SIMPLANT SYSTEM

K033849 · Materialise NV · LLZ · May 25, 2004 · Radiology

Device Facts

• Record ID: K033849
• Device Name: SIMPLANT SYSTEM
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.

Device Story

SimPlant System is a software interface and image segmentation tool; processes medical imaging data (CT or MRI scans); enables simulation and evaluation of dental implant placement and surgical treatment options. Used by clinicians to visualize anatomy and plan procedures. Output assists in surgical decision-making and implant planning. Benefits include improved preoperative assessment and surgical accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing and segmentation system. Operates on medical imaging data (CT/MRI). Non-sterile. Class II device (21 CFR 892.2050).

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring imaging information from CT or MRI scanners to simulate and evaluate dental implant placement and surgical treatment options.

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

• SIM/Plant (K924810)
• CT-Modeller (K970617)

Submission Summary (Full Text)

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## MAY 2 5 2004

### SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SIMPLANT SYSTEM

Ko 33849

PROPRIETARY NAME

SimPlant System

#### COMMON NAME:

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

#### CLASSIFICATION NAME:

This product uses images acquired from Computerized System, Image Processing. Tomography (CT) scanners.

#### DEVICE Classification

This device has been classified as Class II.

#### REGULATORY CLASS:

Class II

Product Code

LLZ

MATERIALISE N.V. SUBMITTER'S NAME AND ADDRESS: Technologielaan 15 B-3001 LEUVEN, BELGIUM Applied for ESTABLISHMENT REGISTRATION NO: Carl Van Lierde, Materialise N.V. Contact Person: Quality Manager

November 28, 2003 SUMMARY PREPARATION DATE:

#### Predicate Device

The SimPlant System is claimed to be substantially equivalent in material, design, and function to the SIM/Plant product which was acquired by Materialise from Columbia Scientific, Inc. and cleared by FDA under 510(k) K924810 on January 15, 1993.

The SimPlant System is claimed to be substantially equivalent in material, design, and function to the CT-Modeller product from Materialise which was cleared by FDA under 510(k) K970617 on April 21, 1997

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#### DEVICE DESCRIPTION

The Materialise SimPlant System is intended for use as a software interface and The Materialise offinitiation system for the transfer of imaging information from a medical image segmentation of over a Magnetic Resonance scanner. It is also intended scanner odon as a c rovare for simulating / evaluating dental implant placement and surgical treatment options.

#### STERILIZATION

The SimPlant System is provided non-sterile.

#### INDICATIONS FOR USE

The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical image sogmentation on a Magnetic Resonance scanner. It is also intended scanner suomas a of 50amfor en a ulating / evaluating dental implant placement and surgical treatment options.

#### SUBSTANTIAL EQUIVALENCE

The SimPlant System is considered to be substantially equivalent to the SIM/Plant product and to the CT-Modeller System.

#### CONCLUSION

The SimPlant System is considered to be substantially equivalent in design, material and function to the SIM/Plant product and the Ct-Modeller System

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Mr. Carl Van Lierde Quality Manager Materialise N.V. Technologielaan 15 3001 Leuven BELGIUM

Re: K033849

Trade/Device Name: SimPlant System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: April 6, 2004 Received: April 8, 2004

Dear Mr. Van Lierde:

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

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 (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

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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 premainted 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 11 you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. lxxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

510(k) Number (if known): _K033849

Device Name: _SimPlant System_________________________________________________________________________________________________________________________________________________

Indications for Use:

The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

(Division Sign Division of Reproductive, and Radiological Device 510(k) Number