(20 days)
Not Found
No
The description focuses on basic image acquisition, display, editing (resize, contrast), storage, and distribution. There is no mention of AI, ML, or advanced image analysis features typically associated with these technologies.
No
The device is described as diagnostic software used for acquiring, displaying, editing, and distributing images, and explicitly as a "diagnostic aide." It does not perform any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is a "diagnostic aide for licensed radiologists, dentists and clinicians." It also mentions "windows based diagnostics."
Yes
The device description explicitly states that DBSWIN and VistaEasy are "imaging software" and "clinical software applications" that run on "user provided PC-compatible computers" and utilize "previously cleared digital image capture devices". It does not include any hardware components as part of the device itself.
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: The description clearly states that DBSWIN and VistaEasy are imaging software intended for use with radiography devices, digital video capture devices, and scanners. These devices capture images of anatomical structures (like teeth and surrounding tissues in a dental context), not analyze biological samples.
- Intended Use: The intended use is for "windows based diagnostics" and as a "diagnostic aide" for interpreting images from these imaging sources. This is distinct from analyzing biological samples.
The software's function is to acquire, display, edit, and manage medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.
DBSWIN and VistaEasy software are not intended for mammography use.
Product codes
LLZ
Device Description
DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition. VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a reduced feature version of DBSWIN.
Mentions image processing
Acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images, enhance images (brightness, contrast, colorize, crop, rotate, zoom in/out, invert, sharpen, measure, over/under exposure, annotate).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography (Phosphor Plate, Digital Panoramic), Laser Fluorescence Caries Detection Aid, Video, Photos, TWAIN compliant imaging devices (e.g., generic image devices such as scanners).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians.
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
Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices.
Full functional software cross check testing was performed.
Summary of Performance Studies
Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices.
Full functional software cross check testing was performed. The verification testing demonstrates that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness.
Key Metrics
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
April 1, 2019
Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FLORIDA 34114
Re: K190629
Trade/Device Name: DBSWIN and VISTAEASY Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 4, 2019 Received: March 12, 2019
Dear Mr. Daniel Kamm:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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
Thalia Mills, Ph.D. 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) K190629
Device Name DBSWIN and VISTAEASY Imaging Software
Indications for Use (Describe)
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.
DBSWIN and VistaEasy software are not intended 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) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
510(k) Summary, DÜRR DENTAL SE,
DBSWIN and VISTAEASY Imaging Software
K190629
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Date Summary Prepared:
March 5, 2019
Submitter's Identification: 2.
DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Responsible Individual Contact/Prepared by: Oliver Lange, Head Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: 49-7142-705-190 Email: lange.o@duerr.de oliver.lange@duerrdental.com
U.S. Agent Contact: Vincent Vega Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Phone: 516 2145512 Fax: 516 4336171 Email: Vincent.Vega@airtechniques.com
3. Device:
Trade /Proprietary Name: DBSWIN and VISTAEASY Imaging Software Medical Imaging Software Device: Regulation Description: Picture archiving and communications system. Regulation Medical Specialty: Radiology Review Panel Radiology Product Code LLZ Regulation Number 892.2050
4
4. Predicate Device:
| Legally Marketed Predicate Device Information: | ||||
|---|---|---|---|---|
| 510(k) Number: | K161444 | |||
| Manufacturer: | "DÜRR DENTAL SE". | |||
| Trade /Proprietary Name | DBSWIN and VistaEasy Imaging Software | |||
| Device: | Medical Imaging Software | |||
| Regulation Description: | Picture archiving and communications system. | |||
| Regulation Medical Specialty: | Radiology | |||
| Review Panel | Radiology | |||
| Product Code | LLZ | |||
| Regulation Number | 892.2050 | |||
| Device Class | 2 |
5. Device Description:
DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition. VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a reduced feature version of DBSWIN.
6. Indications for Use
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.
DBSWIN and VistaEasy software are not intended for mammography use.
7. Summary of the technological characteristics of the device compared to the predicate device:
DBSWIN and VistaEasy imaging software by DÜRR DENTAL SE are two software components that are substantially equivalent to DBSWIN and VistaEasy Imaging Software K161444 software applications that have identical indications for use, functionality, performance, and features as shown in the following comparison Table.
5
Comparison of the Technological Characteristics
| Descriptive
Information | DBSWIN and VistaEasy Imaging
Software K161444 | DBSWIN and VistaEasy Imaging
Software (Modified) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | DBSWIN and VistaEasy imaging
software are intended for use by
qualified dental professionals for
windows based diagnostics. The
software is a diagnostic aide for
licensed radiologists, dentists and
clinicians, who perform the actual
diagnosis based on their training,
qualification, and clinical experience.
DBSWIN and VistaEasy are clinical
software applications that receive
images and data from various imaging
sources (i.e., radiography devices and
digital video capture devices) that are
manufactured and distributed by DÜRR
Dental and Air Techniques. It is
intended to acquire, display, edit (i.e.,
resize, adjust contrast, etc.) and
distribute images using standard PC
hardware. In addition, DBSWIN enables
the acquisition of still images from 3rd
party TWAIN compliant imaging devices
(e.g., generic image devices such as
scanners) and the storage and printing
of clinical exam data, while VistaEasy
distributes the acquired images to 3rd
party TWAIN compliant PACS systems
for storage and printing.
DBSWIN and VistaEasy software are not
intended for mammography use. | SAME, unchanged. |
| Patient
Management | YES | YES |
| Image Management | YES | YES |
| Acquisition Sources
X-ray
(i.e., Phosphor
Plate, Digital
Panoramic) | YES | YES |
| Laser
Fluorescence
Caries
Detection Aid | YES | YES |
| Video | YES | YES |
| Descriptive
Information | DBSWIN and VistaEasy Imaging
Software K161444 | DBSWIN and VistaEasy Imaging
Software (Modified) |
| Photos | YES | YES |
| Documents | YES | YES |
| Import* | YES | YES |
| Display Images | YES | YES |
| Safe/Store Images* | YES | YES |
| Produce Reports* | YES | YES |
| Print/Export
Images* | YES | YES |
| Enhance
Images | | |
| Brightness | YES | YES |
| Contrast | YES | YES |
| Colorize* | YES | YES |
| Crop | YES | YES |
| Rotate | YES | YES |
| Zoom In/Out | YES | YES |
| Invert* | YES | YES |
| Sharpen* | YES | YES |
| Measure* | YES | YES |
| Over/Under
Exposure | YES | YES |
| Annotate* | YES | YES |
| Run on
standard PC
compatible
computers | YES | YES |
| Descriptive
Information | DBSWIN and VistaEasy Imaging
Software K161444 | DBSWIN and VistaEasy Imaging
Software (Modified) |
| Supported Devices | VistaCam iX Proof
CamX Spectra
VistaCam iX Cam
CamX Elara
CamX Polaris
VistaCam iX HD
CamX Triton HD
CamX Luna HD
VistaCam iX Macro
VistaPano S
ProVecta S-Pan
VistaPano S CEPH
ProVecta S-PAN CEPH
ScanX Swift
ScanX Duo
ScanX Classic
ScanX Ortho
ScanX Intraoral | Same, plus these newly integrated
devices:
ScanX Swift View
VistaScan Nano
ScanX Classic View
CamX Triton HD Proxi
CamX Triton HD Spectra |
| Computer
operating systems | Microsoft Windows 7, 32 bit (from Home
Premium),
Microsoft Windows 7, 64 bit (from Home
Premium),
Microsoft Windows 8, 64 bit Microsoft
Windows 10, 64-bit
Microsoft Windows Server 2012 | Microsoft Windows 7, 32-bit (from Home to
Premium)
Microsoft Windows 7, 64-bit (from Home to
Premium)
Microsoft Windows 8.1, 64-bit
Microsoft Windows 10, 64-bit
Microsoft Windows Server 2012
Microsoft Windows Server 2016 |
| CPU | ≥ Intel Pentium IV compatible, 1.4 GHz,
≥ Intel Core i3 | ≥ Intel Pentium IV compatible, 1.4 GHz |
| RAM | ≥ 1GB (2GB recommended), ≥ 4 GB | ≥ 1GB (2GB recommended) |
| Drive | DVD-ROM | No change |
| Hard Disk | Workstation (without database) ≥50 GB | Workstation (without database) ≥50 GB
The memory requirements of the database
depend on the number of images taken at
the office. (Camera image: Approx. 1 MB, X-
ray image: Approx. 2 MB - 10 MB) |
| Data Backup | Daily data back up | No change |
| Interface | Ethernet ≥ 100 Mbit | No change |
| Diagnostic Monitor | SVGA ≥ 17", ≥ 1024 x 768 pixel, 24/32 bit color
depth | No change |
| Resolution /Graphics | ≥ 1024 x 768 | ≥ 1024 x 768
Depth of color 32-bit, 16.7 million colors |
| Run on standard PC
compatible
computers | Yes | No change |
6
7
- Not available on VistaEasy
8
8. Discussion of Similarities and Differences:
The list of compatible operating systems has changed. We no longer support Windows XP and Windows 8. We now support these additional operating systems: Microsoft Windows 8.1, 64bit, Microsoft Windows 10, 64-bit Microsoft Windows Server 2016.
We have added Cybersecurity precautions and information.
Compatibility with these additional image sources has been added: ScanX Swift View; VistaScan Nano; ScanX Classic View; CamX Triton HD Proxi; CamX Triton HD Spectra.
Firmware Files for DÜRR Dental SE and Air Techniques scanner devices has been updated. UDI information display has been added.
9. Non-Clinical Data and Performance Testing
DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements.
DBSWIN product has been in sales and distribution in the European dental market for over 19 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 3rd party software.
Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices.
DBSWIN is DICOM compliant.
Risk Analysis based design development and design reviews were conducted.
Full functional software cross check testing was performed.
Labeling has been updated to assure compliance with the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014
-
- Clinical Data: Not required for a finding of substantial equivalence.
11. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DURR DENTAL SE concludes that the DBSWIN and VistaEasy Imaging Software is substantially equivalent to the predicate device as described herein.
The minor device modifications to DBSWIN/VistaEasy do not alter the fundamental scientific technology of the predicate device and summary level information is adequate to assess the modifications. The verification testing demonstrates that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness. Therefore, the modified DBSWIN/VistaEasy can be found substantially equivalent to the predicate device as cleared in K161444.