Smith & Nephew SURESHOT Distal Targeting System V4.0

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font. April 28, 2017 Smith & Nephew, Inc. Allison Chan Regulatory Affairs Specialist II 1450 East Brooks Road Memphis. Tennessee 38116 Re: K170280 Trade/Device Name: Smith & Nephew SURESHOT™ Distal Targeting System V4.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2017 Received: January 30, 2017 Dear Allison Chan: 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. 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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 {1}------------------------------------------------ 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. 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Sincerely, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|--| | Food and Drug Administration | | | <b>Indications for Use</b> | | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | | 510(k) Number (if known) | K170280 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SURESHOT ^TM Distal Targeting System V4.0 | | Indications for Use (Describe) | The Smith & Nephew SURESHOT ^TM 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 ^TM Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate. | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange. | Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Date of Summary: | April 24, 2017 | | Contact Person and Address: | Allison Chan<br>Regulatory Affairs Specialist II<br>T 901-399-1098 | | Name of Device: | Smith & Nephew, Inc. SURESHOT™ Distal<br>Targeting System V4.0<br>Computer Assisted Surgery System | | Device Classification Name<br>and Reference: | 21 CFR 888.4560 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™ Targeting System to include software updates (V4.0) to include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program 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 software is intended to be used with existing Smith & Nephew platform, instruments and implants. No new instruments or implants are being cleared via this premarket notification. {4}------------------------------------------------ #### Indications for Use The Smith & Nephew SURESHOT™ Targeting System is intended to be an intraoperative image quided 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 K130748 with the primary differences being additional software features which include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program ## Summary of Pre-Clinical Testing 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 . - 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 . {5}------------------------------------------------ - 12.317 Translations Italian ● - . 12.318 Translations Japanese - 12.319 Translation Portuquese . - 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 software 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 | Smith & Nephew<br>SURESHOT™ Distal Targeting<br>System V.3.0 | K130748 | August 4,<br>2013 | | Smith &<br>Nephew | Smith & Nephew<br>SURESHOT™ Distal Targeting<br>system V.2.1 | K110240 | April 4, 2011 | | Smith &<br>Nephew | Smith & Nephew<br>SURESHOT™ Distal Targeting<br>System V.2.0.2 | K102967 | November 4,<br>2010 | | Smith &<br>Nephew | Smith & Nephew<br>SURESHOT™ Distal Targeting<br>System V.2.0 | K100107 | February 23,<br>2010 | | Smith &<br>Nephew | Smith & Nephew PiGalileo<br>Screw Targeting System V1.1 | K092497 | September<br>11, 2009 | Table 5.1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System {6}------------------------------------------------ | Design Aspect<br>Reviewed | SURESHOT™<br>Distal Targeting<br>System v.4.0 | SURESHOT™<br>Distal Targeting<br>System v.3.0 –<br>primary<br>predicate | SURESHOT™<br>Distal Targeting<br>System v.2.1 | SURESHOT<br>Distal Targeting<br>System v.2.0.2 | SURESHOT<br>Distal Targeting<br>System v.2.0 | PiGalileo Screw<br>Targeting<br>System V1.1 | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------|----------------------------------------------|---------------------------------------------| | 510(k) Number | Subject Device | K130748 | K110240 | K102967 | K100107 | K092497 | | Manufacturer | Smith & Nephew | Smith & Nephew | Smith & Nephew | Smith & Nephew | Smith & Nephew | Smith & Nephew | | Similar<br>Indications for<br>Use? | The Smith & Nephew SURESHOT ™ Targeting System is intended to be an intraoperative image guided localization system.<br>It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail<br>implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing<br>intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT ™ Targeting System is indicated<br>for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery 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 targeting software | | | | | | | Similar<br>Sterilization? | Y | Y | Y | Y | Y | Y | | Similar<br>Packaging? | Y | Y | Y | Y | Y | Y | | Similar<br>Materials? | Y | Y | Y | Y | Y | Y | | Software<br>Design | Addition of ability<br>to target for<br>TRIGEN META- | Addition of drill<br>depth<br>measurement, | Addition of<br>humeral nail<br>application. | | | | | Design Aspect<br>Reviewed | SURESHOT™<br>Distal Targeting<br>System v.4.0 | SURESHOT™<br>Distal Targeting<br>System v.3.0 –<br>primary<br>predicate | SURESHOT™<br>Distal Targeting<br>System v.2.1 | SURESHOT<br>Distal Targeting<br>System v.2.0.2 | SURESHOT<br>Distal Targeting<br>System v.2.0 | PiGalileo Screw<br>Targeting<br>System V1.1 | | | (K092748),<br>updates to<br>Trauma<br>Launcher<br>program, ability<br>of on screen<br>image rotation<br>using targeter,<br>additional<br>languages for<br>the graphical<br>user interface,<br>updates to<br>graphical user<br>interface. | Launcher<br>updates, GUI<br>updates, new<br>instrument and<br>Japan Nail<br>application. | | | | | A comparison of the subject device to the predicate device is described in the following table. {7}------------------------------------------------ ## Conclusion The SURESHOT™ Distal Targeting System V4.0 is substantially equivalent to the existing System V3.0 cleared in K130748 in that the indications for these devices are identical and the core technological principals for these devices are also equivalent.