(301 days)
Not Found
Not Found
No
The document describes a computer-assisted surgical navigation system based on stereotactic methodology and video-optical tracking. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No
The device is described as a planning and intraoperative guidance system for surgery, not as a device that directly treats or provides therapy.
No
The device is described as a "planning and intraoperative guidance system" for surgery, utilizing diagnostic images and stereotactic methodology for precise targeting. It does not state that it provides a diagnosis of a medical condition.
No
The device description explicitly states that the system is comprised of "hardware and software components."
Based on the provided information, the Stryker Navigation System – Knee Module is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery." This describes a surgical navigation system used during a surgical procedure, not a test performed on biological samples outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on tracking, localization, and stereotactic determination within the surgical field. It uses diagnostic images for planning but the core function is guiding the surgeon during the operation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Stryker Navigation System – Knee Module does not fit this description. It's a surgical tool that utilizes imaging and tracking technology to assist the surgeon during knee procedures.
N/A
Intended Use / Indications for Use
The Stryker Navigation System - Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Knee Module is a part of the product series of the Stryker Navigation System. The system comprises a knee joint kinematics analysis module based on a wireless videooptical tracking localization device for the use in primary total knee arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Not Found
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
JUN - 2 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: STRYKER NAVIGATION SYSTEM – KNEE MODULE TRADITIONAL 510(K)
General Information
| Proprietary Name: | Stryker Navigation System -- Knee
Module |
|--------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Image Guided Surgery System |
| Classification Name(s): | Stereotaxic Instrument |
| Classification Code(s): | 84 HAW |
| 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: 616-323-4215 |
| Summary Preparation Date: | August 2, 2002 |
Device Description
The Knee Module is a part of the product series of the Stryker Navigation System. The system comprises a knee joint kinematics analysis module based on a wireless videooptical tracking localization device for the use in primary total knee arthroplasty.
Intended Use
The Stryker Navigation System - Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
1
The surgeon has to determine whether the patient's conditions are appropriate for this kind of procedure or not. A pathological condition against the use of this system could be in some cases advanced osteoporosis or a displastic hip.
The Stryker Navigation System provides precise stereotactic determination of surgical targets using a stereotactic methodology. 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.
Substantial Equivalence
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, Medtronic, Brainlab and Aesculap.
The 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.
Kell J. Bitterburg
Reculatory Affairs Associate
Dated: 6/2/03
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 2 2003
Kelli Bitterburg Regulatory Agent Stryker Leibinger 4100 E. Milham Ave. Kalamazoo, MI 49001
Re: K022579
Trade/Device Name: Stryker Navigation System-Knee Module Regulation Number: 21 CFR 882.4650 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: March 3, 2003 Received: March 4, 2003
Dear Ms. Bitterburg:
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.
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. 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) you may obtain. 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.
Miriam C. Provost
for 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 - Knee Module
Intended Use:
The Stryker Navigation System – Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Contraindications:
The surgeon has to determine whether the patient's conditions are appropriate for this kind of procedure or not. A pathological condition against the use of this system could be in some cases advanced osteoporosis or a displastic hip.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
KO22579 510(k) Number _
Prescription Use or (per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)