(49 days)
No
The summary describes navigated surgical instruments used with existing navigation systems (StealthStation and Mazor X). There is no mention of AI or ML in the intended use, device description, or performance testing sections. The focus is on navigation accuracy and compatibility with existing systems.
No
The device, Medtronic Surgical Instruments, is intended to assist in precisely locating anatomical structures during spinal surgery, specifically for the preparation and placement of Medtronic implants. It is described as navigated or non-navigated manual instruments. This indicates that the device itself is a surgical tool used to aid in a procedure, rather than directly treating or mitigating a disease or condition. Therapeutic devices are typically those that provide treatment, such as delivering energy, substances, or implants for a therapeutic effect.
No
Explanation: The device, Medtronic Surgical Instruments, is described as tools used during preparation and placement of implants during spinal surgery to assist in precisely locating anatomical structures. While it references CT or MR-based models, fluoroscopy images, or digitized landmarks, its primary function is surgical assistance and navigation, not diagnosis (identifying a disease or condition). The "Intended Use" section clearly states their purpose is for surgical procedures, not for diagnosis.
No
The device description explicitly states that the devices are "navigated instruments manufactured from stainless steel," indicating they are physical hardware components. The submission is seeking clearance for these physical instruments to be navigated with different systems (MAZOR X™ and StealthStation™ System).
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 precisely locating anatomical structures and preparing for implant placement. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details surgical instruments like inserters, trials, shavers, and drivers, all designed for use within the surgical field.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Focus on Surgical Guidance: The primary function described is navigation and guidance during surgery, often in conjunction with imaging modalities like CT, MR, and fluoroscopy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on assisting in a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
OLO, MAX, OVD, HBE
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.
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).
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
Not Found
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
| 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 |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K050438, K201189, K182077, K203005, K111520, K123270
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).
0
Build Correspondence
Image /page/0/Picture/12 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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)
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.
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 Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133 |
|---------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alex Underberg
Regulatory Affairs Specialist
Telephone Number: (901) 344-1443
Email: Alex.R.Underberg@Medtronic.com |
II. Device:
| Proprietary Trade Name: | 1. Catalyft™ PL Expandable Interbody System
Navigated Instruments
2. Anteralign™ TL Spinal System with Titan
nanoLOCK™ Surface Technology Navigated
Instruments
3. CD Horizon™ Solera™ Voyager™ Spinal System
Navigated, 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, MAX
Anteralign™ TL: OLO, MAX, OVD
CD 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 II
FDA Product Code: OLO
Catalyft™ PL Expandable Interbody
System Navigated Instruments (K210425,
S.E. 05/24/2021)
Classification: Class II
FDA Product Code: OLO, MAX |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional Predicate | Anteralign™ TL Spinal System with
Titan nanoLOCK™ Surface Technology
Navigated Instruments (K212524, S.E.
12/08/2021)
Classification: Class II
FDA 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
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.
Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments
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.
CD Horizon™ Solera™ Voyager™ Navigated. Guided, and Powered Drivers
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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).
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.