(209 days)
Not Found
No
The summary explicitly states "Neither automatic diagnosis nor automatic disease detection is performed" and the description focuses on standard 3D imaging and planning tools without mentioning AI or ML.
No
The device is described as implant planning software that supports diagnosis and planning. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software transforms patient data into 3D volume and different multi-planar 2D images "for diagnosis." Additionally, the "Device Description" mentions that the software supports "all the common 3D medical imaging functionalities used by professionals to support their diagnosis."
Yes
The device is described as a "standalone application" and "software" that imports and processes data from external hardware (CT/CBCT scanners) but does not include or rely on any specific hardware components for its operation.
Based on the provided information, ZIRKONZAHN.Implant-Planner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ZIRKONZAHN.Implant-Planner's Function: The software processes medical imaging data (DICOM files from CT/CBCT scanners) of the patient's anatomy. It is used for planning surgical procedures (implant placement and guide design) based on this imaging data.
- No Specimen Analysis: The software does not analyze any biological specimens from the patient. Its input is imaging data, not biological samples.
- Intended Use: The intended use is for implant planning and surgical guide design, not for diagnosing diseases or conditions based on laboratory analysis of specimens.
Therefore, ZIRKONZAHN.Implant-Planner falls under the category of medical imaging software used for surgical planning, not as an IVD device.
N/A
Intended Use / Indications for Use
ZIRKONZAHN.Implant-Planner is an implant planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.
Product codes
LLZ
Device Description
ZIRKONZAHN.Implant-Planner is a fully-featured 3D imaging standalone application for implant planning and surgical guide design. ZIRKONZAHN.Implant-Planner supports all the common 3D medical imaging functionalities used by professionals to support their diagnosis. It includes various volume and surface rendering, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. The software is provided in 2 versions and 2 modules: the first version is a full version (called "ZIRKONZAHN.Implant-Planner") that covers all applications for use, the second version is a basic/limited version (called "ZIRKONZAHN.Implant-Planner Practice") only for implant planning. The first module is a CAD/CAM STL Converter that converts DICOM data into STL files for further processing. The second one is the CAD/CAM Z-Tray for designing individual impression trays.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM files from CT/CBCT scanners
Anatomical Site
Not Found (Implied dental/maxillofacial from context)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.
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 is performed in accordance with the procedures described in this submission and in accordance with the applicable FDA guidelines. Code review, unit, integration and system testing were conducted to establish the functionality characteristics of the subject device. Software validation confirms that the particular requiremented through software are consistently fulfilled. Implemented controls such as collision detection related to device hazards identified in the risk management procedures are validated to establish the safety of the device. Bench tests demonstrate the accuracy of critical items in the whole workflow of the device. The tests performed on the single items report satisfying results that back up the accurate performance of the new device for its achieved outputs when used as intended. The accuracy of data elaboration with its relative outcomes will ensure a safety placement of the clinical use and a positive impact on the overall healthcare situation. Clinical testing is not a requirement and has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
July 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zirkonzahn SRL % Ms. Sandra Leitner Regulatory Affairs Via An der Ahr 7 Gais, BZ 39030 ITALY
Re: K203765
Trade/Device Name: ZIRKONZAHN.Implant-Planner Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 23, 2021 Received: April 26, 2021
Dear Ms. Leitner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 either 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203765
Device Name ZIRKONZAHN.Implant-Planner
Indications for Use (Describe)
ZIRKONZAHN.Implant-Planner is an implant planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Section 05
| 510(k) Summary | K20376 | |
|---|---|---|
| 510(k) SUMMARY | ||
| APPLICANT | ZIRKONZAHN SRL | |
| Via An der Ahr 7 | ||
| Gais, ITALY 39030 | ||
| Phone: +39 0474 066 660 | ||
| Fax: +39 0474 066 661 | ||
| E-mail: info@zirkonzahn.com | ||
| CONTACT PERSON | Sandra Leitner | |
| Regulatory Affairs | ||
| ZIRKONZAHN SRL |
Via An der Ahr 7 Gais, ITALY 39030
Phone: +39 0474 066 784 Fax: +39 0474 066 661
E-mail: sandra.leitner@zirkonzahn.com
Date Summary Prepared: June 30, 2021
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | ZIRKONZAHN.Implant-Planner |
|---|---|
| Generic/Common Name: | Diagnostic imaging software for implant planning |
| Regulation Number: | 892.2050 |
| Regulation Description: | Medical Image Management and Processing System |
| Class: | II |
| Product Code: | LLZ |
LEGALLY MARKED PREDICATE DEVICE
| Trade name: | 3DIEMME RealGUIDE |
|---|---|
| 510(k) holder: | 3DIEMME Srl |
| 510(k) number: | K173041 |
INDICATIONS FOR USE
ZIRKONZAHN.Implant-Planner is an implant planning and surgery planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.
4
DEVICE DESCRIPTION
ZIRKONZAHN.Implant-Planner is a fully-featured 3D imaging standalone application for implant planning and surgical guide design. ZIRKONZAHN.Implant-Planner supports all the common 3D medical imaging functionalities used by professionals to support their diagnosis. It includes various volume and surface rendering, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. The software is provided in 2 versions and 2 modules: the first version is a full version (called "ZIRKONZAHN.Implant-Planner") that covers all applications for use, the second version is a basic/limited version (called "ZIRKONZAHN.Implant-Planner Practice") only for implant planning. The first module is a CAD/CAM STL Converter that converts DICOM data into STL files for further processing. The second one is the CAD/CAM Z-Tray for designing individual impression trays.
| Software | Item No | Nomenclature | Description |
|---|---|---|---|
| ZIRKONZAHN. | |||
| Implant-Planner | SY1600 | ZIRKONZAHN.Implant- | |
| Planner | All applications of the indications for | ||
| use. | |||
| SY1620 | ZIRKONZAHN.Implant- | ||
| Planner Practice | Version only for dental implant | ||
| planning without surgical guide design. | |||
| SY1610 | CAD/CAM STL Converter | Converts DICOM volume data into 3D | |
| geometry (STL files) for further | |||
| processing using other CAD software. | |||
| SY1630 | CAD/CAM Z-Tray | For manufacturing individual | |
| impression trays. |
Table 1: Versions and additional modules description
As there is at least one medical function and at least one non-medical function ZIRKONZAHN.Implant-Planner is considered as multiple function device with the following structure:
| Function | Device Function | Other Function | Item No |
|---|---|---|---|
| ZIRKONZAHN.Implant-Planner | X | SY1600 | |
| ZIRKONZAHN.Implant-Planner Practice | X | SY1620 | |
| CAD/CAM STL Converter | X | SY1610 | |
| CAD/CAM Z-Tray | X | SY1630 |
Table 2: Multiple Function Device Structure
NON-CLINICAL TESTS
Software verification and validation is performed in accordance with the procedures described in this submission and in accordance with the applicable FDA guidelines. Code review, unit, integration and system testing were conducted to establish the functionality characteristics of the subject device. Software validation confirms that the particular requiremented through software are consistently fulfilled. Implemented controls such as collision detection related to device hazards identified in the risk management procedures are validated to establish the safety of the device. Bench tests demonstrate the accuracy of critical items in the whole workflow of the device. The tests performed on the single items report satisfying results that back up the accurate performance of the new device for its achieved outputs when used as intended. The accuracy of data elaboration with its relative outcomes will ensure a safety placement of the clinical use and a positive impact on the overall healthcare situation.
CLINICAL TESTS
Clinical testing is not a requirement and has not been performed.
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SUBSTANTIAL EQUIVALENCE
| Devices | ZIRKONZAHN.Implant-Planner | 3DIEMME RealGUIDE | Comparison | System Requirements | ||
|---|---|---|---|---|---|---|
| Company | Zirkonzahn Srl | 3DIEMME Srl | Patient reconstructed volume (this operation is called "virtual plan") |
- Dental/maxillofacial surgical guides and prosthetic modelling. The virtual plan is used to design a surgical guide that is used by the doctor to drive the surgery drills according to the planned implants direction and depth. This surgical guide can be manufactured by any 3D printer working from STL files. The user can also design the patient prosthesis (typically a denture) with the surface and volume free-form tools implemented in the software. The result is exported in STL format for 3D printing or CAD/CAM technologies.
Mobile version: The RealGUIDE software APP is intended for the following uses: Projects visualization and editing. The input PROJECT files, pre-processed with the RealGUIDE desktop version, are used by trained professionals to evaluate the implants projects, edit them and share them with other colleagues through the cloud, as well as for a more effective Patient treatment communication. The RealGUIDE APP version is NOT INTENDED for managing a 3D diagnosis starting from DICOM images, due to the mobile devices screen resolution limitations. For this reason, the APP is not reading directly the DICOM files but only pre-processed project files, exported through the cloud by the RealGUIDE desktop version. | |
| Product Code | LLZ | LLZ | Same | PC Installation
- Processor: Intel i5 or i7 | PC Installation
- Processor: Intel i5 or i7 | Similar: |
| Regulation Number | 892.2050 | 892.2050 | Same | | | |
| Indication for use | ZIRKONZAHN.Implant-Planner is an implant planning
and surgery planning software. The software imports
and reads DICOM files from CT/CBCT scanners. The
patient data is then transformed into 3D volume and
different multi-planar 2D images for diagnosis and
further implant and surgery guide planning with
precise step by step instructions. The software is a
stand-alone product that is not connected to any
other medical device. Neither automatic diagnosis
nor automatic disease detection is performed. The
software is intended for use by dental professionals
only and requires appropriate training for its use and
knowledge in the practice of implantology. | 1. Support to the diagnosis for trained professionals. The
input DICOM files acquired by a CT/CBCT scanner are not
modified in any way but they are showed to the doctor
through the classical imaging and volume rendering
techniques. It is a stand-alone product. No information
of the patient is modified, all the parameters used for the
image processing are read from the DICOM file itself.
Neither automatic diagnosis is made, nor automatic
disease detection is performed. This software is not
connected to any medical instrumentation and it doesn't
control any medical or energy supplying device. The user
imports DICOM data coming from any CT/CBCT imaging
device and the software enables him to view the Patient
exam in different multi-planar 2D images and easily
reconstruct the 3D volume for an immediate
visualization of bone structures and surrounding tissues.
- Virtual oral and maxillofacial surgery planning. Doctors
can plan virtual implants and surgeries on 2D/3D
reconstructions and export the projects in open or
proprietary format for further processing. The user can
choose different implant models (for example dental
implants models) from a library provided by the
Manufacturers and simulate the positioning in the | Similar | | | |
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7
| | - RAM: minimum 4 GB, 8 GB are suggested
- Hard disk: 300 – 500 GB
- Required Hard Disk Space: approx. 900 MB
- Graphic Card: Nvidia Geforce. For higher
- performance Nvidia GTX or QUADRO
- Screen Resolution: 1920 x 1080
- OS: Windows 7 (64 bit), Windows 8 (64 bit),
- Windows 10 (64 bit) | - RAM: minimum 4 GB, for big datasets 8 GB are suggested
- Hard disk: 300 – 500 GB (for Patients storage)
- Graphics card: Nvidia Geforce line (€150-200 price range). For higher performances Nvidia GTX or QUADRO line
- Screen resolution: 1920 x 1080 for optimal visualization
- OS: Windows 7 (64 bit), Windows 8 (64 bit), Windows 10
- For professional use we suggest the Dell XPS 15 (9560) notebook lineup.
MAC Installation - Macbook PRO 15
- iMac OS: OS X (starting from Yosemite, to activate hardware rendering)
IOS Installation - iPad PRO iPhone 7 Plus | Identical for a PC
Installation with
Windows OS.
MAC and IOS
Installation are
not available for
the subject
device. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Features | - DICOM 2D/3D Reconstruction - Import and Matching STL Files
- Implant Planning from Library
- Surgical Guides Design
- Connection with Lab Software
- PC Version | - DICOM 2D/3D Reconstruction
- Import and Matching STL Files
- Implant Planning from Library
- Surgical Guides Design
- Connection with Lab Software
- PC Version
- Segmentation of Anatomy and Dentures
- MAC and Mobile Versions | Similar |
| Principle of Operation | - Desktop application with intuitive step-by-step guidance | - Desktop application with intuitive step-by-step guidance | Similar
Slightly differences in the GUI |
| Technical Data | - DICOM compliant
Image Import Formats: DICOM, STL, OBJ, OFF -
Image Export Formats: STL | - DICOM compliant
Image Import Formats: DICOM, STL, OBJ, OFF
-
Image Export Formats: STL | Same |
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Table 4: Device Comparison
CONCLUSION
Based on a comparison and discussion of indications for use, system requirements, features, principle of operation and the ZIRKONZAHN.Implant-Planner software is found to be substantially equivalent to the predicate device, as it is not raising and effectiveness. Performance data are included in this premonstrate the effectiveness and safety of the subject device regarding its design, functional and safety requirements.