(86 days)
Not Found
No
The summary describes a navigated surgical instrument system that uses optical tracking and pre-existing imaging data (CT, MR, fluoroscopy) for guidance. There is no mention of AI or ML in the device description, intended use, or performance testing. The testing focuses on accuracy, functionality, and compatibility, not on learning or adaptive capabilities.
No.
The device description states it is a surgical instrument (taps and screwdrivers), and the intended use describes its role in guiding placement of screws, not directly treating a medical condition.
No
The device is described as surgical instruments (taps and screwdrivers) for preparing and placing screws during spinal surgery, and its intended use focuses on navigation and guidance during a surgical procedure, not on diagnosing a medical condition.
No
The device description explicitly states that the Navigated Taps and Screwdrivers are "surgical instruments" and "attach to the Medtronic NavLock™ Tracker," indicating they are physical hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Navigated Taps and Screwdrivers are used during spinal surgery for the preparation and placement of screws. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces that these are surgical instruments used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical navigation tool used to guide the placement of implants during surgery, which is a different category of medical device entirely.
N/A
Intended Use / Indications for Use
The Navigated Taps and Screwdrivers 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, 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 the 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
The Navigated Taps and Screwdrivers are surgical instruments 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. The Navigated Taps and Screwdrivers attach to the Medtronic NavLock™ Tracker, which allows for optical tracking of the surgical instrument. They are designed for use with the Medtronic CD HORIZON® LEGACY™ and CD HORIZON® SOLERATM screw systems. As described in the instructions for use, the instruments may also be used with the Medtronic IPC® POWEREASE™ System and NIM-ECLIPSE® System.
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 (for the StealthStation® System)
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: Accuracy
Description: Tested navigated instrument accuracy in both 2D and 3D space.
Test: Accelerated Life Functionality
Description: Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions.
Test: Simulated Use
Description: Tested navigated instruments according to the user's needs and intended use.
Test: Shipping
Description: Tested navigated instruments after simulated shipping conditions.
Test: CAD Model Testing
Description: Verified that the CAD models are accurately reflected in the application software.
Test: Cleaning Verification
Description: Verified that the product can be effectively cleaned using automated and manual methods.
Test: Spine Tools (Toolcards)
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.
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
K124004
510(k) Summary
February 14, 2012
MAR 2 2 2013
I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
Contact: Michael Blasco Principal Regulatory Affairs Specialist
- II. Proprietary Trade Name: Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps
III. Common Name: Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II (21 CFR 882.4560)
VI. Product Code: OLO
VII. Product Description:
The Navigated Taps and Screwdrivers are surgical instruments 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. The Navigated Taps and Screwdrivers attach to the Medtronic NavLock™ Tracker, which allows for optical tracking of the surgical instrument. They are designed for use with the Medtronic CD HORIZON® LEGACY™ and CD HORIZON® SOLERATM screw systems. As described in the instructions for use, the instruments may also be used with the Medtronic IPC® POWEREASE™ System and NIM-ECLIPSE® System.
VIII. Indications for Use:
The Navigated Taps and Screwdrivers 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, 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 the 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.
1
IX. Identification of Legally Marketing Devices (Predicate Devices)
| Item | Subject Devices | Predicate Devices |
|---|---|---|
| Indications for Use | The Navigated Taps and Screwdrivers 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, 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 the 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. | Working Ends Compatible with the | |
| POWEREASE™ System - K111520 | ||
| The working ends are intended for drilling, | ||
| tapping, or driving screws during spinal | ||
| surgery, including open and minimally | ||
| invasive procedures. | ||
| StealthStation System Update - K050438 | ||
| The StealthStation® System is intended as | ||
| an aid for precisely locating anatomical | ||
| structures in either open or percutaneous | ||
| procedures. The StealthStation® System 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 the 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. | ||
| For the optical-based and EM-based system, | ||
| example procedures include, but are not | ||
| limited to: | ||
| Spinal Procedures: | ||
| Spinal Implant Procedures, such as Pedicle | ||
| Screw Placement | ||
| Operating Principle | ||
| (Tracking Method) | Identical | StealthStation System Update - K050438 |
| Optical (infra-red) | ||
| Materials - Taps | Identical | Working Ends Compatible with the |
| POWEREASE™ System - K111520 | ||
| 455 SS | ||
| Materials - | ||
| Screwdrivers | Identical | Working Ends Compatible with the |
| POWEREASE™ System - K111520 | ||
| 455 SS (shaft) and 17-4 SS (sleeve) | ||
| Sterilization Method | Identical | Working Ends Compatible with the |
| POWEREASE™ System - K111520 | ||
| Steam sterilization |
X. Comparison of the Technological Characteristics:
The subject devices have the same intended use and technological characteristics as the predicate devices.
.
2
XI. 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 completed:
| Test | Description |
|---|---|
| Accuracy | Tested navigated instrument accuracy in both 2D and 3D space. |
| Accelerated Life | |
| Functionality | Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions. |
| Simulated Use | Tested navigated instruments according to the user's needs and intended use. |
| Shipping | Tested navigated instruments after simulated shipping conditions. |
| CAD Model | |
| Testing | Verified that the CAD models are accurately reflected in the application software. |
| Cleaning | |
| Verification | Verified that the product can be effectively cleaned using automated and manual methods. |
| Spine Tools | |
| (Toolcards) | Verified that the Spine tools package has met the required interface needs of the spine application software. |
XII. Conclusions
The Navigated Taps and Screwdrivers have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Navigation, Incorporated % Mr. Michael Blasco Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
March 22, 2013
Re: K124004
Trade/Device Name: Navigated CD HORIZON® SOLERA™ Screwdrivers. CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Blasco:
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. Ilsting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Michael Blasco
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, FOR
Peter DifRumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K124004
Device Name:
Navigated CD HORIZON® SOLERA™ Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps
Indications for Use:
The Navigated Taps and Screwdrivers 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, 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 the 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lona Chen
for MXM
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K124004
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