PIGALILEO 4TH GENERATION SYSTEM

K080875 · Smith & Nephew, Inc. · HAW · Jul 18, 2008 · Neurology

Device Facts

• Record ID: K080875
• Device Name: PIGALILEO 4TH GENERATION SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.

Device Story

Software-controlled electromechanical stereotaxic device; assists surgeons in total knee and hip arthroplasty. Inputs: 3D tracking data of surgical instruments and anatomical landmarks. Operation: computer-controlled image-guided system tracks instruments in 3D space relative to bone alignment axes. Output: real-time visual display of instrument location and bone alignment measurements. Used in OR by surgeons. Benefits: enables precise positioning of prosthetic components and provides intraoperative quantitative feedback on bone alignment.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Electromechanical stereotaxic instrument; 3D tracking sub-system; computer-controlled image-guided platform. Software-controlled. Class II device (21 CFR 882.4560).

Indications for Use

Indicated for use as a stereotaxic instrument to assist surgeons in positioning total knee and total hip replacement components intra-operatively by determining reference alignment axes relative to 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

• PiGalileo Total Knee Replacement (TKR) System (K061362)
• PiGalileo Total Hip Replacement (THR) System (K070731)

Submission Summary (Full Text)

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# 14080875

Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo 4th Generation System

JUL 1 8 2008

#### Contact Person and Address

Date of Summary: 06/30/2008

Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: PiGalileo 4th Generation System Common Name: PiGalileo

## Device Description

The PiGalileo 4th Generation System is a software-controlled electromechanical sterotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.

The subject device incorporates new hardware components as well as new platform system software. The PiGalileo 4th Generation System allows for existing knee applications to run on the new platform system.

### Device Classification

21 CFR 882.4560 Stereotaxic Instrument - Class II

#### Indications for Use

The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.

#### Substantial Equivalence Information

The overall design of the Smith & Nephew PiGalileo 4th Generation System is substantially equivalent to previously cleared devices listed below.

| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---------------------|-----------------------------------------------|---------|----------------|
| PLUS Orthopedics AG | PiGalileo Total Knee Replacement (TKR) System | K061362 | 10/06/06 |
| PLUS Orthopedics AG | PiGalileo Total Hip Replacement (THR) System | K070731 | 7/31/07 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in uppercase and black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2008

Smith & Nephew, Inc. % Rishi Sinha Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K080875

Trade/Device Name: PiGalileo 4th Generation Regulation Number: 21 CFR 882.4560 Regulation Name. Stercotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 30, 2008 Received: July 1, 2008

Dear Rishi Sinha:

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. Iisting 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 – Rishi Sinha

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 चा [phone]. YouTuay buain 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. Millican

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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Indications for Use

14080875 510(k) Number (if known):

Device Name: PiGalileo 4th Generation

Indications for Use:

The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking subsystem. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks; as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intracperative measurements of bone alignment.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |

## (PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE)<br>(Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices | Page 1 of 1 |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Number | I2080875 |