DBSWIN and VistaEasy Imaging Software

K143290 · Durr Dental AG · LLZ · Feb 18, 2016 · Radiology

Device Facts

• Record ID: K143290
• Device Name: DBSWIN and VistaEasy Imaging Software
• Applicant: Durr Dental AG
• Product Code: LLZ · Radiology
• Decision Date: Feb 18, 2016
• 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 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.

Device Story

DBSWIN and VistaEasy are clinical software applications for dental imaging management; they receive inputs from radiography devices, digital video capture devices, and TWAIN-compliant scanners. The software runs on standard PC hardware; it allows clinicians to acquire, display, edit (resize, contrast adjustment, rotation, cropping, colorization, inversion, sharpening), measure, annotate, store, and print clinical images. VistaEasy functions as a subset of DBSWIN, focusing on distribution to third-party PACS systems. Used in dental clinics by dentists and radiologists; the software serves as a diagnostic aid, with the clinician performing the final diagnosis based on their professional experience. The system facilitates clinical workflow by centralizing image management and enabling integration with various imaging hardware.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes verification of software functionality, cross-check testing between software and image capture devices, and adherence to IEC 62304 software life cycle standards. The device is DICOM compliant and underwent risk-analysis-based design reviews.

Technological Characteristics

Software-only device; runs on standard PC-compatible hardware (Windows XP/7/8/Server 2012). Connectivity via Ethernet (≥100 Mbit). DICOM compliant. Developed per IEC 62304. No patient contact. Does not control life-sustaining equipment.

Indications for Use

Indicated for qualified dental professionals, including licensed radiologists, dentists, and clinicians, for Windows-based diagnostic assistance in dental imaging. Not intended 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

• Visix Imaging (K082623)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2016

Duerr Dental AG % Ms. Suzanne Lucas Ouality Specialist, Regulatory Affairs Air Techniques, Inc. 1295 Walt Whitman Road MELVILLE NY 11747

Re: K143290

Trade/Device Name: DBSWIN and VistaEasy Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2016 Received: February 8, 2016

Dear Ms. Lucas:

This letter corrects our substantially equivalent letter of February 18, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely you

For Robert 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K143290

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 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

J Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

# General Information

| Submitted by: | Duerr Dental AG<br>Höpfigheimer Strasse 17<br>D-74321 Bietigheim-Bissingen<br>Deutschland / Germany<br>Email: [e-mail] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Oliver Lange<br>Head of Quality Management<br>Duerr Dental AG<br>Höpfigheimer Strasse 17<br>D-74321 Bietigheim-Bissingen<br>Deutschland / Germany |
| | Phone: + 49 (0) 7142 / 705-0<br>Fax: + 49 (0) 7142 / 705-500<br>Email: [e-mail] |
| U.S.A. Contact Person: | Suzanne Lucas<br>1295 Walt Whitman Road<br>Melville, NY 11747<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 4, 2016 |

# Device

| Name of Device: | DBSWIN and VistaEasy Imaging Software |
|-----------------------|---------------------------------------------------------------|
| Common or Usual Name: | Radiological Image Processing System |
| Classification Name: | Picture archiving and communications system (21 CFR 892.2050) |
| Regulatory Class: | II |
| Primary Product Code: | LLZ |

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## Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|------------------|---------------|------------|
| Televere Systems | Visix Imaging | K082623 |

#### 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 defeatured version of DBSWIN.

## Indication 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 30 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 3'd party TWAIN compliant PACS systems for storage and printing.

DBSWIN and VistaEasy software are not intended for mammography use.

## Comaptible Hardware Devices

The DBSWIN System can record images from any of the Duerr Dental image acquisition devices listed below.

| Common<br>Name | Trade Name | FDA 510(k) |
|-----------------------------------|-------------------|------------|
| Intraoral<br>Camera | VistaCam iX Proof | K150672 |
| | VistaCam iX Cam | n/a |
| | VistaCam iX Macro | n/a |
| Extraoral<br>Radiography<br>X-Ray | VistaPano S | K130585 |
| | ProVecta S-Pan1 | |
| Phosphor Plate<br>Scanner | ScanX Swift2 | K013893 |

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1 Identical to VistaPano S from Duerr Dental 2 Identical to VistaScan Mini from Duerr Dental

## Technological Characteristics

DBSWIN and VistaEasy are software devices that do not come in contact with patients, and do not control life sustaining devices. DBSWIN and VistaEasy imaging software have the same main technological characteristics as the predicate devices.

## Predicate Similarities and Technological Comparison:

DBSWIN and VistaEasy imaging software by Duerr Dental AG are two software components that are substantially equivalent to Visix Imaging PACS software applications that have similar indications for use, functionality, performance, and features as shown in the following comparison Table.

| Parameters | DBSWIN/VistaEasy<br>Duerr AG<br>K143290 | Visix Imaging<br>Televere Systems<br>K082623 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | DBSWIN and VistaEasy imaging software are intended<br>for use by qualified dental professionals for windows<br>based diagnostics. The software is a diagnostic aide for<br>licensed radiologists, dentists and clinicians, who<br>perform the actual diagnosis based on their training,<br>qualification, and clinical experience. DBSWIN and<br>VistaEasy are clinical software applications that receive<br>images and data from various imaging sources (i.e.,<br>radiography devices and digital video capture devices)<br>that are manufactured and distributed by Duerr Dental<br>and Air Techniques. It is intended to acquire, display,<br>edit (i.e., resize, adjust contrast, etc.) and distribute<br>images using standard PC hardware. In addition,<br>DBSWIN enables the acquisition of still images from 3rd<br>party TWAIN compliant imaging devices (e.g., generic<br>image devices such as scanners) and the storage and<br>printing of clinical exam data, while VistaEasy distributes<br>the acquired images to 3rd party TWAIN compliant PACS<br>systems for storage and printing.<br>DBSWIN and VistaEasy software are not intended for<br>mammography use. | Visix Imaging is a clinical software<br>application that receives images and data<br>from various imaging sources (e.g.,<br>radiographic devices, digital video<br>capture devices, and generic image<br>devices such as scanners). Visix Imaging<br>is intended to acquire, display, edit (e.g.,<br>resize, adjust contrast, annotate, etc.),<br>review, store, print, and distribute,<br>images, plus store clinical notes in the<br>form of annotations and measurements,<br>using standard PC hardware.<br>Visix Imaging is currently intended for<br>dental use. It is not intended for<br>mammography use. |
| Patient<br>Management* | Yes | Yes |
| Image<br>Management | Yes | Yes |

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______________________________________________________________________________________________________________________________________________________________________________

| | Parameters | DBSWIN/VistaEasy<br>Duerr AG<br>K143290 | Visix Imaging<br>Televere Systems<br>K082623 |
|----------------|----------------------------------------------------------|-----------------------------------------|----------------------------------------------|
| Acquire Images | | | |
| | 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 |
| | Photos | Yes | Yes |
| | Documents | Yes | Yes |
| | Import* | Yes | Yes |
| | Display Images | Yes | Yes |
| | Save/Store<br>Images* | Yes | Yes |
| | Produce<br>Reports* | Yes | Yes |
| | Print/Export<br>Images* | Yes | Yes |

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| Parameters | DBSWIN/VistaEasy<br>Duerr AG<br>K143290 | Visix Imaging<br>Televere Systems<br>K082623 |
|---------------------------------------------------|-----------------------------------------|----------------------------------------------|
| 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 |

*Features unavailable on VistaEasy.

## Clinical and Non-Clinical Testing include:

- . 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 15 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 3td 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.

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Minimum System Requirement for Computer Imaging Systems and Differences between DBSWIN and VistaEasy:

| Hardware<br>Requirements | DBSWIN/ VistaEasy |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | Microsoft Windows XP Professional, 32 bit, SP 3,<br>Microsoft Windows 7, 32 bit (from Home Premium),<br>Microsoft Windows 7, 64 bit (from Home Premium),<br>Microsoft Windows 8, 64 bit (not Windows RT),<br>Microsoft Windows Server 2012 |
| CPU | ≥ Intel Pentium IV compatible, 1.4 GHz,<br>≥ Intel Core i3 |
| RAM | ≥ 1GB (2GB recommended), ≥ 4 GB |
| Drive | DVD-ROM |
| Hard Disk | Workstation (without database) ≥50 GB |
| Data Backup¹ | Daily data back up |
| Interface | Ethernet ≥ 100 Mbit |
| Diagnostic Monitor | SVGA ≥ 17", ≥ 1024 x 768 pixel, 24/32 bit color<br>depth |
| Resolution /Graphics | ≥ 1024 x 768 |
| Run on standard PC-<br>compatible computers | Yes |

4 - Daily data backup is not required for VistaEasy since it does not allow the storage of data.

## Summary

Duerr Dental AG's DBSWIN and VistaEasy imaging software have demonstrated to perform as intended, and comply with industry compliance standard.

## Conclusions

DBSWIN and VistaEasy Imaging software, and predicate devices are substantially equivalent in the areas of technical characteristics, function, intended use, and performance.

DBSWIN and VistaEasy Imaging software, and predicate devices are substantially equivalent with respect to safety and effectiveness to existing legally marketed devices and Picture Archiving and Communications Systems (PACS).