The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.

Navigated instruments are specifically designed for use with the 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.

Device Description

The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel as the predicate, per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate to facilitate a discectomy or boney resection during spinal surgery. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.

AI/ML Overview

This document describes the regulatory clearance for the Navigated Anterolateral Disc Prep Instruments designed for use with the Medtronic StealthStation™ System.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a summary of performance testing but does not explicitly state numerical acceptance criteria or detailed reported device performance in a table format. However, it lists the types of tests conducted and their descriptions. The "reported device performance" is generally implied as passing the tests to ensure functionality and compatibility.

Test Title	Description
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy.
Navigation Simulated Use	Confirmed navigation system functionality under expected use conditions.
CAD Model Evaluation	Verified that the CAD models are accurately reflected in the application software.
Spine Tools Package Functional Testing	Verified that the Spine Tools package has met the required interface needs of the spine application software.
Verification & Validation	Verified that the instruments function according to their intended use.
Biocompatibility	Verified that the instrument material meets the ASTM standards.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for any of the tests conducted. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for the test sets. These details are typically provided in more comprehensive study reports or validation documentation, which are not fully contained within this FDA 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test sets. The tests described (e.g., navigation accuracy, simulated use, CAD model evaluation) suggest engineering and technical evaluations rather than clinical expert reviews for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method for the test set. Given the nature of the tests (functional and technical evaluations), formal adjudication methods like those used in clinical trials for expert-based ground truth might not be applicable or were not deemed necessary to be included in this summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device described is a set of navigated surgical instruments, not an AI-assisted diagnostic or interpretative system where "human readers" would be involved in interpreting data that the device processes. Therefore, this question is not applicable to the device under review.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a set of physical surgical instruments designed to be used with a navigation system (StealthStation™) and operated by a human surgeon. It is not an algorithm-only or standalone AI system. Therefore, the concept of "standalone (algorithm only)" performance without human intervention is not applicable to this device. The navigation system itself might undergo separate standalone performance testing, but this document focuses on the instruments.

7. The type of ground truth used:

The "ground truth" for the tests described appears to be based on:

Engineering specifications and design requirements: For tests like "Navigation Accuracy Analysis," "CAD Model Evaluation," and "Spine Tools Package Functional Testing," the ground truth would be precise engineering measurements, CAD model data, and software interface requirements.
Intended use functionality validation: For "Navigation Simulated Use" and "Verification & Validation," the ground truth involves confirming that the instruments perform as expected and meet their intended functional objectives.
Material standards: For "Biocompatibility," the ground truth is adherence to established ASTM material standards.

8. The sample size for the training set:

The document does not mention a training set as this device is not an AI/machine learning system that requires model training. The tests described are related to the physical and functional performance of surgical instruments.

9. How the ground truth for the training set was established:

As there is no training set for this type of device, this question is not applicable.

Summary

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November 22, 2019

Medtronic Sofamor Danek USA, INC. Parwinder Singh Associate Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K192336

Trade/Device Name: Navigated Anterolateral Disc Prep Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 27, 2019 Received: August 28, 2019

Dear Parwinder Singh:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192336

Device Name

Naviagted Anterolateral Disc Prep Insturments

Indications for Use (Describe)

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

October 31, 2019

I. Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133
Contact:	Parwinder SinghAssociate Regulatory Affairs SpecialistTelephone Number: (901) 396-3133Email: parwinder.singh@medtronic.com

II. Device :

Proprietary Trade Name:	Navigated Anterolateral Disc Prep Instruments
Common Name:	Navigated Instruments
Classification Name:	Stereotaxic Instrument
Regulation Number:	21 CFR 882.4560
Classification:	Class II
Product Code:	OLO

Purpose: The purpose of this submission is to seek clearance for the Navigated Anterolateral Disc Prep Instruments, utilized with the StealthStation® System.

	III. Predicates:
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Primary Predicate		K150231, SE.06/16/2015
Predicate Two	Nav T2 Stratosphere Inserters andNavigated Templates	K191039, SE.08/26/2019
Predicate Three(Reference)	Nav CD Horizon SoleraScrewdrivers, Taps, Iliac Taps,Legacy Taps	K124004, SE.3/22/2013

This predicate has not been subject to a design-related recall.

IV. Product Description:

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Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.

V. Indications for Use:

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to be used to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.

VI. Comparison of Technological Characteristics:

The subject Navigated Anterolateral Disc Prep Instruments have the same indications. intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared primary predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015)

VII. Discussion of the Performance Testing:

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The K124004 was used as a comparator for performance testing. The following table summarizes the performance testing completed:

Test	Description
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy.
Navigation Simulated Use	Confirmed navigation systemfunctionality under expected useconditions.
CAD Model Evaluation	Verified that the CAD models areaccurately reflected in the applicationsoftware.
Spine Tools Package Functional Testing	Verified that the Spine Tools package hasmet the required interface needs of thespine application software.

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Verification & Validation	Verified that the instruments function according to their intended use.
Biocompatibility	Verified that the instrument material meets the ASTM standards

VIII. Conclusion:

Based on the supporting information provided in this pre-market notification, the subject Navigated Anterolateral Disc Prep Instruments are substantially equivalent to the primary predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015).

Regulation Number and Section

§ 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).