(90 days)
Not Found
No
The description focuses on standard computer-assisted navigation and tracking based on anatomical landmarks and motion analysis, without mentioning AI or ML algorithms.
No.
The device is an image-guidance system that assists the surgeon in positioning Total Knee Replacement components by displaying their locations and determining alignment axes. It does not directly perform any therapeutic action on the patient.
Yes
The device assists in positioning Total Knee Replacement components and determining reference alignment axes based on anatomical landmarks, which is part of a therapeutic or surgical procedure rather than diagnosing a condition.
No
The device description explicitly lists hardware components such as a computer workstation, an optical tracking system, surgical instruments, and tracking devices. This is not a software-only device.
Based on the provided information, the Navitrack™ System - Optical TKR CT-Less 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.
- Navitrack™ System Function: The description clearly states that the Navitrack™ System is a stereotaxic instrument and a computer-controlled image-guidance system used intra-operatively to assist surgeons in positioning Total Knee Replacement components. It works by tracking the relative locations of surgical instruments and anatomical landmarks in real-time.
- No Sample Analysis: The system does not analyze any samples taken from the patient's body. It operates by tracking physical objects and anatomical structures during surgery.
Therefore, the Navitrack™ System falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Navitrack™ System - Optical TKR CT-Less device consists of a computer workstation, an optical tracking system, surgical instruments, and tracking devices. It is designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Intra-operatively, the tracking devices are attached to the femur and the tibia, and to the alignment and pointing instruments, in order to track and display their relative locations in real-time. The pointing instruments are used to digitize the relative locations of anatomical landmarks that are commonly used clinically for TKR alignment. In the case of the femoral head landmark, it is computed by the system as based on a motion analysis of the femur. From the landmarks the system then computes and displays the alignment axes. The alignment instrument is then navigated and positioned relative to these axes on each bone which in turn sets the placement of the cutting guides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, intraoperatively
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)
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended.
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.
The Navitrack System™ - Optical Option, from Orthosoft Inc. (K002053), The Orthopilot®, from Kinamed Inc. (K003347)
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
KO21760
SECTION 2: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant: ORTHOsoft Inc. 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel .: 514 861 4074 Fax: 514 866 2197
Contact Person: Christopher McLean
Date Summary Prepared: May 27, 2002
Device Trade Name: Navitrack™ System - Optical TKR CT-Less
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Reason for 510(k) Notification: Modifications of indications and technology to a currently cleared device from Orthosoft Inc.
Susbtantial Equivalence Claimed To:
The Navitrack System™ - Optical Option, from Orthosoft Inc. (K002053) The Orthopilot®, from Kinamed Inc. (K003347)
Device Description:
The Navitrack™ System - Optical TKR CT-Less device consists of a computer workstation, an optical tracking system, surgical instruments, and tracking devices. It is designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Intra-operatively, the tracking devices are attached to the femur and the tibia, and to the alignment and pointing instruments, in order to track and display their relative locations in real-time. The pointing instruments are used to digitize the relative locations of anatomical landmarks that are commonly used clinically for TKR alignment. In the case of the femoral head landmark, it is computed by the system as based on a motion analysis of the femur. From the landmarks the system then computes and displays the alignment axes. The alignment instrument is then navigated and positioned relative to these axes on each bone which in turn sets the placement of the cutting guides.
Indications for Use / Intended Use:
The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference
1
alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
♥ ♥ U U ▲ !
Technological Comparisons to Substantial Equivalent Devices:
The comparisons showed that the proposed product is equivalent to both the Navitrack and the Orthopilot predicates in terms of the workstation and the tracking technology. The main departures of the proposed product relative to the Navitrack predicate related to its intended use in TKR procedures, and to the technology change of navigating relative to knee alignment axes instead of 3D bone models reconstructed pre-operatively. These new elements were however found to be equivalent to the Orthopilot predicate.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack "1" System - Optical TKR CT-Less device is substantially equivalent to the legally marketed predicates: the Navitrack System™ - Optical Option, and the Orthopilot®.
2
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
ORTHOsoft Inc. Christopher McLean Regulatory Affairs & Quality Assurance Manager 75, Queen Street, suite 3300 Montreal, Quebec Canada H3C 2N6
Re: K021760
Trade/Device Name: Navitrack™ System Optical TKR CT-Less Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: May 27, 2002 Received: May 29, 2002
Dear Mr. McLean:
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.
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Page 2 - Mr. Christopher McLean
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 vour 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 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
ncerely vours 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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KOZI760 510(k) Number:
Device Name: Navitrack™ System - Optical TKR CT-Less
Indications for Use:
The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.
It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21CFR 801.109)
OR
Over-the-Counter Use
Stupt Plurdu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021760