(211 days)
No
The summary describes standard medical image processing and planning software. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on visualization, registration, and design based on user input and component libraries.
No.
The device is a medical software intended for planning dental implant placement and designing surgical guides; it does not directly treat or diagnose a disease or condition.
No
Explanation: The software's intended use is to "support the planning of dental implants using the visualization of the implant placement." It explicitly states that it "does not extend or change indications of dental implants" and should not be used for "any purpose other than planning dental implant placement or design of surgical guides." While it uses diagnostic data (CT/CBCT), its function is planning and guide design, not providing a medical diagnosis.
Yes
The device is described as a "standalone software application" that runs on "off-the-shelf" PC hardware. It processes data from other medical devices (CT/CBCT, optical scanners) and exports data for the manufacture of a separate physical product (surgical guides). It has no direct contact with the patient and its verification and validation are focused on the software itself.
Based on the provided information, exoplan is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- exoplan's Intended Use: exoplan's intended use is to support the planning of dental implants and the design of surgical guides based on medical images (CT/CBCT and optical scans). It does not analyze biological specimens from the patient.
- Device Description: The device description confirms it's a software application for pre-operative planning and surgical guide design. It interacts with image data, not biological samples.
- No Contact with Patient: The description explicitly states "exoplan has no contact with the patient." This is a key characteristic that differentiates it from devices that interact directly with the patient or their specimens.
While exoplan is a medical device that uses medical data, its function is related to surgical planning and guide design, not the in vitro analysis of biological samples for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/CBCT data sets, optical scan(s) of the patient's anatomy, 3D surface data
Anatomical Site
Dental, patient's anatomy (implants will be placed endosseous dental implants)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets.
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 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.
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.
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.
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).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| 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
| Criteria | Device under evaluation | Predicate device | Reference device | Eval. |
|---|---|---|---|---|
| Trade/ | ||||
| proprietary | ||||
| Name, 510(k) #: | exoplan | exoplan (K183458) | K202256, Implant Studio™ | --- |
| Reason for | ||||
| comparison | --- | Primary software features and | ||
| functionality. | ||||
| Predecessor of the exoplan | ||||
| version that is subject to this | ||||
| submission. | Features that are not available | |||
| in the predicate device: |
- Edentulous case planning
- Virtual tooth extraction | --- |
| Device
Classification
Name: | Medical image
management and
processing system | Medical image
management and
processing system | Medical image
management and
processing system | same |
| Regulation
Number: | 892.2050 | 892.2050 | 892.2050 | same |
| Classification: | Class II | Class II | Class II | same |
| Product Code: | LLZ | LLZ | LLZ | same |
| Prescription/
over the counter
use | Prescription use | Prescription use | Prescription use | same |
| 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 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 | 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 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.
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 | 3Shape Implant Studio 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
and optical scanners. It allows
pre-operative simulation and
evaluation of patient anatomy
and dental implant placement.
Surgical guides and the
planned implant position can be
exported as 3D models and the
guides can be manufactured
using said 3D models when
used as input to 3D
manufacturing systems. | Highly Similar
to the
predicate
Similar to the
reference |
| | 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. | 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. | | |
| Users | dental professionals with
sufficient medical training in
dental implantology and surgical
dentistry | dental professionals with
sufficient medical training in
dental implantology and surgical
dentistry | dental professionals who have
appropriate knowledge in
dental implantology and
surgical dentistry | Same as
predicate
Highly similar
to reference |
| Input data | CT image data and
optical surface scan | CT image data and
optical surface scan | CT image data and
optical surface scan | same |
| Registration /
Alignment of CR
image data and
optical surface
scan | Yes | Yes | Yes | same |
| Output data | Implant planning report, surgical
protocol, STL file with designed
guide for manufacturing | Implant planning report, surgical
protocol, STL file with designed
guide for manufacturing | surgical report, drill protocol is
provided, STL file with
designed guide for
manufacturing | same |
| Avoidance of
Risk Areas
(anatomical
markers) | Mandibular nerve canal and
sinus cavity | Mandibular nerve | Mandibular nerve | same
technology,
additional
locations,
validated
through
performance
testing. |
| Ability to create
guides for
edentulous
patients | Yes | No | Yes | same as
reference |
| Virtual Tooth
Extractor | Yes | No | Yes | Same as
reference |
| Surgical guide
manufacturing | Transfer to a manufacturing site. | Transfer to a manufacturing site. | Transfer to a manufacturing
site. | same |
| Hardware | Any compatible off-the-shelf PC
with a dedicated GPU, monitor
and network connection | Any compatible off-the-shelf PC
with a dedicated GPU, monitor
and network connection | Any compatible of-the shelf PC,
GPU, monitor and network
connection | same |
| GUI OS | Windows ® 10; 64-bit Operating
System | Windows ® 7, 8.1, 10 ; 64-bit
Operating System | Windows ® 7, 8.1, 10 ; 32 and
64-bit Operating System | Highly similar-
removed older,
not supported
OS for security |
6
Overall, the subject and predicate as well as reference devices are the same or highly similar, with any differences mitigated through non-clinical performance testing and software validation, supporting a finding of substantial equivalence. New features are similar to those included in the reference device and the results of verification and validation ensure that the new device is as safe and as effective.