(88 days)
No
The document describes surgical instruments used with a robotic navigation system (MAZOR X Stealth™ Edition) but does not mention any AI or ML components within the instruments themselves or the described system functionality. The focus is on navigation, tracking, and compatibility with existing systems.
No
The device, Medtronic Surgical Instruments, is a surgical tool used for preparation and placement of implants during spinal surgery. It does not directly provide therapy or treatment to the patient. Its function is to assist in the surgical procedure, not to be a therapeutic agent itself.
No
The device is described as "surgical instruments" intended for "preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures." It is used during surgery, not for diagnosis before or after.
No
The device description explicitly states that the CD HORIZON™ Spinal System surgical instruments are "non-sterile, single or re-usable instruments" made of "a variety of materials commonly used in orthopedic and neurological procedures," indicating they are physical hardware components, not software only.
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 the surgeon in locating anatomical structures and placing implants. This is an in-vivo (within the living body) procedure.
- Device Description: The description details surgical instruments used in orthopedic and neurological procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body during surgery.
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 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 Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, 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. DO NOT IMPLANT THE INSTRUMENTS
Product codes
OLO
Device Description
The CD HORIZON™ Spinal System surgical instruments are non-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 specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments 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, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field.
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 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)
Tests were completed to ensure functionality and compatibility.
- Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
- Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
- 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.
- Navigation Software Module Instrument Functional Testing: Verified that the instrument attributes are correctly implemented in the navigation software module.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K140454, K153442, K163221, K124004, K111520
Reference Device(s)
K153442, K163221, K124004, 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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Medtronic Sofamor Danek USA, Inc. Erikka Edwardsen Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
November 2, 2018
Re: K182121
Trade/Device Name: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 31, 2018 Received: November 1, 2018
Dear Erikka Edwardsen:
This letter corrects our substantially equivalent letter of November 2, 2018
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Jesse Muir
-S
Digitally signed by Jesse Muir -S
Date: 2018.11.02 16:01:49 -04'00
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CD HORIZON Spinal System 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 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 Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, 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. DO NOT IMPLANT THE INSTRUMENTS
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K182121
510(k) SUMMARY
October 31, 2018
- I. Medtronic Sofamor Danek, USA Inc. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Erikka Edwardsen Senior Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: rikka.r.edwardsen(@medtronic.com
Shweta Sharma Principal Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: shweta.s.sharma@medtronic.com
Proprietary Trade Name: CD HORIZON™ Spinal System Instruments for use II.
with MAZOR X Stealth Edition
Common Name: Stereotaxic Instrument, Navigated Instruments
Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II
Product Code: OLO
III. Predicate Devices:
Primary Predicate:
Navigated CD HORIZON™ SOLERA™ Spinal System (K140454, S.E. 05/22/2014)
Reference Predicates:
CD HORIZON™ BALLAST™ Spinal System (K153442, S.E. 02/18/2016)
MAZOR X (K163221, S.E. 04/04/2017)
Navigated CD HORIZON™ SOLERATM Spinal System (K124004, S.E 03/22/2013)
IPCTM POWEREASE™ System (K111520, S.E. 10/26/2011)
This predicate devices have not been subject to a design-related recall.
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IV. Device Description:
The CD HORIZON™ Spinal System surgical instruments are non-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 specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments 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, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field.
Indications for Use: V.
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 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 Arm Guide. Medtronic surgical drills shall only be used
5
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 label and the instrument.
DO NOT IMPLANT THE INSTRUMENTS
Comparison of the Technological Characteristics with the Predicate Device: VI.
The CD HORIZON™ instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the MAZOR X Stealth™ Edition. Like the predicate devices, the subject instruments work through an arm guide for trajectory guidance and attach to NavLock™ Trackers to allow for optical navigation. The subject devices have similar designs, principle of operation, fundamental scientific technology, material, intended use, as the predicate devices and incorporate the same design features to enable navigation, arm guide compatibility and use with the IPC™ POWEREASE™ System, when desired.
The only difference between the subject and predicate devices is, the predicate devices are navigated on the Stealth ™ Station and the predicate devices are navigated via the MAZOR XTM Stealth Edition.
Performance Data: VII.
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:
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| Test | Description |
|---|---|
| Navigation | |
| Accuracy Analysis | Confirmed navigated instrument accuracy |
| Anatomical | |
| Simulated Use | Confirmed instrument functionality under expected use conditions |
| 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 | |
| Navigation | |
| Software Module | |
| Instrument | |
| Functional Testing | Verified that the instrument attributes are correctly implemented in |
| the navigation software module. |
Conclusions VIII.
The CD HORIZON™ Instruments for use with the MAZOR X Stealth™ Edition have shown through comparison and testing to be substantially equivalent to the identified predicate devices.