Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter

K180277 · Smith & Nephew, Inc. · OLO · Apr 24, 2018 · Neurology

Device Facts

• Record ID: K180277
• Device Name: Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
• Applicant: Smith & Nephew, Inc.
• Product Code: OLO · Neurology
• Decision Date: Apr 24, 2018
• 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 V4.0 is an intraoperative electromagnetic (EM) tracking system for orthopedic trauma surgery. It assists surgeons in locating and positioning screws during intramedullary nail implantation. The system uses sensor-embedded instruments placed within controlled, varying magnetic fields; induced voltages in sensor coils allow the system to calculate 3D virtual positions of instruments. This eliminates line-of-sight constraints inherent in optical systems. The device consists of a targeter (handheld field generator), trauma interfaces, and software. Surgeons use the system to visualize drill positioning on a display, aiding in accurate screw placement. The V4.0 targeter features reduced size (~750g) and weight compared to the predicate. It is used in the OR by surgeons to improve surgical precision and potentially reduce radiation exposure by minimizing the need for fluoroscopic imaging.

Clinical Evidence

No clinical data was required. Evidence consists of bench testing, including electromagnetic compatibility (IEC 60601-1-2:2007) and electrical safety (IEC 60601-1:2005 + A1:2012), and comprehensive software verification and validation testing covering workflow, tool connections, drill depth measurement, and targeting calculations.

Technological Characteristics

Electromagnetic tracking system; handheld field generator (targeter) weighing ~750g. Operates via induced voltages in sensor-embedded instruments within magnetic fields. Complies with IEC 60601-1 and IEC 60601-1-2. Software-controlled; integrates with existing trauma interfaces and software (K170280).

Indications for Use

Indicated for patients with long bone fractures treated with intramedullary nails 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 Screw Targeting System V1.1 (K092497)

Reference Devices

• SURESHOT trauma interfaces (K170977, K100107)
• SURESHOT software V4.0 (K170280)

Submission Summary (Full Text)

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April 24, 2018

Smith & Nephew, Inc. Brad Sheals Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K180277

Trade/Device Name: Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 23, 2018 Received: March 26, 2018

Dear Brad Sheals:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180277

Device Name

Smith & Nephew SURESHOT Distal Targeting System V4.0

Indications for Use (Describe)

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 fracted with intramedulary nails in which the use of stereotactic surgery may be appropriate.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> <b> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> </div> |

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| Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | April 20, 2018 |
| Contact Person and Address: | Brad Sheals<br>Regulatory Affairs Manager<br>T 901-399-6897 |
| Name of Device: | Smith & Nephew, Inc. SURESHOT™ Distal<br>Targeting System V4.0 |
| Common Name: | Computer Assisted Surgery System |
| Device Classification Name<br>and Reference: | 21 CFR 882.4560 Stereotaxic Instrument |
| Device Class: | Class II |
| Panel Code: | Neurology/84 |
| Product Code: | OLO |

#### Device Description

Subject of this premarket notification are modifications to the SURESHOT™ Distal Targeting System V4.0- targeter which has been designed with a reduced size and weight compared to the previous design of the targeter (K092497). The SURESHOT Targeting system targeter is intended to be used the SURESHOT trauma interfaces (K170977, K100107) and software V4.0 (K170280).

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 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™ Distal Targeting System V4.0 targeter is intended to be used with existing Smith & Nephew software, trauma interface, instruments and implants, No new instruments or implants are being cleared via this premarket notification.

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### 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.

#### Comparison to Technological Characteristics with the Predicate Device

Device comparisons described in this premarket notification demonstrated that the proposed SURESHOT™ Targeting System is equivalent to the legally marketed predicate devices cleared in the below table with regard to intended use, indications for use, and performance characteristics.

The subject devices feature characteristics as previously cleared in K092497 with the primary differences being the reduced size and weight.

#### Summary of Pre-Clinical Testing

Electromagnetic compatibility and electrical safety validation testing has been conducted on the SURESHOT™ Distal Targeting System. The SURESHOT Distal Targeting System V4.0 targeter is used with the trauma interface. The subject device generates the same electromagnetic tracking technology as the existing targeter cleared in PiGalileo Screw Targeting System V1.1. The electromagnetic capability and electrical safety testing that was conducted includes.

- IEC 606061-1-2:2007 Class A for Emissions, Immunity for Non Life . Supporting Equipment
- IEC 60601-1: 2005 + A1 :2012 Medical Electrical Equipment Part 1: General . Requirements for Safety.

Results of the electromagnetic compatibility and electrical safety validation testing demonstrate the device is found to meet the application performance requirements to those standards.

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. Preclinical testing included the following tests:

- 12.102 Software Validation and Verification Report ●
- 12.201 Deployment Distal Targeting Software ●
- 12.301 Workflow and System Settings ●
- 12.302 Tool Connections ●
- . 12.303 Sleeve Selection

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- 12.304 Implant Selection ●
- . 12.305 Drilling Screen
- 12.306 Hardware Failure .
- 12.307 Drill Depth Measurement
- 12.308 Targeting Calculations META ●
- 12.309 Targeting Calculations TAN/FAN ●
- 12.310 Targeting Calculations Humeral ●
- 12.311 Targeting Calculations Field Check ●
- 12.312 Targeting Calculations META-TAN
- 12.313 Translations Chinese
- 12.314 Translations English
- 12.315 Translations French ●
- 12.316 Translations German ●
- 12.317 Translations Italian ●
- 12.318 Translations Japanese ●
- 12.319 Translation Portuguese ●
- 12.320 Translation Finnish ●
- 12.321 Translation Spanish
- 12.322 Nail Rotation ●
- 12.323 View Selection ●
- 12.401 Customer Validation ●
- 12.402 Regression Test ●

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 as compared to the predicate. Clinical data was not needed to support the safety and effectiveness of the subject device.

#### Substantial Equivalence Information

The substantial equivalence of the SURESHOT™ Targeting System V4.0 - targeter is based on its similarities in indications for use, design features, sterilization methods and operational principles to the predicate systems listed in the following table.

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|-------------------|------------------------------------------|----------------------|-----------------------|
| Smith &<br>Nephew | PiGalileo Screw Targeting<br>System V1.1 | K092497 | September 11,<br>2009 |

### Table 5.1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System

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| Design Aspect Reviewed | SURESHOT ™ Distal Targeting System<br>V4.0-Targeter | PiGalileo Screw Targeting System V1.1 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject device | K092497 |
| Manufacturer | Smith & Nephew | Smith & Nephew |
| Similar Indications for Use | The Smith & Nephew SURESHOT™<br>Targeting System is intended to be an<br>intraoperative image guided localization<br>system. It is a computer assisted<br>orthopedic surgery tool to aid the surgeon<br>with drill positioning for screws during<br>intramedullary nail implantation. It<br>provides information to the surgeon that is<br>used to place surgical instruments during<br>surgery utilizing intraoperatively obtained<br>electromagnetic tracking data. The Smith<br>& Nephew SURESHOT™ Targeting<br>System is indicated for long bone fractures<br>treated with intramedullary nails in which<br>the use of stereotactic surgery may be<br>appropriate. | The Smith & Nephew PiGalileo Screw<br>Targeting System is intended to be an<br>intraoperative image guided localization<br>system. It is a computer assisted<br>orthopedic surgery tool to aid the surgeon<br>with drill positioning for screws during<br>intramedullary nail implantation. It provides<br>information to the surgeon that is used to<br>place surgical instruments during surgery<br>utilizing intraoperatively obtained<br>electromagnetic tracking data. The Smith<br>& Nephew PiGalileo Screw Targeting<br>System V1.1 is indicated for long bone<br>fractures treated with intramedullary nails<br>in which the use of stereotactic surgery<br>may be appropriate. |
| Intended Use | Intraoperative image guided localization system | |
| Instrumentation | Used to assist surgeon in placing nail implants and for specific use with the distal<br>targeting software | |
| Similar Sterilization | Y | Y |
| Similar Packaging | Y | Y |
| Similar Materialsf the | Y | Y |
| Similar Design | Y | Y |
| Overall Weight Targeter | ~750g | ~1kg |

A comparison of the subject device to the predicate device is described in the following table.

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| Design Aspect Reviewed | SURESHOT ™ Distal Targeting System<br>V4.0-Targeter | PiGalileo Screw Targeting System V1.1 |
|------------------------|------------------------------------------------------------|----------------------------------------------------|
| Software Compatibility | SURSHOT Distal Targeting System V4.0<br>software (K170280) | PiGalileo Screw Targeting System V1.1<br>(K092497) |

# Conclusion

The SURESHOT™ Distal Targeting System V4.0 targeter is substantially equivalent to the existing PiGalleo Screw Targeting System V1.1 handheld field generator (targeter) cleared in K092497 in that the indications for use for these devices are identical and the core technological principals for these devices are also equivalent.