SWISSMEDA DENTAL PLANNING SYSTEM

K112251 · Swissmeda AG · LLZ · Jan 25, 2012 · Radiology

Device Facts

• Record ID: K112251
• Device Name: SWISSMEDA DENTAL PLANNING SYSTEM
• Applicant: Swissmeda AG
• Product Code: LLZ · Radiology
• Decision Date: Jan 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning. The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options. Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices. The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

Device Story

Stand-alone Windows-based software; processes DICOM imaging data from CT/DVT scanners; calculates 3D volumetric data sets; displays bone density via voxel grey values and 2D slices. Dental professionals use software to define occlusion splines/planes; select implants from catalog; simulate implant placement in 3D space. Output: planning data exported to external drilling device (Georg Schick) for manufacturing surgical templates in laboratory. Used by dentists for pre-operative planning; aids in precise implant positioning; improves surgical outcomes via template-guided placement.

Clinical Evidence

No clinical data; bench testing only. Device is a software-only planning tool; safety and effectiveness established through verification and validation of software functions and equivalence to predicate.

Technological Characteristics

Stand-alone Windows-based software; DICOM-compliant; volumetric 3D rendering; voxel-based density visualization; supports export to external manufacturing hardware. No patient-contact materials. Moderate level of concern software.

Indications for Use

Indicated for qualified dental professionals to perform pre-operative diagnostics, simulation, and evaluation of dental implant placement in the mandible/maxilla using CT or DVT scan data. Not for direct patient contact or use with life-sustaining devices.

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

• coDiagnostiX® (K071636)

Submission Summary (Full Text)

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K112251

JAN 2 5 2012

# 5. 510(k) Summary

#### 5.1 Submitter

Swissmeda AG Technoparkstrasse 1 8005 Zürich Switzerland E-Mail: [e-mail], [e-mail]

#### 5.2 Official Correspondent

Dr. Jörg Danzberg, Chief Executive Officer Swissmeda AG Technoparkstrase 1 8005 Zürich Switzerland Phone: [phone] Fax: [phone] E-Mail: [e-mail]

## 5.3 Date of Submission

07/01/2011

### 5.4 Device Information

| Trade name: | Swissmeda Dental Planning System |
|-------------------------|---------------------------------------------|
| Version: | 2.4 |
| Common Name: | Dental Planning System |
| Device Class: | Class II |
| Classification Name: | System, Image Processing System, Radiology |
| Regulation Description: | Picture archiving and communications system |
| Classification Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |

### 5.5 Predicate Device

Manufacturer: Germany Trade Name: 510(k) Number: Regulation Number: Product Code:

IVS Solutions AG, Annaberger Strasse 240, Chemnitz,

coDiagnostiX® K071636 892.2050 LLZ

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#### 5.6 Device Description

Swissmeda Dental Planning System is a stand-alone software device.

It is a Windows® based software application for the visualization of imaging information of the patient's mandible/maxilla region. It is intended to be used for diagnostics and a precise and reproducible pre-operative planning of dental implants and surgical treatment by aid qualified dental professionals.

Imaging data from medical scanners such as CT or DVT scanners (DICOM Standard) will be read in. The software calculates a volumetric (3 dimensional) data set which will be displayed in different windows: One shows the data as volume data where every voxel of the data set is shown with a grey value that defines the density of the bone substance. Three other windows show a slice through the 3d data set as a flat image. During a planning session the data can be stored to pause the planning session and can be reloaded to continue the planning session.

By inspection of the 3d information of the bone the dental professional can deduct hints where to place what kind of implants. To support planning the user is enabled to predefine a dental occlusion spline and an occlusion plane. He can select implants from a given implant catalog and insert them into the 3d data set at the predefined position given by the dental spline and the tooth number. The implant catalog contains real geometry of several implants from several different vendors. Swissmeda Dental Planning System has no limitations regarding material or surface types of implants.

For each patient several versions of the plan can be created, restored and exported each time.

The final planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick Dental GmbH* for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning during the surgery.

* The drilling device from company Georg Schick Dental GmbH is a high accuracy positioning table, which also can be used like conventional rotary tables for purposes of model making.

### 5.7 Intended Use

Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.

The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and

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evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

The planning data may be exported from Swissmeda Dental Planning System and used as input data for the mentioned drilling device for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

### 5.8 Safety Information

Swissmeda Dental Planning System is a stand-alone software device that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices.

All potential hazards have been identified and analyzed. The result of this analysis indicates that the device is of moderate level of concern as per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

## 5.9 Substantial Equivalence

The Swissmeda Dental Planning System is substantially equivalent to and performs as good as the predicate device coDiagnostiX® (K071636) based on the equivalence of the intended use, similar features and technological characteristics. Any differences between the devices do not raise new issues of safety and effectiveness.

### 5.10 Conclusion

Swissmeda Dental Planning System considered to be substantially equivalent to the coDiagnostiX® System.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human figures or birds in flight. The emblem is rendered in black, providing a stark contrast against the white background.

#### 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

JAN 2 5 2012

Dr. Jorg Danzberg Chief Executive Officer Swissmeda AG Technoparkstrase 1 8005 ZURICH SWITZERLAND

Re: K112251

Trade/Device Name: Swissmeda Dental Planning System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 6, 2011 Received: December 19, 2011

Dear Dr. Danzberg:

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,

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

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## Indications for Use Form

510(k) Number (if known): _(1112251

Swissmeda Dental Planning System Device Name:

Indications for Use:

Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.

The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

AND/OR Over-The-Counter Use Prescription Use _ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division Sign-Øff Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112251

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