SIMPLANT GO

K120733 · Materialise Dental NV · LLZ · Jul 5, 2012 · Radiology

Device Facts

• Record ID: K120733
• Device Name: SIMPLANT GO
• Applicant: Materialise Dental NV
• Product Code: LLZ · Radiology
• Decision Date: Jul 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options.

Device Story

SimPlant Go is a pre-operative dental planning software. It takes CT image data as input; allows 3D assessment of anatomical structures; enables simulation of dental implant placement and surgical treatment options. Used by medically trained professionals in a clinical setting. Output consists of visual representations of implant positions and surgical plans, intended to support diagnostic tools and expert clinical judgment. Benefits include non-invasive visualization of anatomy and improved surgical planning. The software runs on Windows; utilizes C# programming language. It does not perform segmentation or advanced measurements found in the predicate device.

Clinical Evidence

No clinical data. Bench testing included unit, integration, IR, smoke, formal, acceptance, alpha, and beta testing. Design validation included usability testing with 28 external and 5 internal users. Clinical case planning was validated. Testing confirmed identical output to the predicate device.

Technological Characteristics

Software-based medical device; runs on Windows OS; programmed in C#. Connectivity includes DICOM import/export. Complies with DICOM NEMA PS 3.1-3.18, ISO 14971, ISO 13485, and ISO 9001. No hardware components. Does not include segmentation or advanced measurement tools.

Indications for Use

Indicated for medically trained personnel to visualize gray value images and simulate/evaluate dental implant placement and surgical treatment options pre-operatively.

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® 2011 (K110300)

Submission Summary (Full Text)

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K1204333 Page . I of . 6

> 5 2012 JUL

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 892.2050.

| Submitter: | Materialise Dental NV<br>Technologielaan 15<br>Leuven<br>Belgium |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Reg. Number: | 3006638827 |
| Contact: | Carl Van Lierde<br>Management Representative QARA<br>Materialise Dental NV<br>Technologielaan 15<br>Leuven<br>Belgium<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] |
| Date Prepared: | January 31, 2012 |
| Trade/<br>Proprietary<br>Name: | SimPlant Go |
| Common/Usual<br>Name: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-end<br>software that can be used by medically trained people for the purpose of visualizing<br>gray value images. It is intended for use as a pre-operative software program for<br>simulating /evaluating dental implant placement and surgical treatment options. |
| Classification<br>Name/ FDA<br>Reviewing<br>Branch: | Radiology branch |

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| Predicate Device<br>Manufacturer: | SimPlant® 2011; (K110300) | | | | | | | | | | | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|
| Purpose of the<br>510(k) notice: | The reason for this 510k submission is to request clearance for a device that has been<br>referred to herein as SimPlant Go referenced under 21 CFR §892.2050 and considered<br>a Class II device. | | | | | | | | | | | |
| Device<br>Description: | SimPlant Go allows the individual patient's CT image to be assessed in a three-<br>dimensional way, to see the anatomical structures without patient contact or surgical<br>insult. It includes features for dental implant treatment simulation. Additional<br>information about the exact geometry of the tooth surfaces can be visualized together<br>with the CT data and periodontic procedures with dental implants can be simulated.<br>The output file is intended to be used in conjunction with diagnostic tools and expert<br>clinical judgment. | | | | | | | | | | | |
| Indications for<br>Use: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-end<br>software that can be used by medically trained people for the purpose of visualizing<br>gray value images. It is intended for use as a pre-operative software program for<br>simulating /evaluating dental implant placement and surgical treatment options. | | | | | | | | | | | |
| Technological<br>Characteristics: | Materialise Dental NV's SimPlant Go included in this submission has the same<br>technological characteristics as the previously cleared SimPlant® 2011; (K110300).<br>Both software devices run on the Windows operating system. The main technological<br>difference between SimPlant Go and the predicate device is the fact that the<br>programming language used is C# as opposed to C++.<br>SimPlant Go and the predicate device SimPlant 2011 are manufactured by Materialise<br>Dental.<br>Similarities and differences between predicate and subject device in terms of<br>functions: | | | | | | | | | | | |
| | Category Features Available (X) or not (0) Predicate Subject File open tools Open and save .Go projects X X | | | | | | | | | | | |

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K120733 are 3 of 6

| Planning Tools | Selection, sizing and manipulating implant<br>representations for planning /simulating their<br>positions and orientations relative to<br>anatomical structures of interest | X | X |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|
| Communication tools: | Link to an online shop | X | X |
| File open tools | (CB)CT images import;<br>Image selector | X | 0 |
| Visualization tools | 2D gray value images; Panoramic curve;<br>Volume rendering | X | 0 |
| Segmentation tools: | SimPlant Go does not have segmentation<br>tools (e.g. thresholding, region growing,<br>dynamic region growing, manual editing,<br>cavity filling, morphological or<br>Boolean<br>operations) | X | 0 |
| Measurement tools: | Gray values around implants; Profile line;<br>Image statistics | X | 0 |
| Preparation tools | Reorient axial images to occlusal plane;<br>Nerve; Virtual teeth; Optical scan registration;<br>Dual scan registration; Grafts and volumes | X | 0 |
| Planning Tools | Abutments; Fixation screws; Simulation of<br>distraction / osteotomy; Occlusion tool | X | 0 |
| Evaluation tools: | Virtual occludator; Soft tissue simulation | X | 0 |
| Communication tools: | Distribute View; E-mail project; Upload for<br>support; Save or print screenshot; Capture<br>movie; Export DICOM | X | 0 |

Performance

Software Validation in addition to bench top performance testing was conducted to

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| Data: | ensure the compatibility of all system components and to support the safety and<br>effectiveness of the device. In particular the following V&V activities were performed:<br><br><b>Testing:</b><br>The testing of the software consisted of unit testing, peer code reviewing, integration<br>testing, IR testing, smoke testing, formal testing, acceptance testing, alpha testing, beta<br>testing. The results of the complete testing are on file in the Materialise Dental offices<br>and are contained within the Design History File.<br>The results of the testing were:<br>BUGS: differences between software and requirements. The project manager, if<br>necessary after consulting with the application engineer or the acquirer of the<br>project, set the priorities for these bugs; the development manager or team<br>leader assigned a developer to fix the bug. SUGS: suggestions for improvements on the software. Design Review was<br>performed to decide if these suggestions would be implemented. <b>Validation:</b><br>Several validation activities were performed:<br>Design validation Beta validation by use of mockups, prototypes and internal validation Clinical Beta validation For SimPlant GO an extensive design validation was performed by an external<br>usability company i.e. Macadamian. Interviews and usability tests were performed.<br>As part of the Beta validation additional usability tests were performed with in total 28<br>external users and 5 internal users.<br>Clinical case planning in SimPlant GO was validated. All validation criteria were met.<br>Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identical<br>output when using identical input data. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Data: | N/A |
| Performance<br>Standards: | DICOM NEMA PS 3.1-3.18: Digital imaging and communication in medicine: 2009<br>ISO14971: Applications of risk management to medical devices: 2007<br>ISO 13485: Medical devices Quality Management System: 2003<br>ISO 9001: Quality Management System: 2008 |

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# Substantial Equivalence:

Materialise Dental NV's SimPlant Go included in this submission uses similar (K110300).

| | Device comparison table | |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device for premarket notification | K110300 |
| Trade name | SimPlant® Go | SimPlant® 2011 |
| Common.name | SimPlant® Basic Software | SimPlant® Software |
| Classification | Product Code: LLZ<br>21 CFR. § 892.2050 | Product code: LLZ<br>21 CFR. § 892.2050 |
| | Classification Panel: Radiology<br>Device Class: II | Classification Panel: Radiology<br>Device Class: II |
| Intended Use | Materialise Dental's SimPlant Go<br>software is indicated for use as a medical<br>front-end software that can be used by<br>medically trained people for the purpose<br>of visualizing gray value images. It is<br>intended for use as a pre-operative<br>software program for simulating<br>/evaluating dental implant placement<br>and surgical treatment options. | Materialise Dental's SimPlant®<br>software is intended for use as a<br>software interface and image<br>segmentation system for the transfer<br>of imaging information from a<br>medical scanner such as a CT scanner<br>or a Magnetic Resonance scanner. It<br>is also intended as pre-planning<br>software for dental implant<br>placement and surgical treatment. |
| Material | Software - Magnetic media | Software - Magnetic media |
| Design | Software for use in pre-operative<br>planning. | Software for use in pre-operative<br>planning. |
| | Materialise Dental's SimPlant Go<br>software is intended for use as a<br>software interface for the transfer of<br>imaging information from a medical<br>scanner such as a CT (either conventional<br>multislice or cone beam CT) scanner to a<br>computer file usable in conjunction with<br>other diagnostic tools and expert clinical<br>judgment. The software is intended to be<br>used for simulating / evaluating dental<br>implant placement and surgical<br>treatment options, supporting a wide | SimPlant® software provides<br>means for image segmentation and<br>advanced pre-operative planning.<br>Surgical templates may be fabricated<br>based on the output of the pre-<br>operative planning. |

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| Function | The SimPlant® software component is<br>used to incorporate the images from<br>either an MRI or CT scan of the affected<br>joint into the specialized planning<br>software.<br><br>The SimPlant® software is used by a<br>qualified surgeon to plan, inspect, fine-<br>tune and approve the pre-surgical plan.<br>The software is used pre-operatively.<br><br>SimPlant® software contains a library of<br>dental implants, and additional<br>instruments for the placement of<br>implants. | SimPlant® software is used to<br>incorporate the images from either<br>an MRI or CT scan of the affected<br>joint into the specialized planning<br>software.<br><br>The SimPlant® software is used by a<br>qualified surgeon to plan, inspect,<br>fine-tune and approve the pre-<br>surgical plan. The software is used<br>pre-operatively.<br><br>SimPlant® software contains a<br>library of dental implants, and<br>additional instruments for the<br>placement of implants. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Programming<br>language | C# | C++ |
| Operating<br>system | Windows | Windows |
| Hardware<br>Testing | N/A | N/A |
| Software<br>testing | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing |

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is 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. Carl Van Lierde Management Representative QARA Materialise Dental NV Technologielaan 15 LEUVEN 3001 BELGIUM

5 2012 JUL

Re: K120733

Trade/Device Name: SimPlant® GO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2012 Received: June 1, 2012

#### 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 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 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,

Janine M. Morris

Acting 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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# K120733

### 510(k) Premarket Notification -SimPlant® Go

# Indications for Use

510(k) Number (if known): K 12 o + 3 3

Device Name: SimPlant® GO

Indications for Use:

Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating dental implant placement and surgical treatment options.

Prescription Use _

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

AND/OR

(Part 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)

Aranald D. O'Hern

Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

S10K 120733