(184 days)
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Not Found
No
The summary describes a computer-assisted surgical navigation system but does not mention AI, ML, or related terms, nor does it describe features typically associated with AI/ML in medical imaging or analysis.
No.
The device is described as a "planning and intraoperative guidance system" and is used to "support [...] surgical procedures" and "position instruments, implants and bony tissue." It assists in surgery but does not directly treat or diagnose a medical condition itself.
No
Explanation: The device is described as a "planning and intraoperative guidance system" used during surgery, not for diagnosing a medical condition. Its purpose is to assist in surgical procedures by precisely positioning instruments and implants.
No
The device description explicitly states it is a "system" intended for "computer assisted surgery," which strongly implies the inclusion of hardware components for navigation and guidance, not just software.
Based on the provided information, the Stryker Navigation System - Hip Module is not an IVD (In Vitro Diagnostic) device.
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 description of the Stryker Navigation System clearly states its purpose is for planning and intraoperative guidance during surgery. It interacts directly with the patient's anatomy during a surgical procedure, not with a specimen in a lab.
- The intended use and device description focus on surgical assistance and navigation. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Stryker Navigation System - Hip Module falls under the category of a surgical navigation system or computer-assisted surgery system, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Navigation System - 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 must be used within the operating theatre and 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 of 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
84HAW, 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
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, operating theatre
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko22365
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: STRYKER NAVIGATION - HIP MODULE
JAN 2 2 2003
General Information
| Proprietary Name: | Stryker Navigation System - Hip
Module
HipTrac |
|--------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Image Guided Surgery System |
| Classification Name(s): | Instrument, Stereotaxic |
| Classification Code(s): | 84HAW |
| Submitter: | Stryker Corporation
Stryker Leibinger
4100 East Milham Avenue
Kalamazoo, MI 49001
800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Kelli J. Bitterburg
Regulatory Affairs Associate
Phone: 616-324-5346 x4026
Fax: 616-324-5454 |
| Summary Preparation Date: | July 19, 2002 |
Summary of Safety and Effectiveness:
The Stryker Navigation System – 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 must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
1
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 of minimal-O invasive
- Precisely position instruments, implants and bony tissue during O orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
- o Revisions
The Stryker Navigation System is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems being marketed by companies such as Stryker, Sofamor Danek, and BrainLab.
They Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System is substantially equivalent to these existing devices.
Kelli J. Bitterburg
Regulatory Affairs Associate
Dated: 7/19/02
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
Ms. Kelli Bitterburg Regulatory Affairs Associate Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K022365
Trade Name: Stryker Navigation System - Hip Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 25, 2002 Received: October 28, 2002
Dear Ms. Bitterburg:
We have reviewed your Section 510(k) premarket 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) 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 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); 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.
3
Page 2 - Ms. Kelli Bitterburg
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 contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
4
510(K) Number (if known):
Device Name: Stryker Navigation System - Hip Module
Intended Use:
The Stryker Navigation System - 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 must be used within the operating theatre and 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 of 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 .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-The-Counter Use
Muriam C. Provost (Optional Format 1-2-96)
or
ivision Sign-Off) Jivision of General, Restorative and Neurological Devices
Number K022 365