SURGICASE

K073449 · Materialise NV · LLZ · Apr 16, 2008 · Radiology

Device Facts

• Record ID: K073449
• Device Name: SURGICASE
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: Apr 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

Device Story

SurgiCase System functions as software interface and image segmentation tool; inputs medical imaging data (CT or MRI scans); transforms imaging data into 3D visualizations for pre-operative planning; enables simulation and evaluation of implant placement and surgical treatment options; used by clinicians in clinical settings; output assists surgeons in surgical planning and decision-making; potential patient benefit includes improved surgical accuracy and planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system; utilizes CT or MRI imaging data; provides image segmentation and 3D simulation capabilities; non-sterile; standalone software interface.

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring medical imaging data (CT/MRI) and as pre-operative software for simulating and evaluating implant placement and surgical treatment options. No specific patient population or contraindications defined.

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 (K033849)

Submission Summary (Full Text)

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K073449

## APR 1 6 2008

## SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SURGICASE SYSTEM

Proprietary Name:

SurgiCase System

COMMON NAME:

Image processing system and preoperative software for simulating implant placement and surgical treatment options

#### CLASSIFICATION NAME

This product uses images acquired from Computerized System, Image Processing. Tomography (CT) or Magnetic Resonance Imaging (MRI) scanners.

#### DEVICE CLASSIFICATION:

This device has been classified as Class II.

REGULATORY CLASS:

Class II

Product Code:

LLZ

SUBMITTER'S NAME AND ADDRESS:

MATERIALISE N.V. Technologielaan 15 B-3001 Leuven, Belgium

ESTABLISHMENT REGISTRATION NO:

3003998208

Contact Person:

Mieke Janssen, Materialise N.V. Quality Engineer

December 6, 2007 Summary Preparation Date:

#### PREDICATE DEVICE

The SurgiCase System is claimed to be substantially equivalent in material, design, and function to the SimPlant product from Materialise Dental which was cleared by FDA under 510(k) K033849 on May 25, 2004.

#### DEVICE DESCRIPTION

The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

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#### STERILIZATION

The SurgiCase System is provided non-sterile.

#### INDICATIONS FOR USE

The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

### SUBSTANTIAL EQUIVALENCE

The SurgiCase System is considered to be substantially equivalent to the SimPlant product.

#### CONCLUSION

The SurgiCase System is considered to be substantially equivalent in design, material and function to the SimPlant product.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 6 2008

Mr. Mieke Janssen Quality Engineer Materialise NV Technologielaan 15 3001 Leuven BELGUM

Re: K073449

Trade/Device Name: SurgiCase Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 27, 2008 Received: February 29, 2008

Dear Mr. Janssen:

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 (PMA), 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.

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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); good manufacturing practice requirements as set forth in the quality systems (OS) 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) 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Buxton

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K073449

Device Name: SurgiCase

Indications For Use:

The Materialise SurgiCase System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. If is also intended as pre-operative software for simulating I evaluating implant placement and surgical treatment options.

MICKE JANSSEN

14.4.2008

Prescription Use (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)

Aomith Wh

(Division Sign-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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