(77 days)
Not Found
No
The description focuses on electromagnetic tracking and computer-assisted guidance based on spatial measurements, not AI/ML algorithms. There is no mention of AI, ML, or related terms in the document.
No
Explanation: The device is an image-guided surgical tool that assists the surgeon with drill positioning during intramedullary nail implantation. It does not directly treat a disease or condition; rather, it aids in a surgical procedure performed by a healthcare professional.
No
The device is described as an "intraoperative image guided localization system" that aids the surgeon with drill positioning 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." This indicates it is a surgical guidance and targeting system, not a device that diagnoses a disease or condition.
No
The device description explicitly lists hardware components (Humeral Set Stop, Humeral Drill Guide Probe, Humeral Hexdriver, Humeral Drill Sleeve, Humeral AO Drill) that are part of the device subject to this premarket notification, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 instruments, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description details an "electromagnetic tracking system" that assists the surgeon in locating and positioning screws. It explains how it uses electromagnetic fields to track instruments in 3D space. This is consistent with a surgical guidance system, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device's function is to provide real-time spatial information to the surgeon during surgery, which is a completely different purpose than 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 (comma separated list FDA assigned to the subject device)
OLO
Device Description
Subject of this premarket notifications to the SURESHOT Targeting System. The modifications to the SURESHOT® Targeting System V2.1 implement the ability to target for humeral nails, along with the former applications with the META, TAN and FAN Nails previously cleared via K100107. Targeting for humeral nail is implemented in the same way as for META/TAN nails.
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 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 humeral nail application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT® Distal Targeting System Software V2.1 .
- Humeral Set Stop .
- Humeral Drill Guide Probe .
- Humeral Hexdriver
- Humeral Drill Sleeve .
- . Humeral AO Drill
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
Not Found
Anatomical Site
long bone fractures (specifically humeral nails, META, TAN and FAN 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
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. 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.
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.
K092497, K100107, K102967, K101499
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.
Not Found
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
Kilo240
p. 1/3
Ne are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | January 26, 2011 |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist
T (901) 399-6325 F (901) 566-7075 |
| Name of Device: | Smith & Nephew, Inc. SURESHOT® Distal Targeting System V2.1 |
| 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 notifications to the SURESHOT Targeting System. The modifications to the SURESHOT® Targeting System V2.1 implement the ability to target for humeral nails, along with the former applications with the META, TAN and FAN Nails previously cleared via K100107. Targeting for humeral nail is implemented in the same way as for META/TAN nails.
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 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 humeral nail application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT® Distal Targeting System Software V2.1 .
- Humeral Set Stop .
- Humeral Drill Guide Probe .
- Humeral Hexdriver �
- Humeral Drill Sleeve .
- . Humeral AO Drill
No new implants are being cleared via this premarket notification
1
Image /page/1/Picture/0 description: The image shows handwritten text. The text on the left reads "K110240". To the right of that, the text reads "p. 2/3". The handwriting is in black ink on a white background.
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
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 SURESHOTY 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 SURESHO™ 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 | Journey CR Knee System | K101499 | 08/26/10 |
Table 1: Substantially Equivalent Predicate Systems to SURESHOT® Targeting System
2
K110240 p. 3/3
A comparison of the subject device to the predicate devices is described in the following table.
| Table 2: Comparison of Substantial Equivalence |
|---|
| Design Aspect
Reviewed | 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 | Journey CR Knee
System |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------|---------------------------|
| 510(k) Number | K110240 | K092497 | K100107 | K102967 | K101499 |
| Manufacturer | Smith & Nephew | Smith & Nephew | Smith &
Nephew | Smith &
Nephew | Smith & Nephew |
| Similar
Indications for
Use? | Y | Y | Y | Y | N |
| 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 | Total cruciate retaining knee implant system
Used to assist surgeon in implanting total knee components | | | |
| Similar
Sterilization? | Y | Y | Y | Y | Y |
| Similar
Packaging? | Y | Y | Y | Y | Y |
| Similar
Materials? | Y | Y | Y | Y | N |
| Software
Design | 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. | N/A | | |
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem features a staff with a serpent entwined around it, and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Shereen Myers 1450 Brooks Road Memphis, Tennessee 38116
APR 1 4 2011
Re: K110240
Trade/Device Name: Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 15, 2011 Received: March 16, 2011
. . . . . . . . . . . . . . . .
1000
Dear Ms. Myers:
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
4
Page 2 – Ms. Shereen Myers
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 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/ucm115809.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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ating B. Reta
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KiiOayo p. 1/
Premarket Notification Indications for Use Statement
510(k) Number (if known):
Device Name: SURESHOT Targeting System V2.1
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 X AND/OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K. Dale for mkin
Division Sign bm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110240