(458 days)
No
The summary describes standard image acquisition, display, editing, and management software for dental imaging, with no mention of AI or ML capabilities.
No
The device is described as a diagnostic aide for image acquisition, display, editing, and distribution, which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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".
Yes
The device is described as "imaging software" that runs on "user provided PC-compatible computers" and utilizes "previously cleared digital image capture devices". The description focuses solely on the software's functions (acquire, display, edit, view, store, print, and distribute images) and its compatibility with existing hardware, without mentioning any proprietary hardware components included with the device itself.
Based on the provided text, 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 used to acquire, display, edit, and distribute medical images from various imaging sources like radiography devices, digital video capture devices, and scanners.
- Intended Use: The intended use is for windows based diagnostics by qualified dental professionals, licensed radiologists, dentists, and clinicians. The software is a diagnostic aide for these professionals who perform the actual diagnosis based on their training and experience.
- Input: The input is image data, not biological samples.
The software is designed to manage and process images for diagnostic purposes, but it does not perform tests on biological samples, which is the defining characteristic of an IVD.
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 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.
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 defeatured version of DBSWIN.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiography devices, digital video capture devices, 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, 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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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
1
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
2
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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3
510(k) SUMMARY
General Information
| Submitted by: | Duerr Dental AG
Höpfigheimer Strasse 17
D-74321 Bietigheim-Bissingen
Deutschland / Germany
Email: lange.o@duerr.de |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Oliver Lange
Head of Quality Management
Duerr Dental AG
Höpfigheimer Strasse 17
D-74321 Bietigheim-Bissingen
Deutschland / Germany |
| | Phone: + 49 (0) 7142 / 705-0
Fax: + 49 (0) 7142 / 705-500
Email: lange.o@duerr.de |
| U.S.A. Contact Person: | Suzanne Lucas
1295 Walt Whitman Road
Melville, NY 11747
Email: slucas@airtechniques.com
Phone: 516-214-5514
Fax: 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 |
4
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
| Name | Trade Name | FDA 510(k) |
|---|---|---|
| Intraoral | ||
| Camera | VistaCam iX Proof | K150672 |
| VistaCam iX Cam | n/a | |
| VistaCam iX Macro | n/a | |
| Extraoral | ||
| Radiography | ||
| X-Ray | VistaPano S | K130585 |
| ProVecta S-Pan1 | ||
| Phosphor Plate | ||
| Scanner | ScanX Swift2 | K013893 |
5
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
Duerr AG
K143290 | Visix Imaging
Televere Systems
K082623 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Visix Imaging is a clinical software
application that receives images and data
from various imaging sources (e.g.,
radiographic devices, digital video
capture devices, and generic image
devices such as scanners). Visix Imaging
is intended to acquire, display, edit (e.g.,
resize, adjust contrast, annotate, etc.),
review, store, print, and distribute,
images, plus store clinical notes in the
form of annotations and measurements,
using standard PC hardware.
Visix Imaging is currently intended for
dental use. It is not intended for
mammography use. |
| Patient
Management* | Yes | Yes |
| Image
Management | Yes | Yes |
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| | Parameters | DBSWIN/VistaEasy
Duerr AG
K143290 | Visix Imaging
Televere Systems
K082623 |
|----------------|----------------------------------------------------------|-----------------------------------------|----------------------------------------------|
| Acquire Images | | | |
| | 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 |
| | Save/Store
Images* | Yes | Yes |
| | Produce
Reports* | Yes | Yes |
| | Print/Export
Images* | Yes | Yes |
7
| Parameters | DBSWIN/VistaEasy
Duerr AG
K143290 | Visix Imaging
Televere Systems
K082623 |
|---------------------------------------------------|-----------------------------------------|----------------------------------------------|
| 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 |
*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.
8
Minimum System Requirement for Computer Imaging Systems and Differences between DBSWIN and VistaEasy:
| Hardware
| Requirements | 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 color |
| depth | |
| 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).