(30 days)
No
The document describes surgical instruments used with a robotic system (Mazor X Stealth™ Edition) for navigation and guidance during spinal surgery. While the robotic system itself might incorporate AI/ML, the description of the instruments focuses on their mechanical design, compatibility with the system and other tools, and navigation features, with no mention of AI or ML being part of the instruments themselves.
No.
The device is described as surgical instruments used for the preparation and placement of implants during spinal surgery, focusing on assisting in precisely locating anatomical structures. It facilitates the therapeutic procedure (spinal surgery) but does not directly provide therapy itself.
No
The device is described as surgical instruments used during the preparation and placement of implants in spinal surgery, assisting in precisely locating anatomical structures. Its function is to facilitate surgical procedures, not to diagnose a condition.
No
The device description explicitly states that the device is comprised of "non-sterile or sterile, single, or re-usable instruments" made of various materials, which are physical hardware components. While the instruments are compatible with navigation software and systems, the instruments themselves are not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are used during spinal surgery to assist in preparing and placing implants and precisely locating anatomical structures. This is an in vivo (within the living body) application.
- Device Description: The description details surgical instruments used for physical manipulation and placement during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on samples taken from a patient. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
OLO
Device Description
Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
rigid anatomical structure, such as a vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical setting
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)
The following verification/validation activities were completed to ensure functionality and compatibility with the subject instruments:
Design Validation and Anatomical Simulated Use – Confirmed instrument functionality under expected use conditions
Navigation Simulated Use – Confirmed navigation system functionality under expected use conditions
Navigation Accuracy Analysis – Confirmed navigated instrument accuracy
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K171267, K182104, K201327, K111520
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).
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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 Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133 |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Justin O'Connor
Sr. Regulatory Affairs Specialist
Email: 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 X
Stealth™ 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 X
Stealth™ Edition |
| | 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. |
| 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
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. |
| VI. Comparison of
Technological
Characteristics with
the Predicate Devices | The subject instruments have the same intended use, indications,
material, fundamental technology, and sterilization method as the
instruments in the following CD Horizon™ Spinal System
predicates: |
| | CD Horizon™ Spinal System Instruments for use with
Mazor 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 to
ensure functionality and compatibility with the subject instruments: |
| | Design Validation and Anatomical Simulated Use –
Confirmed instrument functionality under expected use
conditions Navigation Simulated Use – Confirmed navigation system
functionality under expected use conditions Navigation Accuracy Analysis – Confirmed navigated
instrument accuracy |
| VIII. Conclusion | The CD HORIZON™ ModuLeX™ Instruments for use with the
Mazor X Stealth™ Edition have shown to be substantially
equivalent to the predicates listed above. |
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