ORTOMED
Device Facts
| Record ID | K131348 |
|---|---|
| Device Name | ORTOMED |
| Applicant | Infomed Servicios Informaticos S.L. |
| Product Code | LLZ · Radiology |
| Decision Date | Aug 5, 2014 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning and communication as well as case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
Device Story
ORTOMED is a PC-based radiological image processing software for specialized dental practices. It ingests patient images via direct digital radiology connection, TWAIN-compliant scanners, digital cameras, or external files. The software manages patient data via the Gesden database and Gesimag suite. Core functions include cephalometric landmarking (lateral, frontal, models), analysis (Bolton, Moyers, Dentoalveolar discrepancy), and treatment simulation (VTO/STO) using warping and morphing. It produces diagnostic visualizations and reports for orthodontic and orthognathic planning. Operated by dental practitioners, the software aids in treatment decisions by providing automated landmark insertion, growth forecasts, and superimposition tools. The output is interpreted by the clinician to guide patient care and surgical/orthodontic planning.
Clinical Evidence
Bench testing only. No clinical data provided. Software verification and validation were performed according to documented procedures and FDA guidance for medical imaging and software submissions, including hazard analysis per ISO 14971 and software lifecycle processes per ISO 62304.
Technological Characteristics
PC-based software application; runs on Windows 2000/XP/Vista/7. Uses Microsoft SQL database engine. Inputs via TWAIN, digital radiology, or file import. Features include cephalometric landmarking, automated tooth/structure templates, and VTO/STO simulation. Connectivity via standard PC interfaces. No 3D imaging or implant modules.
Indications for Use
Indicated for specialized dental practices to capture, store, and present patient images/radiographs for cephalometric analysis, orthodontic/orthognathic treatment planning, and case follow-up. Results require interpretation by trained, licensed dental practitioners.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
INFOMED SERVICIOS INFORMATICOS S.L.
% Mr. Santiago Sola General Manager Via Augusta 158, 4th Floor 08006 Barcelona SPAIN
Re: K131348 Trade/Device Name: ORTOMED Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 28, 2014 Received: July 31, 2014
Dear Mr. Sola:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smhff)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K131348
Device Name ORTOMED
#### Indications for Use (Describe)
ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning and communication as well as case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (1/14)
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HENRY SCHEIN®
infomed
Healthcare Software
510(k) Premarket Notification - Ortomed
Section 5 - 510(k) Summary
| DATE OF SUBMISSION: | 2013-04-23 |
|---------------------|---------------------------------------------------------------------|
| SUBMITTER NAME: | INFOMED Servicios Informáticos S.L. |
| SUBMITTER ADDRESS: | Vía Augusta 158, 4th floor<br>08006 Barcelona<br>BARCELONA<br>SPAIN |
| CONTACT: | Santiago Solà |
| TELEPHONE: | +34 934 14 4340 |
| Fax: | +34 932 080809 |
| e-mail: | ssola@infomed.es |
| DEVICE TRADE NAME: | ORTOMED |
| COMMON NAME. | Radiological Image Processing System |
| DEVICE TRADE NAME: | ORTOMED |
|-------------------------|--------------------------------------------------------|
| COMMON NAME: | Radiological Image Processing System |
| CLASSIFICATION NAME: | Radiological Image Processing System (21 CFR 892.2050) |
| PRODUCT CODE: | LLZ |
| REGULATION DESCRIPTION: | Picture archiving and communications system |
| PREDICATE DEVICE(S): | Dolphin Imaging (K110430)<br>CS Orthodontic Imaging and CS OMS Imaging Software (K122427) |
|----------------------|-------------------------------------------------------------------------------------------|
|----------------------|-------------------------------------------------------------------------------------------|
## DEVICE DESCRIPTION:
-
Ortomed is an imaging software designed for use by specialized dental practices for capturing, storing and presenting patient's dental images and for assisting in treatment planning and case diagnosis, specifically cephalometric tracing for orthodontic and orthognathic cases. Results produced by the software's diagnostic and treatment planning tools must be interpreted by the trained, licensed practitioner. The software features and capabilities include image and management using the Gesden database and Gesimag image management suite and also specific cephalometric analysis functions and treatment simulation. Features and capabilities include:
- Cephalometric landmarking and analysis: lateral, frontal, models and soft profile -
- Analysis of models: Bolton, Moyers, Dentoalveolar discrepancy analysis -
- Lateral tracing superimposition, overlays on patient images -
- -CO/CR conversion, growth forecasts, simulation of facial profile growth
- VTO (Visual Treatment Objective) treatment simulation for orthodontic cases -
- STO (Surgical Treatment Objective) treatment simulation for orthognathic surgical cases -
- -Simulation and display of VTO/STO treatments using warping and morphing.
#### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the Software ORTOMED is compared with the following previously cleared device:
- Dolphin Imaging 11.5 (K110430)
- CS Orthodontic Imaging and CS OMS Imaging Software (K122427)
Comparison of the proposed devices with the predicate device is summarized in the following table:
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Image /page/4/Picture/0 description: The image shows the logo for Henry Schein Infomed Healthcare Software. The logo features the Henry Schein logo in the upper left corner, with the words "infomed" in large, red letters to the right. Below "infomed" are the words "Healthcare Software" in a smaller, blurred font.
| Characteristic / Feature | Proposed Device | Predicate Device | Predicate Device |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ORTOMED | DOLPHIN IMAGING 11.5 | CARESTREAM CS |
| 510(k) number | Pending | K110430 | K122427 |
| General Features | | | |
| Basic Technology Platform | PC-based software application | PC or Mac | IBM-compatible PC or PC network |
| Operating System | Windows® 2000/XP, Vista and<br>Windows® 7 | Windows XP Pro with SP2, 2003 Server, 2008 Server or Windows 7 (supports both 32 and 64-bit versions) | Microsoft Windows |
| User Interface | Mouse, Keyboard | Mouse, Keyboard | Mouse, Keyboard |
| Patient Management | GESDEN module for patient registration<br>and file management<br>GESIMAG module for image<br>management. | Imaging Plus Module for patient registration<br>and file management | - |
| Charting and Reports | Customizable report contents and image<br>layers.<br>Custom formatting<br>Min: 720 dpi color printer | Printer output:<br>Min: 720 dpi color printer<br>Rec: 1440 dpi color inkjet or dye<br>sublimination printer | - |
| Import / Export capabilities | Paper or electronic formats (PDF or<br>image formats JPEG, PNG, GIF, BMP.<br><br>Export of complete studies to an<br>exchange file (.OSE). / Import of<br>previously exported studies. | Export to multiple formats, copy images to<br>Windows clipboard, e-mail images<br>DICOM support (optional) | Includes DICOM |
| Patient Database Engine | Microsoft® SQL® | Microsoft® SQL® | SQL |
| Image Features | | | |
| Image Input Sources | - Digital Radiology devices connected<br>directly to the computer.<br>- Scanner (TWAIN) with backlighting<br>for X-rays.<br>- Digital photography (minimum 3MP<br>camera recommended)<br>- External files from USB. network or | X-rays, slides and other images<br>- Digital x-ray images (optional)<br>- TWAIN -compliant input devices;<br>- Flatbed scanner - min. 150 dpi for<br>x-rays, 300 dpi for photographs and<br>1600 dpi for slides.<br>- Existing files in industry-standard | Images can be scanned, loaded from digital<br>cameras or card readers, or imported from<br>specific interfaced radiographic imaging<br>devices. |
| Characteristic / Feature | Proposed Device<br>ORTOMED | Predicate Device<br>DOLPHIN IMAGING 11.5 | Predicate Device<br>CARESTREAM CS |
| | digital camera. | image formats<br>- Creates 2D radiographs from<br>volumetric CBCT data using<br>Dolphin 3D software (optional)<br>- Digital photography (minimum 3MP<br>camera recommended) | |
| Image manipulation tools | Preview<br>Rotate<br>Enhance ((brightness, contrast, gamma,<br>hue, saturation)<br>Align<br>Zoom in/out, Brightness, contrast,<br>sharpness, emboss | Preview<br>Crop<br>Rotate<br>Enhance (brightness, contrast, gamma, hue,<br>saturation, red-eye reduction)<br>Align<br>Zoom in/out, Brightness, contrast, sharpness,<br>emboss | Greyscale, invert, emboss, brightness,<br>contrast, gamma, sharpen, median,<br>despeckle, hue, saturation, equalize, flip,<br>mirror, masking, rotate, annotation,<br>cephalometric tracing, ceph growth<br>projections, implant simulations. |
| Image Measurement | Yes (linear distance, angle) | Yes (linear distance, angle) | Yes (linear distance, angle) |
| Matching / Adjustment of<br>Photograph to X-ray | Yes | Yes | - |
| Analytical and Planning Functional Features | | | |
| Cephalometric Analyses | In addition to user-configured analysis,<br>standard orthodontic tracing analyses<br>include: | Both standard and user-configured analyses<br>may be used. | In addition to user-configured analysis,<br>standard orthodontic tracing analyses<br>include: |
| | Lateral Analyses:<br>- Ricketts<br>- McNamara<br>- Steiner (Tweed)<br>- Jarabak<br>- Roth<br>- Downs<br>- Bjork-Williams<br>- Holdaway | Lateral Analyses:<br>- Ricketts<br>- McNamara<br>- Steiner (Tweed)<br>- Jarabak<br>- Roth<br>- Sassouni<br>- McLaughlin<br>- Downs-Northwestern | - Downs<br>- Jarabek<br>- McNamara<br>- Ricketts<br>- Roth<br>- Sassouni<br>- Steiner<br>- Tweed |
| Characteristic / Feature | Proposed Device | Predicate Device | Predicate Device |
| | ORTOMED | DOLPHIN IMAGING 11.5 | CARESTREAM CS |
| | - Burstone-Legan<br>- ... and many more. | - Bjork<br>- Alexander (Vari-Simplex)<br>- Holdaway<br>- Alabama<br>- Burstone<br>- Gerety<br>- ... more than 400 in all | |
| | Frontal Analyses:<br>- Ricketts Frontal<br>- Frontal M.<br>- HSR Panoramic | Frontal Analyses:<br>- Ricketts<br>- Van Arsdale<br>- Grummons<br>- Grummons Simplified | |
| | Models Discrepancy Studies:<br>- Bolton<br>- Moyers<br>- Schwartz-Korkhaus<br>- Transversal<br>- ADS-ADI Cervera | Arch Analysis (Models Study)<br>- Bolton<br>- Schwarz | |
| | Photo studies of soft tissues<br>- Facial profile<br>- Photo/Radiograph<br>Superimposition, Tracing /<br>photo superimposition | Photo Studies of Soft Tissues:<br>- Photo/Radiograph Superimposition,<br>Tracing / photo superimposition | |
| Cephalometric Tracing | - Automatic landmark insertion,<br>- Manual repositioning of<br>landmarks and control points<br>- Automated tooth and<br>cephalometric structure | - Automated tooth and cephalometric<br>structure templates | Yes |
| Characteristic / Feature | Proposed Device | Predicate Device | Predicate Device |
| | ORTOMED | DOLPHIN IMAGING 11.5 | CARESTREAM CS |
| | templates | | |
| | Superimposition of tracings | Superimposition of tracings | |
| Treatment Planning,<br>Simulation and Follow-up | Orthodontic treatment<br>- Translate, tip and rotate<br>- incisors, reposition molars,<br>- auto-rotate mandible<br>- Arch length discrepancy<br>- worksheet<br>- CO/CR Conversion<br>- Growth Forecast (Ricketts algorithm)<br>- Growth simulation on a traced<br>- x-ray or tracing overlaid on<br>- photograph<br>- Superimpose one or more<br>- growth tracings over original<br>- tracing<br>- VTO - Visual Treatment Objective<br>- SVTO - Surgical Visual Treatment<br>- Objective (orthognathic surgery)<br>- Warping and Morphing | Orthodontic treatment<br>- Translate, tip and rotate incisors,<br>- reposition molars, auto-rotate<br>- mandible<br>- Arch length discrepancy worksheet<br>- CO-CR conversion<br>- Growth Forecast (Bolton or Ricketts growth<br>- algorithms)<br>- Growth simulation on a traced x-ray<br>- or tracing overlaid on photograph<br>- Superimpose one or more growth<br>- tracings over original tracing<br>- VTO<br>- SVTO (Orthognathic surgery)<br>- Movie Morphing | Simulated growth projections on lateral<br>photos used for patient communication. |
| Implant module | No | Additional module (IMPLANNER™) | Yes - includes implant libraries. |
| 3D image capabilities | No | Optional conversion from 3D volumetric<br>CBCT data to 2D radiographs. | None - includes interface to 3D imaging<br>software provided with specific systems..<br>Does not view, transfer or process 3D<br>radiographs. |
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Image /page/7/Picture/0 description: The image shows the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a blue and black font, with a red square containing a white spine graphic. To the right of the square, the word "infomed" is written in red, with the words "Healthcare Software" in a smaller, gray font below it.
Table 5.1 Summary comparison of characteristics and features – proposed and predicate devices.
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510(k) Premarket Notification – Ortomed
Image /page/8/Picture/1 description: The image contains the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a smaller font above the word "infomed" in a larger, bold, red font. Below "infomed" is the text "Healthcare Software" in a smaller font. To the left of the text is a red square with a white design.
Section 5 – 510(k) Summary
### INTENDED USE:
As established in the Indications for Use Statement:
ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthgnathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
Ortomed has similar intended uses as the predicate devices and has very similar technological characteristics.
## SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA quidance documents:
- Guidance for the Submission of Premarket Notifications for Medical Imaging -Management Devices
- -Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971. Integration, verification and validation testing have been successfully completed following standard ISO 62304.
## SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
## CONCLUSIONS:
We believe the intended use, the indications for use and performance of the Ortomed software is substantially equivalent to the intended use, indications for use and performance of the predicate device. We also believe that the Ortomed software does not suppose any new or increased risk compared with the predicate device. Based on the information included in this submission, we conclude that Ortomed is substantially equivalent to the listed legally marketed predicate devices.
