(129 days)
Not Found
No
The document describes navigated surgical instruments that use a computer-assisted surgery system (StealthStation™) for tracking and guidance based on pre-operative imaging or digitized landmarks. There is no mention of AI or ML being used for image processing, decision support, or any other function. The performance studies focus on navigation accuracy and instrument functionality, not on AI/ML performance metrics.
No
The device is a set of navigated instruments intended for surgical preparation, size selection, and placement of implants during spinal surgery. It does not exert any direct therapeutic effect on the patient.
No
The device is described as surgical instruments and templates intended for use during spinal surgery to facilitate procedures like discectomy, bone resection, and implant size selection. It is not mentioned anywhere that this device is used for diagnostic purposes.
No
The device description explicitly states the instruments are made of "high-grade stainless steel" and are "reusable instruments," indicating they are physical hardware components, not software only. While they are used with a software-based navigation system (StealthStation™), the instruments themselves are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes instruments used during surgical procedures (discectomy, boney resection, implant size selection, implant placement) to facilitate those procedures. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details surgical instruments made of stainless steel, designed for use with a computer-assisted surgery system to track their position in the surgical field. This aligns with surgical tools, not diagnostic tests performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information about a patient's health status based on such analysis. The device's function is to aid in the physical manipulation and placement of instruments and implants during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 be used to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle preparation. 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 (comma separated list FDA assigned to the subject device)
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.
The purpose of this submission is to seek clearance for Navigated T2 STRATOSPHERE™ Inserters and Navigated Template, compatible with T2 STRATOSPHERE™ Expandable Corpectomy System for lateral and posterior procedures in thoracolumbar cases only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
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)
Test: Navigation Accuracy Analysis
Description: Confirmed navigated instrument accuracy in both 2D and 3D space.
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
Test: CAD Model Evaluation
Description: Verified that the CAD models are accurately reflected in the application software.
Test: Implant/ Instrument Mating Conditions
Description: Verified that the instruments can be assembled with the appropriate devices according to their intended use.
Test: Spine Tools Package Functional Testing
Description: Verified that the Spine Tools package has met the required interface needs of the spine application software.
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.
K163581, K173125, K131425, K150231
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.
Not Found
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
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.
August 26, 2019
Medtronic Sofamor Danek, USA Inc Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K191039
Trade/Device Name: Navigated T2 STRATOSPHERE Inserters and Navigated Templates Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 24, 2019 Received: May 28, 2019
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
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 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, MPH 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)
K191039
Device Name
Navigated T2 Stratosphere Inserters and Navigated Templates
Indications for Use (Describe)
The Navigated Disc Preparation Instruments are intended to facilitate a discectorny 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 be used to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle preparation. 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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K191039
510(K) SUMMARY April 15, 2019
| I. | Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: (901) 396-3133
Telefax: (901) 346-9738 |
|----|----------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Elizabeth Hamilton |
Elizabeth Hamilton Contact: Regulatory Affairs Specialist Telephone number: (901) 399-3395 Email: elizabeth.c.hamilton@medtronic.com
Proprietary Trade Name: Navigated T2 STRATOSPHERE™ II. Inserters and Navigated Templates
Common Name: Stereotaxic Instrument, Navigated Instruments Classification Name: Stereotaxic Instrument (21CFR 882.4560) Classification: Class II Product Code: OLO
III. Predicate Devices:
- . Primary Predicate- Navigated Elevate™ Inserter Disc prep Instruments (K163581, S.E.04/14/2017)
- Predicate 2-T2 STRATOSPHERE™ Expandable Corpectomy System . (K173125, S.E. 12/20/2017)
- . Predicate 3-Navigated Capstone® Trials, Clydesdale® Trials, Capstone® and Clydesdale® Inserter (K131425, S.E. 08/14/2013)
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- Predicate 4-Navigated Disc Prep Instrument and Capstone® Trials . (K150231, S.E. 06/16/2015)
IV. 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.
The purpose of this submission is to seek clearance for Navigated T2 STRATOSPHERE™ Inserters and Navigated Template, compatible with T2 STRATOSPHERE™ Expandable Corpectomy System for lateral and posterior procedures in thoracolumbar cases only.
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 be used to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant.
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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.
Substantial Equivalence VI
Substantial equivalence for the Navigated T2 Stratosphere™ Inserters and Navigated Templates was established in terms of design features, performance testing, materials, sterilization method and indications for use as compared to the predicate devices. The subject devices also have an identical principle of operation and incorporate the same features to enable compatibility with StealthStation® System as the predicate devices. Based on the information provided within this submission, the subject devices have demonstrated to be substantially equivalent to the previously marketed predicate devices.
VII. Performance Data
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Table 6.0 below summarizes the performance testing 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 |
Table 6.0: Description of Performance Testing
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| Test | Description |
|---|---|
| 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 |
Conclusion VIII.
Based on the test results and additional supporting information provided in this premarket notification, Medtronic believes the subject devices, (Navigated T2 STRATOSPHERE™ Inserters and Navigated Templates) are at least as safe and effective as the legally marketed predicate devices:
- . Primary Predicate-Navigated Elevate™ Inserter Disc Prep Instruments (K163581, S.E. 04/14/2017)
- Predicate 2- T2 STRATOSPHERE™ Expandable Corpectomy System . (K173125, S.E. 12/20/2017)
- Predicate 3-Navigated Capstone® Trials, Clydesdale® Trials, Capstone® . and Clydesdale® Inserter (K131425, S.E. 08/14/2013)
- . Predicate 4-Navigated Disc Prep Instrument and Capstone® Trials (K150231, S.E. 06/16/2015)