(88 days)
No
The description focuses on electromagnetic tracking and computer-assisted guidance based on calculated 3D positions, with no mention of AI or ML algorithms for image analysis, prediction, or decision support. The software updates are related to compatibility, UI, and calculations, not AI/ML capabilities.
No
Explanation: The device is an intraoperative image-guided localization system that aids the surgeon with drill positioning during intramedullary nail implantation. It does not directly treat or prevent a disease or condition.
No
The device is an intraoperative image-guided localization system that aids surgeons with drill positioning for screws during intramedullary nail implantation. It assists in placing surgical instruments based on electromagnetic tracking data, but it does not diagnose medical conditions.
No
The device description explicitly states it is a "computer controlled electromagnetic tracking system" and relies on "electromagnetic spatial measurement systems" which are hardware components. While the submission focuses on software updates, the underlying device is not software-only.
Based on the provided information, the Smith & Nephew SURESHOT ™ Targeting System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation." This describes a device used during a surgical procedure to guide the surgeon's actions, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details an electromagnetic tracking system that helps the surgeon locate and position screws. This is a surgical guidance tool, not a diagnostic tool.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens like blood, urine, tissue, etc., to diagnose diseases, monitor conditions, or screen for health issues. The SURESHOT™ system does none of these. It interacts directly with the patient's body during surgery to assist with a surgical procedure.
Therefore, the Smith & Nephew SURESHOT ™ Targeting System falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperatively obtained electromagnetic tracking data
Anatomical Site
long bone fractures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130748, K110240, K102967, K100107, K092497
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.