Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image visualization, enhancement, measurement, and storage functionalities typical of dental imaging software. There is no mention of AI, ML, deep learning, or any related terms or concepts that would indicate the use of such technologies for tasks like automated detection, segmentation, or diagnosis. The performance studies section also does not mention any AI/ML-specific validation methods or metrics.

Therapeutic

No.
The device specifically states its purpose is to "support the diagnostic process" and to "display and enhance digital images," not to treat or cure any condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" states that the software "supports the diagnostic process" and the "Device Description" section states it is "used to support the image-based diagnostic process" and has functionalities "for facilitating diagnosis". These phrases clearly indicate its role in diagnosis.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "software program" and a "software solution" for image transfer, visualization, and analysis. It is compatible with standard operating systems (Windows and Mac OS X) and does not mention any proprietary hardware components required for its function beyond a standard computer. The performance studies section focuses on software validation.

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.
Device function: DTX Studio diagnose is a software program that processes and visualizes medical images (X-rays, CT scans, etc.) taken from the patient's body. It supports the diagnostic process by displaying and enhancing these images and allowing measurements.
No sample analysis: The software does not analyze biological samples or perform any tests on substances taken from the body. Its function is solely related to the manipulation and interpretation of imaging data.

Therefore, while it is a medical device used to aid in diagnosis, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DTX Studio diagnose is a software program for the transfer and visualization of dental and craniomaxillofacial image information. It displays and enhances digital images from various sources to support the diagnostic process It stores and communicates these images within the system or across computer systems at distributed locations.

Product codes

LLZ

Device Description

DTX Studio diagnose is a software solution used to support the image-based diagnostic process of dental and cranio-maxillofacial cases.

DTX Studio diagnose has specific functionalities to visualize imaging information for facilitating diagnosis, e.g. 2D and 3D X-ray information, and to perform specific measurements on the data to support users with the diagnostic process.

The types of digital image data which are supported by the DTX Studio diagnose include, for example, 3D (CB)CT images, orthopantomograph(OPG)/panorex images, intraoral images, cephalograms and clinical pictures.

DTX Studio diagnose allows the user to view and inspect the patient images, and to add findings and measurements. Indicated findings can be saved within the patient profile in DTX Studio. For the purposes of diagnosis, different workspaces are available within the diagnostic module.

The DTX Studio diagnose software is compatible with both Windows and Mac OS X operating systems. Two different software versions/installers are available based on the user's operating system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

2D and 3D images such as (CB)CT scans and 2D images such as OPG/ panorex images, cephalometric images intra-oral images and clinical pictures

Anatomical Site

dental and cranio-maxillofacial

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)

The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation", issued on January 11, 2002. This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.
No clinical data was used to support the decision of substantial equivalence.

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

Not Found

Predicate Device(s)

K162799, K132773

Reference Device(s)

Not Found

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

January 11, 2018

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, California 92887

Re: K172224

Trade/Device Name: DTX Studio diagnose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2017 Received: December 14, 2017

Dear Charlemagne Chua:

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);

1

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. 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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3

A.4.

I. SUBMITTER

Nobel Biocare AB Västra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: December 12, 2017

II. DEVICE

Name of Device: DTX Studio diagnose Common or Usual Name: System, Image Processing, Radiology Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

III. PREDICATE DEVICE

Primary predicate: Palodex Group Oy - Cliniview (K162799)

Reference predicate: Sirona Dental Systems - Sidexis 4 (K132773)

IV. DEVICE DESCRIPTION

DTX Studio diagnose is a software solution used to support the image-based diagnostic process of dental and cranio-maxillofacial cases.

DTX Studio diagnose has specific functionalities to visualize imaging information for facilitating diagnosis, e.g. 2D and 3D X-ray information, and to perform specific measurements on the data to support users with the diagnostic process.

The types of digital image data which are supported by the DTX Studio diagnose include, for example, 3D (CB)CT images, orthopantomograph(OPG)/panorex images, intraoral images, cephalograms and clinical pictures.

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DTX Studio diagnose allows the user to view and inspect the patient images, and to add findings and measurements. Indicated findings can be saved within the patient profile in DTX Studio. For the purposes of diagnosis, different workspaces are available within the diagnostic module.

The DTX Studio diagnose software is compatible with both Windows and Mac OS X operating systems. Two different software versions/installers are available based on the user's operating system.

V. INDICATIONS FOR USE

DTX Studio diagnose is a software program for the transfer and visualization of dental and craniomaxillofacial image information. It displays and enhances digital images from various sources to support the diagnostic process It stores and communicates these images within the system or across computer systems at distributed locations.

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VI. Comparison of Technological Characteristics

	SUBJECT	Primary Predicate	Reference Predicate	Comments
Technological
characteristics	DTX Studio diagnose	Cliniview
(K162799)	Sidexis 4
(K132773)	Except as noted
comparison is made to
the primary predicate
Trade name	DTX Studio diagnose	Cliniview	Sidexis 4
FDA product
code	LLZ	LLZ	LLZ	Same
Classification	Class II	Class II	Class II	Same
Indications for
use / Intended
Use	DTX Studio diagnose is a
software program for the
transfer and visualization of
dental and craniomaxillofacial
image information. It displays
and enhances digital images
from various sources to
support the diagnostic process
It stores and communicates
these images within the
system or across computer
systems at distributed
locations.	Cliniview software program is
indicated for general dental and
maxillofacial diagnostic imaging.
It controls capture, display,
enhancement, and saving of
digital images from various
digital imaging systems. It
stores and communicates these
images within the system or
across computer systems at
distributed locations.	SIDEXIS 4 is software that offers
functions for the acquisition,
administration, analysis,
diagnosis, presentation and
transfer of digital or digitized
image data, e.g. X-ray images or
video recordings, for medical
use, predominantly in dentistry.	Different - See
discussion below
Input data/
Image
acquisition	2D and 3D images such as
(CB)CT scans and 2D images
such as OPG/ panorex
images, cephalometric images
intra-oral images and clinical
pictures	2D (CB)CT scans and 2D
images such as OPG/ panorex
images, cephalometric images
intra-oral images and clinical
pictures	2D and 3D images such as
(CB)CT scans and 2D images
such as OPG/ panorex images,
cephalometric images intra-oral
images and clinical pictures	Same as reference
predicate
Image
processing
functionality	Enhancement, annotation,
measurement, import/export	Enhancement, annotation,
measurement, import/export
and printing	Enhancement and presentation,
import/export	Same
Technological
characteristics	SUBJECT	Primary Predicate	Reference Predicate	Comments
DTX Studio diagnose	Cliniview
(K162799)	Sidexis 4
(K132773)	Except as noted
comparison is made to
the primary predicate
Output data	Data is stored locally or in
remotely accessible database
in the network (DTX core)	Images and related data are
stored in the Cliniview database
or remotely accessible
database in the network.
Image export	2D Views/images export to
specified location or via e-mail
DICOM exam/report/volume
export
Facescan OBJ export
Image and workspace printing	Same
Software
features	The software provides several
workspaces to review the
images. It provides specific
workspaces to review (a
selection of) the imported
images like e.g. full mouth
series template for intraoral
images, and it provides
workspaces to review a
specific set of images to
support diagnosis of a selected
area combining several image
types.	A workspace is available to
work with imported images. It is
also possible to load and view
3D images or multilayer pan
images by using 3rd party
software.	The software provides several
layouts to review the images. It
provides specific layout to review
(a selection of) the imported
images like e.g. full mouth series
template for intraoral images.	Same as reference
predicate
	Access images from DTX core
database or allow manual
import	Access images from database
or allow manual import	Acquire images from x-ray
devices or allow manual import	Same
	Scan requests creation for
image acquisition	Image acquisition from
connected devices	X-ray exposure creation to
request image acquisition	Different - See
discussion below
	2D and 3D data visualization	2D data visualization
Cliniview is able to send 2D and
3D images to 3rd party viewers
and is also able to receive
patient information from 3rd
party patient management
software	2D and 3D data visualization	Same as reference
predicate
	SUBJECT	Primary Predicate	Reference Predicate	Comments
Technological
characteristics	DTX Studio diagnose	Cliniview
(K162799)	Sidexis 4
(K132773)	Except as noted
comparison is made to
the primary predicate
	Adjust patient positioning in
the software and optimize
cross-sections and projected
images	Not available	Adjust data with the panorama
curves editor	Same as reference
predicate
	Apply image filters, make
annotations	Apply image filters, make
annotations	Apply image filters, make
annotations	Same
	Length and angles
measurement	Length, angle and free angle
measurements	Length and angles measurement	Same
System
Requirements	Workstation:
Operating System: Windows®
7, 8.1, 10 (64 bit), Mac OS® X
(Yosemite, El Capitan); Mac
OS® Sierra
HDD ≥ 5 GB of free disk space
RAM ≥ 8 GB
CPU ≥ 2.8 GHz QuadCore
Graphic Card ≥ 2 GB
Screen Full HD (1920 x 1080)
or higher	Workstation PC:
Operating system:
Windows 7
Professional/Ultimate/Enterprise
SP1 (32 or 64-bit)
Windows 8/8.1
Professional/Enterprise (32 or
64-bit)
Windows 10
HDD ≥ 8 GB
RAM ≥ 4GB
CPU Intel Core i3 or better	Workstation PC:
Operating System:
Windows 7 Pro SP1 (32 o. 64
bit)
Windows 8.1 Pro (64 bit)
Windows 10 Pro (64 bit)
HDD ≥ 5 GB
RAM ≥ 4 GB
CPU ≥ 2 GHz DualCore
Graphic Card ≥ 512 MB
Screen 1280 x 1024 Pixel	Different - See
discussion below

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7

8

Analysis of Differences Between Subject Device and Predicates

The subject device DTX Studio diagnose and primary predicate Cliniview (K162799) have the same intended use and share most software features. Other software features are shared with the reference predicate Sidexis 4 (K132773). Differences in indications for use and software features are discussed below.

Indications for Use/ Intended Use

The Indications for Use statement between the subject and the primary predicate devices (K162799) are primarily the same. Minor differences in wording do not alter the intended therapeutic use of the subject device.

Both DTX Studio diagnose and the primary predicate Cliniview (K162799) allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image within the system (locally) or across computer systems at distributed locations. DTX Studio diagnose allows transfer of images and patient data (store and retrieval) to and from the DTX core database, thus making the data available at different locations. The primary predicate Cliniview (K162799) allows to store and retrieve patient data and related image data in a local or central database called Data Warehouse.

Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete cranio-maxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire cranio-maxillofacial area, as a support for the diagnostic process.

Software features

Scan request - The subject DTX Studio diagnose allows to request scans through DTX core by selecting the scanner device, e.g. 3D scan or OPG / panorex. Cliniview (K162799) controls image capturing of imaging devices for image acquisition and image exposure. Both devices allow for the placing of scan requests and retrieval of scan data. The difference between the subject and the primary predicate is that the predicate software controls the acquisition of scan data including the exposure settings. The subject device allows placing of a scan request where the exposure is set or confirmed and the scanning started by the operator directly on the scanner. The change in scanner operation does not affect the scan output or the use of the scan data in the software.

System requirements - The subject device DTX Studio diagnose is available for both Windows and Mac OS X operating systems. The primary predicate Cliniview (K162799) is only available for the Windows operating system. This change is supported by verification and validation testing conducted on both operating systems.

VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation", issued on January 11, 2002. This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance

9

document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.

No clinical data was used to support the decision of substantial equivalence.

VIII. CONCLUSIONS

The DTX Studio diagnose was evaluated for substantial equivalence using standard testing. Based on technological characteristics and non-clinical test data included in this submission, the DTX Studio diagnose was shown to be substantially equivalent to the Cliniview software (K162799).