(30 days)
No
The summary describes navigated surgical instruments used with existing computer-assisted surgery systems (StealthStation™ System, MAZOR X Stealth™ Edition). The focus is on tracking and guidance based on pre-operative imaging or digitized landmarks, not on AI/ML-driven analysis or decision-making. There is no mention of AI, ML, or related concepts like training/test sets for algorithms.
No
The device, Medtronic Surgical Instruments, is intended to assist surgeons in precisely locating anatomical structures during spinal surgery for implant placement, not to directly treat a condition or provide therapy itself. It is a surgical tool used in conjunction with other systems for surgical procedures.
No
The device description indicates that these are surgical instruments designed for use during spinal surgery to assist in precisely locating anatomical structures and placing implants. They are tools used during a procedure, not for diagnosing a condition.
No
The device description explicitly states the instruments are made of high-grade stainless steel and are compatible with physical trackers and spheres, indicating a hardware component.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are "Medtronic Surgical Instruments" intended for use during spinal surgery to assist the surgeon in locating anatomical structures and preparing for implant placement. They are physical tools used directly on the patient's body during a surgical procedure.
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is entirely focused on guiding surgical actions based on imaging data and anatomical landmarks.
Therefore, the intended use and description of the device align with a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
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 Stealth™ Edition Arm Gide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the UC'M 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 Navigated Manual Reusable Instruments for Use with the 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 can be 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, a 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 as described on the label and the instruments.
Product codes
OLO
Device Description
The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation™ System or MAZOR X Stealth™ Edition System 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, or digitized landmarks of the anatomy.
Anatomical Site
skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Open or minimally invasive procedures
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: Navigation Accuracy Analysis
Description: Confirmed navigated instrument accuracy
Test: CAD Model Verification
Description: Confirmed CAD models are accurately reflected in the application software
Test: Tools Package Functional Verification
Description: Provides confirmation that the Spine tools package has met the required interface needs of the spine application software
Test: NAV Simulated Use
Description: No new testing completed
Test: Anatomical Simulated Use
Description: No new testing completed
Key Metrics
Not Found
Predicate Device(s)
Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015; K203005, S.E. 10/27/2020), Navigated Anterolateral Disc Prep Instruments (K192336, S.E. 11/22/2019)
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).
0
Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 9, 2021
Medtronic Sofamor Danek USA, INC. Alex Underberg Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K211441
Trade/Device Name: Navigated Anterolateral Disc Prep Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: Mav 7, 2021 Received: May 10, 2021
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.
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
1
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,
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
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Indications for Use
510(k) Number (if known)
Device Name Navigated Anterolateral Disc Prep Instruments
Indications for Use (Describe) Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
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 Stealth™ Edition Arm Gide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the UC'M 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.
| 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K211441
Device Name Navigated Anterolateral Disc Prep Instruments
Indications for Use (Describe) Medtronic Navigated Manual Reusable Instruments for Use with the 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 can be 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, a 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 as described on the label and the instruments.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 3: 510(k) Summary
K211441
510(k) Summary
May 7th, 2021
- l. 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: | Navigated Anterolateral Disc Prep Instrument |
|---|---|
| Common Name: | Navigated Instruments |
| Classification Name: | Orthopedic Stereotactic Instrument |
| Regulation Numbers: | Class II (21 CFR 882.4560) |
|---|---|
| Classification: | Class II |
| Product Code: | OLO |
III. Predicates:
| Primary Predicate | Navigated Disc Prep Instruments (K150231,
S.E. 06/16/2015; K203005, S.E. 10/27/2020)
Classification: Class II
FDA Product Code: OLO |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional Predicate | Navigated Anterolateral Disc Prep
Instruments (K192336, S.E. 11/22/2019) |
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| | Classification: Class II
FDA Product Code: OLO |
| -- | --------------------------------------------------- |
|---|
The predicates have not been subject to a design-related recall.
IV. Product Description:
The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation™ System or MAZOR X Stealth™ Edition System to track the instruments in the surgical field.
V. Indications for Use:
-
- Medtronic Navigated Manual Reusable Instruments for Use with the 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 can be 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, a long bone, or vertebra, can be identified relative to a CT or MRbased model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
- Medtronic Navigated Manual Reusable Instruments for Use with the StealthStation™ System"
2. Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
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 MRbased 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 Gide. 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.
6
VI. Comparison of Technological Characteristics:
The subject Navigated Anterolateral Disc Prep 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 additional use with MAZOR X Stealth™ Edition System. The use with Station™ System and MAZOR X Stealth™ Edition is identical indications to the primary predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015; K203005, S.E. 10/27/2020).
The subject Navigated Anterolateral Disc Prep Instruments were previously cleared within (K192336, S.E. 11/22/2019) and are not undergoing any design changes.
VII. Discussion of the Performance Testing:
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. 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 | No new testing completed |
| Anatomical Simulated Use | No new testing completed |
VIII. Conclusion:
Based on the supporting information provided in this pre-market notification, the subject Navigated Anterolateral Disc Prep Instruments are substantially equivalent to the predicate devices.