(90 days)
Not Found
No
The description focuses on standard image processing tools (contrast, brightness, reversal, magnification) and DICOM compliance, with no mention of AI, ML, or related concepts like training or test sets for algorithmic performance.
No
The device is described as software for general dental diagnostic imaging, controlling capture, display, transfer, enhancement, and storage of X-ray dental images and aiding in diagnosis. There is no mention of it treating or preventing any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is for "general dental diagnostic imaging," and the "Device Description" mentions that it provides "easy-to-use image processing tools that aid providers in analyzing images and making diagnoses."
No
The device description explicitly states that the software "will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources" and "will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI." This indicates a direct interaction and control over hardware components (acquisition modalities, cameras, etc.), which goes beyond a purely software-only device that would typically receive data from separate hardware.
No, 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.
- Device Function: The Corporate Dental Imaging (CDI) Application™ is a software device that handles the capture, display, transfer, enhancement, and storage of images (specifically dental X-rays and other visual dental images). It processes and presents visual information, not biological samples.
- Intended Use: The intended use is for "general dental diagnostic imaging," which involves interpreting visual representations of the dental anatomy, not analyzing biological markers in a sample.
The device is clearly focused on medical imaging and image processing for diagnostic purposes based on visual data, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Corporate Dental Imaging (CDI) Application™ is a software device for general dental diagnostic imaging. It controls capture, display, transfer, enhancement, and storage of X-ray dental images from digital imaging systems.
Product codes
LLZ
Device Description
The Corporate Dental Imaging (CDI) Application™ is a software application used for storing and displaying medical dental images. The application conforms to the DICOM 3.x standard to allow interoperability with other DICOM compliant systems. The implementation of CDI interface has been tested to assure compliance with the DICOM Conformance Statement. However, the DICOM Conformance Statement for the Subject device and the DICOM standard itself does not guarantee interoperability of the system to other vendor products. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.
The Corporate Dental Imaging (CDI) Application ™ system is being designed as a replacement for the legacy PACS system known as DEVAA. CDI will replace the legacy PACS technologies found in DEVAA with a more robust software and hardware solution. In addition, CDI will add additional capabilities not available in legacy capture/view tools. Additional benefits include providing a global view of images through DICOM image data query across multiple service image archives and the capability to migrate existing DICOM images to new image servers. In addition, CDI offers the capability to query and retrieve images at any location within the digital enterprise for primary, ghosted and retake images.
CDI is comprised of one (1) desktop client for Modality Image Capture, one (1) web-based client for Image Viewing and Diagnostics with Microsoft SQL Server back-end database(s) for storing DICOM images. There is at least one instance of this environment. Each Military clinical post will most likely have multiple instances of this environment depending upon the volume of productivity. CDI will form the core of the acquisition and viewing operations within the enterprise architecture. CDI will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources. CDI is loaded onto the Acquisition PCs in the clinic where either the images will be acquired or where the images will need to be viewed. If the PC is being used to acquire images, CDI is configured to use the attached acquisition modalities. CDI is has been designed to be able to acquire an image regardless of the acquisition modality used to capture the image. CDI will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI. It does not matter which type of modality is used to acquire the image, or which type of image series that might be taken, the user is always presented with the same interface. CDI will be designed to create a standard DICOM object that conforms to industry standards. The use of DICOM is an absolute necessity to ensure interoperability with current and future imaging systems. CDI will also provide easy-to-use image processing tools that aid providers in analyzing images and making diagnoses. CDI will allow users to enhance the contrast and brightness of an image, reverse image values to show dental caries, and magnify specific areas of concern.
Note: Modifications can be saved, but they are only saved as a copy of the original image. The original image will always remain untouched.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray dental images from digital imaging systems.
intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources.
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical testing: The Corporate Dental Imaging (CDI) Application™ device has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Corporate Dental Imaging (CDI) Application™ software in each operational mode and followed the process documented in the Validation Test Plan. Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by the manufacturer, integration and installations verification tests will be conducted against acceptance criteria prior to being released to the user facility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2015
U.S. Army Dental Command (DENCOM) % Mr. Carl Alletto Consultant OTech, Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K151371
Trade/Device Name: Corporate Dental Imaging (CDI) Application"*** Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 29, 2015 Received: August 4, 2015
Dear Mr. Alletto:
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.
Michael O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K151371
Device Name Corporate Dental Imaging (CDI) Application™
Indications for Use (Describe)
Corporate Dental Imaging (CDI) Application™ is a software device for general dental diagnostic imaging. It controls capture, display, transfer, enhancement, and storage of X-ray dental images from digital imaging systems.
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.
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"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."
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
May 5, 2015
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. William K. Porter Chief Operating Officer (COO) Information Management and Technology Division (IMTD) U.S. Army Dental Command (DENCOM) 4270 Gorges Circle Suits 101, B1070 Fort Sam Houston, Texas 78234 Tel: 210 808-2748 Fax: 210 295-3013 Email: William.k.porter.civ@mail.mil
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Product Name: | Corporate Dental Imaging (CDI) Application™ |
|---|---|
| Common Name: | Picture, archive and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
The Corporate Dental Imaging (CDI) Application™ system is substantially equivalent to:
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K102684 |
| Device Name | XELIS DENTAL |
| Original Applicant | INFINITT CO., LTD. |
| 12f Daerung Post Tower III | |
| 182-4 Guro-Dong, Guro-Gu | |
| Seoul, KR 152-050 | |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/17/2010 |
| Decision Date | 10/01/2010 |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
Device Description: 21 CFR 807 92(a)(4)
The Corporate Dental Imaging (CDI) Application™ is a software application used for storing and displaying medical dental images. The application conforms to the DICOM 3.x standard to allow interoperability with other DICOM compliant systems. The implementation of CDI interface has been tested to assure compliance with the DICOM Conformance Statement. However, the DICOM Conformance Statement for the Subject device and the DICOM standard itself does not guarantee interoperability of the system to other vendor products. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test
4
suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.
Note: The subject device does not include any automated or semi-automated processes for the detection of nodules or other shapes.
The Corporate Dental Imaging (CDI) Application ™ system is being designed as a replacement for the legacy PACS system known as DEVAA. CDI will replace the legacy PACS technologies found in DEVAA with a more robust software and hardware solution. In addition, CDI will add additional capabilities not available in legacy capture/view tools. Additional benefits include providing a global view of images through DICOM image data query across multiple service image archives and the capability to migrate existing DICOM images to new image servers. In addition, CDI offers the capability to query and retrieve images at any location within the digital enterprise for primary, ghosted and retake images.
CDI is comprised of one (1) desktop client for Modality Image Capture, one (1) web-based client for Image Viewing and Diagnostics with Microsoft SQL Server back-end database(s) for storing DICOM images. There is at least one instance of this environment. Each Military clinical post will most likely have multiple instances of this environment depending upon the volume of productivity. CDI will form the core of the acquisition and viewing operations within the enterprise architecture. CDI will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources. CDI is loaded onto the Acquisition PCs in the clinic where either the images will be acquired or where the images will need to be viewed. If the PC is being used to acquire images, CDI is configured to use the attached acquisition modalities. CDI is has been designed to be able to acquire an image regardless of the acquisition modality used to capture the image. CDI will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI. It does not matter which type of modality is used to acquire the image, or which type of image series that might be taken, the user is always presented with the same interface. CDI will be designed to create a standard DICOM object that conforms to industry standards. The use of DICOM is an absolute necessity to ensure interoperability with current and future imaging systems. CDI will also provide easy-touse image processing tools that aid providers in analyzing images and making diagnoses. CDI will allow users to enhance the contrast and brightness of an image, reverse image values to show dental caries, and magnify specific areas of concern.
Note: Modifications can be saved, but they are only saved as a copy of the original image. The original image will always remain untouched.
Indications for Use: 21 CFR 807 92(a)(5)
Corporate Dental Imaging (CDI) Application™ is a software device for general dental diagnostic imaging. It controls capture, display, transfer, enhancement, and storage of X-ray dental images from digital imaging systems.
Technological Characteristics: 21 CFR 807 92(a)(6)
Corporate Dental Imaging (CDI) Application™ is a software device that handles and manipulates digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and or printed. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The subject device and predicate device are substantially equivalent in the areas of technical
5
510(k) Summary of Safety
characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The predicate and subject devices are substantially equivalent in the areas of general function, application, and intended use. Any difference between the two devices does not affect safety or efficacy. The predicate device and the new device are compared below:
| Functionality | Predicate:
Xelis
DENTAL
(K102684) | Subject
Device: CDI
Application™ | If different, Impact on Safety and or
Efficacy |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer platform (minimum
requirements) | IBM
compatible
Memory:
1GB
Disk: 200MB
free hard
disk space | IBM
compatible
CPU: 1 Dual
Core
Processor
Memory: 8GB
RAM
HDD: C:
(OS)=140GB;
D: (Data)=2TB | Yes, there are differences.
Current computer platforms have these
added hardware features to support the
operating system, Microsoft Windows 64
bit 2008 R2 Enterprise, and they are for
the operating system to run efficiently.
The difference does not create new risks
and does not impact safety or efficacy as
explained in rationale below section 6.1.1
(a) below |
| Computer Operating System | Microsoft
Windows
XP/Vista or
higher (32bit
& 64 bit)
Professional | Microsoft
Windows 64 bit
2008 R2
Enterprise | Yes, there are differences.
The Windows XP and Vista is no longer
supported by Microsoft. CDI uses the
Microsoft Windows 64 bit 2008 R2
Enterprise operating system. The system
has passed testing against pre-
determined criteria and the difference
does not create new risks and does not
impact safety or efficacy. |
| Enterprise distribution of
images and data via Internet
or Intranet | Yes | Yes | No differences |
| Networking Communications
Protocol - DICOM 3.x | Yes | Yes | No differences |
| Image Compression: | No
compression
or Lossless | No
compression
or Lossless | No differences |
| Standard Interfaces -
Ethernet | Yes | Yes | No differences |
| Image Storage- Server & on
board hard disk size &
compression dependent. Can
store to Short or Long Term
Archives | Yes | Yes | No differences |
| Multi-Planar Reformation
(MPR) - MPR into any classic
planes (axial, sagittal,
coronal, oblique planes) and
curved and free-draw planar
reformation. 3D image-guided
reformation on VR, MIP/MinIP | Yes | No | Yes, there are differences.
MPR is not a feature that is implemented
in the Medical Viewer and there are no
claims as such in the CDI device labeling.
This feature is not required to meet the
subject device intended use. The system
has been tested against pre-determined
criteria and passed. The difference does
not create new risks and does not impact
safety or efficacy. |
| Virtual Endoscopy - Observe
the internal structure using
the virtual camera. | Yes | No | Virtual Endoscopy is not a feature that is
implemented in the CDI and there are no
claims in the CDI device labeling for this |
| Functionality | Predicate:
Xelis
DENTAL
(K102684) | Subject
Device: CDI
Application™ | If different, Impact on Safety and or
Efficacy |
| Reporting - Save, email,
DICOM send, or print to
standard Windows printers | Yes | No | Yes, there are differences.
Reporting - Save, email, DICOM send, or
print to standard Windows printers is not a
feature implemented in CDI and there are
no claims in the CDI device labeling for
this feature. This feature is not required to
meet the subject device intended use. The
system has been tested against pre-
determined criteria and passed. The
difference does not create new risks and
does not impact safety or efficacy. |
| Move, rotate, flip and delete
template | Yes | Rotate and flip
images only | Yes there are differences.
The CDI application itself cannot move or
delete images. This feature is not required
to meet the subject device intended use.
The system has been tested against pre-
determined criteria and passed. The
difference does not create new risks and
does not impact safety or efficacy. |
| Draw line | Yes | Yes | No differences |
| Draw arrow | Yes | Yes | No differences |
| Write text | Yes | Yes | No differences |
| Measure distance | Yes | No | Yes, there are differences.
Measurement is not a feature in the CDI
application. This feature is not required to
meet the subject device intended use. The
system has been tested against pre-
determined criteria and passed. The
difference does not create new risks and
does not impact safety or efficacy. |
| Measure angle | Yes | Yes | No differences |
| Measure area | Yes | Yes | No differences |
| Print image | Yes | Yes | No differences |
| 2D Image Viewer- 2D image
viewer with real-time pan,
zoom, centering, windowing,
flip, rotation, free layouts, cine
and annotation Tools for
removal of obscuring
anatomy including ROI
drawing, ROI dilation and
erosion, paint, fence,
thresholding, 2D & 3D region
growing and balloon.
Analytical tools for measuring
distance, angle, ROI, grid,
table, profile, time-density
curve, pixel coordinate, and
scale bar. | Yes | 2D image
viewer - 2D
image viewer
has the
following: real-
time pan,
zoom,
centering,
windowing, flip,
rotation, free
layouts and
annotation
Tools. | Yes there are differences in the CDI
application which has reduced
functionality compared to the predicate
device. However, these features are not
required to meet the subject device
intended use. The system has been
tested against pre-determined criteria and
passed. The difference does not create
new risks and does not impact safety or
efficacy. |
| MIP/MinIP - maximum
intensity projection | Yes | No | Yes there are differences in the CDI
application which has reduced |
| Functionality | Predicate:
Xelis
DENTAL
(K102684) | Subject
Device: CDI
Application™ | If different, Impact on Safety and or
Efficacy |
| | | | functionality compared to the predicate
device. However, this feature is not
required to meet the subject device
intended use. The system has been
tested against pre-determined criteria and
passed. The difference does not create
new risks and does not impact safety or
efficacy. |
| Dental volume reformat
functions, such as arch/curve,
drawing nerve-canal, axis and
re-slice based on dental arch | Yes | No | Yes there are differences in the CDI
application which has reduced
functionality compared to the predicate
device. However, this feature is not
required to meet the subject device
intended use. The system has been
tested against pre-determined criteria and
passed. The difference does not create
new risks and does not impact safety or
efficacy. |
| Dental implant planning,
which provides simulations of
implant placement, bone-
structure analysis and
location of the mandibular
canal. | Yes | No | Yes there is a difference. This is not a
feature in the CDI application. A feature
for simulations of implant placement,
bone-structure analysis and location of the
mandibular canal is not implemented or
claimed. This feature is not required to
meet the subject device intended use. The
system has been tested against pre-
determined criteria and passed. The
difference does not create new risks and
does not impact safety or efficacy. |
| Intended Use1 | Picture
archiving
and
communication
on systems
(PACS) | Picture
archiving and
communication
systems
(PACS) | Yes, there are differences but both
systems are a picture archiving and
communication systems (PACS) is a
combination of hardware and software
dedicated to the short and long term
storage, retrieval, management,
distribution, and presentation of images.
Electronic images and reports are
transmitted digitally via PACS; this
eliminates the need to manually file,
retrieve, or transport film jackets. The
universal format for PACS image storage
and transfer is DICOM (Digital Imaging
and Communications in Medicine). There
are differences in the features and
functions used in the subject device when
compared to the predicate.
The subject device has less features.
However, the features and functions that
are no in the subject device are not |
| Functionality | Predicate:
Xelis
DENTAL
(K102684) | Subject
Device: CDI
ApplicationTM | If different, Impact on Safety and or
Efficacy |
| | | | required to meet the subject device
intended use. The system has been
tested against pre-determined criteria and
passed. The difference does not create
new risks and does not impact safety or
efficacy. |
6
7
1 "Intended Use" is the "Objective Intent" for the device of the persons legally responsible for labeling the device. The FDA defines "Intended Use" as: The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)
8
Nonclinical Testing:
The Corporate Dental Imaging (CDI) Application™ device has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Corporate Dental Imaging (CDI) Application™ software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by the manufacturer, integration and installations verification tests will be conducted against acceptance criteria prior to being released to the user facility.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the Corporate Dental Imaging (CDI) Application™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of general function, application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is safe and effective for its' intended use. Therefore, the Corporate Dental Imaging (CDI) Application™ is substantially equivalent to the predicate device.