K Number
K041369
Device Name
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
Manufacturer
Date Cleared
2004-06-22

(29 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Device Description
Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free 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 Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented. The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.
More Information

Not Found

No
The description focuses on optical tracking and user-identified anatomical landmarks for guidance, with no mention of AI or ML algorithms for image processing, data analysis, or decision support.

No.
The device assists in positioning hip replacement components, which is a surgical aid function, not a direct therapeutic intervention for a disease or condition.

No

Explanation: The device is described as a "stereotaxic instrument to assist in the positioning of hip replacement components" and an "image-guidance system." Its purpose is to help surgeons precisely position components intra-operatively, not to diagnose a condition.

No

The device description explicitly states it consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, indicating it includes hardware components beyond just software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The Navitrack™ System is a surgical navigation system. It assists surgeons in positioning implants during surgery by tracking the position of instruments and anatomical landmarks. It does not analyze biological samples.
  • Intended Use: The intended use clearly states it's a "stereotaxic instrument to assist in the positioning of hip replacement components." This is an intra-operative surgical aid, not a diagnostic test performed on a sample.
  • Device Description: The description details a system with a workstation, optical tracking, surgical instruments, and tracking accessories used to display positions relative to anatomical axes. This aligns with a surgical navigation system, not an IVD.

The device's purpose is to guide surgical procedures, not to diagnose or monitor a patient's condition through the analysis of biological samples.

N/A

Intended Use / Indications for Use

The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

Product codes

HAW

Device Description

Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free 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 Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.

The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip, pelvis, femur

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, intra-operatively

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 in depicting the positioning of the femoral THR component was adequate for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030827

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

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack™ System - Total Hip Replacement CT-Free

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: September 19, 2003

Device Trade Name: Navitrack TM System - Total Hip Replacement CT-Free

Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560

Predicate Device:

Navitrack System™ - Total Hip Replacement CT-Free Cup, from Orthosoft Inc, 510(k) #K030827

Device Description:

Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free 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 Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.

The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.

Indications for Use / Intended Use:

The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

1

This is identical to the Navitrack System™ - Total Hip Replacement CT-Free Cup predicate.

Technological Comparisons to the Predicate:

The comparisons showed that the proposed device is substantially equivalent to the predicate, the Navitrack System - Total Hip Replacement CT-Free Cup. It is a modification to the predicate. The fundamental scientific technology of the Navitrack predicate is unchanged. It utilizes the same workstation and tracking technology. The modification consists in extending the capabilities of the predicate to also track the femur and its instrumentation in addition to the pelvis and its instrumentation in the predicate. Similarly as for the pelvis in the predicate, it employs the same method of having the user identify and digitize key landmarks from which the system determines femoral alignment axes relative to which the user can verify the placement of the femoral THR components. The software was correspondingly modified to handle the added capabilities, and the instrument set extended to include femoral instrumentation.

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 in depicting the positioning of the femoral THR component was adequate for its intended use.

Conclusion:

The information and data provided in this 510(k) Premarket Notification established that the Navitrack 100 System - Total Hip Replacement CT-Free device is substantially equivalent to the Navitrack System™ - Total Hip Replacement CT-Free Cup predicate.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Mr. Christopher McLean RA/OA Director Orthosoft, Inc. 75, Queen Street, Suite 3300 Montréal, Quebec Canada H3C 2N6

Re: K041369

K041369
Trade/Device Name: Navitrack™ System – S & N Image Free Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 21, 2004 Received: May 24, 2004

Dear Mr. McLean:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematically equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally maneves por the Medical Device Ameralments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 28, 1970, the chacatience with the provisions of the Federal Food, Drug, devices that have been recuired in accordance with as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a providions of the Act. The and Cosment Act (Act) that to not require approvate of the general controls of the Act. The You may, inerefore, market the devices, basjest to the may be supportunent in the specifically and general controls provisions of the rice 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 if your device is classifica (seculove) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such adultional controls. Linbang may of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachar Sincerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualted of a basedianal with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon that your steered by other Federal agencies. You must of any Federal Statutes and regulations adminities or registration and listing (21 l comply with an the Act 3 requirements, me; good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 16 am 1960 form in the quality systems (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) I ms letter will anow you to obgin manieting your and equivalence of your device to a legally premarket nothleadon: "The FDA midning of castification 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 If you desire specific advice 101 Jour as 1) 594-4659. Also, please note the regulation entitled, Contact the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain Misoranung of Tereforee to prenezionsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octass 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

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510(k) Number: |