(55 days)
No
The document describes navigated surgical instruments used with existing computer-assisted surgery systems (Stealth Station System and MAZOR X™ System Stealth™ Edition) for tracking and guidance. There is no mention of AI or ML being used for image processing, decision support, or any other function within the described device or its interaction with the navigation systems. The performance testing focuses on navigation accuracy and simulated use, not AI/ML performance metrics.
No.
The device is described as surgical instruments used to assist in precisely locating anatomical structures during spinal surgery, rather than providing therapy itself.
No
The device is described as surgical instruments used for preparation and placement of implants during spinal surgery, assisting in precisely locating anatomical structures. Its purpose is to guide and track instruments in the surgical field, not to diagnose medical conditions or diseases.
No
The device description explicitly states the device is made of "high-grade stainless steel" and describes physical instruments like "navigated trials and a navigated interbody inserter." It also mentions compatibility with physical components like "NavLock trackers" and "Medtronic single-use sterile spheres." This indicates a hardware component is central to the device.
Based on the provided information, 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, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details surgical instruments made of stainless steel, compatible with navigation systems for tracking within the surgical field. This aligns with surgical tools, not diagnostic reagents or equipment used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Medtronic Surgical Instruments described are surgical tools used in a clinical setting for procedural guidance and manipulation, not for in vitro diagnostic purposes.
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 (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Anteralign™ LS Navigated Reusable Surgical Instruments are spine preparation instruments made of high-grade stainless steel. The subject navigated instruments consist of existing navigated trials and a navigated interbody inserter, which were recently cleared in K221180, S.E. 5/25/22 for use in Anteralign Interbody System procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System. Per this 510(k) submission, Medtronic is seeking clearance of the navigated instruments to also be compatible with the MAZOR X™ Stealth Edition. The instruments are compatible with NavLock trackers and Medtronic single -use sterile spheres to allow the Medtronic computer-assisted surgery system, such as the Stealth Station System and MAZOR X™ System (Stealth™ Edition), to track the 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data Previous testing completed on the predicate device was leveraged for the subject devices. The subject instruments do not represent a new worst-case and the testing previously performed for the predicate devices is deemed applicable for the subject devices as there are no changes to the methods in which these instruments are used within the procedure.
Test: Navigation Accuracy Analysis - Description: Confirmed navigated instrument accuracy
Test: Anatomical Simulated Use - Description: Confirmed instrument functionality under expected use conditions
Test: Navigated Simulated Use - Description: Confirmed navigation system functionality under expected use conditions
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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September 29, 2022
Medtronic Sofamor Danek USa, Inc. Elizabeth Hamilton Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K222383
Trade/Device Name: Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 30, 2022 Received: September 1, 2022
Dear Elizabeth Hamilton:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222383
Device Name
Anteralign(TM) LS Spinal System with Titan nanoLOCK(TM) Surface Technology Navigated Instruments with Mazor X(TM) (Stealth Edition)
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 nonnavigated 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 [ 2 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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3
K222383 - 510(k) SUMMARY MEDTRONIC Sofamor Danek 23 September 2022
| Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)399-3395
Fax: (901) 346-9738 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Elizabeth Hamilton
Sr. Regulatory Affairs Specialist
Email : elizabeth.c.hamilton@medtronic.com |
| Alternate Contact: | Raphael McInnis
Sr. Regulatory Affairs Manager
Email : raphael.mcinniss@medtronic.com |
| Date Prepared: | 23 September 2022 |
| Name of Device | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface
Technology Navigated Instruments with MAZOR X™ (Stealth™
Edition) |
| Common Name | Navigated Instruments |
| Classification Name | Stereotaxic Instruments (21 CFR 882.4560) |
| Regulatory Class | Class II |
| Product Code | OLO |
| Predicate Devices | Primary Predicate -Anteralign™ TL Spinal System with Titan
nanoLOCK™ Surface Technology Navigated Instruments Compatible
with MAZOR X™ system (Stealth™ Edition) (K214011, S.E.
02/09/2022) |
4
Description of Device
The Anteralign™ LS Navigated Reusable Surgical Instruments are spine preparation instruments made of high-grade stainless steel. The subject navigated instruments consist of existing navigated trials and a navigated interbody inserter, which were recently cleared in K221180, S.E. 5/25/22 for use in Anteralign Interbody System procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System. Per this 510(k) submission, Medtronic is seeking clearance of the navigated instruments to also be compatible with the MAZOR X™ Stealth Edition. The instruments are compatible with NavLock trackers and Medtronic single -use sterile spheres to allow the Medtronic computer-assisted surgery system, such as the Stealth Station System and MAZOR X™ System (Stealth™ Edition), to track the instruments in the surgical field.
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 instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.
5
Comparison of Technological Characteristics with Predicate Devices
The subject Anteralign™ LS Spinal System with Titan nanoLOCK" Surface Technology Navigated Instruments have an identical intended use, fundamental scientific technology, sterilization method, materials, and compatibilities with StealthStation™ System as the recently cleared predicate devices listed above. The subject devices are seeking compatibility with MAZOR X™ system, which is identical to the Primary Predicate's Indications for Use.
Performance Data Previous testing completed on the predicate device was leveraged for the subject devices. The subject instruments do not represent a new worst-case and the testing previously performed for the predicate devices is deemed applicable for the subject devices as there are no changes to the methods in which these instruments are used within the procedure. The following table summarizes the performance testing that was rationalized:
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy |
| Anatomical Simulated Use | Confirmed instrument functionality under |
| expected use conditions | |
| Navigated Simulated Use | Confirmed navigation system functionality |
| under expected use conditions |
Conclusion
Based on the information contained in this submission, Medtronic believes that the subject instruments are substantially equivalent to the predicate device.