(9 days)
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.
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.
The provided text is a 510(k) summary for a medical device software (DBSWIN and VISTAEASY Imaging Software). It describes the software's purpose, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
However, this document does NOT contain information about specific acceptance criteria for performance metrics (like sensitivity, specificity, or image quality scores) or a study proving the device meets those criteria in the traditional sense of a clinical performance study with human-in-the-loop or standalone AI performance.
Instead, this 510(k) submission leverages the concept of substantial equivalence to a previously cleared predicate device (DBSWIN and VistaEasy Imaging Software K190629). The "proof" that the device meets acceptance criteria is primarily demonstrated through:
- Direct comparison of technological characteristics: Showing that the modified device has the same intended use, functionality, and performance as the predicate device.
- Verification testing: Ensuring that the software performs as intended and that the minor modifications (operating system changes, new hardware support) do not introduce new safety or effectiveness concerns. This is typically bench testing and does not involve clinical performance metrics.
- Adherence to recognized standards and guidance documents: Demonstrating that the software development and risk management processes follow established regulatory guidelines.
Therefore, many of the requested points about "acceptance criteria" for performance metrics and clinical study details (like sample size for test sets, expert consensus, MRMC studies, ground truth establishment) are not applicable or not detailed in this specific document, because the submission path is based on substantial equivalence to an existing device rather than demonstrating de novo clinical performance for a novel algorithm.
Here's a breakdown of what can be extracted and what information is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, specific quantitative performance acceptance criteria (e.g., sensitivity, specificity, AUC) are not detailed in this 510(k) summary because it's a substantial equivalence submission based on an existing device's functionality. The "performance" is implicitly deemed equivalent to the predicate.
The acceptance criteria are more related to functional equivalence and safety:
| Acceptance Criterion (Implied/Functional) | Reported Device Performance (from comparison table) |
|---|---|
| Indications for Use: Same as predicate | YES (SAME, unchanged) |
| Patient Management: Same as predicate | YES |
| Image Management: Same as predicate | YES |
| Acquisition Sources (X-ray, Laser Fluorescence, Video, Photos, Documents): Same as predicate | YES (All listed sources are supported) |
| Display Images: Same as predicate | YES |
| Save/Store Images: Same as predicate | YES |
| Produce Reports: Same as predicate | YES |
| Print/Export Images: Same as predicate | YES |
| Image Enhancement (Brightness, Contrast, Colorize, Crop, Rotate, Zoom, Invert, Sharpen, Measure, Over/Under Exposure, Annotate): Same as predicate | YES (All listed enhancements are supported) |
| Run on standard PC compatible computers: Same as predicate | YES |
| Supported Devices: Same as predicate, plus new integrations | YES (Supports ScanX, ProVecta S-Pan, CamX, and new SensorX) |
| Computer operating systems: Updated but compatible subset of predicate's supported OS | Microsoft Windows 8.1, 64-bit; Microsoft Windows 10, 64-bit; Microsoft Windows Server 2012; Microsoft Windows Server 2016 |
| CPU, RAM, Drive, Hard Disk, Data Backup, Interface, Diagnostic Monitor, Resolution/Graphics: Same as predicate | No change |
| Safety and Effectiveness: Minor modifications do not alter fundamental scientific technology, verification testing successfully conducted, no new safety/effectiveness issues raised. | Confirmed through non-clinical testing and risk analysis update. |
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing, effectiveness, and functionality were successfully conducted and verified with the compatible image capture devices."
- Sample Size for Test Set: Not specified. This typically refers to the number of patient cases or images used in a clinical performance study. For a substantial equivalence claim based on functional changes to image management software, detailed test set sample sizes for performance metrics are often not provided in the public summary if the testing is primarily functional verification rather than clinical validation of an AI algorithm.
- Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective). Not relevant given the type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission is for image management software, not an AI diagnostic algorithm that requires expert-established ground truth for clinical performance evaluation. The "ground truth" for this type of device would be its ability to correctly acquire, display, edit, store, and distribute images as per its specifications, which is verified through functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical image-based test set requiring adjudication is described for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI diagnostic device. It is an image management software. Therefore, an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI diagnostic algorithm. The software performs functions like image acquisition, display, editing, and distribution. Its "performance" is its ability to execute these functions correctly, which is evaluated through functional bench testing, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. For a software acting as a PACS-like system, the "ground truth" is typically whether the software correctly implements its specified functions (e.g., does it display the image correctly? Does it store it without corruption? Can it apply the specified edits?). This isn't a diagnostic ground truth established by medical experts or pathology.
8. The sample size for the training set
Not Applicable. This is not an AI/Machine Learning device that undergoes "training."
9. How the ground truth for the training set was established
Not Applicable. As per point 8, this is not an AI/Machine Learning device requiring a training set and its associated ground truth.
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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
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- 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
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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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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 SEHöpfigheimer Str. 1774321 Bietigheim-BissingenGermanyPhone: + 49 (0) 7142 70 5-0Fax: + 49 (0) 7142 705-500E-Mail: info@duerr.dewww.duerrdental.com | Establishment RegistrationName in FURLS:Duerr DENTAL SE |
|---|---|---|
| Establishment RegistrationNumber: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver LangeDirector of Quality ManagementDÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-Bissingen,GermanyPhone: + 49 (0) 7142 70 5-190Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph LatkowskiDirector of Quality and RegulatoryAir Techniques, Inc.1295 Walt Whitman RoadMelville, NY 11747, USAU.S. Phone: 516-214-5574E-Mail: Joseph.Latkowski@airtechniques.com |
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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.
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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 ImagingSoftware K190629 | DBSWIN and VistaEasyImaging Software(Modified) |
|---|---|---|
| Indications for Use | DBSWIN and VistaEasy imaging softwareare intended for use by qualified dentalprofessionals for windows baseddiagnostics. The software is a diagnosticaide for licensed radiologists, dentistsand clinicians, who perform the actualdiagnosis based on their training,qualification, and clinical experience.DBSWIN and VistaEasy are clinicalsoftware applications that receiveimages and data from various imagingsources (i.e., radiography devices anddigital video capture devices) that aremanufactured and distributed by DuerrDental and Air Techniques. It is intendedto acquire, display, edit (i.e., resize,adjust contrast, etc.) and distributeimages using standard PC hardware. Inaddition, DBSWIN enables theacquisition of still images from 3rd partyTWAIN compliant imaging devices (e.g.,generic image devices such as scanners)and the storage and printing of clinicalexam data, while VistaEasy distributesthe acquired images to 3rd party TWAINcompliant PACS systems for storage andprinting.DBSWIN and VistaEasy software are notintended for mammography use. | SAME, unchanged. |
| Patient Management | YES | YES |
| Image Management | YES | YES |
| Descriptive Information | DBSWIN and VistaEasy ImagingSoftware K190629 | DBSWIN and VistaEasyImaging Software(Modified) |
| Acquisition SourcesX-ray (i.e., PhosphorPlate, DigitalPanoramic) | YES | YES |
| Laser FluorescenceCaries 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/UnderExposure | YES | YES |
| Annotate* | YES | YES |
| Run on standard PCcompatible computers | YES | YES |
| Supported Devices | Supported Device Families:• ScanX• ProVecta S-Pan• CamX | Supported Device Families:• ScanX• ProVecta S-Pan• CamXSame, plus this newly integrateddevice: SensorX |
| Descriptive Information | DBSWIN and VistaEasy ImagingSoftware K190629 | DBSWIN and VistaEasyImaging Software(Modified) |
| Computer operatingsystems | Microsoft Windows 7, 32-bit (from Home toPremium)Microsoft Windows 7, 64-bit (from Home toPremium)Microsoft Windows 8.1, 64-bitMicrosoft Windows 10, 64-bitMicrosoft Windows Server 2012Microsoft Windows Server 2016 | Microsoft Windows 8.1, 64-bitMicrosoft Windows 10, 64-bitMicrosoft Windows Server 2012Microsoft 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 GBThe memory requirements of the databasedepend on the number of images taken atthe 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 bitcolor depth | No change |
| Resolution /Graphics | ≥ 1024 x 768Depth of color 32-bit, 16.7 million colors | No change |
| Run on standard PCcompatiblecomputers | Yes | No change |
8. Comparison of the Technological Characteristics
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*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.
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-
- 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.
§ 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).