GALILEOS IMPLANT, V 1.0

K061472 · Sicat GmbH & Co. KG · LLZ · Jun 9, 2006 · Radiology

Device Facts

• Record ID: K061472
• Device Name: GALILEOS IMPLANT, V 1.0
• Applicant: Sicat GmbH & Co. KG
• Product Code: LLZ · Radiology
• Decision Date: Jun 9, 2006
• 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 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.

Device Story

GALILEOS Implant is a software add-on for Sirona GALAXIS 3D-viewing software; processes 3D volume data from Sirona GALILEOS cone beam scanners. Enables dental professionals (implantologists) to visualize, name, position, move, rotate, and resize generic dental implants and anatomical structures (e.g., nerve canals) within 3D volumes. Used in clinical settings for pre-operative surgical planning. Output consists of planned implant positions and orientations, which can be exported for use in CAD or Rapid Prototyping Systems to facilitate surgical procedures. Benefits include precise surgical planning and improved treatment outcomes.

Clinical Evidence

Bench testing only; no clinical data provided. Validation focused on software functionality and performance of planning/simulation tools.

Technological Characteristics

Pure software device; add-on to Sirona GALAXIS 3D-viewing software. Functions as a radiological image processing system (21 CFR 892.2050). Operates on 3D volume data from cone beam CT scanners. Connectivity includes export capability for CAD/Rapid Prototyping systems.

Indications for Use

Indicated for qualified dental professionals to plan and simulate 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 System (K033849)

Submission Summary (Full Text)

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# 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: [phone] 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.

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#### 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.

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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

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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)<br>(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 [phone] or [phone]

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

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#### 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