SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0

K090420 · Smith & Nephew, Inc. · OLO · May 27, 2009 · Neurology

Device Facts

• Record ID: K090420
• Device Name: SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
• Applicant: Smith & Nephew, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 27, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Device Story

Computer-controlled electromagnetic tracking system; assists surgeons with drill positioning during intramedullary nail implantation. System utilizes instruments embedded with sensor coils; sensors placed in varying magnetic fields generate induced voltages; measurement system calculates 3D virtual position of instruments. Electromagnetic tracking allows for non-line-of-sight measurement, unlike optical systems. Used in OR during orthopedic trauma surgery; operated by surgeon. Output provides real-time 3D localization data to guide surgical instrument placement; aids in accurate screw targeting; potentially improves surgical precision and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Electromagnetic tracking system; utilizes sensor-embedded instruments; low-field strength magnetic field generation; 3D spatial measurement; software-based navigation; Class II stereotaxic instrument.

Indications for Use

Indicated for patients with long bone fractures requiring intramedullary nail implantation where stereotactic surgery is appropriate.

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 Navigation System (4th Generation) (K080875)
• SNT StealthStation AxiEM Imageless Knee Module (K043088)

Reference Devices

• Vector Vision Trauma (K012448)

Submission Summary (Full Text)

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K096420 (.1 of 1

# MAY 27 2009

# Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Screw Targeting System V1.0

Date of Summary: 02/05/2009

Contact Person and Address Susan Bell Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: Smith & Nephew PiGalileo Screw Targeting System V1.0 Common Name: Computer Assisted Surgery System

#### Device Description

Device Description
The PiGalieo Screw Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in mo roallist below harged in an intramedullary nail implant during orthopedic trauma surgery.

The link between the sterile surgical area (patient) and the instrument system is provided through an electromagnetic tracking system. Electromagnetic spatial measurement systems determine the location of instruments that are embedded with sensor coils. When the sensor-embedded instrument is placed inside controlled, varying magnetic fields, voltages wn roduced in the sensor coils. These induced voltages are used by the measurement system to calculate a 3D virtual position of the instrument. Because the magnetic fields are of a low field strength and can safely pass through human tissue, location measurement of an object is possible without the line-of-sight constraints of an optical spatial measurement system that requires a camera.

#### Device Classification

21 CFR 882.4560 Stereotaxic Instrument - Class II

## Indications for Use

The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization me online a respent reasisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during n urgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

## Substantial Equivalence Information

Substantial Equivalence information
The overall design and indications for use/intended use of the PiGalileo Screw Targeting System is substantially equivalent to previously cleared devices listed below.

| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---------------------|----------------------------------------------|---------|----------------|
| Smith & Nephew, Inc | PiGalileo Navigation System (4th Generation) | K080875 | 7/18/2008 |

# Predicate Electromagnetic Tracking Technology Systems

| RE AMANUFACTURER | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . 510 Kirki - | CLEARANCE DATE : " "<br>- Com I W |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------|
| Medtronic Navigation, Inc | SNT StealthStation AxiEM Imageless | K043088 | 01/05/2005 |
| | Knee Module | | |

### Indications for Use

| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|--------------|----------------------|---------|----------------|
| BrainLAB AG | Vector Vision Trauma | K012448 | 03/14/2002 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

MAY 27 2009

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Susan Bell Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K090420

Trade/Device Name: PiGalileo Screw Targeting Software Application V1.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: May 13, 2009 Received: May 14, 2009

Dear Ms. Bell:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

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Page 2 - Ms. Susan Bell

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for
Mark N. Melkerson

kerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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L090420 0.1 of 1

Indications for Use

## 510(k) Number (if known):

Device Name: PiGalileo Screw Targeting Software Application V1.0

## Indications for Use:

The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Neil B.P. Oder Sas mkn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090420

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