Who is the manufacturer of Smith & Nephew SURESHOT Distal Targeting System V4.0?

Smith & Nephew, Inc. filed the 510(k) submission for Smith & Nephew SURESHOT Distal Targeting System V4.0 (K170280).

What is the FDA product code for Smith & Nephew SURESHOT Distal Targeting System V4.0?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Smith & Nephew SURESHOT Distal Targeting System V4.0?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Smith & Nephew SURESHOT Distal Targeting System V4.0?

Smith & Nephew SURESHOT™ Distal Targeting System V.3.0 (K130748); Smith & Nephew SURESHOT™ Distal Targeting system V.2.1 (K110240); Smith & Nephew SURESHOT™ Distal Targeting System V.2.0.2 (K102967); Smith & Nephew SURESHOT™ Distal Targeting System V.2.0 (K100107); Smith & Nephew PiGalileo Screw Targeting System V1.1 (K092497).

Who can help prepare an FDA 510(k) submission like Smith & Nephew SURESHOT Distal Targeting System V4.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Smith & Nephew SURESHOT Distal Targeting System V4.0

K170280 · Smith & Nephew, Inc. · OLO · Apr 28, 2017 · Neurology

Device Facts

Record ID	K170280
Device Name	Smith & Nephew SURESHOT Distal Targeting System V4.0
Applicant	Smith & Nephew, Inc.
Product Code	OLO · Neurology
Decision Date	Apr 28, 2017
Decision	SESE
Submission Type	Traditional
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 image-guided localization system for orthopedic trauma surgery. It uses electromagnetic tracking to assist surgeons in positioning drill screws during intramedullary nail implantation. The system consists of sensor-embedded instruments placed within controlled, varying magnetic fields; induced voltages in the sensor coils allow the system to calculate a 3D virtual position of the instrument. This eliminates line-of-sight constraints inherent in optical systems. The surgeon views the calculated position on a graphical user interface to guide instrument placement. The system is used in the OR by surgeons to improve accuracy in screw placement, potentially reducing surgical time and radiation exposure. V4.0 adds support for TRIGEN META-TAN nails, on-screen rotation, and updated GUI/Launcher software.

Clinical Evidence

No clinical data was required. Safety and effectiveness were established through bench testing, specifically software verification and validation. Testing included workflow, system settings, tool connections, drill depth measurement, targeting calculations for various nails (META, TAN, FAN, Humeral, META-TAN), and regression testing.

Technological Characteristics

Computer-controlled electromagnetic tracking system. Uses sensor-embedded instruments and magnetic field generators to calculate 3D spatial position. Software-based system with GUI. Connectivity: Standalone system for intraoperative use. Sterilization: Compatible with existing Smith & Nephew instruments/implants.

Indications for Use

Indicated for 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

Smith & Nephew SURESHOT™ Distal Targeting System V.3.0 (K130748)
Smith & Nephew SURESHOT™ Distal Targeting system V.2.1 (K110240)
Smith & Nephew SURESHOT™ Distal Targeting System V.2.0.2 (K102967)
Smith & Nephew SURESHOT™ Distal Targeting System V.2.0 (K100107)
Smith & Nephew PiGalileo Screw Targeting System V1.1 (K092497)

Reference Devices

TRIGEN META-TAN Nail (K092748)

Related Devices

K180277 — Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter · Smith & Nephew, Inc. · Apr 24, 2018
K130748 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 · Smith & Nephew, Inc. · Aug 4, 2013
K110240 — SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 · Smith & Nephew, Inc. · Apr 14, 2011
K100107 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 · Smith & Nephew, Inc. · Feb 23, 2010
K102967 — SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 · Smith & Newphew, Inc. · Nov 4, 2010

Submission Summary (Full Text)

{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. 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 {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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 | | | Indications for Use | | | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF | |----------------------|-------------|----------------------------------------|----| |----------------------|-------------|----------------------------------------|----| 18 - 11 ୍ର {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. 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. Advanced Surgical Devices Division 1450 East Brooks Road Memphis, Tennessee 38116 | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Date of Summary: | April 24, 2017 | | Contact Person and Address: | Allison Chan Regulatory Affairs Specialist II T 901-399-1098 | | Name of Device: | Smith & Nephew, Inc. SURESHOT™ Distal Targeting System V4.0 Computer Assisted Surgery System | | Device Classification Name 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 Number | Clearance Date | |-------------------|----------------------------------------------------------------|----------------------|-----------------------| | Smith & Nephew | Smith & Nephew SURESHOT™ Distal Targeting System V.3.0 | K130748 | August 4, 2013 | | Smith & Nephew | Smith & Nephew SURESHOT™ Distal Targeting system V.2.1 | K110240 | April 4, 2011 | | Smith & Nephew | Smith & Nephew SURESHOT™ Distal Targeting System V.2.0.2 | K102967 | November 4, 2010 | | Smith & Nephew | Smith & Nephew SURESHOT™ Distal Targeting System V.2.0 | K100107 | February 23, 2010 | | Smith & Nephew | Smith & Nephew PiGalileo Screw Targeting System V1.1 | K092497 | September 11, 2009 | Table 5.1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System {6}------------------------------------------------ | Design Aspect Reviewed | SURESHOT™ Distal Targeting System v.4.0 | SURESHOT™ Distal Targeting System v.3.0 – primary predicate | SURESHOT™ Distal Targeting System v.2.1 | SURESHOT Distal Targeting System v.2.0.2 | SURESHOT Distal Targeting System v.2.0 | PiGalileo Screw Targeting 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 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. | | | | | | | 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 Sterilization? | Y | Y | Y | Y | Y | Y | | Similar Packaging? | Y | Y | Y | Y | Y | Y | | Similar Materials? | Y | Y | Y | Y | Y | Y | | Software Design | Addition of ability to target for TRIGEN META- | Addition of drill depth measurement, | Addition of humeral nail application. | | | | | Design Aspect Reviewed | SURESHOT™ Distal Targeting System v.4.0 | SURESHOT™ Distal Targeting System v.3.0 – primary predicate | SURESHOT™ Distal Targeting System v.2.1 | SURESHOT Distal Targeting System v.2.0.2 | SURESHOT Distal Targeting System v.2.0 | PiGalileo Screw Targeting System V1.1 | | | (K092748), updates to Trauma Launcher program, ability of on screen image rotation using targeter, additional languages for the graphical user interface, updates to graphical user interface. | Launcher updates, GUI updates, new instrument and Japan Nail 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.