ORTHOVISION

K131570 · Ewoosoft Co., Ltd. · LLZ · Aug 15, 2013 · Radiology

Device Facts

• Record ID: K131570
• Device Name: ORTHOVISION
• Applicant: Ewoosoft Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

OrthoVision is a 2D orthodontic analysis and simulation software. It accepts images from scanners, digital cameras, card readers, or radiographic imaging devices. The software provides tools for image manipulation (grayscale, invert, sharpen, etc.), cephalometric tracing, growth projections, and VTO/STO simulations. It manages patient information and stores treatment records in a SQL database. Used in clinical settings by orthodontists and dentists to assist in treatment planning and patient consultation. The software does not perform automated diagnosis; it presents analyzed results for interpretation by a licensed practitioner. The output aids clinicians in visualizing treatment outcomes and communicating with patients.

Clinical Evidence

Bench testing only. The manufacturer performed software validation testing to evaluate all input/output functions and operational modes. Validation confirmed that risk analysis and performance results met predetermined acceptance criteria. No clinical data was required.

Technological Characteristics

Software-only device; no patient contact. Operates on IBM-compatible PCs (Windows 7/8). Supports 32-bit/64-bit architectures. Image inputs: scanned, digital camera, card reader, or radiographic device. Image formats: BMP, JPG/JPEG, GIF. Database: SQL. Features: linear/angle measurement, cephalometric tracing (Burstone, Downs, Jarabek, McNamara, Ricketts, Steiner), growth projections, and image annotation. Complies with IEC 62304 (software life-cycle) and ISO 14971 (risk management).

Indications for Use

Indicated for use by orthodontists for orthodontic image analysis, simulation, profilogram generation, growth forecasting, and VTO/STO treatment planning. For use by trained and licensed practitioners or dentists.

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

• CS Orthodontic and OMS (K122427)

Submission Summary (Full Text)

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K131570

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

# Date

May 28, 2013

#### Manufacturer

Ewoo Soft Co., Ltd

S-402, 231 Pangyoyeok-ro, Bundang-Gu,

Seongnam-Si, Gyeonggi-do, Korea, 463-400

Tel: [phone]

Fax: [phone]

Contact person: Mr. Young. Seok. Kim Email: [e-mail]

# United States Sales Representative (U.S. Designated agent)

Mtech Group 12946 Kimberley Ln Houston, TX 770779 Tel: [phone] Fax: [phone] Contact person: Mr. Dave Kim

# Trade/Proprietary Name:

Ortho Vision

#### Common Name:

Radiological Image Processing System

## Classification Name:

System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class2)

AUG 1 5 2013

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## Description:

OrthoVision is a 2D orthodontic analysis and simulation program created by EWOO Software.

Ortho Vision manages patient information and images during orthodontic analysis. This software also assists in orthodontic treatment by providing diagnostic image analysis, growth forecasts, profilograms, superimpositions, and VTO/STO simulations. The analyzed results are saved in a chart format and the user can easily store and track treatment records of each patient.

## Indication for use:

OtrhoVision 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.

## Predicate Device:

| Manufacturer | : Carestream Dental LLC. |
|---------------|------------------------------------------------|
| Device | : CS Orthodontic and OMS |
| 510(k) Number | : K122427 (Decision Date - September 12, 2012) |

#### Comparison Table:

| Characteristic | Ortho Vision | CS Orthodontic and OMS<br>Imaging v 11.0 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K number | K131570 | K1222427 |
| Manufacturer | EWOOSOFT | Carestream Dental LLC |
| Indications for use | OtrhoVision software is<br>indicated for use by<br>orthodontists for image<br>analysis, simulation,<br>profilogram, growth<br>forecast, VTO/STO and<br>patient consultation.<br>Results produced by the<br>software's diagnostic,<br>treatment planning and<br>simulation tools are<br>dependent on the<br>interpretation of trained<br>and licensed practitioners<br>or dentists. | CS Orthodontic Imging and CS<br>OMS Imaging Software is<br>indicated for use by<br>orthodontists or oral<br>maxillofacial surgeons and<br>their staff in storing and<br>organizing images, including<br>digital photographs and x-rays.<br>The device includes the<br>capability to trace digital<br>cephalometric radiograph,<br>analyze the measurements<br>taken and make growth<br>projections or surgical<br>predicitons. |
| | | |
| Platform | IBM-compatible PC or PC | IBM-compatible PC or PC |

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| | network | network |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating System | Microsoft Window 7, Window 8 | Microsoft Windows |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Image Input Sources | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device |
| 32 bit / 64 bit | 32 bit / 64 bit | 32 bit |
| Image format | BMP, JPG/JPEG, GIF | DICOM |
| Patient Database Compatibility | SQL | SQL |
| Includes Image Measurement tools | Linear distance, angle | Linear distance, angle |
| Image viewing | Full, side by side, gallery, thumbnail | Full, side by side, gallery, thumbnail |
| Image manipulation | Grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, despeckle, hue, saturation, equalize flip, mirror, masking, rotate, annotation, cephalometric tracing, ceph growth projections, | Grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, despeckle, hue, saturation, equalize flip, mirror, masking, rotate, annotation, cephalometric tracing, ceph growth projections, implant simulations |
| Cephalometric tracing | In addition to the user-configured analysis, standard orthodontic tracing analysis include:<br>Burstone<br>Downs<br>Jarabek<br>McNamara<br>Ricketts<br>Steiner | In addition to the user-configured analysis, standard orthodontic tracing analysis include:<br>Downs<br>Jarabek<br>McNamara<br>Ricketts<br>Roth<br>Sassouni<br>Steiner<br>Twee |
| Growth projections | Simulated growth projections on lateral photos used for patient communication | Simulated growth projections on lateral photos used for patient communication |
| Implant module | None | Include implant libraries from Nobel Biocare, Bicon, 3i, and Straumann, and generic |
| 3D imaging capability | None. | None.<br>Includes interface to 3D imaging software provided with Kodak 9000, Kodak 9500, or CS 9300 systems. CS Orthodontic and OMS imaging software does not view |
| | | transfer or process 3D<br>radiographs. |
| Image annotation | Text, paint, ellipse,<br>pointer, select, draw,<br>magnify, line, rectangle,<br>polygon, ruler, protractor,<br>smile library, smudge,<br>brush, redeye reduction,<br>select region, copy / paste | Text, paint, ellipse, pointer,<br>select, draw, magnify, line,<br>rectangle, polygon, ruler,<br>protractor, smile library,<br>smudge, brush, redeye<br>reduction, select region, copy<br>/ paste |

.

.

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#### Substantial Equivalence:

Ortho Vision described in this 510(k) has the similar intended use and similar technical characteristics as CS Orthodontic and OMS of Carestream Dental LLC.

The model CS Orthodontic and OMS is the primary predicate device. The subject device and predicate device are substantially equivalent, having the similar indications for use and functionalities like operation software, image processing features, windowing, zoom, rotation. The differences are cosmetic, arrangement and components use only. Both Ortho Vision, the proposed device, and CS Orthodontic and OMS, the predicate device are categorized in product code LLZ; equivalence between these models is evident.

Differences between the subject device and predicate device include the PC server requirements such as processor, RAM, networking and image format type. These differences do not raise any new questions of safety or effectiveness.

## 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. A physician, providing ample opportunity for competent human intervention interprets images and information being presented.

## Nonclinical Testing:

The complete system configuration has been assessed and tested by the manufacturer and passed all in-house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by OrthoVision. Each operational mode and

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the process followed are documented in the Software Validation Report.

The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.

#### Safety and Performance Data:

- IEC 62304 Medical device software – Software life-cycle processes : 2006

- ISO 14971 Medical Devices - Application of risk management to medical device : 2007

#### Conclusion:

The premarket notification for OrthoVision contains adequate information and data to determine substantial equivalence to the predicate device and predicate 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 nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the OrthoVision described in this submission is substantially equivalent to the predicate device.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized emblem with three wave-like lines, which is positioned to the right of the circular text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the emblem.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

August 15. 2013

EWOO SOFT CO., LTD % DAVE KIM MTECH GROUP 12946 KIMBERLEY LN HOUSTON TX 77079

Rc: K131570 Trade/Device Name: OrthoVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 09, 2013 Received: August 06, 2013

Dear Mr. Kim:

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 for ass sured on the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provide that have been recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (71cc) that to not required to the general controls provisions of the Act. The I ou may, mercelore, market the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and aceration. 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 cither class II (Special Controls) or class III (PMA), If your device is classince (500 aborty) mExisting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of reacharts 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 that IDA has made a delerinmation and Jountinistered by other Federal agencies. You must or any rederal statutes and regalations and limited to: registration and listing (21 Comply with an the Net 3 requirements (1): medical device reporting (reporting of medical CFK Fall 807); adeing (21 CFR 803); good manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as s forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Kim

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely yours.


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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# Indications for Use

510(k) Number (if known): K131570

Device Name: Ortho Vision

Indications for Use:

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.

Image /page/7/Picture/5 description: The image shows the words "Prescription Use" followed by "(Part 21 CFR 801 Subpart D)". There is a line under the words "Prescription Use" and a check mark above the line. The text is in black font and the background is white.

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K131570

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