SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

K111641 · Materialise NV · LLZ · Sep 26, 2011 · Radiology

Device Facts

• Record ID: K111641
• Device Name: SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: Sep 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

Device Story

SurgiCase is a software platform for pre-operative simulation of orthognathic surgical procedures. It ingests medical imaging data (CT or MRI) to generate 3D visualizations and measurements. The 'Orthognathic wizard' module provides a step-by-step interface for surgeons to plan specific surgical routines, fine-tune parameters, select implants, and design patient-specific surgical guides or splints. The software is used by surgeons in a clinical setting to transfer planned dental occlusion and implant positioning to the operating room. By facilitating precise pre-operative planning, the device assists in surgical decision-making and potentially improves surgical outcomes.

Clinical Evidence

No clinical data. Bench testing only, consisting of software verification and validation.

Technological Characteristics

Software-based image processing system for 3D visualization, measurement, and surgical simulation. Operates on medical imaging data (CT/MRI). Modular architecture with a general platform and specific 'wizard' modules for surgical routines. Connectivity via standard medical imaging formats. No hardware components.

Indications for Use

Indicated for pre-operative simulation of orthognathic surgical treatment options using CT or MRI imaging data. No specific patient population age or gender restrictions provided.

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

• SurgiCase (K073449)

Submission Summary (Full Text)

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# 510(k) Summary

# Submitter information

| Company name | Materialise N.V. |
|-----------------------------------|-------------------------------------|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Principal contact name | Oliver Clemens |
| Contact title | Quality & Regulatory officer |
| Contact e-mail address | [e-mail] |
| Additional contact name | Alexandra Razzhivina |
| Contact title | Regulatory officer |
| Contact e-mail address | [e-mail] |
| Additional contact name | Dieter Vandoren |
| Contact title | Continuous Improvement Manager CMF |
| Contact e-mail address | [e-mail] |

### Submission date

The date of the Traditional 510(k) submission is June 10th, 2011

## Submission information

| Trade Name | SurgiCase, SurgiCase CMF, ProPlan CMF |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|
| Common Name | Image processing system and software for<br>simulating/evaluating implant placement and surgical<br>treatment options |
| Classification Name | System, Image processing, Radiological |
| Product code | LLZ (21 CFR 892.2050) |

## Predicate device

| Trade or proprietary or model name | SurgiCase |
|------------------------------------|------------------|
| 510(k) number | K073449 |
| Decision date | 2008/04/16 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |

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#### Device Information

#### Description of the device

This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.

SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:

- The software planning can be used to select appropriate implants or implant sizes for use during surgery.
- . Based on the planning, patient-specific surgical guides and implants can be designed.
- . Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.

#### Functioning of the device

The SurgiCase software platform is the basis of all clinical Materialise software designed for surgery planning. The platform allows basic functionality such as visualizing 3D objects, visualizing medical image data, generating 3D objects from medical image data and measuring.

On top of this platform, modules, also called wizards, can be added that each offer additional functionality such as planning a specific surgical routine. This platform is the main general wizard, while additional modules (wizards) are mainly based on the functionality of this general wizard; they assist the surgeon to plan specific surgery types step-by-step by providing each a different user interface, giving the surgeon the opportunity to fine tune parameters specific for that type of surgery. Current premarket notification is only for the Orthognathic wizard of the SurgiCase software. The rest of software wizards have been cleared under K073449 submission for the SurgiCase software.

#### Intended use

SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

² The surgical splints are Class I, 510k exempt and therefore are not submitted for review in this 510k submission. References to the splints are provided as an example throughout this submission to give a complete overview on the whole process (from planning to surgery).

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### Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.

# Performance data

#### Non-clinical testing

Software verification and validation testing will be completed by the end of August 2011. Verification and validation reports will be on file at Materialise from that point on and can be sent on request.

#### Clinical testing

Not applicable.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### 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

Mr. Oliver Clemens Quality and Regulatory Officer Materialise NV Technologielaan 15 3001 Leuven BELGIUM

SEP 26 2011

Re: K111641

Trade/Device Name: SurgiCase Orthognathic software Wizard Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: L.L.Z Dated: September 1, 2011 Received: September 2, 2011

Dear Mr. Clemens:

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

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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 Safery 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 Patel

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

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# Indications for Use

#### 510(k) Number (if known):

Device Name: SurgiCase Orthognathic software wizard

Indications for Use:

SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

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

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Mary Stated

(Division Sign-Division f Radiological Devic Office of In Vitro Djagr

K111 641
510K