(86 days)
No
The summary describes navigated surgical instruments used with a computer-assisted surgery system (StealthStation™) for image guidance. While this involves image processing and tracking, there is no mention of AI or ML being used for tasks like image analysis, decision support, or automated control. The focus is on instrument tracking and visualization relative to pre-operative imaging or digitized landmarks.
No
The device is a set of surgical instruments intended to facilitate discectomy, boney resection, and implant selection/placement during spinal surgery, not to treat a disease or condition itself.
No
The device description and intended use focus on facilitating surgical procedures (discectomy, boney resection, implant size selection, implant placement) and tracking instruments within a surgical field, rather than diagnosing a medical 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that these are surgical instruments intended to facilitate procedures during spinal surgery (discectomy, boney resection, implant size selection, implant placement). They are used directly on the patient's anatomy, guided by imaging.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
The device is a surgical instrument designed for use in conjunction with an image guidance system during spinal procedures.
N/A
Intended Use / Indications for Use
The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.
Navigated 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.
Product codes
OLO
Device Description
The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel as the predicate, per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate to facilitate a discectomy or boney resection during spinal surgery. 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® Image Guidance 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
Anatomical Site
Spinal surgery (vertebra, skull, long bone)
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: Performance Testing
Sample Size: Not specified
Key Results:
- Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
- Navigation 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.
- Spine Tools Package Functional Testing: Verified that the Spine Tools package has met the required interface needs of the spine application software.
- Verification & Validation: Verified that the instruments function according to their intended use.
- Biocompatibility: Verified that the instrument material meets the ASTM standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
Medtronic Sofamor Danek USA, INC. Parwinder Singh Associate Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K192336
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: August 27, 2019 Received: August 28, 2019
Dear Parwinder Singh:
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
1
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,
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
Naviagted Anterolateral Disc Prep Insturments
Indications for Use (Describe)
The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.
Navigated 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.
| 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
October 31, 2019
| I. Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Parwinder Singh
Associate Regulatory Affairs Specialist
Telephone Number: (901) 396-3133
Email: parwinder.singh@medtronic.com |
II. Device :
| Proprietary Trade Name: | Navigated Anterolateral Disc Prep Instruments |
|---|---|
| Common Name: | Navigated Instruments |
| Classification Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Classification: | Class II |
| Product Code: | OLO |
Purpose: The purpose of this submission is to seek clearance for the Navigated Anterolateral Disc Prep Instruments, utilized with the StealthStation® System.
| III. Predicates: | |
|---|---|
| -- | ------------------ |
| Primary Predicate | | K150231, SE.
06/16/2015 |
|--------------------------------|-------------------------------------------------------------------------|----------------------------|
| Predicate Two | Nav T2 Stratosphere Inserters and
Navigated Templates | K191039, SE.
08/26/2019 |
| Predicate Three
(Reference) | Nav CD Horizon Solera
Screwdrivers, Taps, Iliac Taps,
Legacy Taps | K124004, SE.
3/22/2013 |
This predicate has not been subject to a design-related recall.
IV. Product Description:
The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel as the predicate, per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate to facilitate a discectomy or boney resection during spinal surgery. The instruments are compatible with
4
Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.
V. Indications for Use:
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere templates are intended to be used to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle preparations. The Navigated Inserters are intended to be used for the placement of an implant.
Navigated 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.
VI. Comparison of Technological Characteristics:
The subject Navigated Anterolateral Disc Prep Instruments have the same indications. intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared primary predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015)
VII. Discussion of the Performance Testing:
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The K124004 was used as a comparator for performance testing. The following table summarizes the performance testing completed:
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy. |
| Navigation 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. | |
| 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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| Verification & Validation | Verified that the instruments function according to their intended use. |
|---|---|
| Biocompatibility | Verified that the instrument material meets the ASTM standards |
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 primary predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015).