(52 days)
No reference devices were used in this submission.
No
The document does not mention AI, ML, deep neural networks, or any related concepts. The description focuses on navigated instruments and their compatibility with existing navigation systems, with performance testing centered on accuracy and functionality.
No
The device is described as navigated instruments used during spinal surgery to assist in precisely locating anatomical structures, rather than directly treating a medical condition.
No
The device is described as "navigated instruments" and its "Intended Use" states it "assist[s] the surgeon in precisely locating anatomical structures" during spinal surgery. This indicates it is an intraoperative tool for guidance and placement, rather than a device used to diagnose a medical condition.
No
The device description explicitly states that the Navigated VERTEX SELECT® Instruments are both non-sterile, reusable and sterile, single use instruments, indicating they are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Medtronic Navigated Instruments are surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and placing screws. They are used directly on the patient's anatomy, not on specimens taken from the body.
- Intended Use: The intended use clearly states their role in surgical procedures for navigation and instrument placement, not for diagnostic testing of biological samples.
The device is a surgical navigation and instrument system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE™ System.
Product codes
OLO
Device Description
The Navigated VERTEX SELECT® Instruments are both non-sterile, reusable and sterile, single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the VERTEX® Reconstruction System. The Navigated VERTEX SELECT® Instruments are also compatible with the StealthStation® and IPC® POWEREASE® 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, a 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 |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions |
| 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 |
| 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)
No reference devices were used in this submission.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Tejas Patel Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
February 12, 2015
Re: K143628
Trade/Device Name: Navigated VERTEX SELECT® Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2014 Received: December 22, 2014
Dear Mr. Patel:
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. 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 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); good manufacturing practice requirements as set
1
Page 2 - Mr. Tejas Patel
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Navigated VERTEX SELECT® Instruments
Indications for Use (Describe)
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE™ System.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
December 19, 2014
- I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Tejas Patel Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: tejaskumar.r.patel@medtronic.com
- II. Proprietary Trade Name: Navigated VERTEX SELECT® Instruments
Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap, Navigated Drill Bit
Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II
Product Code: OLO
III. Predicate Device:
Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454, S.E. 05/22/2014)
This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.
No reference devices were used in this submission.
IV. Device Description:
The Navigated VERTEX SELECT® Instruments are both non-sterile, reusable and sterile, single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the VERTEX® Reconstruction System. The Navigated VERTEX SELECT® Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.
V. Indications for Use:
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely
4
locating anatomical structures in either open or minimally invasive procedures. Medtronic 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.
VI. Comparison of the Technological Characteristics with the Predicate Device:
The Navigated VERTEX SELECT® Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. Identical to the predicates, the Navigated VERTEX SELECT® Instruments attach to the NavLock™ Tracker, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation and use with the IPC® POWEREASE® System, when desired. Like the predicate devices, the subject Navigated VERTEX SELECT® Instruments are also made from stainless steel.
The following technological differences exist between the subject and predicate devices:
- . The Navigated VERTEX SELECT® Instruments are intended to be used with VERTEX ® Reconstruction System screws whereas the predicate Navigated CD HORIZON® SOLERA® instruments are intended to be used with the CD HORIZON® SOLERA® screws.
- The subject devices include a sterile drill bit while the predicate devices do not.
- The subject Navigated Taps & Drill Bits have a single lead threadform as compared to the dual lead threadform of the predicate Navigated Taps.
The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® and IPC® POWEREASE® Systems.
VII. Performance Data:
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:
| Test | Description |
|---|---|
| Navigation Accuracy | |
| Analysis | Confirmed navigated instrument accuracy |
| Anatomical Simulated Use | Confirmed instrument functionality under expected |
| use conditions |
5
| 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 |
| 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 |
VIII. Conclusions
The Navigated VERTEX SELECT® Instruments have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.