(27 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard image analysis and simulation tools.
No
This software is for image analysis, simulation, and treatment planning, but it does not directly treat a medical condition. The results are dependent on interpretation by trained practitioners, indicating it's a tool for practitioners rather than a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software provides "diagnostic, treatment planning and simulation tools," with results dependent on the interpretation of trained practitioners. This indicates a diagnostic function, even if interpretation is required by a human expert.
Yes
The device description explicitly states "OrthoVision is a 2D orthodontic analysis and simulation program created by EWOOSOFT," and the intended use and device description focus solely on the software's functions for image analysis, simulation, and data management. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for image analysis, simulation, and treatment planning for orthodontists. It focuses on analyzing images and providing tools for planning and simulating orthodontic procedures.
- Device Description: The description reinforces this by detailing its functions related to managing patient information, analyzing images, and assisting in orthodontic treatment planning.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This software does not interact with or analyze any biological samples. Its input is 2D imaging.
- Focus on Image Analysis and Planning: The core function is the analysis of images and the provision of tools for treatment planning and simulation, which are not typical functions of an IVD.
Therefore, based on the provided text, Ortho Vision software falls under the category of medical image analysis and treatment planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Otrho Vision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Product codes
LLZ
Device Description
OrthoVision is a 2D orthodontic analysis and simulation program created by EWOOSOFT. OrthoVision manages patient information and images during orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, growth forecasts, profilograms, superimpositions, and VTO/STO simulations. The analyzed results are saved in chart format so that you can easily store and track treatment and records of each patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontists, trained and licensed practitioners or dentists.
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
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
EWOO SOFT Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt IRVINE CA 92620
October 26, 2017
Re: K173094
Trade/Device Name: OrthoVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 26, 2017 Received: September 29, 2017
Dear Ms. Chung:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Michael D.'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name OrthoVision
Indications for Use (Describe)
Ottho Vision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
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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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
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- Date: 09/26/2017
2. Applicant / Submitter
EWOOSOFT Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Young Seok Kim Email: eddie.kim@ewoosoft.com
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
OrthoVision
5. Common Name:
Dental Imaging Software
6. Classification:
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
7. Device Description:
OrthoVision is a 2D orthodontic analysis and simulation program created by EWOOSOFT. OrthoVision manages patient information and images during orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, growth forecasts, profilograms, superimpositions, and VTO/STO simulations. The analyzed results
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are saved in chart format so that you can easily store and track treatment and records of each patient.
8. Indication for use:
Otrho Vision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
9. Predicate Device:
- Manufacturer: EWOOSOFT Co., Ltd.
- Device: OrthoVision
- 510(k) Number: K131570 ●
10. Substantial Equivalence:
OrthoVision v2.1 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.
The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation.
The differences are that the subject device has additional 2D Imaging Viewer link option, features in printing the current Appointment screen and searching for a patient in Appointment tab, Image Aligner feature for image box, and adding [Fusion to Original Image] function and Jefferson Analysis (T-Point). These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness. Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate device.
11. Technological Characteristics:
OrthoVision is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists. clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.
12. Performance Data:
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
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13. Conclusion:
The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the modifications are validated through system level test. Therefore, it is our opinion that the OrthoVision described in this submission is substantially equivalent to the predicate device.