(98 days)
No
The description focuses on electromagnetic tracking and spatial measurement, which are traditional navigation technologies, and does not mention any AI or ML components.
No
The device is a computer-assisted surgical tool to aid the surgeon with drill positioning during intramedullary nail implantation, not to directly treat or diagnose a disease.
No
This 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." It provides "information to the surgeon that is used to place surgical instruments during surgery." This functionality indicates it is a surgical aid or guidance tool, not a device that diagnoses a condition or disease.
No
The device description explicitly states it is a "computer controlled electromagnetic tracking system" and describes hardware components like sensor coils and the generation of magnetic fields, indicating it is not solely software.
Based on the provided information, the Smith & Nephew PiGalileo Screw Targeting System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living organism (in vitro).
- Device Function: The PiGalileo Screw Targeting System is an intraoperative image guided localization system. It uses electromagnetic tracking data obtained during surgery to assist the surgeon with drill positioning within the patient's body.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is to provide real-time spatial guidance during a surgical procedure.
Therefore, the device's intended use and mechanism of action clearly place it outside the scope of an In Vitro Diagnostic device. It is a surgical navigation and guidance tool used in vivo (within the living organism).
N/A
Intended Use / Indications for Use
The Smith & Nephew PiGalileo Screw 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 PiGalileo Screw Targeting System V 1.0 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
The PiGalieo Screw Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in mo roallist below harged 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 wn roduced 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.
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
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)
Not Found
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.
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
K096420 (.1 of 1
MAY 27 2009
Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Screw Targeting System V1.0
Date of Summary: 02/05/2009
Contact Person and Address Susan Bell Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 (901) 399-5412
Name of Device: Smith & Nephew PiGalileo Screw Targeting System V1.0 Common Name: Computer Assisted Surgery System
Device Description
Device Description
The PiGalieo Screw Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in mo roallist below harged 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 wn roduced 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.
Device Classification
21 CFR 882.4560 Stereotaxic Instrument - Class II
Indications for Use
The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization me online a respent reasisted 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 n urgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Substantial Equivalence Information
Substantial Equivalence information
The overall design and indications for use/intended use of the PiGalileo Screw Targeting System is substantially equivalent to previously cleared devices listed below.
| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|---|
| Smith & Nephew, Inc | PiGalileo Navigation System (4th Generation) | K080875 | 7/18/2008 |
Predicate Electromagnetic Tracking Technology Systems
| RE AMANUFACTURER | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . 510 Kirki - | CLEARANCE DATE : " "
- Com I W |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------|
| Medtronic Navigation, Inc | SNT StealthStation AxiEM Imageless | K043088 | 01/05/2005 |
| | Knee Module | | |
Indications for Use
| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|---|
| BrainLAB AG | Vector Vision Trauma | K012448 | 03/14/2002 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
MAY 27 2009
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Susan Bell Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K090420
Trade/Device Name: PiGalileo Screw Targeting Software Application V1.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: May 13, 2009 Received: May 14, 2009
Dear Ms. Bell:
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 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
2
Page 2 - Ms. Susan Bell
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
kerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
L090420 0.1 of 1
Indications for Use
510(k) Number (if known):
Device Name: PiGalileo Screw Targeting Software Application V1.0
Indications for Use:
The Smith & Nephew PiGalileo Screw 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 PiGalileo Screw Targeting System V 1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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 B.P. Oder Sas mkn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090420
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