SICAT IMPLANT V1.2

K103723 · Sicat GmbH & Co. KG · LLZ · May 20, 2011 · Radiology

Device Facts

• Record ID: K103723
• Device Name: SICAT IMPLANT V1.2
• Applicant: Sicat GmbH & Co. KG
• Product Code: LLZ · Radiology
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 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 treatments. The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.

Device Story

SICAT Implant V1.2 is a software application for dental professionals; processes 3D imaging data (CT or DVT) of oral-maxillofacial region. Users visualize anatomy, identify nerve canals, and position/rotate/resize dental implants within 3D volume. Output consists of surgical planning data, which can be exported for use in CAD or Rapid Prototyping Systems. Device aids clinicians in precise surgical planning and implant placement; benefits include improved surgical preparation and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness validated through software function testing and validation protocols.

Technological Characteristics

Pure software application for radiological visualization and dental implant planning. Operates on 3D volumetric data from CT/DVT scanners. Features include 3D visualization, object positioning, and data export for CAD/Rapid Prototyping.

Indications for Use

Indicated for qualified dental professionals to visualize oral-maxillofacial imaging data (CT/DVT) for planning and simulation of dental implant placement and surgical treatments.

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

• SICAT Implant (V 1.0 incl. SP1) (K090119)
• Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 2 0 2011

# 510(k) Summary for the SICAT GmbH & Co. KG SICAT Implant V 1.2

(per 21 CFR 807.92 and http://www.fdagov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

#### 1. SUBMITTER/510(K) HOLDER

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

+49-228/854 697 82 Telephone: [phone] Facsimile:

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

Date Prepared: December 16, 2010

## 2. DEVICE NAME AND DEVICE CLASSIFICATION

| Proprietary Name: | SICAT Implant V 1.2 |
|-------------------------|----------------------------------------------------------------------------------|
| Common/Usual Name: | Radiological Visualization Software for Diagnosis and<br>Dental Implant Planning |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Picture archiving and communications system |
| Product Code: | LLZ |
| Regulation Number: | 892.2050 |
| Classification Class: | Class II Product |

#### 3. PREDICATE DEVICES

- · SICAT Implant (V 1.0 incl. SP1), K090119
- · Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K081402

## 4. DEVICE DESCRIPTION

SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT

{1}------------------------------------------------

scanners. SICAT Implant V1.2 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 treatments.

SICAT Implant V1.2 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 SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.

## 5 INTENDED USE

SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 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 treatments. The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.

# 6 SUBSTANTIAL EQUIVALENCE

The SICAT Implant V1.2 system is substantially equivalent to the SimPlant System (K033849. K053592. K081402) and the SICAT Implant (V1.0 incl. SP1) System (K090119) based on the equivalence of the intended use, similar features and technical characteristics.

Performance testing to validate the safety and effectiveness of the SICAT Implant V1.2 system included validation testing and bench tests of the software functions.

# 7 CONCLUSION

SICAT Implant V1.2 is considered to be substantially equivalent to the SimPlant System and the SICAT Implant (V1.0 incl. SP1) System.

Based on the information and supporting documentation provided in the premarket notification, the SICAT Implant V1.2 is substantially equivalent to the predicate devices in design, material and function. Testing demonstrates that the SICAT Implant V 1.2 fulfills prospectively defined design and performance specifications.

{2}------------------------------------------------

Image /page/2/Picture/0 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 coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SICAT GMBH & Co. KG % Mr. Mark Sheehan Regulatory Associate Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

MAY 2 0 2011

Re: K103723 Trade/Device Name: SICAT Implant V 1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 16, 2010 Received: December 21, 2010

#### Dear Mr. Sheehan:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K103 723

Device Name: SICAT Implant V 1.2

Indications for Use:

The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. The SICAT Implant V 1.2 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 treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.

Prescription Use X (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)

Mum Slastel
(Division Sign-Off)

510K K163723

~~Page 4~~
Page 1 of 1