DBSWIN and VISTAEASY Imaging Software

K190629 · Durr Dental SE · LLZ · Apr 1, 2019 · Radiology

Device Facts

• Record ID: K190629
• Device Name: DBSWIN and VISTAEASY Imaging Software
• Applicant: Durr Dental SE
• Product Code: LLZ · Radiology
• Decision Date: Apr 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

DBSWIN and VistaEasy are clinical imaging software applications for dental diagnostics; operate on standard Windows-based PCs. Input sources include radiography devices, digital video capture devices, and TWAIN-compliant scanners. Software acquires, displays, edits (resize, contrast adjustment, rotation, cropping, annotation), stores, prints, and distributes images. VistaEasy functions as a reduced-feature version of DBSWIN, focusing on distribution to TWAIN-compliant PACS. Used by dentists and clinicians in dental clinics to facilitate diagnosis; software acts as a diagnostic aid, with final clinical decisions remaining with the provider. Benefits include streamlined image management, enhanced visualization of dental structures, and integration with various imaging hardware to support clinical workflows.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, functional software cross-check testing, and risk analysis. Device developed per IEC 62304 standards.

Technological Characteristics

Software-based image management system; runs on standard PC hardware. Connectivity via Ethernet (≥100 Mbit). Supports TWAIN and DICOM standards. Cybersecurity controls implemented per FDA guidance. No specific hardware materials; software-only device.

Indications for Use

Indicated for use by qualified dental professionals (radiologists, dentists, clinicians) for Windows-based diagnostic imaging. Supports acquisition, display, editing, and distribution of images from radiography and digital video capture devices. Not for mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• DBSWIN and VistaEasy Imaging Software (K161444)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|

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# 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 [e-mail] 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: [phone] Email: [e-mail] [e-mail]

U.S. Agent Contact: Vincent Vega Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 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

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#### 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.

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# Comparison of the Technological Characteristics

| Descriptive<br>Information | DBSWIN and VistaEasy Imaging<br>Software K161444 | DBSWIN and VistaEasy Imaging<br>Software (Modified) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | DBSWIN and VistaEasy imaging<br>software are intended for use by<br>qualified dental professionals for<br>windows based diagnostics. The<br>software is a diagnostic aide for<br>licensed radiologists, dentists and<br>clinicians, who perform the actual<br>diagnosis based on their training,<br>qualification, and clinical experience.<br>DBSWIN and VistaEasy are clinical<br>software applications that receive<br>images and data from various imaging<br>sources (i.e., radiography devices and<br>digital video capture devices) that are<br>manufactured and distributed by DÜRR<br>Dental and Air Techniques. It is<br>intended to acquire, display, edit (i.e.,<br>resize, adjust contrast, etc.) and<br>distribute images using standard PC<br>hardware. In addition, DBSWIN enables<br>the acquisition of still images from 3rd<br>party TWAIN compliant imaging devices<br>(e.g., generic image devices such as<br>scanners) and the storage and printing<br>of clinical exam data, while VistaEasy<br>distributes the acquired images to 3rd<br>party TWAIN compliant PACS systems<br>for storage and printing.<br>DBSWIN and VistaEasy software are not<br>intended for mammography use. | SAME, unchanged. |
| Patient<br>Management | YES | YES |
| Image Management | YES | YES |
| Acquisition Sources<br>X-ray<br>(i.e., Phosphor<br>Plate, Digital<br>Panoramic) | YES | YES |
| Laser<br>Fluorescence<br>Caries<br>Detection Aid | YES | YES |
| Video | YES | YES |
| Descriptive<br>Information | DBSWIN and VistaEasy Imaging<br>Software K161444 | DBSWIN and VistaEasy Imaging<br>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<br>Images* | YES | YES |
| Enhance<br>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<br>Exposure | YES | YES |
| Annotate* | YES | YES |
| Run on<br>standard PC<br>compatible<br>computers | YES | YES |
| Descriptive<br>Information | DBSWIN and VistaEasy Imaging<br>Software K161444 | DBSWIN and VistaEasy Imaging<br>Software (Modified) |
| Supported Devices | VistaCam iX Proof<br>CamX Spectra<br>VistaCam iX Cam<br>CamX Elara<br>CamX Polaris<br>VistaCam iX HD<br>CamX Triton HD<br>CamX Luna HD<br>VistaCam iX Macro<br>VistaPano S<br>ProVecta S-Pan<br>VistaPano S CEPH<br>ProVecta S-PAN CEPH<br>ScanX Swift<br>ScanX Duo<br>ScanX Classic<br>ScanX Ortho<br>ScanX Intraoral | Same, plus these newly integrated<br>devices:<br>ScanX Swift View<br>VistaScan Nano<br>ScanX Classic View<br>CamX Triton HD Proxi<br>CamX Triton HD Spectra |
| Computer<br>operating systems | Microsoft Windows 7, 32 bit (from Home<br>Premium),<br>Microsoft Windows 7, 64 bit (from Home<br>Premium),<br>Microsoft Windows 8, 64 bit Microsoft<br>Windows 10, 64-bit<br>Microsoft Windows Server 2012 | Microsoft Windows 7, 32-bit (from Home to<br>Premium)<br>Microsoft Windows 7, 64-bit (from Home to<br>Premium)<br>Microsoft Windows 8.1, 64-bit<br>Microsoft Windows 10, 64-bit<br>Microsoft Windows Server 2012<br>Microsoft Windows Server 2016 |
| CPU | ≥ Intel Pentium IV compatible, 1.4 GHz,<br>≥ 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<br>The memory requirements of the database<br>depend on the number of images taken at<br>the office. (Camera image: Approx. 1 MB, X-<br>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<br>depth | No change |
| Resolution /Graphics | ≥ 1024 x 768 | ≥ 1024 x 768<br>Depth of color 32-bit, 16.7 million colors |
| Run on standard PC<br>compatible<br>computers | Yes | No change |

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* Not available on VistaEasy

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#### 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

- 10. 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.