(9 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image management and editing functions.
No
The device is described as diagnostic imaging software for dental professionals, intended to acquire, display, edit, and distribute images for diagnosis, not to provide therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the software is "intended for use by qualified dental professionals for windows based diagnostics" and is a "diagnostic aide for licensed radiologists, dentists and clinicians".
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." The software's function is to manage, display, and edit images, not to acquire them directly through integrated hardware.
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 acquiring, displaying, editing, and distributing medical images from radiography devices, digital video capture devices, and scanners. This is image processing and management, not testing biological samples.
- Intended Use: The intended use is for diagnostic aid based on images, not on the analysis of biological specimens.
Therefore, this device 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 using standard PC hardware.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography devices and digital video capture devices, X-ray (i.e., Phosphor Plate, Digital Panoramic), Laser Fluorescence Caries Detection Aid, Video, Photos.
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 with the compatible image capture devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, effectiveness, and functionality were successfully conducted and verified with the compatible image capture devices. The software remains DICOM compliant. 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 (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
November 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dürr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K203287
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: November 6, 2020 Received: November 9, 2020
Dear Mr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203287
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 Durr 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) |
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3
510(k) Summary, DÜRR DENTAL SE,
DBSWIN and VISTAEASY Imaging Software
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
Date Summary Prepared: 1.
November 12, 2020
2. Submitter's Identification:
| Submitter's Identification: | DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Phone: + 49 (0) 7142 70 5-0
Fax: + 49 (0) 7142 705-500
E-Mail: info@duerr.de
www.duerrdental.com | Establishment Registration
Name in FURLS:
Duerr DENTAL SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration
Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange
Director of Quality Management
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen,
Germany
Phone: + 49 (0) 7142 70 5-190
Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski
Director of Quality and Regulatory
Air Techniques, Inc.
1295 Walt Whitman Road
Melville, NY 11747, USA
U.S. Phone: 516-214-5574
E-Mail: Joseph.Latkowski@airtechniques.com | |
4
3. Subject Device:
| 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 |
4. Legally Marketed Predicate Device Information:
| 510(k) Number: | K190629 |
|---|---|
| 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 Duerr 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.
5
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 K190629 software applications that have identical indications for use, functionality, performance, and features as shown in the following comparison Table.
| Descriptive Information | DBSWIN and VistaEasy Imaging
Software K190629 | 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 Duerr
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 |
| Descriptive Information | DBSWIN and VistaEasy Imaging
Software K190629 | DBSWIN and VistaEasy
Imaging Software
(Modified) |
| Acquisition Sources
X-ray (i.e., Phosphor
Plate, Digital
Panoramic) | YES | YES |
| Laser Fluorescence
Caries Detection Aid | YES | YES |
| Video | YES | YES |
| 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 |
| Supported Devices | Supported Device Families:
• ScanX
• ProVecta S-Pan
• CamX | Supported Device Families:
• ScanX
• ProVecta S-Pan
• CamX
Same, plus this newly integrated
device: SensorX |
| Descriptive Information | DBSWIN and VistaEasy Imaging
Software K190629 | DBSWIN and VistaEasy
Imaging Software
(Modified) |
| Computer operating
systems | 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 | 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 | No change |
| RAM | ≥ 1GB (2GB recommended) | No change |
| Drive | DVD-ROM | No change |
| Hard Disk | 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) | No change |
| 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
Depth of color 32-bit, 16.7 million colors | No change |
| Run on standard PC
compatible
computers | Yes | No change |
8. Comparison of the Technological Characteristics
6
7
*Not available on VistaEasy
9. Discussion of Similarities and Differences:
Operating System:
The list of compatible operating systems has changed. Windows 7 is no longer supported. Hardware compatibility:
An additional hardware imaging source is supported by the DBSWIN software: the dental intraoral sensor "SensorX". SensorX is currently under review with the FDA (refer to the Traditional 510(k) K203116).
Risk Analysis Update:
In scope of the proof filter optimization for the dental camera CamX Spectra, newly identified risks have been identified and were added to the software risk analysis.
8
-
- Non-Clinical Data and Performance Testing: Software was updated and validated in accordance with these standards and FDA guidance documents:
EN ISO 14971:2012 Risk Management FDA # 5-40
- Non-Clinical Data and Performance Testing: Software was updated and validated in accordance with these standards and FDA guidance documents:
EN ISO 15223-1:2016 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied FDA # 5-117
EN 62366-1:2015 + AC:2015 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices FDA # 5-114
IEC 62304 Medical Device Software Life-cycle processes FDA # 13-79 FDA Guidance Documents employed:
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 and
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Documentation was generated for a Moderate Level of Concern. Bench testing, effectiveness, and functionality were successfully conducted and verified with the compatible image capture devices. The software remains DICOM compliant.
-
- Clinical Data: Not required for a finding of substantial equivalence.
-
- 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, DÜRR 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 K190629.