NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017

K041369 · Orthosoft, Inc. · HAW · Jun 22, 2004 · Neurology

Device Facts

• Record ID: K041369
• Device Name: NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
• Applicant: Orthosoft, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

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 Story

Navitrack System is a computer-controlled image-guidance workstation; utilizes optical tracking system, surgical instruments, and tracking accessories. Inputs: user-identified anatomical landmarks digitized intra-operatively. Processing: system calculates and records main alignment axes of pelvis and femur; tracks instruments and fixation bases in real-time. Output: visual display of instrument/component positions relative to joint alignment axes. Used in OR by surgeons to assist in total hip replacement component placement. Benefits: provides intra-operative guidance for precise component positioning.

Clinical Evidence

Bench testing only. Testing verified accuracy and performance of the system in depicting the positioning of the femoral THR component.

Technological Characteristics

Stereotaxic instrument; optical tracking system; software-driven workstation; includes surgical instruments and tracking accessories for pelvis and femur. Connectivity: workstation-based. Software: modified to handle femoral tracking. Sterilization: not specified.

Indications for Use

Indicated for use as a stereotaxic instrument to assist surgeons in the intra-operative positioning of total hip replacement components by displaying component positions relative to joint alignment axes based on user-identified anatomical landmarks.

Regulatory Classification

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.

Predicate Devices

• Navitrack System™ - Total Hip Replacement CT-Free Cup (K030827)

Submission Summary (Full Text)

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# 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 .: [phone] Fax: [phone]

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.

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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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#### 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 [phone] 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: |<o4 | 369

Device Name: Navitrack TM System - S&N Image Free Hip

#### Indications for Use:

The Navitrack The System - S&N Image Free Hip 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 threedimensional 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.

Prescription Use_ √ (per 21CFR 801.109)

OR

Over-the-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nuriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K64/369