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 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 IPCT™ 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.

Device Description

The CD HORIZON™ Spinal System surgical instruments are non-sterile or sterile, single, or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connection site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the Mazor X Stealth™ Edition, the instrument dimensions have been designed to work with the Mazor X arm guides. The subject RG FAS Drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The subject instruments are reusable and will be provided non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition) and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria.

The document discusses:

Device Name: CD Horizon™ Spinal System / Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
Regulatory Information: 510(k) clearance, product codes, classification, predicate devices.
Intended Use: Surgical instruments for preparing and placing Medtronic implants during spinal surgery, assisting in precisely locating anatomical structures, compatible with MAZOR X Stealth™ Edition.
Technological Characteristics: Comparison with predicate devices, stating similar intended use, indications, material, fundamental technology, and sterilization method.
Performance Data: This section briefly mentions verification/validation activities, but these are for the surgical instruments themselves and their compatibility with the navigation system, not for an AI/ML algorithm's performance. The activities listed are:
- Design Validation and Anatomical Simulated Use
- Navigation Simulated Use
- Navigation Accuracy Analysis

Given this, I cannot provide the requested information about acceptance criteria and the study that proves an AI/ML device meets them because the provided text does not describe an AI/ML device or its evaluation. It focuses on traditional surgical instruments.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

May 26, 2023

Medtronic Sofamor Danek, USA Inc. Justin O'connor Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K231184

Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 25, 2023 Received: April 26, 2023

Dear Justin O'connor:

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/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 mediation-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-S

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)

Device Name

Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition

Indications for Use (Describe)

Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon 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 any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a 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 Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the instrument.

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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K231184

510(k) Summary

MEDTRONIC CD HORIZON™ Spinal System

April 25, 2023

I. Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133
Contact Person	Justin O'ConnorSr. Regulatory Affairs SpecialistEmail: justin.oconnor@medtronic.com
Date Prepared	April 25, 2023
II. Name of Device	CD Horizon™ Spinal System
Common Name	Orthopedic Stereotaxic Instruments, Navigated Instruments
Classification Name	Stereotaxic Instruments
Classification	Instruments/Accessories: Class II
Product Codes	OLO (882.4560)
III. Predicate Devices	Primary Predicate:CD Horizon™ Spinal System Instruments for use with Mazor XStealth™ Edition (K182121, S.E. 11/02/2018)Additional Predicate:CD Horizon™ Spinal System (K211596, S.E. 06/23/2021)The predicates have not been subject to a design related recall.
IV. Description	Medtronic Surgical Instruments for use with Mazor XStealth™ Edition
	The CD HORIZON™ Spinal System surgical instruments are non-sterile or sterile, single, or re-usable instruments that may be usedduring the preparation and placement of various Medtronic spinalimplants during spinal surgery. The subject instruments are madeof a variety of materials commonly used in orthopedic andneurological procedures which meet available national orinternational standards specifications. Single-use MedtronicSurgical instruments should never be reused under anycircumstances.
	The CD Horizon™ instruments are intended to be used whenpreparing and placing Medtronic screws during spinal surgery. Toenable optical navigation compatibility of the surgical instrumentswith the MAZOR X Stealth™ Edition System, the proximal endsof the instrument shafts have been designed with a bushing thatprovides a connection site where the NavLock™ trackers(K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E.06/18/2020) can be attached. To enable trajectory guidancecompatibility of the surgical instruments with the Mazor XStealth™ Edition, the instrument dimensions have been designed towork with the Mazor X arm guides. The subject RG FAS Driversmay also be operated under power when attached to thePOWEREASE™ Driver (K111520, S.E. 10/26/2011).
	The subject instruments are reusable and will be provided non-sterile.
V. Indications for Use	Medtronic Surgical Instruments for use with Mazor XStealth™ Edition
	Medtronic Surgical Instruments are intended to be used duringpreparation and placement of Medtronic implants during spinalsurgery to assist in precisely locating anatomical structures in eitheropen, or minimally invasive, procedures. Medtronic SurgicalInstruments are specifically designed for use with the Mazor XStealth™ Edition, which is indicated for medical conditions inwhich the use of stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical structure, such as avertebra, 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-navigatedmanual instruments that may or may not be guided through theMazor X Stealth™ Edition Arm Guide. Medtronic surgical drillsshall only be used through the Mazor X Stealth™ Edition armguides, Medtronic cannulas, and Medtronic drill guides. Some ofthe Medtronic Surgical Instruments are also compatible with theIPCT™ Powerease™ System or AO* style quick connect drillingmotors. An instrument may incorporate a measuring function whichhas uses as described on the label and the instrument.
VI. Comparison ofTechnologicalCharacteristics withthe Predicate Devices	The subject instruments have the same intended use, indications,material, fundamental technology, and sterilization method as theinstruments in the following CD Horizon™ Spinal Systempredicates:
	CD Horizon™ Spinal System Instruments for use withMazor X Stealth™ Edition (K182121, S.E. 11/02/2018) CD Horizon™ Spinal System (K211596, S.E. 06/23/2021)
VII. Performance Data	The following verification/validation activities were completed toensure functionality and compatibility with the subject instruments:
	Design Validation and Anatomical Simulated Use –Confirmed instrument functionality under expected useconditions Navigation Simulated Use – Confirmed navigation systemfunctionality under expected use conditions Navigation Accuracy Analysis – Confirmed navigatedinstrument accuracy
VIII. Conclusion	The CD HORIZON™ ModuLeX™ Instruments for use with theMazor X Stealth™ Edition have shown to be substantiallyequivalent to the predicates listed above.

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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).