(30 days)
No
The description focuses on electromagnetic tracking and computer-assisted guidance based on spatial measurements, with no mention of AI or ML algorithms for image processing, data analysis, or decision support. The software validation is based on general principles, not specific to AI/ML.
No.
This device is an intraoperative image-guided localization system that aids surgeons with drill positioning during intramedullary nail implantation. It provides information and assists in placing surgical instruments, but it does not directly treat a disease or condition; it is a surgical tool.
No
The device is an intraoperative image-guided localization system that aids in drill positioning, providing information for placing surgical instruments based on electromagnetic tracking data. It assists the surgeon in locating and positioning screws, but it does not diagnose a condition or disease.
No
The device description explicitly mentions hardware components like the trauma interface with reduced size/weight, HDMI video output, and improved screen resolution. It also describes an electromagnetic tracking system which is a hardware component. Furthermore, performance studies include electromagnetic compatibility and electrical safety validation testing, which are relevant to hardware.
Based on the provided information, the Smith & Nephew SURESHOT™ Targeting System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is 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 on a patient, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description focuses on an electromagnetic tracking system used to determine the spatial position of surgical instruments within the patient's body. This is a surgical guidance tool, not a diagnostic test.
- Input Imaging Modality: The input is "intraoperatively obtained electromagnetic tracking data," which is positional data from sensors within the surgical field, not data from analyzing biological samples.
- Anatomical Site: The device is used on "long bone fractures treated with intramedullary nails," which is a surgical application.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SURESHOT™ Targeting System does not perform this function. It is a surgical guidance system.
N/A
Intended Use / 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.
Product codes
OLO
Device Description
Subject of this premarket notification are modifications to the SURESHOT™ Distal Targeting System trauma interface which include reduced overall size and weight, addition of HDMI video output, removed VESA Mounting Post, improved screen resolution and reduced screen size compared to the previous design of the trauma interface (K100107). The second generation trauma interface uses the SURESHOT Targeting System V4.0 software (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 trauma interface is intended to be used with existing Smith & Nephew software, targeter, 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
Not Found
Anatomical Site
long bone fractures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / intraoperative
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)
Electromagnetic compatibility and electrical safety validation testing has been conducted on the SURESHOT™ Distal Targeting System. The subject device utilizes the same platform and tracking technology as previously cleared in K100107. The electromagnetic capability and electrical safety testing that was conducted includes.
- IEC 60601-1: 2005 + A1:2012 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- IEC 60601-1-2:2007 Class A for Emissions, Immunity for Non Life Supporting . Equipment
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. The software for this device was considered to be a "moderate" level of concern.
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
May 3, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Allison Chan Regulatory Affairs Specialist II 1450 Brooks Rd Memphis, Tennessee 38116
Re: K170977
Trade/Device Name: SURESHOT Distal Targeting System V4.0 Trauma Interface Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 31, 2017 Received: April 3, 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. Isting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170977
Device Name
SURESHOTTM 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | May 1, 2017 |
| Contact Person and Address: | Allison Chan
Regulatory Affairs Specialist II
T 901-399-1098
F 901-566-7022 |
| Name of Device: | Smith & Nephew, Inc. SURESHOT™ Distal
Targeting System V4.0 |
| Common Name: | Computer Assisted Surgery System |
| Device Classification Name
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 trauma interface which include reduced overall size and weight, addition of HDMI video output, removed VESA Mounting Post, improved screen resolution and reduced screen size compared to the previous design of the trauma interface (K100107). The second generation trauma interface uses the SURESHOT Targeting System V4.0 software (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 trauma interface is intended to be used with existing Smith & Nephew software, targeter, 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.
Summary of Pre-Clinical Testing
Electromagnetic compatibility and electrical safety validation testing has been conducted on the SURESHOT™ Distal Targeting System. The subject device utilizes the same platform and tracking technology as previously cleared in K100107. The electromagnetic capability and electrical safety testing that was conducted includes.
- IEC 60601-1: 2005 + A1:2012 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- IEC 60601-1-2:2007 Class A for Emissions, Immunity for Non Life Supporting . Equipment
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. The software for this device was considered to be a "moderate" level of concern.
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.
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.
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The subject devices feature characteristics as previously cleared in K100107 with the primary differences being the reduced size and weight. All software features remain the same as those in K170280.
Substantial Equivalence Information
The substantial equivalence of the SURESHOT™ Targeting System trauma interface 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.
Table 5.1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew | Smith & Nephew SURESHOT™ Distal Targeting System V.2.0 | K100107 | February 23, 2010 |
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A comparison of the subject device to the predicate device is described in the following table.
| Design Aspect Reviewed | SURESHOT™ Distal Targeting System
V4.0 | SURESHOT™ Distal Targeting System
V.2.0 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject device | K100107 |
| Manufacturer | 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 |
| Similar Packaging | Y | Y |
| Similar Materials | Y | Y |
| Overall Dimensions Trauma Interface | 31cm x 26cm x 13cm | 40cm x 38cm x 20cm |
| Overall Weight Trauma Interface | 3.5kg | 9kg |
| System Design | Electromagnetic tracking System, sensor
coils, console (includes PC, control unit,
and display monitor), instruments | Electromagnetic tracking System, sensor
coils, console (includes PC, control unit,
and display monitor), instruments |
| Tracking System | Aurora, Northern Digital Inc. | Aurora, Northern Digital Inc. |
| Software Requirements Hardware | Microprocessor : Celeron n2930 (1.8 Ghz) Memory Devices: 4GB | Microprocessors: P4 Mobile; P4,
P3 (800mhz min) Memory Devices : 512 MB RAM |
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| Sensors : Touch Screen, On Screen keyboard Energy Sources: 110V-240V Safety Features: 3.15 Amp Fuse | (minimum) Sensors: Keyboard, Mouse, Touch Screen, Screen Keyboard Energy Sources: 110V-240V Safety Features: 3.15 Amp Fuse | |
|---|---|---|
| Workstation/ PC | Celeron n2930; Windows Embedded 8 or higher | Intel Pentium Panel PC with touchscreen; |
| Windows XP embedded or higher | ||
| VESA Mounting Posts | N/A | VESA Mounting Posts present on rear panel on trauma interface |
| HDMI Output | Addition of HDMI Connection | N/A |
| VGA Output Resolution | 1280 x800 | 1024 x 768 |
| Screen Size | 10 inch monitor | 15 inch monitor |
| Software Compatibility | SURSHOT Distal Targeting System V4.0 software (K170280) | SURESHOT Distal Targeting System V4.0(K170280) |
| SURESHOT Distal Targeting System V3.0 (K130748) | ||
| SURESHOT Distal Targeting System V2.1 (K102967) | ||
| SURESHOT Distal Targeting System V2.0 (K100107) |
Conclusion
The SURESHOT™ Distal Targeting System V4.0 trauma interface is substantially equivalent to the existing SURESHOT™ Distal Targeting System trauma interface cleared in K100107 in that the indications for use for these devices are identical and the core technological principles for these devices are also equivalent.