(452 days)
Not Found
No
The summary describes standard image processing and analysis tools for dental applications, without mentioning AI or ML algorithms.
No.
The device is an imaging software intended for capturing, storing, and presenting patient images and radiographs, aiding in diagnosis, and facilitating treatment planning and communication, but it does not directly apply or provide therapy.
Yes
The device description explicitly states that Ortomed is "for assisting in treatment planning and case diagnosis, specifically cephalometric tracing for orthodontic and orthognathic cases." The "Intended Use" section also mentions "to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning," which are diagnostic processes.
Yes
The device description explicitly states it is "an imaging software" and details its functions as software-based tools for image management, analysis, and simulation. While it interacts with external imaging modalities, the device itself is the software component performing the analysis and planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that ORTOMED is an imaging software used for capturing, storing, presenting, and analyzing patient images and radiographs. It aids in treatment planning and diagnosis based on these images.
- Input Modality: The input modalities are digital radiology devices, scanners for X-rays, digital photography, and external files. These are all related to imaging the patient directly, not analyzing specimens taken from the patient.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens. The software operates on visual data (images and radiographs).
Therefore, ORTOMED falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
- Digital Radiology devices
- Scanner (TWAIN) with backlighting for X-rays.
- Digital photography (minimum 3MP camera recommended)
- External files from USB. network or digital camera.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
specialized dental practices
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)
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.
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.
Not Found
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/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.
1
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
2
| 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.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
3
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 |
| 08006 Barcelona | |
| BARCELONA | |
| 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)
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:
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 | ||
| 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 | ||
| and file management | |||
| GESIMAG module for image | |||
| management. | Imaging Plus Module for patient registration | ||
| and file management | - | ||
| Charting and Reports | Customizable report contents and image | ||
| layers. | |||
| Custom formatting | |||
| Min: 720 dpi color printer | Printer output: | ||
| Min: 720 dpi color printer | |||
| Rec: 1440 dpi color inkjet or dye | |||
| sublimination printer | - | ||
| Import / Export capabilities | Paper or electronic formats (PDF or | ||
| image formats JPEG, PNG, GIF, BMP. |
Export of complete studies to an
exchange file (.OSE). / Import of
previously exported studies. | Export to multiple formats, copy images to
Windows clipboard, e-mail images
DICOM support (optional) | Includes DICOM |
| Patient Database Engine | Microsoft® SQL® | Microsoft® SQL® | SQL |
| Image Features | | | |
| Image Input Sources | - Digital Radiology devices connected
directly to the computer.
- Scanner (TWAIN) with backlighting
for X-rays. - Digital photography (minimum 3MP
camera recommended) - External files from USB. network or | X-rays, slides and other images
- Digital x-ray images (optional)
- TWAIN -compliant input devices;
- Flatbed scanner - min. 150 dpi for
x-rays, 300 dpi for photographs and
1600 dpi for slides. - Existing files in industry-standard | Images can be scanned, loaded from digital
cameras or card readers, or imported from
specific interfaced radiographic imaging
devices. |
| Characteristic / Feature | Proposed Device
ORTOMED | Predicate Device
DOLPHIN IMAGING 11.5 | Predicate Device
CARESTREAM CS |
| | digital camera. | image formats - Creates 2D radiographs from
volumetric CBCT data using
Dolphin 3D software (optional) - Digital photography (minimum 3MP
camera recommended) | |
| Image manipulation tools | Preview
Rotate
Enhance ((brightness, contrast, gamma,
hue, saturation)
Align
Zoom in/out, Brightness, contrast,
sharpness, emboss | Preview
Crop
Rotate
Enhance (brightness, contrast, gamma, hue,
saturation, red-eye reduction)
Align
Zoom in/out, Brightness, contrast, sharpness,
emboss | Greyscale, invert, emboss, brightness,
contrast, gamma, sharpen, median,
despeckle, hue, saturation, equalize, flip,
mirror, masking, rotate, annotation,
cephalometric tracing, ceph growth
projections, implant simulations. |
| Image Measurement | Yes (linear distance, angle) | Yes (linear distance, angle) | Yes (linear distance, angle) |
| Matching / Adjustment of
Photograph to X-ray | Yes | Yes | - |
| Analytical and Planning Functional Features | | | |
| Cephalometric Analyses | In addition to user-configured analysis,
standard orthodontic tracing analyses
include: | Both standard and user-configured analyses
may be used. | In addition to user-configured analysis,
standard orthodontic tracing analyses
include: |
| | Lateral Analyses: - Ricketts
- McNamara
- Steiner (Tweed)
- Jarabak
- Roth
- Downs
- Bjork-Williams
- Holdaway | Lateral Analyses:
- Ricketts
- McNamara
- Steiner (Tweed)
- Jarabak
- Roth
- Sassouni
- McLaughlin
- Downs-Northwestern | - Downs
- Jarabek
- McNamara
- Ricketts
- Roth
- Sassouni
- Steiner
- Tweed |
| Characteristic / Feature | Proposed Device | Predicate Device | Predicate Device |
| | ORTOMED | DOLPHIN IMAGING 11.5 | CARESTREAM CS |
| | - Burstone-Legan - ... and many more. | - Bjork
- Alexander (Vari-Simplex)
- Holdaway
- Alabama
- Burstone
- Gerety
- ... more than 400 in all | |
| | Frontal Analyses: - Ricketts Frontal
- Frontal M.
- HSR Panoramic | Frontal Analyses:
- Ricketts
- Van Arsdale
- Grummons
- Grummons Simplified | |
| | Models Discrepancy Studies: - Bolton
- Moyers
- Schwartz-Korkhaus
- Transversal
- ADS-ADI Cervera | Arch Analysis (Models Study)
- Bolton
- Schwarz | |
| | Photo studies of soft tissues - Facial profile
- Photo/Radiograph
Superimposition, Tracing /
photo superimposition | Photo Studies of Soft Tissues: - Photo/Radiograph Superimposition,
Tracing / photo superimposition | |
| Cephalometric Tracing | - Automatic landmark insertion, - Manual repositioning of
landmarks and control points - Automated tooth and
cephalometric structure | - Automated tooth and cephalometric
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,
Simulation and Follow-up | Orthodontic treatment - Translate, tip and rotate
- incisors, reposition molars,
- auto-rotate mandible
- Arch length discrepancy
- worksheet
- CO/CR Conversion
- Growth Forecast (Ricketts algorithm)
- Growth simulation on a traced
- x-ray or tracing overlaid on
- photograph
- Superimpose one or more
- growth tracings over original
- tracing
- VTO - Visual Treatment Objective
- SVTO - Surgical Visual Treatment
- Objective (orthognathic surgery)
- Warping and Morphing | Orthodontic treatment
- Translate, tip and rotate incisors,
- reposition molars, auto-rotate
- mandible
- Arch length discrepancy worksheet
- CO-CR conversion
- Growth Forecast (Bolton or Ricketts growth
- algorithms)
- Growth simulation on a traced x-ray
- or tracing overlaid on photograph
- Superimpose one or more growth
- tracings over original tracing
- VTO
- SVTO (Orthognathic surgery)
- Movie Morphing | Simulated growth projections on lateral
photos used for patient communication. |
| Implant module | No | Additional module (IMPLANNER™) | Yes - includes implant libraries. |
| 3D image capabilities | No | Optional conversion from 3D volumetric
CBCT data to 2D radiographs. | None - includes interface to 3D imaging
software provided with specific systems..
Does not view, transfer or process 3D
radiographs. |
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Image /page/5/Picture/0 description: The image features the logo for "Henry Schein Infomed Healthcare Software". The logo is composed of the "Henry Schein" company logo, which is followed by the word "infomed" in a bold, red font. Below "infomed" is the text "Healthcare Software" in a smaller, lighter font.
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Image /page/6/Picture/0 description: The image contains the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a blue font at the top left. Below this text is a red square with a white spine-like design. To the right of the red square is the word "infomed" in a large red font, and below that is the text "Healthcare Software" in a smaller, gray font.
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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.