K Number
K130724
Device Name
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
Manufacturer
Date Cleared
2013-06-28

(102 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.
Device Description
coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants. The software is provided in three configurations: station, client or server. Patient image data is received from various sources such as CT or DVT scanning. The scanned data will be read with the coDiagnostiX DICOM transfer module using the DICOM format, converted into 3dimensional datasets and stored in a database. Surgical planning is performed through the calculation of special views, analysis of graphic data and the placement of virtual dental implants. Additional functions are available to the user for refinement of the surgical planning, such as: - Active measurement tools, length and angle, for individual measuring of implant positions - · Nerve module to assist in distinguishing 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 types of tissue, e.g., bone, skin, and creating a 3D reconstruction for 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, and transverse to, the implant cover area is displayed All working steps are saved automatically to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan.
More Information

Not Found

No
The summary describes standard image processing and measurement tools for dental implant planning, with no mention of AI or ML algorithms.

No
This device is a planning and simulation software for dental implant placement, not a device that directly treats a condition or disease.

No
Explanation: The device is described as an "implant planning and surgery planning software tool" and "designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants," indicating a planning rather than diagnostic function. While it processes imaging information and includes analysis tools, its primary purpose is stated as planning, not to establish a diagnosis of a patient's condition or disease directly.

Yes

The device is described as "coDiagnostiX Implant Planning Software" and its function is entirely based on processing and analyzing imaging data and generating plans and data for manufacturing. While it interacts with external hardware (scanners, 3D manufacturing systems, gonyX table), the device itself is the software component. The description focuses solely on software functionalities and verification/validation.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that coDiagnostiX is a software tool for implant planning and surgery planning for dental professionals. It uses imaging data to simulate and evaluate implant placement. This is a surgical planning and guidance tool, not a diagnostic test performed on biological samples.
  • Device Description: The description details software functions for analyzing imaging data, placing virtual implants, and generating surgical templates. These are all related to surgical planning and execution, not in vitro diagnostic testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.

The device is an image processing and surgical planning software for dental procedures.

N/A

Intended Use / Indications for Use

coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants. The software is provided in three configurations: station, client or server. Patient image data is received from various sources such as CT or DVT scanning. The scanned data will be read with the coDiagnostiX DICOM transfer module using the DICOM format, converted into 3dimensional datasets and stored in a database. Surgical planning is performed through the calculation of special views, analysis of graphic data and the placement of virtual dental implants. Additional functions are available to the user for refinement of the surgical planning, such as:

  • Active measurement tools, length and angle, for individual measuring of implant positions
  • · Nerve module to assist in distinguishing 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 types of tissue, e.g., bone, skin, and creating a 3D reconstruction for 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, and transverse to, the implant cover area is displayed

All working steps are saved automatically to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT or DVT scanners

Anatomical Site

Not Found (Implants are dental, so implies jaw/mouth but not specified)

Indicated Patient Age Range

The target patient population is the general public.

Intended User / Care Setting

dental professionals who have appropriate knowledge in dental implantology and surgical dentistry.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output. Testing has been carried out in accordance with the FDA guidance document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued on January 11, 2002. The proposed software met the acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071636

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

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Image /page/0/Picture/0 description: The image shows the Straumann company logo and the text "Page 1 of 4". The Straumann logo is a stylized design with the company name in bold, black font. The text "Page 1 of 4" is handwritten in black ink and is located to the right of the logo. The text indicates that this is the first page of a four-page document.

510(k) Summary - K130724

JUN 2 8 2013

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Regulatory Project Manager

  • March 15, 2013 2. Date of Submission:

3. Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

coDiagnostiX Implant Planning Software Dental 3D diagnosis and implant planning software Image Processing System 8892.2050

Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device)

K071636, IVS coDiagnostiX

5. Description of the Device

coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants. The software is provided in three configurations: station, client or server. Patient image data is received from various sources such as CT or DVT scanning. The scanned data will be read with the coDiagnostiX DICOM transfer module using the DICOM format, converted into 3dimensional datasets and stored in a database. Surgical planning is performed through the calculation of special views, analysis of graphic data and the placement of virtual dental implants. Additional functions are available to the user for refinement of the surgical planning, such as:

  • Active measurement tools, length and angle, for individual measuring of implant positions
  • · Nerve module to assist in distinguishing the nervus mandibularis channel
  • . 3D cut for a 3dimensional cut through the jaw for fine adjustment of the implant position

1

  • Segmentation module for coloring several areas inside the slice . dataset, e.g., jaw bone, natural tooth series, or types of tissue, e.g., bone, skin, and creating a 3D reconstruction for 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, and transverse to, the implant cover area is displayed

All working steps are saved automatically to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan.

6. Intended Use of the Device

coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

7. Technological Characteristics

coDiagnostiX Implant Planning Software is a dental image diagnosis and implant planning software. A comparison of the technological characteristics of predicate and subject device is below.

2

| FEATURE | PROPOSED DEVICE
coDiagnostiX | PREDICATE DEVICE
IVS coDiagnostiX |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Subject Submission | K071636 |
| Intended Use | Straumann coDiagnostiX is an implant
planning and surgery planning software tool
intended for use by dental practitioners with
appropriate training in dental implantology.
This software reads imaging information
output from medical scanners such as CT or
DVT scanners. It allows pre-operative
simulation and evaluation of patient anatomy,
dental implant placement and surgical
treatment options.

For automated manufacturing of drill guides in
the dental laboratory environment, the
coDiagnostiX software allows for export of
data to 3D manufacturing systems, or
coDiagnostiX can provide printouts of
templant plans for the creation of surgical
templates using a manually operated gonyX
table.

The target patient population is 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. | 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 and evaluation 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
it intended to be used with life sustaining
devices.

It is possible to use coDiagnostiX as a
pattern for manufacturing drilling template
with conventional rotary tables or 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
coDiagnostiX. |
| Minimum
System
Requirements | OS: Microsoft Windows 7, Windows SP,
Vista
Processor: Intel Core or AMD Athlon 64
X2
Main memory: 2 GB
Hard disk: 1GB free, plus 50 MB per
plan
Screen resolution: 1024 x 768 pixels
DVD drive
One free USB port
Optional: Microsoft SQL Server Desktop
Engine (MSDE) if user selects to use
the SQL Server Module
The software can also be run on the
Apple operating system with minimum
system requirements of:
Macintosh computer with Intel
processor
Mac OSX 10.6 or newer
"Parallels Desktop" for Macintosh
including valid Windows license
(software purchased separately) | 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
Optional: Microsoft SQL Server
Desktop Engine (MSDE) if user selects
to use the SQL Server Module
The software can also be run on the
Apple operating system with minimum
system requirements of:
Macintosh computer with Intel
processor
Mac OSX 10.6 or newer
"Parallels Desktop" for Macintosh
including valid Windows license
(software purchased separately) |
| Target Population | Same | General public |
| Supported image
formats | Same | JPEG, BMP |
| DICOM compliant | Yes | yes |
| Image import | Same, plus STL file format | DICOM data from CT/DVT scanner
saved on CDROM, PC or network |
| Image export | STL file format | unknown |
| Printouts | Same | Report/plan with patient information,
screenshot, implant list, template |

and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co

3

K130724
Page 4 of 4

8. Performance Testing

Software verification and validation testing were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output. Testing has been carried out in accordance with the FDA guidance document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued on January 11, 2002. The proposed software met the acceptance criteria.

க் Conclusion

coDiagnostiX Implant Planning Software has identical intended use, and operational and functional features, and level of concern as the currently cleared software. Results of the software validation indicate that the software performs as intended and that the proposed changes do not raise any new issues of safety and effectiveness.

4

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Cantral Center - WO66-G609 Silver Spring, MD 20093-0002

June 28. 2013

Straumann USA. LLC % Ms. Elaine Alan Regulatory Project Manager 60 Minuteman Road ANDOVER MA 01830

Re: K130724

Trade/Device Name: coDiagnostiX Implant Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Alan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive 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.

5

Page 2 - Ms. Alan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

6

Indications for Use

510(k) Number (if known): K130724

Device Name: coDiagnostiX Implant Planning Software

Indications for Use:

coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

Prescription Use X (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 In Vitro Diagnostics and Radiologic Health (OIR)

Jamingh. Mesa

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

510(k) K130724

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