(28 days)
Not Found
No
The description focuses on electromagnetic tracking and spatial measurement, with no mention of AI, ML, or image processing which are common indicators of AI/ML use in medical devices.
No
The device is described as an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool" that "aids the surgeon with drill positioning for screws". It provides information to the surgeon to assist with a surgical procedure, but it does not directly treat or diagnose a disease or condition itself.
No
The device is an intraoperative image-guided localization system that aids in drill positioning for screws, providing information for placing surgical instruments. It does not diagnose medical conditions.
No
The device description explicitly states it is a "computer controlled electromagnetic tracking system" and describes the use of "electromagnetic spatial measurement systems" and "sensor-embedded instruments," indicating the presence of hardware components beyond just 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.
- Device Function: The PiGalileo Screw Targeting System is an intraoperative image guided localization system used during surgery to aid in the positioning of surgical instruments (drills for screws) within the patient's body. It uses electromagnetic tracking data to provide spatial information to the surgeon.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. Its function is to guide surgical actions within the body.
Therefore, the device 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 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 1.1 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
The PiGalileo Screw 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.
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 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
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)
Reference Device(s)
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
K042497 f. lot 1
SEP 1 1 2009
Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Screw Targeting System V1.1
Contact Person and Address
Date of Summary: 08/12/2009
Regina Holmes Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 (901) 399-6538
Name of Device: Smith & Nephew PiGalileo Screw Targeting System V1.1 Common Name: Computer Assisted Surgery System
Device Description
The PiGalileo Screw 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.
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 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 1.1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Substantial Equivalence Information
The overall design of the PiGalifeo Screw Targeting System V1.1 is substantially equivalent to the previously cleared device listed below:
| Manufacturer | Description | 510(k) | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | PiGalileo Screw Targeting System V1.0 | K090420 | 10/29/08 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
SEP 1 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew % Ms. Regina Holmes Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
Re: K092497
Trade/Device Name: PiGalileo Screw Targeting System V1.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instruments Regulatory Class: II Product Code: OLO Dated: August 12, 2009 Received: August 14, 2009
Dear Ms. Holmes:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
2
Page 2 – Ms. Regina Holmes
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.html 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: PiGalileo Screw Targeting System V1.1
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 1.1 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)
Nifre Odu for mxm
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number.
Page 1 of 1