(98 days)
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.
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.
The provided text does not contain detailed information about acceptance criteria and a specific study proving the device meets them. The document is a 510(k) summary for the Smith & Nephew PiGalileo Screw Targeting System V1.0, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone performance study with defined acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding performance and the study context:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or a direct performance table for the PiGalileo Screw Targeting System V1.0. It primarily relies on demonstrating equivalence to the predicate device, the PiGalileo Navigation System (4th Generation) (K080875), and other electromagnetic tracking technology systems.
The closest we can come to "performance" in this document is the description of the device's function: "It assists the surgeon in mo roallist below harged in an intramedullary nail implant during orthopedic trauma surgery." and "It provides information to the surgeon that is used to place surgical instruments during n urgery utilizing intraoperatively obtained electromagnetic tracking data."
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or sample size for performance evaluation is mentioned in this 510(k) summary. The document does not describe a study involving a particular set of cases or data. The focus is on demonstrating substantial equivalence by comparing the design and indications for use to existing cleared devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Since no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
Not applicable, as no test set or study requiring adjudication is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on regulatory clearance through substantial equivalence, not a comparative efficacy trial.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study is explicitly described. The document indicates the system "assists the surgeon," implying a human-in-the-loop system. The data provided focuses on the device's functionality rather than a purely algorithmic performance evaluation.
7. Type of Ground Truth Used:
Not applicable, as no specific performance study requiring ground truth establishment is described. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development or training of an AI algorithm, but rather a computer-assisted surgical system using electromagnetic tracking. Therefore, there's no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for an AI algorithm.
Summary of what can be extracted from the document regarding performance (with caveats):
While a formal "acceptance criteria" table is not present, the underlying implied acceptance is that the new device performs at least as safely and effectively as its predicate devices. The "study" proving this, in the context of a 510(k) submission, is primarily a comparison to predicate devices to establish substantial equivalence based on:
- Overall design: The PiGalileo Screw Targeting System is described as a "computer controlled electromagnetic tracking system" that "assists the surgeon" with drill positioning. This is compared to the predicate, "PiGalileo Navigation System (4th Generation)," and other "Predicate Electromagnetic Tracking Technology Systems."
- Indications for use/intended use: The new device's indications for use are carefully laid out and are considered "substantially equivalent" to those of the predicate devices. This implies that the device is expected to achieve similar surgical guidance outcomes for long bone fractures treated with intramedullary nails.
In essence, the "study" is a regulatory assessment of similarity to legally marketed devices, rather than a clinical performance trial designed to meet specific quantitative performance metrics.
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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 |
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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
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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
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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
Page 1 of 1
§ 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).