(30 days)
Not Found, None
Not Found
No
The summary describes a computer-assisted surgical navigation system that uses anatomical landmarks and intra-operative data for instrument positioning, but there is no mention of AI or ML technologies being used for data analysis, decision support, or other functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a computer-assisted surgical navigation system designed to aid surgeons in bone cuts and implant positioning during joint replacement procedures. It does not directly treat, prevent, or diagnose a condition.
No
The device is described as a computer-assisted surgical navigation system for guiding implant placement during joint replacement, not for diagnosing medical conditions.
No
The device description explicitly states it is a "software-controlled electromechanical stereotaxic device," indicating the presence of hardware components beyond just software.
Based on the provided information, the Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. This is an intra-operative surgical aid, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces that it's a stereotaxic device for computer-aided navigation of surgical instruments to assist the surgeon during arthroplasties.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic information about a patient's condition, or being used in a laboratory setting.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PiGalileo system's function is to guide surgical procedures, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).
Examples of surgical procedures include but are not limited to:
- Total knee replacement supporting bone referencing technique
- . Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement .
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The PiGalileo Navigation System is a software-controlled electromechanical stereotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.
The PiGalileo TKR CAS V4.1 and Base V2.3 software applications are surgical techniques for computer assisted navigation that leverages PiGalleo Total Khee Replacement (TKR) instruments as well as a number of non-navigated knee instruments with the intent to optimally position knee prostheses during total joint arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, orthopedic surgery
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.
Not Found
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
1090313
Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Total Knee Replacement (TKR) CAS V4.1 and Base V2.3
MAR 1 2009
Total Knee Replacement (TKR) CAS V4.1 and base V2.3
Date of Summary: 02/05/2009
Contact Person and Address Mandy Coe Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 (901) 399-6277
Name of Device: Smith & Nephew PiGalileo Total Knee Replacement [TKR] Software Applications CAS V4.1 and Base V2.3
Common Name: PiGalileo Total Knee Software
Device Description
The PiGalileo Navigation System is a software-controlled electromechanical stereotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.
The PiGalileo TKR CAS V4.1 and Base V2.3 software applications are surgical techniques for computer assisted navigation that leverages PiGalleo Total Khee Replacement (TKR) instruments as well as a number of non-navigated knee instruments with the intent to optimally position knee prostheses during total joint arthroplasty.
Device Classification
21 CFR 882.4560 Stereotaxic Instrument - Class II
Indications for Use
The Smith & Nephew PiGalleo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).
Examples of surgical procedures include but are not limited to:
- Total knee replacement supporting bone referencing technique �
- . Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement .
Substantial Equivalence Information
The overall software design and the instruments used with Smith & Nephew PiGalileo Total Knee Replacement (TKR) CAS V4.1 and Base V2.3 software applications are substantially equivalent to the previously cleared applications listed below:
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
MAR I I 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mandy Coe Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K090313
Trade/Device Name: PiGalileo Total Knee Replacement (TKR) Software Applications CAS V4.1 and Base V2.3
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: February 6, 2009 Received: February 9, 2009
Dear Mandy Coe:
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 such 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); good manufacturing practice requirements as set
2
Page 2 - Mandy Coe
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Ln Ahmed. for.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K09 0313
Device Name: PiGalileo Total Knee Replacement (TKR) Software Applications CAS V4.1 and Base V2.3
Indications for Use:
The Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).
Examples of surgical procedures include but are not limited to.
- Total knee replacement supporting bone referencing technique
- Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement
Prescription Use (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 R.S. Ogden Forman
Division of General, Restorative, and Neurological De
510(k) Number
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