(87 days)
Medtronic Navigated Reusable 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 Reusable 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 Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
The Navigated Screwdrivers and Taps are non-sterile, reusable surgical instruments that can be operated manually or under power. These instruments are intended to be used when implanting CD HORIZON® Spinal System devices. The Navigated Screwdrivers and Taps are also compatible with the StealthStation® and IPC® POWEREASE™ Systems.
The provided document does not contain detailed acceptance criteria or a study that extensively proves the device meets those criteria in a quantitative sense as typically seen with AI/ML-based medical devices. The submission concerns a set of navigated surgical instruments (screwdrivers and taps) and focuses on demonstrating substantial equivalence to predicate devices through functional and compatibility testing, rather than performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
However, based on the provided text, I can extract the following information about the performance testing conducted and what it implies about "acceptance criteria" in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy. | Confirmed navigated instrument accuracy. |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions. | Confirmed instrument functionality under expected use conditions. |
| Navigation Simulated Use | Confirmed navigation system functionality under expected use conditions. | Confirmed navigation system functionality under expected use conditions. |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software. | Verified that the CAD models are accurately reflected in the application software. |
| Implant/Instrument Mating Conditions | Verified that the instruments can be assembled with appropriate devices according to their intended use. | 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. | Verified that the Spine Tools package has met the required interface needs of the spine application software. |
Explanation of "Acceptance Criteria (Implied)":
The document lists "Description" for each test, which states what the test confirmed or verified. In the absence of specific numerical thresholds or target metrics (e.g., "accuracy > 95%"), the implied acceptance criterion for each test is that the described functionality or characteristic was successfully demonstrated and met. For instance, for "Navigation Accuracy Analysis," the implied criterion is that the navigation accuracy was found to be acceptable for its intended surgical use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of instruments tested, number of simulated cases) for any of the performance tests. It also does not mention data provenance (country of origin, retrospective/prospective), as the testing appears to be primarily lab-based functional and compatibility testing of physical instruments, not data-driven evaluation of an AI algorithm on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The tests described are primarily engineering validation tests for physical instruments and software integration, not clinical studies requiring expert-established ground truth on patient cases.
4. Adjudication Method
Not applicable, as this is not an evaluation of a system requiring human adjudication of results (e.g., diagnostic image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a navigated surgical instrument, not a diagnostic AI system designed to improve human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a set of physical surgical instruments designed to work with a navigation system, not a standalone algorithm. The "Navigation Accuracy Analysis" and "Navigation Simulated Use" tests confirm the instrument's interface and functionality with the navigation system, not a standalone algorithm's performance.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not directly relevant here. The "ground truth" for these tests would be derived from engineering specifications, design requirements, and direct measurement of physical properties or system outputs to verify functionality and compatibility against established standards. For example, for "Navigation Accuracy Analysis," the ground truth would be precise measurements of instrument tip location compared to the reported navigated location.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no ground truth for it to be established.
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K140454
510(k) Summary
MAY 2 2 2014
February 2013
- Medtronic Sofamor Danek, USA Inc. l. Company: 1800 Pvramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Regina Holmes Sr. Regulatory Affairs Specialist Telephone: (901) 399-3101 Fax: (901) 346-9738
- II. Proprietary Trade Name: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps
- Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap III.
- Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV.
- Classification: Class II V.
- Product Code: OLO, HBE VI.
VII. Product Description:
The Navigated Screwdrivers and Taps are non-sterile, reusable surgical instruments that can be operated manually or under power. These instruments are intended to be used when implanting CD HORIZON® Spinal System devices. The Navigated Screwdrivers and Taps are also compatible with the StealthStation® and IPC® POWEREASE™ Systems.
VIII. Indications for Use:
Medtronic Navigated Reusable 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 Reusable 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 Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
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IX. Identification of Legally Marketing Devices (Predicate Devices)
- NAVIGATED CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, . ILIAC TAPS, LEGACY™ TAPS (K124004)
- IPC® POWEREASE™ System (K111520, K123270) .
Comparison of the Technological Characteristics: X.
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. Identical to the predicates, the Navigated Screwdrivers and Taps 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 Taps and Screwdrivers are also made from stainless steel.
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.
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 |
|---|---|
| NavigationAccuracy Analysis | Confirmed navigated instrument accuracy. |
| AnatomicalSimulated Use | Confirmed instrument functionality under expected use conditions. |
| NavigationSimulated Use | Confirmed navigation system functionality under expected use conditions. |
| CAD ModelEvaluation | Verified that the CAD models are accurately reflected in the application software. |
| Implant/InstrumentMating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use. |
| Spine ToolsPackageFunctional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software. |
XII. Conclusions
The Navigated Screwdrivers and Taps have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three 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
May 22, 2014
Medtronic Sofamor Danek USA, Incorporated Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K140454
Trade/Device Name: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HBE Dated: February 20, 2014 Received: February 24, 2014
Dear Ms. Holmes:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Regina Holmes
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/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140454
Device Name
Navigated CD HORIZON® SOLERA® Screwdrivers and Taps
Indications for Use (Describe)
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the SteathStation® System, which is indical 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 Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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).