(259 days)
Not Found
No
The description focuses on manual digitization and tracing by the user, with no mention of automated landmark detection or analysis using AI/ML.
No
The device is described as software for cephalometric tracing and image analysis to assist in treatment planning and diagnosis, not to directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is utilized by dental professionals to "assist in treatment planning and case diagnosis."
Yes
The device description explicitly states "SmartCeph is a software-only dental image device". While it operates on standard PC hardware, the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of SmartCeph clearly states it operates on "a patient's digital lateral cephalometric x-ray image." This is an image of the body, not a specimen derived from the body (like blood, urine, tissue, etc.).
- The intended use is for analyzing images for diagnosis and treatment planning. While this is a diagnostic process, it's based on interpreting imaging data, not analyzing biological samples.
- The device description focuses on image processing and analysis. The functionalities described are digitizing landmarks, tracing structures, viewing measurements, and superimposing images. These are all related to manipulating and analyzing visual data from an x-ray.
Therefore, SmartCeph falls under the category of a medical imaging device or software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SmartCeph software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
Product codes
LLZ
Device Description
SmartCeph is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x- ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation.
SmartCeph is imaging software designed for use in dentistry. The main SmartCeph software functionality includes image visualization, cephalometric tracing and measurements.
SmartCeph is used by dental professional for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review and treatment planning for orthodontic and orthognathic applications. If a suitable JPEG image (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be utilized to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. If multiple x-ray images for which cephalometric data has been digitized are imported, the resulting tracings can be overlaid to indicate changes and/or differences in the anatomy. The software operates upon standard Windows PC hardware and displays images on the PC's connected display/monitor.
SmartCeph is a standalone product but is designed to work cooperatively with Ortho2's dental practice management software that is used for scheduling and billing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital lateral cephalometric x- ray image (JPEG image)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practices / dental professional
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
Ortho2, LLC has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SmartCeph. All the different components of the SmartCeph have been stress tested to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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October 17, 2019
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ortho2, LLC % W. Edward Johansen Official Correspondent 1239 Stanford Street, #205 SANTA MONICA CA 90404
Re: K190162
Trade/Device Name: SmartCeph Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 10, 2019 Received: September 12, 2019
Dear Mr. Johansen:
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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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
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VI. Indications for Use
510(k) Number (if known)
Device Name SmartCeph
SmartCeph software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
| 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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VII. 510(k) Summary
510k Number: K190162
A. Applicant Information
Date Prepared: October 9, 2019
Corporate Name: Ortho2, LLC
Address: 1107 Buckeye Avenue, Ames, lowa 50010
Device Trade Name: SmartCeph
Manufacturer: Ortho2, LLC
Classification Name: Picture Archiving and Communications System
Product Code: LLZ
Classification: Class II
Panel: Radiology
Regulation Number: 21 C.F.R. 892.2050
Submitter: Amy Schmidt, President
Telephone Number: (515) 233-1026
Contact Person: W. Edward Johansen, Official Correspondent
Telephone Number: (310) 795-7425
B. Predicate Device
SmartCeph is substantially equivalent to the following FDA cleared Dolphin Imaging predicate with regards to indications for use, intended use, performance and technological characteristics:
Proprietary Name: Dolphin Imaging
Corporate Name: Patterson Dental Supply, Inc. doing business as Dolphin Imaging & Management
510(k) Number: K110430
Classification Name: Picture Archiving and Communications System
Product Code: LLZ
Classification: Class II
4
Panel: Radiology
Regulation Number: 21 C.F.R. 892.2050
C. Device Description
SmartCeph is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x- ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation.
SmartCeph is imaging software designed for use in dentistry. The main SmartCeph software functionality includes image visualization, cephalometric tracing and measurements.
SmartCeph is used by dental professional for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review and treatment planning for orthodontic and orthognathic applications. If a suitable JPEG image (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be utilized to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. If multiple x-ray images for which cephalometric data has been digitized are imported, the resulting tracings can be overlaid to indicate changes and/or differences in the anatomy. The software operates upon standard Windows PC hardware and displays images on the PC's connected display/monitor.
SmartCeph is a standalone product but is designed to work cooperatively with Ortho2's dental practice management software that is used for scheduling and billing.
D. Intended Use/Indications for Use
SmartCeph software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
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E. Technical Characteristics
SmartCeph is a software only device that handles digital medical images. SmartCeph neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
SmartCeph allows the user to digitize landmarks on a patient's digital lateral cephalometric x-ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation.
SmartCeph is a Windows Executable written in C# language, that is intended for use on modern Windows PCs. SmartCeph operates on most computer workstations capable of running the Microsoft Windows 7 Professional operating system, and above, with a minimum of 2GB RAM, 128MB Video RAM, DirectX 9 Tier1, resolution of 1600 x 900, and a Windows Experience Index of 4 or better. SmartCeph also requires Microsoft .NET Framework 3.5 SP1 or greater.
F. Recognized Standards
SmartCeph is software that conforms to the following recognized standards.
ISO 14971 Medical Devices-Application of Risk Management to Medical Devices
IEC 62304 Medical Device Software Life Cycle Processes
G. Comparing the Dolphin Imaging Predicate to SmartCeph
Below the Comparison Table compares the Dolphin Imaging predicate to SmartCeph.
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Comparison Table
| 501(k) Number | K110430 | K190162 |
|---|---|---|
| Trade/Device Name | Dolphin Imaging | SmartCeph |
| Intended Use | Dolphin Imaging is | |
| software that is | ||
| designed for use by | ||
| specialized dental | ||
| practices for capturing, | ||
| storing and presenting | ||
| patient images and | ||
| assisting in treatment | ||
| planning and case | ||
| diagnosis. Results | ||
| produced by the | ||
| software's diagnostic | ||
| and treatment planning | ||
| tools are dependent on | ||
| the interpretation of | ||
| trained and licensed | ||
| dental practitioners. | SmartCeph software is | |
| designed for use by | ||
| dental practices for | ||
| cephalometric tracing | ||
| and presenting patient | ||
| images which are | ||
| utilized by dental | ||
| professionals to assist in | ||
| treatment planning and | ||
| case diagnosis. Results | ||
| produced by the | ||
| software's diagnostic | ||
| and treatment planning | ||
| tools are dependent on | ||
| the interpretation of | ||
| trained and licensed | ||
| dental practitioners. | ||
| Operation System | Windows or Mac OS | Windows |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Indication for Use | Dolphin Imaging | |
| software is designed | ||
| for use by specialized | ||
| dental practices for | ||
| capturing, storing and | ||
| presenting patient | ||
| images and assisting | ||
| in treatment planning | ||
| and case diagnosis. | ||
| Results produced by | ||
| the software's | ||
| diagnostic and | ||
| treatment planning | ||
| tools are dependent on | ||
| the interpretation of | SmartCeph software is | |
| designed for use by | ||
| dental practices for | ||
| cephalometric tracing | ||
| and presenting patient | ||
| images which are | ||
| utilized by dental | ||
| professionals to assist | ||
| in treatment planning | ||
| and case diagnosis. | ||
| Results produced by the | ||
| software's diagnostic | ||
| and treatment planning | ||
| tools are dependent on | ||
| the interpretation of | ||
| trained and licensed | ||
| practitioners. | trained and licensed | |
| practitioners. | ||
| Technology Platform | PC and MAC based | PC |
| Image rendering | 2D and 3D | 2D |
| Image manipulation | Preview, Rotate, | |
| Enhance, Zoom, | ||
| Brightness, Contrast, | ||
| Sharpness | Preview, Rotate, | |
| Enhance, Zoom, | ||
| Brightness, Contrast, | ||
| Sharpness | ||
| Basic Image | ||
| measurement | Distance, angle | Distance, angle |
| Standalone software | Yes | Yes |
| Cephalometric | ||
| measurement | Distance, angle, ratio, | |
| difference | Distance, angle, ratio, | |
| difference | ||
| Cephalometric | ||
| tracing | Manual point picking | |
| and automatic | ||
| structure templates | ||
| Software provides | ||
| predefined landmarks | ||
| and tracing structures. | ||
| Can trace on 3D | ||
| volume and 2D photo. | Manual point picking, | |
| auto and manual | ||
| structure drawing. | ||
| Software provides | ||
| predefined landmarks, | ||
| structures and allows | ||
| user to define their | ||
| own. | ||
| Cephalometric | ||
| analysis | Provide both 3D and | |
| 2D analysis. 3D | ||
| analysis is performed | ||
| on 3D volume. 2D | ||
| analysis is performed | ||
| on 2D photo or x-ray. | ||
| Standard orthodontic | ||
| tracing analyses and | ||
| user-configurable | ||
| analysis: | ||
| Lateral Analyses: |
- Ricketts
- McNamara
- Steiner (Tweed)
- Jarabak
- Roth | Provides 2D analysis
on photo or lateral x-
ray. User-configurable
and standard
orthodontic tracing
analyses including:
ABO Analysis
Alabama
Downs
McLaughlin
McNamara
Ricketts
Steiner
Tweed
WITS |
| | | |
| | Sassouni
McLaughlin
Downs-
Northwestern
Bjork
Alexander (Vari-
Simplex)
Holdaway
Alabama
Burstone
| |
| Tracing
superimposition | Yes | Yes |
| Wiggle gram | Yes. Allow user to
enter norms and
standard deviations. | Yes |
| 2D growth simulation | Yes. Growth forecast
on traced x-ray or
tracing overlaid on
photo | No |
| Treatment planning
and simulation | Orthodontic and
orthognatic
applications using
maxillary, mandible,
and chin cuts | Orthodontic and
orthognatic
applications using
predefined and
custom analysis. No |
| | | |
| | User can translate, rotate the cuts. | simulation. |
| Soft tissue
deformation | Yes. 2D and 3D | No |
| Photo wrapping | Can wrap 2D and 3D
photos on volume
image | No |
| Implant module | Yes (IMPLANNER) | No |
| Scanner connection | Yes | No |
| DICOM support | Yes | No |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation Name:
system | Picture archiving and
communications
system | Picture archiving and
communications
system |
| Regulatory Class | Class II | Class II |
| Product Code | LLZ | LLZ |
| Manufacturer | Patterson Dental
Supply, Inc. doing
business as Dolphin
Imaging & Management | Ortho2, LLC |
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8
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H. Substantial Equivalence Rationale
Although there are some differences between SmartCeph and the Dolphin Imaging predicate, comparing the non-clinical (bench) performance testing of SmartCeph for its device description, its technical characteristics, its intended use and its indications of use to similar aspects of the Dolphin Imaging predicate demonstrates that SmartCeph is substantially equivalent to the Dolphin Imaging predicate.
There are some differences between SmartCeph and the Dolphin Imaging predicate in that SmartCeph does not acquire images, but rather receives images.
SmartCeph does not contain the functionalities contained in the Dolphin lmaging major components (modules) of: ImagingPlusTM , Treatment Simulation, Arnett/Gunson FAB, McLauglin Dental VTO, ImplannerTM, Dolphin 3D, or the Dolphin Letter System.
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SmartCeph does not provide simulations of orthodontic or surgical treatment results.
SmartCeph does not perform face, airway, bite, or tooth position analyses and it does not provide for simulated dental implants.
SmartCeph does not accept or process 3D volumetric data in any way, and it does not contain a letter generating system.
The lack of these features does not impact cephalometric tracing, viewing cephalometric measurements, receiving images and superimposing images for analysis and presentation.
None of the above-mentioned differences changes any of the Safety or Effectiveness or Indications for Use of SmartCeph as compared to the Ceph Tracing module of the Dolphin Imaqing predicate.
The comparison table compares SmartCeph to the Dolphin Imaging predicate with respect to intended use, indications of use, environment of use, limitations of use, technical performance and technological characteristics. The comparison chart provides additional information regarding the basis for the determination of substantial equivalence.
I. Summary of Non-Clinical (bench) Performance Testing
Ortho2, LLC has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SmartCeph. All the different components of the SmartCeph have been stress tested to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate.
J. Conclusion
Based on the comparison of intended use, indications for use and technological characteristics SmartCeph is substantially equivalent to the Dolphin Imaging predicate. Ortho2, LLC has conducted extensive non-clinical (bench) performance, validation and verification testing indicating that SmartCeph provides reliable post- processing information to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate.