(113 days)
The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.
The Stryker Navigation System - Neuro Module provides precise stereotactic determiniation of surgical targets using a stereotactic methdology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.
The provided text describes a 510(k) premarket notification for the Stryker Navigation System - Neuro Module. It focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed acceptance criteria and a study proving device performance against specific criteria. Therefore, much of the requested information regarding a specific study and its methodology is not available in the provided document.
However, based on the text, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document states that the device provides "precise stereotactic determination of surgical targets using a stereotactic methodology" and highlights features like "computer calculation of stereotactic coordinates from the diagnostic images" and "measurement of stereotactic coordinates within the surgical field." However, specific numerical acceptance criteria (e.g., accuracy +/- X mm) and corresponding measured performance values are absent.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document does not describe a specific test set of data used to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. As there's no described test set, there's no mention of experts establishing ground truth for it.
4. Adjudication Method for the Test Set
This information is not provided. Without a described test set, there's no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided. The document makes no mention of AI or a comparative effectiveness study involving human readers. The device is a "Navigation System," implying it aids surgeons directly rather than having human readers interpret its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not explicitly provided as a standalone performance study. The document describes the system as one contributing to "precise stereotactic determination" and involving "computer calculation" and "measurement within the surgical field." This indicates the system's function, but it doesn't detail a standalone performance study with specific metrics and results. The focus is on its technical capabilities and equivalence to existing devices.
7. The Type of Ground Truth Used
This information is not explicitly provided. Given the nature of a navigation system, ground truth would likely involve highly accurate physical measurements or potentially anatomical landmarks verified through other precise imaging or surgical techniques. However, the document does not specify how ground truth was established for any performance evaluation.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe AI or machine learning components that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As there's no mention of a training set, this information is not relevant to the provided text.
Summary of the Document's Approach to Demonstrating Acceptability:
The provided document primarily relies on demonstrating substantial equivalence to existing, legally marketed image-guided surgery systems. Key statements supporting this include:
- "The Stryker Navigation System - Neuro Module is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems begin marketed by companies such as Sofamor Danek, Zeiss, and BrainLab."
- "The Stryker Navigation System - Neuro Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
- "Therefore, the Stryker Navigation System - Neuro Module is substantially equivalent to these existing devices."
This approach means that the "acceptance criteria" were effectively met by showing that the new device functions similarly to and is as safe and effective as predicate devices that have already demonstrated their safety and effectiveness to the FDA. The document focuses on describing the device's intended use and technical features that align with established stereotactic methodologies, rather than presenting a novel study with specific quantitative performance criteria for FDA review.
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Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are closely spaced together, creating a solid block of text. The word appears to be a logo or brand name.
4100 East Mitham Avenue
Kalamazoo. Mi 49001
Phone (616) 323-7700
(800) 253-7370
993239
Device Name:
| Trade Name: | Stryker Navigation System Neuro Module |
|---|---|
| Common Name: | Image Guided Surgery System |
| Classification Name: | Instrument, Stereotaxic: 21 CFR 882.4560, Class I |
Device Sponsor:
| Manufacturer: | Stryker CorporationStryker Leibinger GmbH and Co. KGBoetzinger Straße 41D-79111 Freiburg GermanyRegistration No.: 8010177 |
|---|---|
| Distributor: | Stryker CorporationStryker Leibinger4100 E. Milham AvenueKalamazoo, MI 49001Registration No.: 1811755 |
| Regulatory Class: | Class II |
Summary of Safety and Effectiveness:
The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.
The Stryker Navigation System - Neuro Module is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems begin marketed by companies such as Sofamor Danek, Zeiss, and BrainLab.
The Stryker Navigation System - Neuro Module provides precise stereotactic determiniation of surgical targets using a stereotactic methdology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-
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K99 3239
resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.
The Stryker Navigation System - Neuro Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - Neuro Module is substantially equivalent to these existing devices.
By: Nicole Petty
Regulatory Affairs Analyst Stryker Leibinger
Dated: _
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Ms. Nicole Petty Regulatory Affairs Analyst Stryker Leibinger 4100 East Milham Avenue Kalamazoo. Michigan 49001
K993239 Re:
Trade Name: Stryker Navigation System - Neuro Module Regulatory Class: II Product Code: HAW Dated: November 15, 1999 Received: November 16, 1999
Dear Ms. Petty:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Nicole Petty
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Stupt Rhodes
James H. Dillard III
James R. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__1_______________________________________________________________________________________________________________________________________________________________________
| 510(k) Number: | K993239 |
|---|---|
| Device Name: | Stryker Navigation System - Neuro Module |
| Indications For Use: | The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993239 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
§ 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).