INVIVO DENTAL

K123519 · Anatomage, Inc. · LLZ · Feb 1, 2013 · Radiology

Device Facts

• Record ID: K123519
• Device Name: INVIVO DENTAL
• Applicant: Anatomage, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

In VivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, In VivoDental is a preoperative software application used for the simulation of dental implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use.

Device Story

InVivoDental is a volumetric imaging software for Windows PCs; used by clinicians/physicians to visualize/process medical imaging data (CT, MRI, 3D Ultrasound). Input: DICOM files from scanning devices. Processing: software tools for rendering (bone/soft tissue), manipulation (rotate, zoom, flip, contrast/brightness adjustment, slice/cut), and annotation. Output: 2D/3D rendered images, panoramic views, measurements (volume, angle, length), and surgical simulations. Healthcare providers use output for diagnostic assistance, treatment planning, and patient consultation. Benefits: enables preoperative simulation of dental implants/orthodontics and consistent image rendering via proprietary format.

Clinical Evidence

Bench testing only. No clinical data. Performance verified through risk analysis, requirements/design reviews, and bench testing comparing subject software to predicate software. Expert evaluation of rendered images and measurement tools confirmed effectiveness in essential functions.

Technological Characteristics

Standalone software for x86-based Windows PCs. Processes DICOM data from medical imaging devices. Features include 3D volume rendering, 2D image visualization, measurement tools, and surgical simulation. Proprietary export format for consistent rendering.

Indications for Use

Indicated for radiologists, clinicians, and referring physicians to display, visualize, and process medical images (CT, MRI, 3D Ultrasound) for diagnostic assistance, dental implant simulation, orthodontic planning, and surgical treatment evaluation. Not indicated for mammography.

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

• Anatomage, InVivoDental (K070803)
• IMTEC ILUMA Vision v2.0 (K081347)

Submission Summary (Full Text)

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## 5. 510K Summary

## FEB 0 1 2013

Submitter Anatomage Inc. 111 N. Market Street #800 San Jose, CA 95113 Phone: [phone] Fax: [phone] Contact Person Mike Mendez Phone Number: [phone] ext 119 Device Name InVivoDental 510(k) Preparation Date 11/02/12 System, Image Processing, Radiological Common Name Classification Class II Imaging Processing System, LLZ, 21 CFR 892.2050 Classification Name Product Code LLZ, 21 CFR 892.2050 Device Description InVivoDental is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The software is downloaded over the internet and installed on the customer's computer. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing. There are several rendering settings to emphasize bone and/or soft tissue. The software also has the ability to create panoramic images, superimpose images, and create measurements of volume, angle, and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. The software has specialized tools to simulate surgical treatments using models rendered by Antomage, and any view or user modified area can be saved to a gallery. These simulations and galleries can then be reviewed by medical personnel or used for consultation between the doctor and

K 123519

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Intended Use InVivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices. such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, InVivoDental is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use. Equivalent Devices K070803 Anatomage, InVivoDental IMTEC ILUMA Vision v2.0 K081347 Technological Characteristic InVivoDental and the predicate devices are standalone software. All of these software devices are designed to be installed on standard off-the-shelf x86 processor based computers running the Windows operating system. DICOM data from medical imaging devices are visualized as volume or 2D images. A difference between InVivoDental and the predicate software is the output of DICOM files. DICOM files can be distributed and read by a device that reads DICOM files while the format that InVivoDental exports is intended to be read by the InVivoDental reader. This does not impact safety or effectiveness of the device. Limiting the rendering of images to Anatomage software allows for consistent rendering of images and information by eliminating the use of substandard software that is freely distributed on the internet. Non-Clinical Test Results Testing confirmed that the software is stable and operating as designed. The following quality assurance measures were applied to the development of the system: · Risk Analysis · Requirements Reviews · Design Reviews · Performance testing (Verification) · Safety testing (Verification) · Final acceptance testing (Validation) · Bench testing to compare with predicate software

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Testing confirmed that the software is stable and operating as designed. Testing also confirmed that the software evaluated for hazards and that the risk has been reduced to acceptable levels.

Bench testing of the software with predicate software was performed by evaluation of images rendered by InVivoDental and predicate software. This testing and evaluation included testing of measurement tools in both predicate and subject software and was performed by an expert in the field of radiology. This testing confirms that InVivoDental is as effective as its predicates in its ability to perform its essential functions of measurement and rendering of DICOM data.

Based on the intended use, product, performance, and testing information provided in this notification, the subject device has been shown to be substantially equivalent in technology. functionality, and indicated use to the currently marketed predicate devices.

#### Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### February 1, 2013

Anatomage, Inc. c/o Mr. Mike Mendez Official Correspondent 111 N. Market Street, Suite 800 SAN JOSE CA 95113

Re: K123519

Trade/Device Name: InVivoDental Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2012 Received: November 15, 2012

Dear Mr. Mendez:

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. Ilisting 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Safety/Reportal.roblem/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.htm.

Sincerely yours,

#### Sean M. Boyd -S 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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## 4. Indications For Use Statement

510(k) Number (if known): _

Device Name: __ InVivoDental

Indications for Use:

In VivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, In VivoDental is a preoperative software application used for the simulation of dental implants, orthodontic planning and surgical treatments.

This device is not indicated for mammography use.

| Prescription Use | √ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Sean M. Boyd -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR) Evaluation and Safety K123519 510(k)

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