(138 days)
Not Found
No
The document describes a computer-assisted orthopedic surgery tool utilizing electromagnetic tracking for localization and positioning, with no mention of AI or ML technologies.
No.
Explanation: This device is an image-guided localization system that aids surgeons in positioning tools during surgery. It does not directly treat a disease or condition but rather assists in the surgical process.
No
The device is described as 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." Its function is to provide information to the surgeon for placing surgical instruments, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components (SURESHOT™ Drill Depth Inner Drill Sleeves, SURESHOTTM Drill Depth Outer Screw Sleeve) as part of the subject of this premarket notification, in addition to the software.
Based on the provided text, 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'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 surgical guidance system used during a procedure on a patient.
- Device Description: The description details an "electromagnetic tracking system" that assists in locating and positioning screws in an intramedullary nail implant during orthopedic trauma surgery. This is a surgical tool.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The SURESHOT™ system does not perform this function. It interacts directly with the patient during surgery to guide instrument placement.
Therefore, the 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 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™ Targeting System. The modifications to the SURESHOT™ Targeting System V3.0 include the implementation of the drill depth measurement function, the ability to target for 8.5mm Japanese nails, an updated graphical user interface, updates to the Launcher program, and the addition of new drill sleeves.
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 sensorembedded 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 a 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. New instrumentation has been developed for the drill depth measurement application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT™ Distal Targeting System Software V3.0 .
- SURESHOT™ Trauma Launcher Software V1.1.1 .
- SURESHOT™ Drill Depth Inner Drill Sleeves .
- SURESHOTTM Drill Depth Outer Screw Sleeve .
No new implants are being cleared via this premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electromagnetic tracking data
Anatomical Site
long bone fractures (treated with intramedullary nails)
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
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. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
K092497, K100107, K102967, K110240
Reference Device(s)
Not Found
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
We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
1450 East Brooks Road
Memphis, Tennessee 38116 | K130748
Page 1 of 3 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------|
| Date of Summary: | March 5, 2013 | |
| Contact Person and Address: | Bradley Heil, Regulatory Affairs Specialist
T (901) 399-6339
F (901) 566-7831 | |
| Name of Device: | Smith & Nephew, Inc. SURESHOT™ Distal Targeting System
V3.0 | |
| Common Name: | Computer Assisted Surgery System | |
| Device Classification Name and
Reference: | 21 CFR 882.4560 Stereotaxic Instrument - Class II | |
| 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. The modifications to the SURESHOT™ Targeting System V3.0 include the implementation of the drill depth measurement function, the ability to target for 8.5mm Japanese nails, an updated graphical user interface, updates to the Launcher program, and the addition of new drill sleeves.
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 sensorembedded 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 a 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. New instrumentation has been developed for the drill depth measurement application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT™ Distal Targeting System Software V3.0 .
- SURESHOT™ Trauma Launcher Software V1.1.1 .
- SURESHOT™ Drill Depth Inner Drill Sleeves .
- SURESHOTTM Drill Depth Outer Screw Sleeve .
No new implants are being cleared via this premarket notification.
1
K130748 Page 2 of 3
Technological Characteristics
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. 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. Clinical data was not needed to support the safety and effectiveness of the subject device.
Intended Use
i f
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.
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 PiGalileo Screw
Targeting System V1.1 | K092497 | 09/11/09 |
| Smith & Nephew | Smith & Nephew SURESHOT™
Distal Targeting System v.2.0 | K100107 | 02/23/10 |
| Smith & Nephew | Smith & Nephew SURESHOT™
Distal Targeting System v.2.0.2 | K102967 | 11/04/10 |
| Smith & Nephew | Smith & Nephew SURESHOT™
Distal Targeting System v.2.1 | K110240 | 4/14/11 |
Table 1: Substantially Equivalent Predicate Systems to SURESHOT™ Targeting System
2
| Design Aspect
Reviewed | SURESHOT™
Distal Targeting
System v.3.0 | SURESHOT™
Distal Targeting
System v.2.1 | PiGalileo Screw
Targeting System
V1.1 | SURESHOT
Distal
Targeting
System v.2.0 | SURESHOT
Distal
Targeting
System
v.2.0.2 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------|
| 510(k)
Number | | K110240 | K092497 | K100107 | K102967 |
| Manufacturer | Smith & Nephew | Smith & Nephew | Smith & Nephew | Smith &
Nephew | Smith &
Nephew |
| Similar
Indications
for Use? | Y | Y | Y | Y | Y |
| Intended Use | Intraoperative image guided localization system | | | | |
| Instrumentati
on | Used to assist surgeon in placing nail implants and for specific use with the distal targeting
software | | | | |
| Similar
Sterilization? | Y | Y | Y | Y | Y |
| Similar
Packaging? | Y | Y | Y | Y | Y |
| Similar
Materials? | Y | Y | Y | Y | Y |
| Software
Design | Provides
information to the
surgeon that is
used to place
surgical
instruments
during surgery
utilizing
intraoperatively
obtained
electromagnetic
tracking data.
Addition of drill
depth
measurement,
Trauma Launcher
updates, GUI
updates, new
instrument and
Japan Nail
application | Provides
information to the
surgeon that is
used to place
surgical
instruments
during surgery
utilizing
intraoperatively
obtained
electromagnetic
tracking data.
Addition of
humeral nail
application | Provides information to the surgeon that is used
to place surgical instruments during surgery
utilizing intraoperatively obtained
electromagnetic tracking data. | | |
A comparison of the subject device to the predicate devices is described in the following table.
Conclusion
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the SURESHOT™ Targeting System software modifications. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 4, 2013
Smith & Nephew, Inc. % Mr. Bradley Heil 1450 Brooks Road Memphis, Tennessee 38116
Re: K130748
Trade/Device Name: Sureshot Distal Targeting System V3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: July 01, 2013 Received: July 03, 2013
Dear Mr. Heil:
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
4
Page 2 - Mr. Bradley Heil
device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm | 1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification Indications for Use Statement
K130748 510(k) Number (if known):
Device Name: SURESHOT Targeting System V3.0
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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| DSD-DIVISION SIGN-OFF | Joshua C. Nipper |
|---|---|
| Division of Surgical Devices | -S |
| 510(k) Number: | K130748 |
一 Page _________________________________________________________________________________________________________________________________________________________________________