(55 days)
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.
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.
The Medtronic Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments with MAZOR X™ (Stealth™ Edition) is a Class II Stereotaxic Instrument (21 CFR 882.4560). The 510(k) submission (K222383) is for clearance of new navigated instruments to be compatible with the MAZOR X™ Stealth Edition.
1. Table of Acceptance Criteria and Reported Device Performance:
The submission leverages performance data from a previously cleared predicate device (Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments Compatible with MAZOR X™ system (Stealth™ Edition) (K214011)). The acceptance criteria and performance are not explicitly detailed in quantitative terms for the specific subject device in these documents, but the submission states that "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."
Therefore, the acceptance criteria and performance are inferred from the types of tests conducted on the predicate device.
| Test | Acceptance Criteria (Implied) | Reported Device Performance (Implied from predicate device leveraging) |
|---|---|---|
| Navigation Accuracy Analysis | The navigated instrument meets specified accuracy requirements. | Confirmed navigated instrument accuracy (for predicate device, which is deemed applicable to the subject device due to no worst-case changes). |
| Anatomical Simulated Use | The instrument functions as intended under expected anatomical use conditions. | Confirmed instrument functionality under expected use conditions (for predicate device, which is deemed applicable to the subject device due to no worst-case changes). |
| Navigated Simulated Use | The navigation system functions as intended under expected navigated use conditions. | Confirmed navigation system functionality under expected use conditions (for predicate device, which is deemed applicable to the subject device due to no worst-case changes). |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set used for the subject device. Instead, it relies on performance data from a predicate device (K214011). The specifics of the sample size and data provenance (e.g., country of origin, retrospective or prospective) for the predicate device's testing are not provided in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the given documents. The tests appear to be performance engineering tests rather than clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the "Performance Data" described (Navigation Accuracy Analysis, Anatomical Simulated Use, Navigated Simulated Use), it's highly probable that these are engineering verification tests against predefined specifications, rather than clinical studies requiring adjudication of results by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted or described in the provided documents. The submission focuses on substantial equivalence based on engineering performance and functional compatibility, not on assessing the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The device is a system of navigated surgical instruments that are used with the MAZOR X™ Stealth™ Edition system. This is an assistive technology for surgeons, meaning it is inherently designed for "human-in-the-loop" performance. Therefore, a standalone (algorithm only) performance assessment would not be applicable or relevant for this type of device. The "Navigation Accuracy Analysis" and "Navigated Simulated Use" would assess the accuracy and functionality of the system, including the software algorithms, in a simulated environment, but always in the context of guiding human interaction.
7. Type of Ground Truth Used:
The ground truth used for the tests (Navigation Accuracy Analysis, Anatomical Simulated Use, Navigated Simulated Use) is implicitly derived from engineering specifications, physical measurements, and expected functional outcomes in simulated environments. It does not involve expert consensus, pathology, or outcomes data from human patients as these are pre-market device verification tests. For "Navigation Accuracy Analysis," the ground truth would be the known, precise physical location or measurement that the navigated instrument is intended to reflect. For "Simulated Use" tests, the ground truth would be the successful completion of a task or achievement of a specific functional outcome as defined by the device's design specifications.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device consists of physical surgical instruments and compatibility with an existing navigation system. It is not an AI/ML-driven device in the sense of requiring a "training set" for model development. The performance data discussed relates to the physical and functional characteristics of the instruments.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided as there is no mention of a "training set" for this device.
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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.
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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
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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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K222383 - 510(k) SUMMARY MEDTRONIC Sofamor Danek 23 September 2022
| Submitter: | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)399-3395Fax: (901) 346-9738 |
|---|---|
| Primary Contact | Elizabeth HamiltonSr. Regulatory Affairs SpecialistEmail : elizabeth.c.hamilton@medtronic.com |
| Alternate Contact: | Raphael McInnisSr. Regulatory Affairs ManagerEmail : raphael.mcinniss@medtronic.com |
| Date Prepared: | 23 September 2022 |
| Name of Device | Anteralign™ LS Spinal System with Titan nanoLOCK™ SurfaceTechnology 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 TitannanoLOCK™ Surface Technology Navigated Instruments Compatiblewith MAZOR X™ system (Stealth™ Edition) (K214011, S.E.02/09/2022) |
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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.
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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 underexpected use conditions |
| Navigated Simulated Use | Confirmed navigation system functionalityunder 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.
§ 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).