TOTAL HIP SURGETICS NAVIGATION SYSTEM

K072267 · Praxim S.A · HAW · Dec 10, 2007 · Neurology

Device Facts

• Record ID: K072267
• Device Name: TOTAL HIP SURGETICS NAVIGATION SYSTEM
• Applicant: Praxim S.A
• Product Code: HAW · Neurology
• Decision Date: Dec 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks. Example procedures include but are not limited to: Hip arthroplasty

Device Story

Optically based surgical navigation system; tracks reflective markers on anatomical landmarks and surgical instruments via infrared camera. System consists of mobile navigation station, optical localizer, and software. Surgeon uses system in OR to digitize relative locations of anatomy; provides real-time guidance and visualization of instrument position relative to landmarks. Assists in orthopedic procedures like hip arthroplasty; improves surgical accuracy by aiding surgeon in locating anatomical structures.

Clinical Evidence

Bench testing only. Analyses demonstrated system accuracy and performance were adequate for intended use and comparable to predicate devices. No clinical data provided.

Technological Characteristics

Optically based navigation system; uses infrared camera for localization. Components include mobile computer station, optical localizer, ancillary instruments, and reflective markers. Software-driven guidance. No specific material standards or connectivity protocols detailed.

Indications for Use

Indicated for patients requiring stereotaxic surgery where rigid anatomical structures (e.g., pelvis, femur) can be identified via landmark acquisition. Applicable for procedures including hip arthroplasty.

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

• VectorVision Hip (K060468)
• TOTAL KNEE SURGETICS Navigation System (K060282)

Submission Summary (Full Text)

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# 510(k) Summary for TOTAL HIP SURGETICS Navigation System K072267

## 1. Submitter Name and Address:

Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France

DEC 1 0 2007

Contact Name: Mady BATAILH Telephone: [phone]

Date Prepared: August 7th, 2007

## 2. Device Name:

Proprietary Name: TOTAL HIP SURGETICS Navigation System Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory)

# 3. Equivalent to:

K060468 - VectorVision Hip - BrainLAB AG K060282 - TOTAL KNEE SURGETICS Navigation System - PRAXIM S.A.

#### 4. Intended Use:

The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

#### న్. Indications for use

The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks.

Example procedures include but are not limited to:

Hip arthroplasty

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# 6. Device Description:

As the equivalent TOTAL KNEE SURGETICS navigation system, the TOTAL HIP SURGETICS navigation system consists of the following major components and subsystems:

- The Navigation Station, consisting of a mobile computer system and an . optical localizer
- . Ancillary instruments and reflective markers used for reference and registration
- . TOTAL HIP SURGETICS software

# 7. Technological Characteristics and Substantial Equivalence

The TOTAL HIP SURGETICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in orthopedic surgery, including the BrainLab VectorVision Hip and the PRAXIM TOTAL KNEE SURGETICS Navigation Systems. The TOTAL HIP SURGETICS Navigation system and the predicate systems all acquire positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, to aid the surgeon in linear procedures. It allows the surgeon to locate surgical instruments' position in regards to anatomical landmarks. The system uses an infrared camera for localization and guidance of surgical instruments during the procedure.

The underlying technology of the TOTAL HIP SURGETICS Navigation System is the same as the TOTAL KNEE SURGETICS Navigation system. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance.

# 8. Performance Testing

The TOTAL HIP SURGETICS Navigation System was tested to assess that no safety and efficiency issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices. In conclusion the TOTAL HIP SURGETICS Navigation System is substantially equivalent to the Vector Vision Hip #K060468 and the TOTAL KNEE SURGETICS Navigation System #K060282.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

DEC 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Praxim SA % Mady Batailh Quality & Regulatory Affairs Director Le Grand Sablon 4, avenue de l'Obiou 38700 LA Tronche France

Re: K072267

Trade/Device Name: TOTAL HIP SURGETICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 13, 2007 Received: November 23, 2007

Dear Mady Batailh:

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

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Page 2 - Mady Batailh

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE TOTAL HIP SURGETICS Navigation System

510(k) Number (if known): K072267

Device Name: TOTAL HIP SURGETICS Navigation System

Indications for Use:

The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.

The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks.

Example procedures include but are not limited to:

Hip arthroplasty

Prescription Use __X__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Concurrence of CDRH, Office of Division of General, Restorative,
and Neurological Devices

| 510(k) Number | 4072267 |
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November 13th, 2007 Praxim 510(k)-additional information TOTAL HIP SURGETICS Navigation System

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