(130 days)
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No
The provided text does not mention AI, ML, or related terms, and the description focuses on image-guided surgery and navigation, which are typically based on traditional image processing and tracking technologies.
No.
The device is a navigation system intended for planning and guidance during surgery, not for treating a disease or condition itself. It aids in precisely positioning instruments and does not provide therapy.
No
The device is described as a "planning and intraoperative guidance system" used for image-guided surgery, specifically for "precisely positioning instruments." It aids in surgical procedures rather than diagnosing medical conditions.
No
The description refers to a "system" intended for "intraoperative guidance" and "precisely positioning instruments." This strongly implies the use of hardware components (e.g., cameras, trackers, displays, potentially surgical instruments) in addition to software for navigation and guidance. The lack of a "Device Description" section prevents definitive confirmation, but the functional description points away from a software-only device.
Based on the provided information, the Stryker Navigation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Stryker Navigation System's Intended Use: The intended use clearly states that the system is a "planning and intraoperative guidance system to enable open or percutaneous image guided surgery." It is used during surgery to guide instruments based on medical images and anatomical structures.
- Lack of Sample Analysis: There is no mention of the system analyzing biological samples from the patient. Its function is to provide spatial guidance based on imaging data and anatomical references.
Therefore, the Stryker Navigation System falls under the category of a surgical navigation or guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images.
The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures: Pedicle Screw Placement Navigation Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones. This submission is not intended for total joint replacement procedures.
Product codes
HAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skull, or vertebra, spinal structure, hip and bones in the upper and lower extremities and long bones.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Robin L. Rowe Regulatory Affairs Representative Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K012380
Trade/Device Name: Stryker Navigation System - Spine & Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 24, 2001 Received: July 26, 2001
Dear Ms. Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved your 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 for association 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 that + Diederal 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); good manufacturing practice requirements as set 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.
1
Page 2 - Ms. Robin L. Rowe
This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__1____ of _______________________________________________________________________________________________________________________________________________________________
・、
| 510(k) Number: | K012380 |
|---|---|
| Device Name: | Stryker Navigation System -Spine & Fluoroscopy Module |
| Intended Use: | The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. |
| Indications for Use: | The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures: Pedicle Screw PlacementNavigationPrecisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.This submission is not intended for total joint replacement procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
,
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The- Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
Susan Walker, MD
| (Division Sign-Off)
Division of General, Restorative
| and Neurological Devices | (Optional Format 1-2-96) |
|---|---|
| ------------------------------------------------------------------------------------- | -------------------------- |
| 510(k) Number | K012380 |
|---|---|
| --------------- | --------- |