(86 days)
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.
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.
The provided text describes the 510(k) summary for Medtronic Navigation's Navigated CD HORIZON® SOLERA™ Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance values. Instead, it lists the types of tests conducted and concludes that the devices are "substantially equivalent" to predicate devices. The "Discussion of the Performance Testing" section serves as an overview of the tests performed to ensure functionality and compatibility.
| Test | Description of Test | Reported Device Performance (Summary) |
|---|---|---|
| Accuracy | Tested navigated instrument accuracy in both 2D and 3D space. | Performed (Implied adequate for substantial equivalence) |
| Accelerated Life Functionality | Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions. | Performed (Implied adequate for substantial equivalence) |
| Simulated Use | Tested navigated instruments according to the user's needs and intended use. | Performed (Implied adequate for substantial equivalence) |
| Shipping | Tested navigated instruments after simulated shipping conditions. | Performed (Implied adequate for substantial equivalence) |
| CAD Model Testing | Verified that the CAD models are accurately reflected in the application software. | Verified (Implied accurate reflection) |
| Cleaning Verification | Verified that the product can be effectively cleaned using automated and manual methods. | Verified (Implied effective cleaning) |
| Spine Tools (Toolcards) | Verified that the Spine tools package has met the required interface needs of the spine application software. | Verified (Implied interface needs met) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for any of the performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish "ground truth" for the test set. The testing appears to be primarily engineering and functional validation.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the testing focuses on device functionality and accuracy rather than interpretation by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This device is a surgical instrument for navigation, not an imaging diagnostic tool, so an MRMC study with human readers assisting AI or vice versa would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The device itself is a surgical instrument that is used with a navigation system (StealthStation® System). The performance testing described focuses on the instrument's functionality, accuracy, and compatibility. It is not an "algorithm only" device in the sense of AI diagnostics, and thus a standalone algorithm performance study as typically understood in AI/ML medical devices is not applicable or described. The accuracy testing would represent a standalone performance of the instrument's tracking capabilities.
7. Type of Ground Truth Used:
For the "Accuracy" test, the ground truth would likely be established through precise metrology equipment or highly accurate reference points against which the navigated instrument's reported position is compared. For other tests like "Accelerated Life Functionality" and "Simulated Use," the ground truth would be the expected functional behavior and structural integrity under specified conditions. The document does not explicitly state the specific methods or types of ground truth used for each test.
8. Sample Size for the Training Set:
This document describes a medical device (surgical tools) and not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to the information provided.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a training set is not applicable to this device submission.
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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.
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IX. Identification of Legally Marketing Devices (Predicate Devices)
| Item | Subject Devices | Predicate Devices |
|---|---|---|
| Indications for Use | The Navigated Taps and Screwdrivers areintended to be used during the preparationand placement of Medtronic screwsduring spinal surgery and are specificallydesigned for use with the StealthStation®System, which is indicated for anymedical condition in which the use ofstereotactic surgery may be appropriate,and where reference to a rigid anatomicalstructure, such as the skull, a long bone,or vertebra, can be identified relative to aCT or MR based model, fluoroscopyimages, or digitized landmarks of theanatomy. | Working Ends Compatible with thePOWEREASE™ System - K111520The working ends are intended for drilling,tapping, or driving screws during spinalsurgery, including open and minimallyinvasive procedures.StealthStation System Update - K050438The StealthStation® System is intended asan aid for precisely locating anatomicalstructures in either open or percutaneousprocedures. The StealthStation® System isindicated for any medical condition inwhich the use of stereotactic surgery may beappropriate, and where reference to a rigidanatomical structure, such as the skull, along bone, or vertebra, can be identifiedrelative to a CT or MR based model,fluoroscopy images, or digitized landmarksof the anatomy.For the optical-based and EM-based system,example procedures include, but are notlimited to:Spinal Procedures:Spinal Implant Procedures, such as PedicleScrew Placement |
| Operating Principle(Tracking Method) | Identical | StealthStation System Update - K050438Optical (infra-red) |
| Materials - Taps | Identical | Working Ends Compatible with thePOWEREASE™ System - K111520455 SS |
| Materials -Screwdrivers | Identical | Working Ends Compatible with thePOWEREASE™ System - K111520455 SS (shaft) and 17-4 SS (sleeve) |
| Sterilization Method | Identical | Working Ends Compatible with thePOWEREASE™ System - K111520Steam sterilization |
X. Comparison of the Technological Characteristics:
The subject devices have the same intended use and technological characteristics as the predicate devices.
.
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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 LifeFunctionality | 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 ModelTesting | Verified that the CAD models are accurately reflected in the application software. |
| CleaningVerification | 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.
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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
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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
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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
Page 1 of _1
§ 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).