exoplan
Device Facts
| Record ID | K213302 |
|---|---|
| Device Name | exoplan |
| Applicant | Exocad GmbH |
| Product Code | LLZ · Radiology |
| Decision Date | May 3, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
exoplan is a medical software, intended to support the planing of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
Device Story
Standalone software for pre-operative dental implant planning and surgical guide design; operates on off-the-shelf PC hardware with Windows 10 and dedicated GPU. Inputs: CT/CBCT datasets and optical surface scans (teeth, impressions, stone models). Process: Registration of modalities to common coordinate system; user-defined implant positioning; component library integration (implants, drills, sleeves). Output: Surgical protocol, planning report, and STL files for 3D manufacturing of surgical guides. Used in dental office environments by trained dental professionals. Output informs surgical intervention; does not replace clinical due diligence. Benefits: Facilitates guided surgery planning and custom guide design.
Clinical Evidence
Bench testing only. No clinical data performed. Software verification and validation conducted per FDA guidance; accuracy tests verified planning results against defined criteria.
Technological Characteristics
Standalone software; runs on off-the-shelf PC hardware (Windows 10, 64-bit, dedicated GPU). Inputs: DICOM CT/CBCT, STL optical scans. Features: Component libraries (digitally signed), 3D registration, surgical guide design. No patient contact. Cybersecurity: Digitally signed libraries.
Indications for Use
Indicated for dental professionals with training in implantology and surgical dentistry to plan dental implant placement and design surgical guides for endosseous dental implants using CT/CBCT and optical scan data.
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
- exoplan 2.3 (K183458)
Reference Devices
- Implant Studio (K202256)
Submission Summary (Full Text)
{0}------------------------------------------------
May 3, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
exocad GmbH % Tobias Turba Quality Engineer 37. Julius-Reiber-Str. Darmstadt, Hesse 64293 GERMANY
Re: K213302
Trade/Device Name: exoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 29, 2022 Received: March 31, 2022
Dear Tobias Turba:
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
{1}------------------------------------------------
801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K213302
Device Name exoplan
#### Indications for Use (Describe)
exoplan is a medical software, intended to support the planing of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary, Traditional 510(k)
## Submitter Information
exocad GmbH 37, Julius-Reiber-Straße Darmstadt, HE 64293 Germany
Contact Person: Tobias Turba, Quality Engineer Phone: +49-6151-629489-0 fax: +49 6151-629489-9
Establishment Registration number: 3011521456
Date prepared: 2021-09-29
## Manufacturing Facility
Same as submitter.
## Device Information
| Trade/proprietary Name: | exoplan |
|------------------------------|---------------------------------------------------------------------------------------|
| Common Name/Usual name: | Dental Implant Planning and tooth/gingiva supported<br>Surgical Guide design software |
| Device Classification Name: | Medical image management and processing system |
| Regulation Number: | 892.2050 |
| Classification: | Class II |
| Classification Product Code: | LLZ |
#### Predicate Device
exoplan has been compared to the following predicate legally marketed device: 510(k) Number: K183458 Device name: exoplan 2.3 Manufacturer: exocad GmbH, Julius-Reiber-Str. 37, 64293 Darmstadt
## Reference Device
exoplan has been compared to the following reference legally marketed device:
| 510(k) Number: | K202256 |
|----------------|-------------------------------------------------|
| Device name: | Implant StudioTM |
| Manufacturer: | 3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen |
## Indications for Use
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.
exoplan allows the design of surgical quides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions.
Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the
{4}------------------------------------------------
surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical quide designed with the software does not change the necessary due diligence required to conventional (non-quided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
#### Device Description & Summary of Technical Characteristics
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with Microsoft Windows 10 operating system (64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT and optical scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the optical scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called component libraries, which contain (e.g., physical dimensions, compatibility, etc.) provided by the original manufacturer of a component, and cover all components that can be used during treatment and necessary to consider during planning, e.g. implants, drills and drill sleeves. The libraries are digitally signed. This ensures that any modification of the content of a library will be detected by exoplan. The issue is then reported to the user and documented in the Implant Planning Report or the Surgical Protocol.
exoplan has no contact with the patient.
#### Non-Clinical Performance Testing
Software verification and validation is performed in accordance with the applicable guidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of exoplan the verification of the device has been completed. Each user requirement and each derived product requirement has an own acceptance criteria. Detected anomalies are evaluated, resolved or where appropriate (e.g. in case of a minor issue) described in the release notes. The verification and validation include the verification and where appropriate validation of the risk mitigation measure as defined by the risk analysis. Feedback of software testers and feedback from validation is regarded in the device as appropriate. Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined.
#### Clinical
Clinical testing is not a requirement and has not been performed.
{5}------------------------------------------------
# Comparative information on Predicate Device
exoplan has been compared to the following legally marketed devices:
Predicate Device: exoplan 2.3 (K183458) Reference Device: Implant Studio (K202256)
| Comparable<br>Criteria | Device under evaluation | Predicate device | Reference device | Eval. |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Trade/<br>proprietary<br>Name, 510(k) #: | exoplan | exoplan (K183458) | K202256, Implant Studio™ | --- |
| Reason for<br>comparison | --- | Primary software features and<br>functionality.<br>Predecessor of the exoplan<br>version that is subject to this<br>submission. | Features that are not available<br>in the predicate device:<br>- Edentulous case planning<br>- Virtual tooth extraction | --- |
| Device<br>Classification<br>Name: | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | same |
| Regulation<br>Number: | 892.2050 | 892.2050 | 892.2050 | same |
| Classification: | Class II | Class II | Class II | same |
| Product Code: | LLZ | LLZ | LLZ | same |
| Prescription/<br>over the counter<br>use | Prescription use | Prescription use | Prescription use | same |
| indications for<br>use | exoplan is a medical software,<br>intended to support the pre-<br>operative planning of dental<br>implants using the visualization of<br>the implant placement within<br>images of the patient's anatomy.<br>The process is based on<br>CT/CBCT data sets originating<br>from other medical devices, and<br>can be supported by optical<br>scan(s) of the patient's anatomy<br>as well as a virtual prosthetic<br>proposal.<br>exoplan allows the design of<br>surgical guides to support the<br>placement of endosseous dental<br>implants in guided surgery. The<br>design of surgical guides is<br>based on 3D surface data<br>representing the preoperative<br>situation and approved implant<br>positions.<br>Alternatively, instead of optical<br>surface data a second CBCT/CT<br>dataset can be used.<br>The software exports the<br>planning and design results as<br>geometrical data and a digital 3D<br>model of the surgical guide to<br>support the manufacture of a<br>separate physical product.<br>exoplan does not extend or<br>change indications of dental<br>implants. Usage of a surgical<br>guide designed with the software<br>does not change the necessary<br>due diligence required compared<br>to conventional (non-guided)<br>surgery.<br>The software is intended to be<br>used only by dental professionals | exoplan is a medical software,<br>intended to support the pre-<br>operative planning of dental<br>implants using the visualization of<br>the implant placement within<br>images of the patient's anatomy.<br>The process is based on<br>CT/CBCT data sets originating<br>from other medical devices, and<br>can be supported by optical<br>scan(s) of the patient's anatomy<br>as well as a virtual prosthetic<br>proposal.<br>exoplan allows the design of<br>surgical guides to support the<br>placement of endosseous dental<br>implants in guided surgery. The<br>design of surgical guides is<br>based on 3D surface data<br>representing the preoperative<br>situation and approved implant<br>positions.<br>The software exports the<br>planning and design results as<br>geometrical data and a digital 3D<br>model of the surgical guide to<br>support the manufacture of a<br>separate physical product.<br>exoplan does not extend or<br>change indications of dental<br>implants. Usage of a surgical<br>guide designed with the software<br>does not change the necessary<br>due diligence required compared<br>to conventional (non-guided)<br>surgery.<br>The software is intended to be<br>used only by dental professionals | 3Shape Implant Studio is an<br>implant planning and surgery<br>planning software tool intended<br>for use by dental professionals<br>who have appropriate<br>knowledge in dental<br>implantology and surgical<br>dentistry. This software reads<br>imaging information output from<br>medical scanners such as CT<br>and optical scanners. It allows<br>pre-operative simulation and<br>evaluation of patient anatomy<br>and dental implant placement.<br>Surgical guides and the<br>planned implant position can be<br>exported as 3D models and the<br>guides can be manufactured<br>using said 3D models when<br>used as input to 3D<br>manufacturing systems. | Highly Similar<br>to the<br>predicate<br>Similar to the<br>reference |
| | with sufficient medical training in<br>dental implantology and surgical<br>dentistry in office environments<br>suitable for reading diagnostic<br>dental DICOM data sets. exoplan<br>shall not be used for any purpose<br>other than planning dental<br>implant placement or design of<br>surgical guides. | with sufficient medical training in<br>dental implantology and surgical<br>dentistry in office environments<br>suitable for reading diagnostic<br>dental DICOM data sets. exoplan<br>shall not be used for any purpose<br>other than planning dental<br>implant placement or design of<br>surgical guides. | | |
| Users | dental professionals with<br>sufficient medical training in<br>dental implantology and surgical<br>dentistry | dental professionals with<br>sufficient medical training in<br>dental implantology and surgical<br>dentistry | dental professionals who have<br>appropriate knowledge in<br>dental implantology and<br>surgical dentistry | Same as<br>predicate<br>Highly similar<br>to reference |
| Input data | CT image data and<br>optical surface scan | CT image data and<br>optical surface scan | CT image data and<br>optical surface scan | same |
| Registration /<br>Alignment of CR<br>image data and<br>optical surface<br>scan | Yes | Yes | Yes | same |
| Output data | Implant planning report, surgical<br>protocol, STL file with designed<br>guide for manufacturing | Implant planning report, surgical<br>protocol, STL file with designed<br>guide for manufacturing | surgical report, drill protocol is<br>provided, STL file with<br>designed guide for<br>manufacturing | same |
| Avoidance of<br>Risk Areas<br>(anatomical<br>markers) | Mandibular nerve canal and<br>sinus cavity | Mandibular nerve | Mandibular nerve | same<br>technology,<br>additional<br>locations,<br>validated<br>through<br>performance<br>testing. |
| Ability to create<br>guides for<br>edentulous<br>patients | Yes | No | Yes | same as<br>reference |
| Virtual Tooth<br>Extractor | Yes | No | Yes | Same as<br>reference |
| Surgical guide<br>manufacturing | Transfer to a manufacturing site. | Transfer to a manufacturing site. | Transfer to a manufacturing<br>site. | same |
| Hardware | Any compatible off-the-shelf PC<br>with a dedicated GPU, monitor<br>and network connection | Any compatible off-the-shelf PC<br>with a dedicated GPU, monitor<br>and network connection | Any compatible of-the shelf PC,<br>GPU, monitor and networ…
