Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing, visualization, and measurement tools without mentioning any AI/ML specific terms or methodologies.

Therapeutic

No
The device is a software application for image visualization, diagnosis assistance, and treatment planning, but it does not directly treat or restore health.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the software is intended for "assisting in case diagnosis." The "Device Description" also mentions its use for "assisting in case diagnosis and review." These phrases clearly indicate a diagnostic purpose.

SaMD (Software as a Medical Device)

Yes

The device is described as "interactive imaging software device" and "software application" that runs on "standard PC hardware" and visualizes data on a "standard computer screen." It is also described as a "plug-in component" for existing software. There is no mention of proprietary hardware included with the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
CephSimulation's Function: CephSimulation is a software application that processes and visualizes medical images (CT, MRJ, 3D Ultrasound) taken from the patient. It assists in diagnosis and treatment planning by allowing practitioners to review, measure, and simulate procedures based on these images.
No Sample Analysis: The software does not analyze biological samples from the patient. Its input is imaging data, not biological material.

Therefore, while CephSimulation is a medical device used in the diagnostic and treatment process, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.

Product codes

LLZ

Device Description

CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen.

CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT scanners

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist, medical surgeons, and other qualified individuals using a standard PC.

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)

Bench testing of the software with predicate software was performed by evaluation of major function outputs from CephSimulation and predicate software. The testing result was evaluated by an expert in the field of radiology. This testing confirms that CephSimulation is as effective as its predicate in its ability to perform essential functions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110430

Reference Device(s)

K123519

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

January 4, 2017

Anatomage, Inc. % Mr. Changxin Xu Program Director 303 Almaden Blvd., #700 SAN JOSE CA 95110

Re: K161270 Trade/Device Name: CephSimulation

Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 23, 2016 Received: November 29, 2016

Dear Mr. Xu:

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.

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) K161270

Device Name CephSimulation

CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC.

This device is not indicated for mammography use.

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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510K Summary

I. Submitter

Anatomage Inc. 303 Almaden Blvd #700 San Jose, CA 95110 Phone: (408) 885-1474 Fax: (408) 295-9786 Contact Person: Changxin Xu, Program Director Preparation Date: 4/29/2016

II. Device

Device Name	CephSimulation
Common Name	Radiological Image processing System
Classification	Class II
Classification Name	Radiological Imaging Processing System, 21 CFR 892.2050
Product Code	LLZ

III. Predicate Device

Primary Predicate Device: K110430, Dolphin Imaging Reference Device: K123519, InVivoDental

IV. Device Description

CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen.

CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.

V. Indication for Use

CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.

The indication for Use statement for CephSimulation is not identical to the primary predicate

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device. However, the difference is CephSimulation is not indicated for mammography use. This restriction does not affect the safety and effectiveness of the device relative to the predicate.

VI. Technical Characteristics and comparison with the predicate device

CephSimulation is a software only device that handles digital medical images. This device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by this software but by doctors, surgeons and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

CephSimulation is installed on standard off-the-shelf x86 processor based computers.

Comparison of the proposed devices with the primary predicate device and reference device is summarized in the following table:

Characteristic	Proposed Device (CephSimulation)	Primary Predicate Device (Dolphin Imaging)	Reference Device (InVivoDental)
501(k) number	Pending	K110430	K123519
Indication for use	CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.	Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.	InVivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRJ, 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.
Operation system	Windows	Windows or Mac OS	Windows
User interface	Mouse, Keyboard	Mouse, Keyboard	Mouse, Keyboard
Technology
Platform	PC based	PC and MAC	PC based
Standalone
software	Plug-in view of
InVivoDental (K123519)	Yes	Yes
Image
rendering	2D and 3D	2D and 3D	2D and 3D
Image
manipulation	Preview, Rotate,
Enhance, Zoom,
Brightness, Contrast	Preview, Rotate, Enhance,
Zoom, Brightness,
Contrast, Sharpness	Preview, Rotate, Enhance,
Zoom, Brightness, Contrast,
Sharpness
Basic Image
measurement	Distance, angle	Distance, angle	Distance, angle
Cephalometric
measurement	Distance, angle, ratio,
difference	Distance, angle, ratio,
difference	None
Cephalometric
tracing	Manual point picking
and structure drawing,
Software provides
predefined landmarks,
structures and allows
user to define their own.
Can trace on 3D volume.	Manual point picking and
automatic structure
templates
Software provides
predefined landmarks and
tracing structures.
Can trace on 3D volume
and 2D photo.	None
Cephalometric
analysis	Provides both 3D and
2D analysis. All
measurements are
created in 3D. 2D
analysis is created by
projecting 3D
measurements onto
plane (mid-sagittal
plane).
Standard orthodontic
tracing analyses and
user-configurable
analysis:
Lateral Analyses:

ABO
Alabama
Steiner
Alexander
Downs | Provide both 3D and 2D
analysis. 3D analysis is
performed on 3D volume.
2D analysis is performed
on 2D photo or x-ray.
Standard orthodontic
tracing analyses and user-
configurable analysis:
Lateral Analyses:
Ricketts
McNamara
Steiner (Tweed)
Jarabak
Roth
Sassouni
McLaughlin
Downs-Northwestern
Bjork
Alexander (Vari- | None |
| | | | |
| | - Iowa
McLaughlin | Simplex)
Holdaway | |
| | - McNamara | - Alabama | |
| | - Summary | - Burstone | |
| | - Tweed | - ... more than 400 in all | |
| | - Univ. of Pacific | | |
| | - Ricketts | Frontal Analyses: | |
| | - Bjork | - Ricketts | |
| | - Sassouni BottomLine | - Van Arsdale | |
| | | - Grummons | |
| | Frontal Analyses: | - Grummons Simplified | |
| | - Grummons Simplified
Frontal | | |
| | - Grummons Simplified
Midline | Arch Analysis (Models
Study) | |
| | - Grummons Plus
Frontal | - Bolton
Schwarz | |
| | - Grummons Plus
Height, Angle, Ratio | | |
| | | | |
| | 3D Analyses: | | |
| | - Cranial Skeletal | | |
| | - Cranial Dental | | |
| | | | |
| Tracing
superimposition | Yes | Yes | No |
| Wigglegram | Yes. Allow user to enter
norms and standard
deviations. | Yes. Allow user to enter
norms and standard
deviations. | No |
| Profilogram | Yes | No | No |
| Occlusal gram | Yes | No | No |
| 2D growth
simulation | No | Yes. Growth forecast on
traced x-ray or tracing
overlaid on photo | No |
| Treatment
planning and
simulation | Orthodontic and
craniofacial applications
using predefined
maxillary, mandible,
chin, and cheek cuts.
User can translate, rotate
the cuts. | Orthodontic and
orthognatic applications
using maxillary, mandible,
and chin cuts.
User can translate, rotate
the cuts. | No surgery cut functions. |
| Soft tissue
deformation | Yes. 3D only. | Yes. 2D and 3D | No |
| | photos on volume image | photos on volume image | |
| Implant module | Not in this device | Yes (IMPLANNER) | Yes |
| Scanner
connection | No | Yes | No |
| DICOM
support | Yes (through host
device: InVivoDental
K123519) | Yes | Yes |

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VII. Performance Data

The following quality assurance measures were applied to the development of the system:

· Risk Analysis
· Traceability Analysis
· Design Reviews
· Performance testing
· Usability testing
· Final acceptance testing
· Bench testing to compare with predicate software

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

Bench testing of the software with predicate software was performed by evaluation of major function outputs from CephSimulation and predicate software. The testing result was evaluated by an expert in the field of radiology. This testing confirms that CephSimulation is as effective as its predicate in its ability to perform essential functions.

VIII. Conclusions

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 the area of technical characteristics, general functionality, and indicated use to the currently marketed predicate device and does not introduce any new potential risks.