(10 days)
Not Found
No
The summary describes software for planning and simulation based on medical imaging, but there is no mention of AI or ML capabilities for tasks like automated detection, segmentation, or prediction. The functionality described is manual manipulation and visualization of objects within 3D data.
No.
The device is a software for planning and simulation of dental implant placement, not for directly treating a condition.
No
This device is described as "planning and simulation software" and states its purpose is to "aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments." It helps plan procedures but does not diagnose conditions.
Yes
The device description explicitly states that GALILEOS Implant is a "pure software device" and an "Add-On to the 3D-viewing software Sirona GALAXIS." While it relies on data from a hardware scanner, the device itself is presented as solely software.
Based on the provided information, this device 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 GALILEOS Implant software is used for planning and simulating dental implant placement based on medical imaging data (cone beam CT scans). It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments." This is a surgical planning tool, not a diagnostic test performed on a biological sample.
The device processes medical imaging data to assist in surgical planning, which falls under the category of medical imaging software or surgical planning software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
GALILEOS Implant is a pure software device.
GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Sirona GALILEOS medical cone beam scanner
Anatomical Site
patient's mandible/maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental professionals
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)
Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Kob 1472
510(k) Summary
for
GALILEOS Implant
1 Company Name and Address
(JUN - 9 2006
1.1 Sponsor
siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany
Manufacturer
siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany
1.2 Contact
siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany
Telephone: +49-228/854 697 84 Facsimile: +49-228/854 697 99
Primary Contact: Mr. Markus Pfister Secondary Contact: Mr. Dr. Manfred Breuer
2 Device Name
Proprietary Name: GALILEOS Implant Common/Usual Name: Preoperative Dental Implant Planning Software Classification Name: System, Image Processing, Radiological Regulation Description: Picture archiving and communications system
3 Predicate Device
The GALILEOS Implant is claimed to be substantially equivalent in material, design and function to the SimPlant System product which was cleared by FDA under 510(k) K033849 on May 25, 2004.
1
য Device Classification
Picture archiving and communications systems (21 CFR 892.2050, Product Code LLZ) have been classified as Class II devices and are reviewed by the Radiology Panel.
5 Device Description
GALILEOS Implant is a pure software device.
GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
ર Intended Use
GALILEOS Implant is intended for use as planning and simulation software to aid gualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.
7 Substantial Equivalence
The GALILEOS Implant system is substantially equivalent to the SimPlant System (K033849) based on the equivalence of the intended use, similar features and technical characteristics. Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions.
8 Conclusion
GALILEOS Implant is considered to be substantially equivalent in design, material and function to the SimPlant System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 9 2006
siCAT GmbH & Co. KG % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K061472
Trade/Device Name: GALILEOS Implant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 26, 2006 Received: May 30, 2006
Dear Mr. Preiss:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in bold in the center of the logo. The word Centennial is written below the letters FDA.
Protecting and Promoting Public Health
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act thany Federal statutes and regulations administered by other Federal agencies. You must or uny 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witification. The FDA finding of substantial equivalence of your device to a legally premated 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | |
| (Radiology) | 240-276-0115 | |
| 21 CFR 894.xxx | 240-276-0120 | |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Nancy Chrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 2
for GALILEOS Implant
510(k) Number (if known): Ko 6 1 4 7 2
ﮯ
Device Name: GALILEOS Implant
Indications for Use:
GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALLEOS Implant and used as input data for CAD or Rapid Prototyping Systems.
Prescription Use X (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive Andomina and Radiological Devices 510(k) Number