(461 days)
No
The 510(k) summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The description focuses on image processing and simulation based on virtual models and CT/DVT data, which are standard functionalities in orthodontic software and do not inherently require AI/ML.
No
The device is described as software for managing and evaluating images for digital orthodontics, and for simulation and planning of treatments. It does not directly provide a therapeutic effect on the patient.
Yes
The software is intended for "managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics" and can "digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data," which are functions that aid in diagnosis.
Yes
The device description explicitly states "OnyxCeph3™ is a software device" and the intended use and device description focus solely on software functionalities for image management and evaluation in orthodontics. There is no mention of accompanying hardware components included with the device.
Based on the provided information, OnyxCeph3™ software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- OnyxCeph3™ Function: The description clearly states that OnyxCeph3™ is used for managing and evaluating images (2D and 3D) and performing image-based orthodontic workflows. It works with virtual models and CT/DVT volume data.
- No Biological Samples: There is no mention of the software analyzing or interacting with biological samples from the patient. Its function is solely based on processing and analyzing medical images.
Therefore, while OnyxCeph3™ is a medical device used in the context of patient care (orthodontics), its function does not fall under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OnyxCeph3TM software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph7TM requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, PNN
Device Description
OnyxCeph3TM dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3TM is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found (Refers to 2D and 3D images, CT/DVT volume data, but no specific modalities like X-ray, MRI, etc. are listed for input)
Anatomical Site
Maxilla and Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified staff only. The use of OnyxCeph3TM requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
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)
Nonclinical Testing
Software Validation conducted per FDA Guidance for Software Contained in Medical Devices IEC 62304 - Software Life Cycle Processes
Clinical Testing
Clinical testing has not been included and is not required to demonstrate substantial equivalence.
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
Image /page/0/Picture/0 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
January 4, 2023
Image Instruments GmbH % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606
Re: K213263
Trade/Device Name: OnyxCeph3TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, PNN Dated: November 30, 2022 Received: December 5, 2022
Dear Greg Holland:
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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213263
Device Name OnyxCeph3TM
Indications for Use (Describe)
OnyxCeph*™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph7™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.
| 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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5. 510(k) Summary - K213263
| 510(k) Owner | Image Instruments GmbH
Niederwaldstr. 3
09123 Chemnitz
Germany
Phone: +49 371 9093140
Facsimile: +49 371 9093149 | | OnyxCeph3 TM
K213263
Subject Device | VISTADENTTM AT
COMPLETE K053010
Predicate Device | | OnyxCeph3™
K213263
Subject Device | VISTADENT™ AT
COMPLETE K053010
Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------|--------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Greg Holland
Regulatory Specialists, Inc.
3722 Ave. Sausalito
Irvine, CA 92606
Phone: 949.262.0411
Fax: 949.552.2821
Email: greg@regulatoryspecialists.com | Intended Use | Orthodontic Software | Orthodontic Software | Indications for
Use | OnyxCeph3™ software
is intended to be used
for the medical
purpose of managing
and evaluating two-
dimensional and three-
dimensional images in
the framework of
digital orthodontics by
qualified staff only.
The use of
OnyxCeph3™ requires
the user to have the
necessary training and
domain knowledge in
the practice of
orthodontics, as well
as to have received a
dedicated training in
the use of the
software.
The software can be
used to digitally perform
certain image- based
orthodontic workflows,
such as metric and
angular evaluation of
image data. | VISTADENT™ AT
COMPLETE software is
a digital database for
storing, retrieving and
printing images that also
has the ability to perform
image manipulation and
cephalometric analysis. |
| Submission Date | January 3, 2023 | Product Code | LLZ | LLZ | | | |
| Common Name
Trade Name
Classification Name
Regulation
Class
Panel
Primary Product Code
Secondary Product Code | Orthodontic Software
OnyxCeph3TM
Radiological Image Processing System
892.2050
Class II
Dental
LLZ
PNN | 2 Dimensional
Image Import | Yes | Yes | | | |
| Primary Predicate Device | K053010
VISTADENTTM AT
COMPLETE
From: Dentsply INTL.,
Inc. | 2 Dimensional
Image Adjust | Yes | Yes | | | |
| Reference Device | K171634
Ortho SystemTM
From: 3Shape A/S
K192475
NemoFAB
From: Software
Nemotec S.L. | | | | | | |
Description
OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.
4
Intended Use
OnyxCeph3™ is a software only device and is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and threedimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software. Diagnostic and therapeutic decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.
Indications for Use
OnyxCeph3™ software is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.
Technological Characteristics
The predicates and the Image Instruments GmbH OnyxCeph3™ were compared in the following areas and found to have similar technological characteristics and to be equivalent. Both predicates are shown as a comparison in separate tables.
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| | OnyxCeph3™
K213263
Subject Device | VISTADENT™ AT
COMPLETE K053010
Predicate Device |
|----------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 2 Dimensional
Cephalometric
Evaluation | Yes | Yes |
| 2 Dimensional
Image
Combination | Yes | Yes |
| 2 Dimensional
Image
Comparison | Yes | Yes |
| 2 Dimensional
Mirroring | Yes | Yes |
| CO/CR-
Conversion | Yes | Yes |
| Ricketts VTO | Yes | Yes |
| 2 Dimensional
Treatment
Simulation | Yes | Yes |
| Windows Based | Yes | Yes |
| Activation by
Key | Yes | Yes |
| Client
Requirements | Hardware Type, CPU,
RAM, Disk, Network,
Graphic Board, Desktop
Resolution | Hardware Type CPU, RAM,
Disk, Network, Graphic
Board,
Desktop Resolution |
| Client
Requirements | Not Required | Internet Access,
Internet Speed |
| Server
Requirements | Hardware Type, CPU,
RAM, Disk, Network,
Port Sharing | Hardware Type, CPU,
RAM, Disk, Network,
Port Sharing |
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| | OnyxCeph3™
K213263
Subject Device | Ortho System
3Shape A/S
K171634
Reference
Device |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Indications | Orthodontic Software
OnyxCeph3™ software is
intended to be used for the
medical purpose of
managing and evaluating
two-dimensional and
three-dimensional images
in the framework of digital
orthodontics by qualified
staff only. The use of
OnyxCeph3™ requires the
user to have the necessary
training and domain
knowledge in the practice
of orthodontics, as well as
to have received a
dedicated training in the
use of the software.
The software can be used
to digitally perform certain
image- based orthodontic
workflows, such as metric
and angular evaluation of
image data. | Orthodontic Software
The 3Shape Ortho
System™ is intended for
use as a medical front-
end device providing
tools for management of
orthodontic models,
systematic inspection,
detailed analysis,
treatment simulation and
virtual appliance design
options (Custom Metal
Bands, Export of
Models, Indirect
Bonding Transfer
Media) based on 3D
models of the patient's
dentition before the start
of an orthodontic
treatment. It can also be
applied during the
treatment to inspect and
analyze the progress of
the treatment. It can be
used at the end of the
treatment to evaluate if
the outcome is
consistent with the
planned/desired
treatment objectives.
The use of the Ortho
System™ requires the
user to have the
necessary training and
domain knowledge in
the practice of
orthodontics, as well as
to have received a
dedicated training in the
use of the software. |
| Product Code | LLZ | PNN |
| | OnyxCeph3TM
K213263
Subject Device | Ortho System
3Shape A/S
K171634
Reference
Device |
| 2 Dimensional
Evaluation | Yes | Yes |
| 2 Dimensional
Cephalometric
Evaluation | Yes | No |
| 3 Dimensional
Evaluation | Yes | Yes |
| Supported
anatomical areas | Maxilla and Mandible | Maxilla and Mandible |
| Determine arch
shape | Yes | Yes |
| Determine wire
length | Yes | Yes |
| Determine tooth
width | Yes | Yes |
| Determine Bolton | Yes | Yes |
| Determine space
analysis | Yes | Yes |
| Determine overbite | Yes | Yes |
| Determine
occlusion | Yes | Yes |
| Extract/Segment
Volume Scans | Yes | Yes |
| Combine Bony and
Dental Scan Data | Yes | Yes |
| Windows Based | Yes | Yes |
| Data Storage | Local | Local / Cloud |
| Activation by
Dongle | No | Yes |
| | OnyxCeph3™
K213263
Subject Device | Ortho System
3Shape A/S
K171634
Reference
Device |
| Activation by Key | Yes | No |
| Client
Requirements | Hardware Type, CPU,
RAM, Disk, Network,
Graphic Board, Desktop
Resolution | Hardware Type, CPU,
RAM, Disk, Network,
Graphic Board,
Desktop Resolution |
| Client
Requirements | Not required | Internet Access,
Internet Speed |
| Server
Requirements | Hardware Type, CPU,
RAM, Disk, Network,
Port Sharing | Hardware Type, CPU,
RAM, Disk, Network,
Port Sharing |
8
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Although the Indications for Use Statement for the subject device is different from the predicate device, K053010, the intended use of the software is the same, to allow for two-dimensional and three-dimensional evaluation of images. The predicate device includes Internet Access which is not required for the subject device. The subject device includes 3-dimensional evaluation capabilities; whereas the predicate device does not. However, the reference devices support this function.
The reference device, K171634, was included to support the 3-dimensional evaluation capabilities of the subject device. This reference device does not include 2-Dimensional Cephalometric function, and activation by Key. However, the 2-Dimensional Cephalometric function is supported by the predicate device. The reference device offers activation by Dongle. In addition, the reference device supports the use of Data Storage via the Cloud and requires Internet Access whereas the subject device does not.
Additional reference device, K192475 was included to support the devices intended use for supporting the treatment planning process of orthognathic procedures.
In summary, the similarities between the subject device, OnyxCeph3™, and the predicate devices are functionally very similar. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.
Nonclinical Testing
Software Validation conducted per FDA Guidance for Software Contained in Medical Devices IEC 62304 - Software Life Cycle Processes
Clinical Testing
Clinical testing has not been included and is not required to demonstrate substantial equivalence.
Conclusion
Based on the similarities between the intended use, indications, principle of operation, features and technical data, the subject device, OnyxCeph3™, is found to be substantially equivalent to the predicate device.