SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2

K102967 · Smith & Newphew, Inc. · OLO · Nov 4, 2010 · Neurology

Device Facts

• Record ID: K102967
• Device Name: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
• Applicant: Smith & Newphew, Inc.
• Product Code: OLO · Neurology
• Decision Date: Nov 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Smith & Nephew SURESHOT 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 SURESHOT® Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Device Story

SURESHOT Distal Targeting System is computer-controlled electromagnetic tracking system for orthopedic trauma surgery. Input: electromagnetic signals from sensor-embedded instruments placed in varying magnetic fields. Operation: system induces voltages in sensor coils to calculate 3D virtual position of instruments; eliminates line-of-sight constraints inherent in optical systems. Output: real-time 3D visualization of drill/screw position relative to intramedullary nail. Used in OR by surgeons to assist in distal locking screw placement. Benefits: improved accuracy in screw positioning; reduced need for fluoroscopy/radiation exposure. Healthcare provider uses visual output to guide drill trajectory during implantation.

Clinical Evidence

Bench testing only. No clinical data was required to support the safety and effectiveness of the software modifications. Software verification and validation were performed in accordance with FDA's 'General Principles of Software Validation' guidance.

Technological Characteristics

Electromagnetic spatial measurement system; utilizes sensor-embedded instruments; low field strength magnetic field generation; 3D virtual position calculation; software-based tracking; standalone system integration with existing Smith & Nephew surgical platforms.

Indications for Use

Indicated for patients with long bone fractures requiring intramedullary nail fixation where stereotactic surgical guidance 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

• Smith & Nephew PiGalileo Screw Targeting System V1.1 (K092497)
• Smith & Nephew SURESHOT Distal Targeting System v.2.0 (K100107)

Submission Summary (Full Text)

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| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| | NOV - 4 2010 |
| Date of Summary: | October 4, 2010 |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist<br>T [phone] F [phone] |
| Name of Device: | Smith & Nephew, Inc. SURESHOT ^® Distal Targeting System<br>V2.0.2 |
| Common Name: | Computer Assisted Surgery System |
| Device Classification Name and<br>Reference: | 21 CFR 882.4560 Stereotaxic Instrument - Class II |
| Device Class: | Class II |
| Panel Code: | Neurology/84 |
| Product Code: | OLO |

#### Device Description

Subject of this Special Premarket Notifications to existing SURESHOT® Targeting System software. The SURESHOT® Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in locating and positioning screws 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 are induced 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.

The SURESHOT® Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. The software devices subject of this premarket notification are the following:

- SURESHOT® Distal Targeting System Software V2.0.2 .
- . Trauma Launcher V1.0.1

#### Technological Characteristics

Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Clinical data was not needed to support the safety and effectiveness of the subject device.

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#### Intended Use

The Smith & Nephew SURESHOT 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 SURESHOT® Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

### Substantial Equivalence Information

The substantial equivalence of the SURESHOT Targeting System software is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed in the table below.

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|----------------|-----------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew | Smith & Nephew PiGalileo Screw<br>Targeting System V1.1 | K092497 | 09/11/09 |
| Smith & Nephew | Smith & Nephew SURESHOT®<br>Distal Targeting System v.2.0 | K100107 | 02/23/10 |

#### Table 1: Substantially Equivalent Predicate Systems

#### Conclusion

As previously noted, this Special 510|k} Premarket Notification is being submitted to request clearance for the SURESHOT® Targeting System software modifications. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. Orthopaedic Division % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116

Re: K102967

Trade/Device Name: SURESHOT Distal Targeting System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 04, 2010 Received: October 05, 2010

Dear Ms. Myers:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

NOV - 4 2010

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Page 2 - Ms. Shereen Myers

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

For
Mark N. Melkerson

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

Enclosure

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# Premarket Notification Indications for Use Statement

NOV - 4 2010

510(k) Number (if known):

Device Name: SURESHOT Targeting System V2.0.2

Indications for Use:

The Smith & Nephew SURESHOT 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 SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilke Dydem for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102967