(136 days)
No
The summary describes image processing and analysis software but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML models.
No
The device is described as software for image acquisition, management, transfer, analysis, and display to support diagnostic processes and treatment planning, but it does not directly treat or prevent a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "displays and enhances digital images from various sources to support the diagnostic process and treatment planning."
Yes
The device description explicitly states "DTX Studio Clinic is a software interface" and describes its function as processing and displaying imaging data from various devices, without mentioning any accompanying hardware components that are part of the device itself. The performance studies also focus on software 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 the software is for the acquisition, management, transfer, and analysis of image information to support the diagnostic process and treatment planning. It deals with images of the patient's anatomy, not with testing samples taken from the patient (like blood, urine, tissue, etc.).
- Device Description: The description reinforces this by stating it's a software interface used to analyze 2D and 3D imaging data.
- Input Imaging Modality: The input modalities are all imaging techniques (X-rays, CT scans, intraoral scans, cameras, etc.), not laboratory tests or sample analysis.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This software deals with interpreting images of the body itself, which falls under the category of medical imaging software, not IVD.
N/A
Intended Use / Indications for Use
DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
Product codes
LLZ
Device Description
DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image data volumes, 2D and 3D images such as (CB)CT scans and 2D images such as OPG/panorex images, acquisition of X-Ray images from intra-oral sensors, cephalometric images, intra-oral images, clinical pictures and face scans, STL, NXA, PLY files from intraoral and optical scanner.
Anatomical Site
dental and craniomaxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental/medical practitioners
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
Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
March 25, 2022
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the U.S. Food & Drug Administration logo, with the FDA acronym in a blue square.
Nobel Biocare AB % Wim Vrydag QA/RA Manager Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800 BELGIUM
Re: K213562
Trade/Device Name: DTX Studio Clinic 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 18, 2022 Received: February 22, 2022
Dear Wim Vrydag:
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); 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,
, 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) K213562
Device Name DTX Studio Clinic 3.0
Indications for Use (Describe)
DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
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
Image /page/3/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black font on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
1. 510(k) Summary
I. Submitter
Submitted by: Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800, Belgium Establishment Registration No. 3005739655 Telephone: +32 15 44 32 00 Facsimile: +32 15 44 32 09 Email: wim.vrydag@envistaco.com
Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Göteborg, SE-411 17, Sweden Establishment Registration No. 9611992 Date Prepared: January 18, 2022
II. Device
Name of Device: DTX Studio Clinic 3.0 Manufacturer: Nobel Biocare AB Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ
III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary Predicate: Predicate Device: DTX Studio Clinic Predicate 510(k): K203156 Company: Nobel Biocare AB Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ
4
DTX Studio Clinic 3.0 K213562
Image /page/4/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black font on the right. The letters are sans-serif and the TM symbol is present after the word Biocare.
Reference device:
Reference Device: InvivoDental Reference 510(k): K123519 Company: Anatomage Inc. Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image Processing, Radiological CFR Number: 892.2050 Regulatory Class: II Product Code: LLZ
IV. Device Description
DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).
V. Indications for Use
DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
VI. Comparison of Technological Characteristics
The subject and predicate device are software-based data visualization tools which allow for transfer of medical images and enhancement with intention to support diagnostic process and treatment planning of craniomaxillofacial patients.
Summary comparison of technological similarities and differences
The subject device DTX Studio Clinic 3.0 and the predicate device DTX Studio Clinic 2.0 share following characteristics:
- Clinical Use - intended to support the diagnostic and treatment planning process of craniomaxillofacial anatomical area
- Clinical image data import and acquisition from supported devices, data visualization, ● distance and angular measurements
5
Image /page/5/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
- Image enhancement image filter application, annotations .
- . Airway volume segmentation
- Intraoral radiograph (IOR) automatic image sorting to an FMX template ●
- Dental implant planning
- . Patient data management features
DTX Studio Clinic 3.0 is different from the predicate device DTX Studio Clinic 2.0 as follows:
- . Automatic annotation of the dental mandibular canal
- Importing Face scan
- Removal Intra oral scanner module (NOF) .
A comparison of the subject and predicate devices is provided in the table below.
6
Image /page/6/Picture/2 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the text "Nobel Biocare" in black font. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line.
| Criteria | DTX Studio Clinic 3.0 (subject
device) | DTX Studio Clinic 2.0 (Primary
predicate device)
K203156 | InVivoDental (reference device
for automatic annotation of
mandibular canal)
K123519 | Comments |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Indications for
Use Statement | DTX Studio Clinic is a software
program for the acquisition,
management, transfer and analysis
of dental and craniomaxillofacial
image information, and can be used
to provide design input for dental
restorative solutions. It displays and
enhances digital images from
various sources to support the
diagnostic process and treatment
planning. It stores and provides
these images within the system or
across computer systems at different
locations. | DTX Studio Clinic is a software
program for the acquisition,
management, transfer and analysis
of dental and craniomaxillofacial
image information, and can be used
to provide design input for dental
restorative solutions. It displays and
enhances digital images from
various sources to support the
diagnostic process and treatment
planning. It stores and provides
these images within the system or
across computer systems at different
locations. | InVivoDental is a software
application used for the display and
3D visualization of medical image
files from scanning devices, such as
CT, MRI, or 3D Ultrasound. It is
intended for use by radiologists,
clinicians, referring physicians and
other qualified individuals to
retrieve, process, render, review,
store, print, assist in diagnosis, and
dis tribute images utilizing standard
PC hardware. Additionally,
InVivoDental is a preoperative
software application used for the
simulation and evaluation of dental
implants, orthodontic planning and
surgical treatments | Same |
| Classification
code | LLZ | LLZ, NOF | LLZ | |
| Input
data/Image
acquisition | DICOM image data volumes, 2D
and 3D images such as (CB)CT
scans and 2D images such as
OPG/panorex images, acquisition of
X-Ray images from intra-oral
sensors, cephalometric images,
intra-oral images, clinical pictures
and face scans | DICOM image data volumes, 2D
and 3D images such as (CB)CT
scans and 2D images such as
OPG/panorex images, acquisition of
X-Ray images from intra-oral
sensors, cephalometric images,
intra-oral images and clinical
pictures. | 2D and 3D images such as CT and
MRI, optical scans STL or PLY and
prosthetic designs
of restorations, photos.
Image Capture and Export
AVI (Movie) Capture and Export
Import from PACS | Different – See
discussion below |
| | STL, NXA, PLY files from intraoral
and optical scanner. | STL, NXA, PLY files from intraoral
and optical scanner. | | |
| Output data | Data is stored locally or in remotely
accessible database in the network
(DTX Studio Core).
2D and 3D image export (DICOM
image data volumes, 2D and 3D
images such as (CB)CT scans and
2D images such as OPG/panorex
images, acquisition of X-Ray
images from intra-oral sensors,
cephalometric images, intra-oral
images and clinical pictures.), STL,
PLY, NXA file export.
Export implant or restorative
treatment plan
Diagnostic findings report export. | Data is stored locally or in remotely
accessible database in the network
(DTX Studio Core).
2D and 3D image export (DICOM
image data volumes, 2D and 3D
images such as (CB)CT scans and
2D images such as OPG/panorex
images, acquisition of X-Ray
images from intra-oral sensors,
cephalometric images, intra-oral
images and clinical pictures.), STL,
PLY, NXA file export.
Export implant or restorative
treatment plan
Diagnostic findings report export. | Data is stored locally.
2D and 3D image export (DICOM
image data volumes, 2D and 3D
images such as (CB)CT scans and
2D images such as
OPG/panorex images, acquisition of
X-Ray images from intra-oral
sensors, cephalometric
images, intra-oral images and
clinical pictures.), STL, PLY,
NXA file export.)
Export data in
DICOM/DICOMDIR format or
proprietary format, including
treatment plans with implants and
measurements, traced nerves
or other annotations, images
captured, sculpting operations,
imported models, ortho tracings
from 3D analysis.
Export optionally with a
proprietary viewer or with web
browser-based 3D viewer.
Export to PACS | Same |
| Image
processing | Enhancement (image filter
application), annotations,
measurements (distance and
angular, volume and surface area
for data segmentation),
import/export.
Airway volume segmentation. | Enhancement (image filter
application), annotations,
measurements (distance and
angular, volume and surface area
for data segmentation),
import/export.
Airway volume segmentation. | Enhancement (image filter
application), annotations, Linear,
Angular, Circumferential, Area, and
Volumetric Measurements (distance
and angular, volume and surface
area for data
segmentation), bone density evaluat
ion, import/export.
Creation of fly-through /
presentation movies in AVI format. | Same |
| | Alignment of surface scans, such as
intra-oral or dental cast scans
.STL/.PLY files with (CB)CT data
for accurate implant planning | Alignment of surface scans, such as
intra-oral or dental cast scans
.STL/.PLY files with (CB)CT data
for accurate implant planning | Airway volume segmentation.
Endo visualizations.
TMJ visualizations.
Automatic Superimposition and
Mirroring
Alignment of surface scans, such as
intra-oral or dental cast scans
.STL/.PLY files with (CB)CT data
for accurate implant planning. | |
| Software
Features | Scan data: | Scan data: | Scan data: | Same |
| | The software can directly acquire
images from supported imaging
modalities or allow manual import
of images by import dialog. The
data can be manually adjusted with
the wizard editor.
The data can be also imported from
3rd party patient management
systems via standard protocol -
VDDS, or via Nobel Biocare
proprietary OPP protocol. | The software can directly acquire
images from supported imaging
modalities or allow manual import
of images by import dialog. The
data can be manually adjusted with
the wizard editor.
The data can be also imported from
3rd party patient management
systems via standard protocol -
VDDS, or via Nobel Biocare
proprietary OPP protocol | The software can open DICOM
3D images from various device
types and producers by import
dialog. The data can be manually
adjusted with the wizard editor.
Scan can be reoriented in 3D
coordinates.
Stitching of 3D volumes | |
| | Diagnostic:
The diagnostic module allows to
review and diagnose 2D and 3D
image data as well as clinical
images. The user can apply image
filters and can measure length,
angles and HU units.
The software allows to compare 3D
images and 2D intraoral images in
the same workspace | Diagnostic:
The diagnostic module allows to
review and diagnose 2D and 3D
image data as well as clinical
images. The user can apply image
filters and can measure length,
angles and HU units.
The software allows to compare 3D
images and 2D intraoral images in
the same workspace | Diagnostic:
The software allows to review 2D
and 3D image data. The user can
apply image filters, modify
brightness and contrast.
The user can apply image filters and
can measure length, angles, HU
units
volumetric measurements of render
Comparison of multiple 3D | Different - See
discussion below |
| Visualization of airways, volume
segmentation, volume measurement
and maximum constriction point
determination.
Automatic annotation of the
mandibular canals based on
anatomical landmarks | Visualization of airways, volume
segmentation, volume measurement
and maximum constriction point
determination. | Visualization of airways, volume
segmentation, volume measurement
and maximum constriction point
determination.
Creation and visualization of the
nerve manually or by using the
Automatic Nerve feature | | |
| Intraoral scanner:
Import of surface scan files and
their registration with other scans. | Intraoral scanner:
DTX Studio ioscan module is a user
interface supporting a dental optical
impression system, more
specifically an intraoral scanning
device.
Review of STL, PLY, NXA type
data within dedicated workspace | Intraoral scanner:
Import of surface scan files and
their registration with other scans. | Different - See
discussion below | |
| Automatic sorting algorithm:
Intraoral radiograph (IOR)
automatic image sorting to an FMX
template (dental X-ray image
layout). | Automatic sorting algorithm:
Intraoral radiograph (IOR)
automatic image sorting to an FMX
template (dental X-ray image
layout). | N/A | Same | |
| Implant Planning:
Functionality for implant planning
treatment. Adding dental implant
shapes to DICOM data for treatment
planning. | Implant Planning:
Functionality for implant planning
treatment. Adding dental implant
shapes to DICOM data for treatment
planning. | Implant Planning:
Functionality for implant planning
treatment. Adding dental implant
shapes to DICOM data for treatment
planning.
Density profile control
Abutment planning and margin
planning
Bone graft simulation | Same | |
| | Virtual tooth setup: | Virtual tooth setup: | Virtual tooth setup: | Same |
| | Algorithm calculates and visualizes
a 3D tooth shape for a missing tooth
position, based on a set of indicated
landmarks and the loaded intra-oral
scan | Algorithm calculates and visualizes
a 3D tooth shape for a missing tooth
position, based on a set of indicated
landmarks and the loaded intra-oral
scan | Library of wax-up and prosthetic
restorations for crown-down
planning
Mesh editing and collision
detecting features
Articulation | |
| Operating
system
requirements | Windows 10 64-bit, macOS
Catalina, macOS BigSur | Windows 10 64-bit
macOS Mojave, macOS Catalina | Windows 7 64-bit, Windows 8 64-
bit or Windows 10 64-bit., Apple
Bootcamp with Windows, macOS
Yosemite and higher | Different - See
discussion below |
| Recommended
hardware
requirements | CPU: quad-core of 2.8 GHz or more
(such as Intel Core i5 or i7)
RAM: 8GB
Graphics card with support of
OpenGL 3.3 and 2GB memory or
more (4GB or more for 4K
displays)
HDD: 10GB of free space
Monitor: FullHD (1920x1080) or
higher | CPU: quad-core of 2.8 GHz or more
(such as Intel Core i5 or i7)
RAM: 8GB
Graphics card with support of
OpenGL 3.3 and 2GB memory or
more (4GB or more for 4K
displays)
HDD: 10GB of free space
Monitor: FullHD (1920x1080) or
higher | CPU: Intel Core i5 2400,
recommended Intel Core i7 4000 or
similar. RAM min 4GB,
recommended 8GB. Graphic
card Intel HD 4000, recommended
AMD Radeon RX 580 or
comparable.
HDD: 100 GB minimum, 500
GB recommended. | Same |
Table 1: Comparison of DTX Studio Clinic to Predicate Devices
7
DTX Studio Clinic 3.0
Image /page/7/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a stylized red letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
8
DTX Studio Clinic 3.0 K213562
Image /page/8/Picture/2 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like the letter N. To the right of the symbol is the text "Nobel Biocare" in a simple, sans-serif font. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".
9
DTX Studio Clinic 3.0 K213562
Image /page/9/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
10
DTX Studio Clinic 3.0 K213562
Image /page/10/Picture/2 description: The image shows the logo for Nobel Biocare. The logo consists of a red letter N on the left side and the words "Nobel Biocare" on the right side. The letter N is stylized and appears to be made up of two intersecting lines.
11
Discussion
Similarities:
The subject device DTX Studio Clinic 3.0 and primary predicate device DTX Studio Clinic 2.0 (K203156) have the same Intended Use and share most software functions/features. Automatic annotation of the mandibular canals is shared with the reference device InVivoDental (K123519).
As seen in the table above, the subject and predicate devices are equivalent in terms of software functionalities. All devices allow import of variety of 2D/3D imaging data, its enhancement, viewing, processing and visualization for the purpose of supporting the diagnostic and treatment planning process.
Difference in indications for use and software features are discussed below.
Differences:
Indications for Use
The Indications for Use statement between the subject and the primary predicate device (K203156) are the same.
Both DTX Studio Clinic 3.0 and the primary predicate device DTX Studio Clinic 2.0 allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image data within the system (locally) or across computer systems in distributed locations. DTX Studio Clinic 3.0 allows transfer of images and patient data (store and retrieval) to and from the DTX Studio Core database, thus making the data available in different locations.
Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete craniomaxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire craniomaxillofacial area, as a support for the diagnostic process.
Both the subject and primary predicate provide design input for restorative solutions to 3rd party software or software from DTX Studio ecosystem, but it does not provide functionality of designing restorations within the software itself.
12
Differences in software features/functionality
Input data/Image acquisition - 3D Face scans - The difference between the subject device and the predicate device is that 3D facial scans can now be imported and visualized in the software. 3D Face scans can be used to provide the user with additional information to perform diagnosis and treatment planning.
Diagnostic -Automatic annotation of the mandibular canals - The difference between the subject device and the predicate device is that DTX Studio Clinic 3.0 allows the segmentation and visualization of the mandibular canals. The software automatically segments the mandibular canal based on the identification of the mandibular foramen and the mental foramen. This functionality is similar as in the reference device InVivoDental (K123519). The user can also manually indicate or adjust the mandibular canal.
Intraoral scanner- The difference between the subject device and the predicate device is that the DTX Studio ioscan module, classified as NOF, 872.3661 (510k exempt) is no longer available into the DTX Studio Clinic 3.0. This change does not affect the intended use of the software, since customers can import data from optical intraoral scanners into DTX Studio Clinic 3.0
Minor differences:
Various operating systems are currently supported by DTX Studio Clinic 3.0, due to release of new versions of these operating systems during the lifecycle of DTX Studio Clinic 3.0. DTX Studio Clinic 3.0 was tested and validated on these operating systems
VII. Performance Data
DTX Studio Clinic 3.0 is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of IEC 62304:2006 standards. Design Control Activities, including risk management following the ISO 14971:2019, verification/validation testing, were conducted and are included in this submission.
The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.
Software Validation
Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA
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Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
VIII. Conclusion
Based on the comparison of the intended use, the features and workflows, the user interface, the technical characteristics, and based on the software verification/validation activities described in this submission, DTX Studio Clinic 3.0 is found to be substantially equivalent to the identified Predicate Device.