(109 days)
The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.
The PiGalileo 4th Generation System is a software-controlled electromechanical sterotaxic 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 subject device incorporates new hardware components as well as new platform system software. The PiGalileo 4th Generation System allows for existing knee applications to run on the new platform system.
The provided document is a 510(k) summary for the PiGalileo 4th Generation System, a stereotaxic instrument for computer-aided navigation during total knee and hip arthroplasties. However, it does not contain specific acceptance criteria, details of a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment methods for an AI/algorithm-based device.
The document primarily focuses on:
- Device Description: What the device is and its purpose.
- Device Classification: Its regulatory classification.
- Indications for Use: What the device is intended to be used for.
- Substantial Equivalence Information: Comparing it to previously cleared predicate devices (PLUS Orthopedics AG's PiGalileo Total Knee Replacement (TKR) System K061362 and PiGalileo Total Hip Replacement (THR) System K070731). This is the key element for 510(k) clearance, demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Since this device is a stereotaxic instrument and not an AI/algorithm system that processes data for diagnostic or prognostic purposes, the questions regarding acceptance criteria and study designs typically associated with AI/ML-based medical devices (like MRMC, standalone performance, training/test set details, and ground truth methodologies) are not applicable or addressed in this type of 510(k) submission.
Therefore, I cannot extract the requested information from the provided text. The document is about a hardware and software system for surgical navigation, not an AI model requiring a performance study against specific accuracy or precision metrics for a diagnostic task.
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14080875
Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo 4th Generation System
JUL 1 8 2008
Contact Person and Address
Date of Summary: 06/30/2008
Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054
Name of Device: PiGalileo 4th Generation System Common Name: PiGalileo
Device Description
The PiGalileo 4th Generation System is a software-controlled electromechanical sterotaxic 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 subject device incorporates new hardware components as well as new platform system software. The PiGalileo 4th Generation System allows for existing knee applications to run on the new platform system.
Device Classification
21 CFR 882.4560 Stereotaxic Instrument - Class II
Indications for Use
The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.
Substantial Equivalence Information
The overall design of the Smith & Nephew PiGalileo 4th Generation System is substantially equivalent to previously cleared devices listed below.
| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|---|
| PLUS Orthopedics AG | PiGalileo Total Knee Replacement (TKR) System | K061362 | 10/06/06 |
| PLUS Orthopedics AG | PiGalileo Total Hip Replacement (THR) System | K070731 | 7/31/07 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in uppercase and black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2008
Smith & Nephew, Inc. % Rishi Sinha Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K080875
Trade/Device Name: PiGalileo 4th Generation Regulation Number: 21 CFR 882.4560 Regulation Name. Stercotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 30, 2008 Received: July 1, 2008
Dear Rishi Sinha:
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. Iisting 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 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.
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Page 2 – Rishi Sinha
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 चा (240) 276-3464. YouTuay buain 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.
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
14080875 510(k) Number (if known):
Device Name: PiGalileo 4th Generation
Indications for Use:
The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking subsystem. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks; as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intracperative measurements of bone alignment.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| 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)(Division Sign-Off)Division of General, Restorative,and Neurological Devices | Page 1 of 1 |
|---|---|
| 510(k) Number | I2080875 |
§ 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).