Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition. which is indicated for medical conditions 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. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

Device Description

The Catalyft™ PL Expandable Interbody System navigated instruments consist of an Inserter (Outer), Inserter Inner Sleeve, Trials, a NAV Verification Tool, and Navigated Rotating Shavers that were cleared in K210425. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438. S.E. 06/02/2005; K201189. S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

Please note that the Navigated Rotating Shavers were previously cleared for use on MAZOR X™ (K203005, S.E. 10/27/2020), and per this 510(k) submission, the Rotating Shavers can be used for disc prep and to trial for Catalyft™ PL on MAZOR XTM.

The Anteralign™ TL navigated instruments consist of an Inserter and Trials that were originally cleared in K212524. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438, S.E. 06/02/2005; K201189, S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

The CD Horizon™ Solera™ Vovager™ Spinal System navigated instruments consists of new Drivers, which will be manufactured from stainless-steel. Medtronic is seeking clearance of the Drivers to be Navigated and Trajectory Guided via MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) and Powered via IPC™ POWEREASE™ System (K111520. S.E. 10/26/2011: K123270. S.E. 01/11/2013). To enable trajectory guidance compatibility, the Drivers have been designed to work with the MAZOR X™ Arm Guides. To enable power, the Drivers may also be attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

AI/ML Overview

The provided document is a 510(k) summary for Medtronic surgical instruments, outlining their substantial equivalence to predicate devices. It focuses on the compatibility of these instruments with the MAZOR X™ system. However, the document does not contain the detailed acceptance criteria and performance data typically found in a clinical study report for proving a device meets acceptance criteria.

Specifically, it mentions "Performance Testing" and "Discussion of the Performance Testing" but then lists generic test descriptions rather than specific quantitative acceptance criteria or reported device performance metrics. There is no information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document serves as a high-level summary for regulatory submission, not a detailed performance study report.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: The document lists general "performance testing" but does not define quantitative acceptance criteria (e.g., "accuracy shall be within X mm") or specific numerical results.
Sample sizes used for the test set and the data provenance: No information on the number of cases, images, or subjects used in the "performance testing," nor any details on whether it was retrospective or prospective, or data origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth established by experts for performance evaluation. The "ground truth" here is likely engineering validation against design specifications or a simulated environment, not clinical expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no human adjudication described.
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: Not applicable. This device is surgical navigation instrumentation, not an AI / image analysis device that would assist human readers in diagnosis.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance testing" described is likely functional verification of the instruments and their compatibility with the navigation system, not a standalone algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but inferred to be engineering specifications and simulated use assessments rather than clinical ground truth.
The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted (though still lacking detail for your specific request):

Device Type: Surgical Instruments for spinal surgery, intended to assist in precisely locating anatomical structures using navigation systems (MAZOR X™ Stealth™ Edition and StealthStation™ System).
Nature of "Performance Testing": The document briefly lists categories of testing:
- Navigation Accuracy Analysis
- CAD Model Verification
- Tools Package Functional Verification
- NAV Simulated Use
- Anatomical Simulated Use
Purpose of Testing: "To ensure the functionality and compatibility of the identified Medtronic products when used with the Mazor X™ system."
Conclusion: Based on the supporting information (which includes the performance testing), the subject instruments are deemed "substantially equivalent" to the predicate devices. This implies they met internal benchmarks/acceptance criteria, but the specific values are not provided.

In summary, the provided document is a regulatory submission summary demonstrating substantial equivalence, not a detailed technical report of the performance studies with acceptance criteria and results for the device's navigation accuracy or other functionalities.

Summary

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Build Correspondence

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February 9, 2022

Medtronic Sofamor Danek USA, INC. Alex Underberg Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

Re: K214011

Trade/Device Name: Catalyfi™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, MAX, OVD, HBE Dated: January 7, 2022 Received: January 10, 2022

Dear Alex Underberg:

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.

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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 (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,

For: 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) K214011

Device Name

Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Spinal System Navigated, Guided, and Powered Drivers

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

February 8th, 2022

I. Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133
Contact:	Alex UnderbergRegulatory Affairs SpecialistTelephone Number: (901) 344-1443Email: Alex.R.Underberg@Medtronic.com

II. Device:

Proprietary Trade Name:	1. Catalyft™ PL Expandable Interbody SystemNavigated Instruments2. Anteralign™ TL Spinal System with TitannanoLOCK™ Surface Technology NavigatedInstruments3. CD Horizon™ Solera™ Voyager™ Spinal SystemNavigated, Guided, and Powered Drivers
Common Name:	Stereotactic Instruments, Navigated Instruments
Classification Name:	Orthopedic Stereotactic Instrument
Regulation Numbers:	Class II (21 CFR 882.4560)
Classification:	Class II
Product Code:	Catalyft™ PL: OLO, MAXAnteralign™ TL: OLO, MAX, OVDCD Horizon™ Solera™ Voyager™: OLO, HBE

III. Predicates:

Primary Predicate	CD Horizon™ Spinal System ModuLeX
	Instruments for use with MAZOR X
	Stealth Edition (K211596, S.E.)
	06/23/2021)

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Additional Predicate	Classification: Class IIFDA Product Code: OLOCatalyft™ PL Expandable InterbodySystem Navigated Instruments (K210425,S.E. 05/24/2021)Classification: Class IIFDA Product Code: OLO, MAX
Additional Predicate	Anteralign™ TL Spinal System withTitan nanoLOCK™ Surface TechnologyNavigated Instruments (K212524, S.E.12/08/2021)Classification: Class IIFDA Product Code: OLO, MAX, OVD

The predicates have not been subject to a design-related recall.

IV. Product Description:

Catalyft™ PL Expandable Interbody System Navigated Instruments

Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments

CD Horizon™ Solera™ Voyager™ Navigated. Guided, and Powered Drivers

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V. Indications for Use:

Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions 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. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

VI. Comparison of Technological Characteristics:

The Catalyft™ PL and Anteralign™ TL previously cleared navigated instruments have an identical intended use, fundamental scientific technology, materials, sterilization method, and compatibilities with StealthStation™ System as the predicate devices. The subject devices are seeking the compatibility with the MAZOR X™ system, which is identical to the Primary Predicate.

The new CD Horizon™ Solera™ Voyager™ Drivers have been designed with features to enable compatibility with the MAZOR X™ system, MAZOR X™ arm guide, and IPC™ POWEREASE™ System, which is identical to the primary predicate. The Drivers have an identical intended use, fundamental scientific technology, materials, and sterilization method as the predicate devices.

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VII. Discussion of the Performance Testing:

Testing was rationalized or completed new to ensure the functionality and compatibility of the identified Medtronic products when used with the Mazor X™ system. The following table summarizes the performance testing that was rationalized or completed:

Test	Description
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy
CAD Model Verification	Confirmed CAD models are accurately reflected in the application software
Tools Package Functional Verification	Provides confirmation that the Spine tools package has met the required interface needs of the spine application software
NAV Simulated Use	To demonstrate that the navigated-specific procedural steps can be executed to navigate a spinal procedure
Anatomical Simulated Use	To validate that the product appropriately satisfies the user needs by performing simulated use testing per the instructions outlined in the surgical technique

*Please note the tests mentioned above were evaluated for all systems

VIII. Conclusion:

Based on the supporting information provided in this pre-market notification, the subject instruments are substantially equivalent to the predicate devices.

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).