CODIAGNOSTIX (R) 5.72

K071636 · Ivs Solutions AG · LLZ · Aug 9, 2007 · Radiology

Device Facts

• Record ID: K071636
• Device Name: CODIAGNOSTIX (R) 5.72
• Applicant: Ivs Solutions AG
• Product Code: LLZ · Radiology
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software. This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surqical treatment options. The patient population will be the general public. coDiognostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices. lt's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

Device Story

coDiagnostiX® is a Windows-based dental software for 3D diagnosis and implant planning. It ingests DICOM data from CT or DVT scanners, storing datasets in a database. The software provides tools for 3D reconstruction, nerve canal identification, bone densitometry, and implant placement simulation. Dentists or lab technicians operate the software to generate drilling templates, which are manufactured using rotary or gonyX® tables. These templates guide the actual surgical procedure. The software enables clinicians to visualize anatomy, measure bone density, and plan implant positions, facilitating precise surgical execution and potentially improving patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were established through risk analysis, verification, and validation testing processes in accordance with ISO 14971 and software guidance for moderate level of concern devices.

Technological Characteristics

Windows-based software; requires Pentium-compatible processor (800MHz), 128MB RAM, 500MB disk space. Supports DICOM 3.0, JPEG, BMP, TIFF. Features 3D reconstruction, nerve module, bone densitometry, and collision detection. Hardware copy protection via USB eToken-Dongle. Complies with ISO 9001, ISO 13485, ISO 14971, and IEC 60601-1-4.

Indications for Use

Indicated for general public patients requiring dental implant planning and surgical simulation. Intended for use by medically trained professionals. Not for direct patient contact or life-sustaining applications.

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 System (K033849)
• Vimplant™ (K053155)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white graphic. The graphic appears to be a stylized representation of a human head or brain. The words "Solutions AG" are visible in the lower left corner of the image.

# IVS Solutions AG

Annaberger Straße 240, 09125 Chemnitz, Germany

[phone] ABR 를 [phone]

网 [e-mail] (4) www.ivs-solutions.com

.ivs-solutions.com

AUG - 9 2007

# 5. 510(k) Summary of Safety and Effectiveness

K071636

## 5.1. Submitter

IVS Solutions AG Annaberger Strasse 240 D- 09125 Chemnitz, GERMANY E- Mail: [e-mail]

### 5.2. Official Correspondent

Mr. Frank Stockmann, Chief Executive Officer IVS Solutions AG Annaberger Strasse 240 D- 09125 Chemnitz, Germany Phone: [phone] Fax: [phone] E- Mail: [e-mail]

#### 5.3. Date of submission

05/24/2007

#### 5.4. Device Information

Trade name: coDiagnostiX® Version: 5.7.2 Common Name: Dental 3D diagnosis and implant planning software Device Class: Class II Classification name: Image Processing System Classification Panel: Radiology Classification number: 21 CFR 892.2050 Product Code: LLZ

# 5.5. Predicate Device(s)

| | Predicate #1 | Predicate #2 |
|-------------------|------------------|----------------|
| Manufacturer | MATERIALIZE N.V. | CyberMed, Inc. |
| Trade Name | SimPlant System | Vimplant™ |
| 510(k) Number | K033849 | K053155 |
| Regulation Number | 892.2050 | 892.2050 |
| Product Code | LLZ | LLZ |

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Image /page/1/Picture/0 description: The image shows a black and white graphic of a human head in profile. The head is facing right, and the details of the face and head are somewhat obscured, giving it an abstract appearance. Below the head, the text "Solutions AG" is visible in a contrasting color, likely white or a light shade, against the dark background.

# IVS Solutions AG

naberger Straße 240, 09125 Chemnitz, Germany

9-371-5347 380 49-371-5347 428

- [e-mail] www.ivs-solutions.com
#### 5.6. Device Description

coDiagnostiX® is designed for diagnosis of 3dimensional datasets and precise image- quided and reproducible pre- operative planning of dental implants.

The software will be provided either as station version, client or server version.

Basically, patient's medical image data from different sources like CT (computer tomography) - or DVT (Digital Volume Tomography resp. NewTom) scanner will be read in with the coDiggnostix® DICOM transfer module, transferred into 3dimensional datasets and stored in a database.

The succeeded planning is realized through the calculation of special views, the analysis of graphic data and the placement of dental implants. For assistance of the planning procedure, several functions are available:

- Active measurement tools (length and angle) for individual measuring of implant positions -
- Nerve module for distinguishing the behaviour of the nervus mandibularis channel -
- -3D Cut for a 3dimensional cut through the jaw for fine adjustment of the implant position
- -Segmentation module for coloring several areas inside the slice dataset (e.g. jaw bone, natural tooth series) or kinds of tissue (e.g. bone, skin) and creating a 3D reconstruction of the dataset
- -Parallelizing function for adjustment of adjacent images
- -Bone densitometry with a density statistic for density measuring in the area around the positioned implant; a density allocation along the and transverse to the implant cover area is displayed

All working steps will be saved automatically to the actual plan of the patient. For each patient several plans are possible to generate several proposals, so that the dentist or lab is free to choose the ideal proposal for generating an according drilling template needed for realization of the planning during the main operation.

As in the station version of the coDiognostiX® software all functions are available, the client version needs the patient data provided by the server version.

## 5.7. Intended Use

coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software.

This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surqical treatment options.

The patient population will be the general public.

coDiognostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

lt's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

## 5.8. Applicable mandatory and voluntary standards

coDiognostix® complies with the following mandatory and voluntary standards:

- ISO 9001:2000 Quality management systems 1
- ISO 13485:2003 Quality management systems, requirements for regulatory purposes -
- ISO 14971:2001 Application of risk management to medical devices -
- IEC 60601-1-4:1996 + A1:1999 Medical electrical equipment Part 1-4: General requirements -

for safety; Collateral standard: Programmable electrical medical systems

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Image /page/2/Picture/0 description: The image is a black and white graphic. The graphic appears to be a head or skull. At the bottom of the image, the text "Solutions AG" is visible.

IVS Solutions AG Annaberger Straße 240, 09125 Chemnitz, Germany

49-371-5347 380 [phone]

[e-mail] www.ivs-solutions.com

- 93/42/EEC Medical Device Directive
- -DICOM (Digital Imaging and Communications in Medicine) -The standard protocol to exchange and transfer the data acquired by Medical Image Devices; developed by the American College of Radiology and the National Electrical Manufacturers Association (ACR- NEMA).
- .
. JPG/ JPEG (Joint Photographic Experts Group) -A compression technique that is designed to compress color and greyscale continuous- tone images reversible and irreversible.

## 5.9. Technological Characteristics

coDiagnostiX® is a dental image diagnosis and implant planning software, designed to run on industrial standard PC platforms with the following minimum system requirements:

- WIN 98/NT/2000/XP -
- Pentium compatible Processor with 800MHz -
- . 128 MB RAM
- -500 MB hard disc
- . 17" color display with 1024x768 resolution and 16.7 Million colors
- -CD- ROM device
- -USB interface.

The software will be delivered on CD with a hardware copy protection (eToken- Dongle). If the user wants to work with coDiagnostix®, the Dongle has to be connected to the PC via USB interface. In addition coDiognostiX® is designed for:

- utilization of the DICOM 3.0 standard to acquire images from network or CD- ROM -
- supporting standard image file formats for storage and retrieval of images (DICOM, JPEG, BMP, TIFF)
- importing and exporting images
- . 3D image reconstruction
- image- quided implant planning
- nerve creation and displaying
- collision detection
- printing images, image sets, implant list, drilling template plan

#### 5.10. Safety Information

coDiagnostX® is a software product 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 studied and controlled as part of the product development process according to written procedures, including risk analysis, test and design considerations, verification and validation testing processes. The results of the hazard analysis indicate that the device is of moderate level of concern as per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

#### 5.11. Conclusion

coDiagnostiX® has similar intended use, operational and functional features as the predicate devices. Any differences between the devices do not raise new issues of safety and effectiveness. That indicates, that coDiggnostiX® is substantially equivalent to and performs as good as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# AUG - 9 2007

Mr. Frank Stockmann Chief Executive Officer IVS Solutions AG Annaberger Strasse 240 Chemnitz, Saxony 09125 GERMANY

Re: K071636

Trade/Device Name: coDiagnostix® Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 24, 2007 Received: June 15, 2007

#### Dear Mr. Stockmann:

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 (Premarket Approval), 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.

Image /page/3/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large, bold "PA" and the word "Centennial" underneath. The letters "USA" are at the bottom of the logo. The logo appears to be a centennial celebration emblem, possibly for an organization or event.

Protecting and Promoting Public Health

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Page 2 -

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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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Image /page/5/Picture/0 description: The image shows a black and white graphic of a brain inside of a skull. The brain is highly detailed with many curves and lines. The skull is also detailed, with the eye socket and nasal cavity clearly visible. At the bottom of the image, the text "Solutions AG" is visible.

# IVS Solutions AG

Annaberger Straße 240, 09125 Chemnitz, Germany [phone] [e-mail] X [phone]

- www.ivs-solutions.com
# 4. Indications for Use Statement

| 510(k) Number (if known): | K071636 |
|---------------------------|---------------|
| Device Name: | coDiagnostiX® |

Indications for Use:

coDiagnostix® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software.

This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surgical treatment options.

The patient population will be the general public.

coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

lt's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helus Remen

Division Sign-Off)
ivision of Reproductive, Abdominal,
and Radiological Devices K071636
10(k) Number

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coDiagnostiX_510(k)_ Premarket Notification.doc