indications for Use

Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic System, which is indicated for anv medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model. fluoroscopy images, or digitized landmarks of the anatomy. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE System.

Product codes (comma separated list FDA assigned to the subject device)

OLO

Device Description

Navigation Enabled Instruments are nonsterile, reusable instruments, including taps which are operated manually and drivers that can be manually operated or operated with the Medtronic IPC POWEREASE System. These instruments are intended to be used with the Medtronic StealthStation system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy

Anatomical Site

rigid anatomical structure, such as a skull, a long bone, or vertebra

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon, spinal surgery

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)

Design validation testing, including registration, and accuracy, was conducted to ensure the Navigation Enabled Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Accuracy testing was completed for comparison to the predicate instruments.

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.

Globus Navigation Instruments (K153203), Medtronic Navigated Instruments (K143628, K143375, K140454, K180690)

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.

Not Found

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).

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May 17, 2019

Stryker Megan Callanan Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401

Re: K183381

Trade/Device Name: Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 3, 2019 Received: May 6, 2019

Dear Megan Callanan:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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.htm); 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 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.

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183381

Device Name Navigation Enabled Instruments

Indications for Use (Describe)

Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medironic System, which is indicated for anv medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model. fluoroscopy images, or digitized landmarks of the anatomy. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE 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)

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510(k) Summary

510(k) Summary: Navigation Enabled
Submitter:Stryker Spine
2 Pearl Court
Allendale, NJ 07401
Contact Person:Name: Megan Callanan
Phone: (201)845-4900
Email: megan.callanan1@stryker.com
Date Prepared:12/04/18
Trade Name:Navigation Enabled Instruments
Common Name:Navigation Instruments
Proposed Class:Class II
Classification Name:Orthopedic / Orthopedic Stereotaxic Instruments
Regulation Number:21 CFR 882.4560
Product Code:OLO
Predicate Devices:Primary Predicate: Globus Navigation Instruments (K153203)
Additional Predicates: Medtronic Navigated Instruments (K143628,
K143375, K140454, K180690)
Device Description:Navigation Enabled Instruments are nonsterile, reusable instruments,
including taps which are operated manually and drivers that can be manually
operated or operated with the Medtronic IPC POWEREASE System. These
instruments are intended to be used with the Medtronic StealthStation
system.
Indications for use:Stryker Spine Navigation Enabled Instruments are intended to be used in the
preparation and placement of Stryker screws (including XIA 3 (including
Serrato), XIA 4.5 (including XIA CT), ES2, Mantis, Mantis Redux, and XIA 2)
during spinal surgery to assist the surgeon in precisely locating anatomical
structures in either open or minimally invasive procedures. These
instruments are specifically designed for use with the Medtronic
StealthStation® System, which is indicated for any medical condition in
which the use of stereotactic surgery may be appropriate, and where
reference to a rigid anatomical structure, such as a skull, a long bone, or
vertebra, can be identified relative to a CT or MR based model, fluoroscopy
images, or digitized landmarks of the anatomy. Stryker Spine Navigation
Enabled Screwdrivers are also compatible with the Medtronic IPC
POWEREASE System.
Summary of the
Technological
CharacteristicsNavigation Enabled Instruments have the same technological characteristics
as the predicate devices including design, material composition, intended
use, function, and range of sizes. Biocompatibility of patient-contacting
510(k) Summary: Navigation Enabled
materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Summary of the
Performance DataDesign validation testing, including registration, and accuracy, was conducted to ensure the Navigation Enabled Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.
Accuracy testing was completed for comparison to the predicate instruments.
ConclusionStryker Spine Navigation Enabled Instruments are substantially equivalent to the noted predicate devices as they have the same intended use, technological characteristics, safety and efficacy profile, and performance specifications.
The content of this submission supports the determination of substantial equivalence.

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