(23 days)
No
The description focuses on computer-controlled image guidance, 3D tracking, and anatomical landmark identification for surgical navigation, without mentioning AI or ML algorithms for analysis, prediction, or decision support.
No
The device is described as a stereotaxic instrument and an image-guidance system intended to assist surgeons in the precise positioning of Total Knee Replacement components, not to treat a condition itself.
No
Explanation: The device is described as a stereotaxic instrument and a computer-controlled image-guidance system intended to assist in the positioning of Total Knee Replacement components intra-operatively, not to diagnose a condition.
No
The device description explicitly states that the system consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, indicating the presence of hardware components beyond just software.
Based on the provided information, the Navitrack® System -- S&N Image Free Knee is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Navitrack System Function: The Navitrack System is used intra-operatively (during surgery) to assist the surgeon in positioning components within the patient's body during Total Knee Replacement. It uses tracking technology and anatomical landmarks to guide the surgical procedure.
- No Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient.
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 -- S&N Image Free Knee 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
HAW
Device Description
Identically as in the predicate, the Navitrack® System - S&N Image Free Knee device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicate are to incorporate a new set of instruments to be tracked corresponding to assisting the placement of two new TKR implant lines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee (femur and tibia)
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. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KOY 3536 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack® System - S&N Image Free Knee
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: December 21, 2004
Device Trade Name: Navitrack System - S&N Image Free Knee
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR & 882.4560
Predicate Device:
Navitrack System - Optical TKR CT-Less; from Orthosoft Inc; 510(k) # K021760.
Device Description:
Identically as in the predicate, the Navitrack® System - S&N Image Free Knee device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicate are to incorporate a new set of instruments to be tracked corresponding to assisting the placement of two new TKR implant lines.
Indications for Use / Intended Use:
The Navitrack System -- S&N Image Free Knee 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.
1
This is identical to the predicate.
Technological Comparisons to the Predicate:
The fundamental scientific technology of the predicate is unchanged. The intended use, the indications, along with the main operating principle and control mechanism, are maintained in the proposed device to perform the same surgery to provide the same image guidance assistance in the placement of TKR orthopedic implants. The main changes to the predicate generally included secondary engineering and software modifications in relation to navigating two new implant lines. In addition, the software was modified to increase the joint laxity information provided for ligament balance assistance, and the calibration/registration method for one of the instruments was modified.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack System - S&N Image Free Knee device is substantially equivalent to the Navitrack System । Optical TKR CT-Less predicate.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image shows a partial view of a seal or logo. The visible portion includes the words "DEPARTMENT OF HEALTH & HUMAN..." arranged in a circular pattern around the edge. To the right of the text, there are three curved, parallel lines that appear to be part of a larger design or symbol. The overall impression is that of an official emblem or insignia, possibly related to a health or government organization.
JAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher McLean, Eng. Regulatory Affairs and Quality Assurance Director ORTHOsoft, Inc. 75. Queen Street, Suite 3300 Montréal, Quebec Canada H3C 2N6
Re: K043536
Trade/Device Name: Navitrack® System - S&N Image Free Knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 21, 2004 Received: December 22, 2004
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.
3
Page 2 - Mr. Christopher McLean, Eng.
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 Iogal|v marketed predicate device results in a classification for your device and thus, perceits 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain 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) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Muriam 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
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510(k) Number: KO43533
Device Name: Navitrack® System - S&N Image Free Knee
Indications for Use:
The Navitrack® System -- S&N Image Free Knee 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.
Prescription Use (per 21CFR 801.109)
OR
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_H043536