(43 days)
Not Found
No
The description focuses on computer-assisted surgery, tracking, and pre/intra/post-operative assessments based on CT scans and kinematics, without mentioning AI or ML technologies.
No
The device is a navigation and guidance system used during surgery, not a device that directly treats a medical condition.
No
This device is described as a "planning and intraoperative guidance system" for surgery, focusing on precisely positioning instruments and implants. It uses CT scans for pre-operative, intraoperative, and post-implantation assessments of joint kinematics, but its primary function is guidance during surgical procedures, not diagnostic evaluation of a patient's condition.
No
The device description explicitly states the system comprises a "wireless video-optical tracking localization device," which is a hardware component. The system is described as a "computer assisted hip implantation control and monitoring module," implying interaction with physical surgical procedures and potentially controlling hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Stryker Navigation System - CT Based Hip Module does not perform any analysis on biological specimens.
- The intended use and device description clearly state that the system is a planning and intraoperative guidance system for surgical procedures. It uses CT scans of the patient's anatomy to assist surgeons during hip arthroplasty and other orthopedic surgeries.
- The system's function is to provide navigation and guidance based on anatomical structures and imaging data, not to analyze biological samples.
Therefore, the Stryker Navigation System - CT Based Hip Module 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 - CT Based Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures
- Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive .
- . Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
- Revisions .
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The CT Based Hip Module is part of the product series of the Stryker Navigation System. The system comprises a computer assisted hip implantation control and monitoring module based on a wireless video-optical tracking localization device for the use in total hip arthroplasty. The CT-Based Hip module will allow the importation of CT scans into the system. Unique to other hip navigators the Stryker system provides Surgeons with pre-operative, intraoperative and postimplantation assessments of the patient's joint kinematics. The system supports different surgical protocols. The order of femoral and acetabular preparation is configurable as well as other user specific settings. The user settings adjust the workflow and the graphical interface sequence in order to match the user habits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
pelvis, or femur, Hip and bones in the upper extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel such as orthopedic surgeons and clinic staff.
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)
Not Found
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.
K022365 Stryker Navigation - Hip Module, K993239 Stryker Navigation - Neuro Module, K010602 VectorVision Hip System
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
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com
:
:
APR 2 1 2005
Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is capitalized. There is a registered trademark symbol to the right of the word. The word is likely a company name or brand name.
Instruments
KOSOGIS
| 510(k) Summary | |
|---|---|
| Device Sponsor: | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| (p) 269-323-7700 | |
| (f) 269-324-5412 | |
| Registration No.: | 1811755 |
| Trade Name: | Stryker Navigation System - CT Based Hip Module |
| Common Name: | Navigation System |
| Classification Name: | Stereotactic Instruments |
| Equivalent to: | K022365 Stryker Navigation - Hip Module |
| K993239 Stryker Navigation - Neuro Module | |
| K010602 VectorVision Hip System | |
| Device Description: | Stryker Navigation System - CT Based Hip Module |
| The CT Based Hip Module is part of the product series of the Stryker Navigation System. The system comprises a computer assisted hip implantation control and monitoring module based on a wireless video-optical tracking localization device for the use in total hip arthroplasty. The CT-Based Hip module will allow the importation of CT scans into the system. Unique to other hip navigators the Stryker system provides Surgeons with pre-operative, intraoperative and postimplantation assessments of the patient's joint kinematics. The system supports different surgical protocols. The order of femoral and acetabular preparation is configurable as well as other user specific settings. The user settings adjust the workflow and the graphical interface sequence in order to match the user habits. | |
| Intended Use: | Stryker Navigation System - CT Based Hip Module |
| The Stryker Navigation System - CT Based Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. | |
| Indications for Use: | The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff. |
The Stryker Navigation System - CT Based Hip Module supports, but is not limited to the following surgical procedures
■ Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive
■ Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities |
- Page 1 of 2
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Substantial Equivalence (SE) Rational:
The Stryker Navigation System - CT Based Hip Module are equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker and BrainLab.
Safety and Effectiveness:
The Stryker Navigation System - CT Based Hip Module do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - CT Based Hip Module are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Leibinger's and Stryker Instrument's Quality Management System covered by QSR 21CFR 820.
Submitted by:
Becky Ditty Regulatory Affairs Representative
Signature
Date submitted:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines that suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Ms. Becky Ditty Regulatory Affairs Representative Stryker Instruments, Inc. 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K050615
Trade/Device Name: Stryker Navigation System-CT Based Hip Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 8, 2005 Received: March 10, 2005
Dear Ms. Ditty:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associous to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror co may 2011-12-11 accordance with the provisions of the Federal Food, Drug, de noes mat have been require approval of a premarket approval application (PMA). and Cosmetic rece (110.) that to novice, subject to the general controls provisions of the Act. The r ou may, incretere, mains of the Act include requirements for annual registration, listing of general controls proficituring 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 n may of back 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 I Dri has made a and regulations administered by other Federal agencies. You must or any I cacal statuated and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 607); adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Becky Ditty
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), please 11 you t the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
11
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): K050615
Device Name: Stryker Navigation System - CT Based Hip Module
Intended Use:
The Stryker Navigation System - CT Based Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
Indications for Use:
The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures
- Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive .
- . Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
- Revisions .
Prescription Use X (per 21 CFR 801 Subpart D)
or
Over-The-Counter Use (per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ncurrence of CDRH: Office of Device Evaluation (ODE) - Nove . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .