GALILEOS IMPLANT, VERSION 1.7

K093090 · Sicat GmbH & Co. KG · LLZ · Dec 17, 2009 · Radiology

Device Facts

• Record ID: K093090
• Device Name: GALILEOS IMPLANT, VERSION 1.7
• Applicant: Sicat GmbH & Co. KG
• Product Code: LLZ · Radiology
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

GALILEOS Implant V1.7 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 (Computer-Aided Design) or Rapid Prototyping Systems.

Device Story

GALILEOS Implant V1.7 is a software-only device used by dental professionals for preoperative implant planning. It ingests 3D medical imaging volumes generated by the Sirona GALAXIS 3D viewer (sourced from Sirona GALILEOS cone beam CT scanners). The software provides tools for clinicians to visualize, name, position, rotate, resize, and move virtual dental implants and anatomical structures like nerve canals within the 3D volume. The output consists of a surgical plan that can be exported for use in CAD or rapid prototyping systems to facilitate surgical guidance. By enabling precise virtual placement and orientation of implants, the device assists clinicians in optimizing surgical procedures and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Pure software device. Operates as a 3D image processing and planning tool. Integrates with Sirona GALAXIS 3D viewer and Sirona GALILEOS cone beam CT data. Supports export to CAD/Rapid Prototyping systems.

Indications for Use

Indicated for use by qualified dental professionals to plan dental implant placement and surgical treatments using 3D medical imaging data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• SimPlant 12 (K033849, K053592, K081402)
• GALILEOS Implant V1.0 (K061472)

Submission Summary (Full Text)

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K093090

### 510(k) Summary

for

### GALILEOS Implant V 1.7

# DEC 1 7 2009

#### I Company Name and Address

- 1.1 Sponsor
SICAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany

### Manufacturer

SICAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany Registration Number: 3006098230 Operations: Manufacturer Status: Active

#### 1.2 Contact

SICAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany

Telephone: [phone] Facsimile: +49-228/854 697 99

Primary Contact: Mr. Markus Pfister . Secondary Contact: Mr. Dr. Manfred Breuer

#### 2 Device Name and Classification

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

Product Code: Regulation Number; Classification Class:

LLZ 892.2050 Class II Product

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#### 3 Predicate Device

GALILEOS Implant V 1.7 is claimed to be substantially equivalent in material, design and function to the SimPlant 12 product which was cleared by FDA under 510(k) K033849 (May 25, 2004), K053592 (Feb 8, 2006), K081402 (JUL 18, 2008) and the GALILEOS Implant V1,0 product which was cleared by FDA under 510(k) K061472 on June 9, 2006,

#### 4 Device Description

GALILEOS Implant V1.7 is a pure software device.

GALILEOS Implant V 1.7 is a 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.

GALILEOS Implant V1.7 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. 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.

The dental professionals' planning data may be exported from GALILEOS Implant V1.7 and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.

#### 5 Intended Use

GALILEOS Implant V1.7 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. GALLEOS 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 (Computer-Aided Design) or Rapid Prototyping Systems.

#### ବ Substantial Equivalence

The GALILEOS Implant V 1.7 system is substantially equivalent to the SimPlant 12 System (K033849, K053592, K081402) and the GALILEOS Implant V1.0 System (K061472) based on the equivalence of the intended use, similar features and technical characteristics. Performance festing to validate the safety and effectiveness of the GALLEOS Implant V 1.7 system included validation testing and bench tests of the software functions.

#### 7 Conclusion

GALLEOS Implant V1.7 is considered to be substantially equivalent in design, material and function to the SimPlant 12 System and the GALILEOS Implant V1.0 System.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SICAT GmbH & Co. KG % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 25112-1891

Re: K093090

Trade/Device Name: GALILEOS Implant V1.7 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 1, 2009 Received: December 4, 2009

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.

DEC 1 7 2009

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Singerely yours

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### l INDICATIONS FOR USE STATEMENT

for GALILEOS Implant V1.7

510(k) Number (if known):

KO93090

Device Name: GALILEO\$ Implant V1.7

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 (Computer-Aided Design) or Rapid Prototyping , Systems.

Prescription Use X (Part 21 CFR 801 Subpart D) ાર

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)

(Division Sign-Off

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K093090