(30 days)
Not Found
No
The summary describes navigated surgical instruments used with an image guidance system (StealthStation™). While image guidance systems can potentially incorporate AI/ML for tasks like image processing or segmentation, this specific summary focuses on the instruments themselves and their compatibility with the system for tracking and navigation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
This device is an instrument used during surgical procedures to assist the surgeon in precisely locating anatomical structures, rather than directly treating a medical condition itself.
No
These navigated surgical instruments are intended to assist the surgeon in precisely locating anatomical structures during surgery, not to diagnose a medical condition. Their function is guidance and localization, not diagnosis.
No
The device description explicitly states the device is made of "high-grade stainless steel" and describes physical components like "tracker passive stems" and "single-use sterile spheres," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medtronic Navigated Surgical Instruments are tools used during surgery to assist the surgeon in precisely locating anatomical structures and placing implants. They are used directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly states the instruments are used "during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is an in-vivo (within the living body) application, not in-vitro (in glass/outside the living body).
- Device Description: The description reinforces that these are "spine preparation instruments" used in surgical procedures.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Medtronic Navigated Surgical Instruments are intended to be used during 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 Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
Product codes
OLO
Device Description
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
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, 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
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy in both 2D and 3D space |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions |
| Navigated 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 |
| Implant/ Instrument Mating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 25, 2022
Medtronic Sofamor Danek USA, Inc. Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K221180
Trade/Device Name: Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 21, 2022 Received: April 25, 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.
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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K221180
Device Name
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments
Indications for Use (Describe)
Medtronic Navigated Surgical Instruments are intended to be used during 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 Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
| 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 MEDTRONIC Sofamor Danek 20 April 2022
| Submitter: | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)399-3395 | |
| Fax: (901) 346-9738 | |
| Contact Person | 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: | 20 April 2022 |
| Name of Device | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface |
| Technology Navigated Instruments | |
| 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 | |
| (K212524, S.E. 12/08/2021) |
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Description of Device
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Indications for Use
Medtronic Navigated Manual Reusable Instruments for Use with StealthStation™ System
Medtronic Navigated Surgical Instruments are intended to be used during 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 Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
Comparison of Technological Characteristics with Predicate Devices
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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. Please refer to the substantial equivalence section of this submission for more details.
Performance Data
Testing was rationalized or completed new to ensure the functionality and compatibility of the subject instruments when used with StealthStation™ System. The following table summarizes the performance testing that was rationalized or completed:
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument |
| accuracy in both 2D and 3D space | |
| Anatomical Simulated Use | Confirmed instrument functionality |
| under | |
| expected use conditions | |
| Navigated 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 | |
| Implant/ Instrument Mating Conditions | Verified that the instruments can be |
| assembled with the appropriate devices | |
| according to their intended use | |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package |
| has | |
| met the required interface needs of the | |
| spine application software |
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Conclusion
Based on the information contained in this submission, Medtronic believes that the subject instruments are substantially equivalent to the predicate device.