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 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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (DBSWIN and VistaEasy Imaging Software). It describes the device, its intended use, and its similarities to a predicate device to establish substantial equivalence for FDA clearance.

However, this document does not contain information about specific acceptance criteria related to a study proving the device meets performance metrics. It focuses on demonstrating equivalence to a legally marketed predicate device rather than presenting results from a standalone performance study with defined acceptance criteria.

The "Clinical and Non-Clinical Testing" section mentions:

"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 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."

These points indicate software development and general testing, but none of them are described as a quantitative performance study with specific acceptance criteria that would fall under the categories requested in your prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement).

Therefore, based only on the provided text, I cannot answer the questions about acceptance criteria and the specifics of a study proving the device meets them because such details are not present. The clearance is based on substantial equivalence to an existing predicate device (Visix Imaging - K082623), meaning the FDA determined it performs as safely and effectively as the predicate, not necessarily through novel clinical performance studies for this specific submission.

If this were a more complex AI/ML device, the FDA would likely require a more detailed study with quantitative performance metrics as part of the 510(k) submission. This document, however, describes a "Picture archiving and communications system" which primarily functions for image management and display, and its clearance relies on demonstrating it is technologically similar and has similar indications for use as a previously cleared device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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 AGHöpfigheimer Strasse 17D-74321 Bietigheim-BissingenDeutschland / GermanyEmail: lange.o@duerr.de
Contact Person:	Oliver LangeHead of Quality ManagementDuerr Dental AGHöpfigheimer Strasse 17D-74321 Bietigheim-BissingenDeutschland / Germany
	Phone: + 49 (0) 7142 / 705-0Fax: + 49 (0) 7142 / 705-500Email: lange.o@duerr.de
U.S.A. Contact Person:	Suzanne Lucas1295 Walt Whitman RoadMelville, NY 11747Email: slucas@airtechniques.comPhone: 516-214-5514Fax: 516-433-6171
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

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.

CommonName	Trade Name	FDA 510(k)
IntraoralCamera	VistaCam iX Proof	K150672
	VistaCam iX Cam	n/a
	VistaCam iX Macro	n/a
ExtraoralRadiographyX-Ray	VistaPano S	K130585
	ProVecta S-Pan1
Phosphor PlateScanner	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/VistaEasyDuerr AGK143290	Visix ImagingTelevere SystemsK082623
Indications forUse	DBSWIN and VistaEasy imaging software are intendedfor use by qualified dental professionals for windowsbased diagnostics. The software is a diagnostic aide forlicensed radiologists, dentists and clinicians, whoperform the actual diagnosis based on their training,qualification, and clinical experience. DBSWIN andVistaEasy are clinical software applications that receiveimages and data from various imaging sources (i.e.,radiography devices and digital video capture devices)that are manufactured and distributed by Duerr Dentaland Air Techniques. It is intended to acquire, display,edit (i.e., resize, adjust contrast, etc.) and distributeimages using standard PC hardware. In addition,DBSWIN enables the acquisition of still images from 3rdparty TWAIN compliant imaging devices (e.g., genericimage devices such as scanners) and the storage andprinting of clinical exam data, while VistaEasy distributesthe acquired images to 3rd party TWAIN compliant PACSsystems for storage and printing.DBSWIN and VistaEasy software are not intended formammography use.	Visix Imaging is a clinical softwareapplication that receives images and datafrom various imaging sources (e.g.,radiographic devices, digital videocapture devices, and generic imagedevices such as scanners). Visix Imagingis intended to acquire, display, edit (e.g.,resize, adjust contrast, annotate, etc.),review, store, print, and distribute,images, plus store clinical notes in theform of annotations and measurements,using standard PC hardware.Visix Imaging is currently intended fordental use. It is not intended formammography use.
PatientManagement*	Yes	Yes
ImageManagement	Yes	Yes

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	Parameters	DBSWIN/VistaEasyDuerr AGK143290	Visix ImagingTelevere SystemsK082623
Acquire Images
	X-ray(i.e., PhosphorPlate, DigitalPanoramic)	Yes	Yes
	LaserFluorescenceCariesDetection Aid	Yes	Yes
	Video	Yes	Yes
	Photos	Yes	Yes
	Documents	Yes	Yes
	Import*	Yes	Yes
	Display Images	Yes	Yes
	Save/StoreImages*	Yes	Yes
	ProduceReports*	Yes	Yes
	Print/ExportImages*	Yes	Yes

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Parameters	DBSWIN/VistaEasyDuerr AGK143290	Visix ImagingTelevere SystemsK082623
EnhanceImages
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/UnderExposure	Yes	Yes
Annotate*	Yes	Yes
Run onstandard PC-compatiblecomputers	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:

HardwareRequirements	DBSWIN/ VistaEasy
Platform	Microsoft Windows XP Professional, 32 bit, SP 3,Microsoft Windows 7, 32 bit (from Home Premium),Microsoft Windows 7, 64 bit (from Home Premium),Microsoft Windows 8, 64 bit (not Windows RT),Microsoft Windows Server 2012
CPU	≥ Intel Pentium IV compatible, 1.4 GHz,≥ 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 colordepth
Resolution /Graphics	≥ 1024 x 768
Run on standard PC-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).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).