(113 days)
ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric Xray images in dental radiography for adult and pediatic patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians.
Not intended for mammography use.
This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The Xrays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional individual images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard. This device is similar to our reference device, K181432, but we have now added cephalometric capability, making it entirely equivalent to our predicate device for indications. An option would allow the customer to purchase this new device without the CEPH function, if desired.
Here's a breakdown of the acceptance criteria and study information for the ProVecta 3D Prime Ceph based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not include specific acceptance criteria in numerical or quantifiable terms (e.g., minimum sensitivity/specificity, specific image quality scores). Instead, it relies on demonstrating compliance with recognized standards and comparing its performance to a predicate device.
The "reported device performance" primarily comes from conformity to these standards and the implicit performance derived from its technological characteristics being similar to or the same as the predicate.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance |
|---|---|
| Safety: | Complies with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-3 (Radiation Protection in Diagnostic X-Ray Equipment), IEC 60825-1 (Safety of laser products). |
| Essential Performance: | Verified through compliance with IEC 60601-1, IEC 60601-2-63 (Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment). |
| Image Quality (Dental Radiography): | Acceptance testing was performed for both panoramic and cephalometric modes according to DIN 6868-151 (Image quality assurance in diagnostic X-ray departments - Acceptance testing of dental radiographic equipment) and DIN 6868-161 (Image Quality Assurance In Diagnostic X-Ray Departments - Acceptance Testing Of Dental Radiographic Equipment For Digital Cone-Beam Computed Tomography). Line pair and contrast were evaluated using a phantom designed for this purpose. The device's technological characteristics (kV, mA, focal spot, detector) are similar to the predicate. |
| Usability: | Complies with IEC 60601-1-6 (Usability) and IEC 62366 (Application of usability engineering to medical devices). |
| Software Life-cycle Processes: | Complies with IEC 62304 (Medical Device Software Life-cycle processes). Firmware evaluated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; risk management documented. |
| Biocompatibility: | Chin Holder (material PBT) complies with EN ISO 10993-5 (Cytotoxicity). Other accessories were previously cleared. |
| Substantial Equivalence: | The device is deemed substantially equivalent to the predicate (K152106) and reference device (K181432) regarding technology, performance, and indications for use. Key performance differences with the reference device (K181432, which lacked CEPH) are resolved by the addition of cephalometric capability, making it entirely equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of patient data or clinical images. The testing described focuses on non-clinical performance and engineering standards (e.g., electrical safety, image quality with phantoms).
- Test Set Sample Size: Not applicable/not provided for patient data.
- Data Provenance: Not applicable, as no patient data test set is described. The non-clinical testing appears to have been conducted by the manufacturer, presumably in Germany (country of origin for DÜRR DENTAL SE).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided as the evaluation relies on non-clinical phantom-based testing and compliance with recognized standards, rather than expert-derived ground truth from clinical images.
4. Adjudication Method for the Test Set
This information is not provided as the evaluation relies on non-clinical phantom-based testing and compliance with recognized standards.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and thus, no effect size of human reader improvement with AI assistance is reported. This device is an X-ray imaging system, not an AI-powered diagnostic aid for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The device is a medical imaging hardware system.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established through:
- Phantoms: For image quality assessment (line pair, contrast).
- Engineering Standards: Electrical safety, radiation protection, EMC, usability, software life-cycle, and biocompatibility standards provide the "ground truth" for compliance.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is demonstrating that the ProVecta 3D Prime Ceph performs as safely and effectively as the legally marketed predicate device (Vatech Co. Ltd. PaX-i3D Smart, K152106).
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is an X-ray imaging system, not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
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March 5, 2020
DÜRR DENTAL SE
% Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K193139
Trade/Device Name: ProVecta 3D Prime Ceph Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: January 27, 2020 Received: January 29, 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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) K193139
Device Name ProVecta 3D Prime Ceph
ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric Xray images in dental radiography for adult and pediatic patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians.
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, ProVecta 3D Prime Ceph
K193139
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Date Summary Prepared: 25. October 2019
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 |
3. Device:
| Trade /Proprietary Name: | ProVecta 3D Prime Ceph |
|---|---|
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 892.1750 |
| Device Class: | 2 |
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4. Predicate Device:
| 510(k) Number: | K152106 |
|---|---|
| Manufacturer: | Vatech Co. Ltd. |
| Trade /Proprietary Name: | PaX-i3D Smart (PHT-30LFO) |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 892.1750 |
| Device Class: | 2 |
5. Reference Device:
| 510(k) Number: | K181432 |
|---|---|
| Manufacturer: | DÜRR DENTAL SE |
| Trade /Proprietary Name: | ProVecta 3D Prime with VistaSoft |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 892.1750 |
| Device Class: | 2 |
| Reason: | This device used K152106 as a predicate but it lacked the CEPH option. With this submission we add the CEPH option. |
6. Device Description:
This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The Xrays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional individual images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard. This device is similar to our reference device, K181432, but we have now added cephalometric capability, making it entirely equivalent to our predicate device for indications. An option would allow the customer to purchase this new device without the CEPH function, if desired.
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7. Indications for use:
ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric X-ray images in dental radiography for adult and pediatric patients. lt provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.
8. Summary of the technological characteristics of the device compared to the predicate devices:
| Descriptive Information | K152106, PaX-i3D Smart(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime Ceph | |
|---|---|---|---|
| Indications for Use | PHT-30LFO is a computedtomography x-ray systemintended to produce panoramic,cephalometric or cross-sectionalimages of the oral anatomy on areal time basis by computerreconstruction of x-ray imagedata from the same axial planetaken at different angles. Itprovides diagnostic details of theanatomic structures by acquiring360° rotational image sequencesof oral and maxillofacial area fora precise treatment planning inadult and pediatric dentistry. Thedevice is operated and used byphysicians, dentists, and x-raytechnicians. | ProVecta 3D Prime Ceph is acomputed tomography x-rayunit intended to generate3D, panoramic andcephalometric X-ray imagesin dental radiography foradult and pediatric patients.It provides diagnostic detailsof the maxillofacial areas fora dental treatment. Thedevice is operated and usedby physicians, dentists, andx-ray technicians. Notintended for mammographyuse.SAME, equivalent language. | |
| Image Acquisition Modes | Panoramic, cephalometricand computed tomography | SAME | |
| Imaging Software | EasyDent: 2D viewer and patientmanagement softwareEz3D Plus : 3D viewer and imageanalysis software | VisionX, includes 2D and 3D.Cleared in K192743 | |
| Input Voltage | AC 100-240 V | AC 200-240V | |
| Tube Voltage | 50-99 kV | 60-99 kV | |
| Tube Current | 4 ~16 mA | 4~16mA | |
| Focal Spot Size | 0.5 mm | 0.5 mm | |
| Exposure Time | Max. 18 s | Max. 20 s | |
| Descriptive Information | K152106, PaX-i3D Smart(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime Ceph | |
| Total Filtration | 2.8 mm Al | 2.5 mm Al | |
| Chin Rest | Equipped Headrest | Bite block, chin restand headrest | |
| Mechanical | Compact design | Compact design | |
| Electrical | LDCP logic circuit (Low DarkCurrent Processing) | LDCP logic circuit (LowDark CurrentProcessing) | |
| Software | DICOM 3.0 Formatcompatible | VistaSoft, DICOM 3.0compatible | |
| 2D Image ViewingProgram | EasyDent | VisionX | |
| 3D Image ViewingProgram | Ez3D Plus | VisionX | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| ImageReceptor | ComputedTomography | Xmaru1404CF | Xmaru1404CF (SAME) |
| Panoramic | Xmaru1404CF | Xmaru1404CF (SAME) | |
| Cephalometric | Xmaru2301CF1210SGA910SGAXmaru2301CF-O | Xmaru 2602CF | |
| Size of Imaging Volume(cm) | Xmaru1404CF : Max. 10x8.5 | Xmaru1404CF: Max.10x8.5 (SAME) | |
| PixelResolution | ComputedTomography | Xmaru1404CF:- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning | 2.5 lp/mm - 4x4 binningDoes not support:5.0 lp/mm - 2x2 binning |
| Panoramic | Xmaru1404CF :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning | 2.5 lp/mm - 4x4 binningDoes not support:5.0 lp/mm - 2x2 binning | |
| Cephalometric | Xmaru2301CF: 5 lp/mm1210SGA: 3.9 lp/mm910SGA: 3.9 lp/mmXmaru2301CF-O: 5 lp/mm | Xmaru 2602CF | |
| Pixel SizeComputedTomography | Xmaru1404CF :- 99 m- 2x2 binning- 198 m- 4x4 binning | Xmaru1404CF :99 µm - 2x2 binning198 µm- 4x4 binning | |
| Descriptive Information | K152106, PaX-i3D Smart(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime Ceph | |
| Panoramic | Xmaru1404CF :- 99 μm- 2x2 binning- 198 μm- 4x4 binning | Xmaru1404CF :99 μm - 2x2 binning198 μm- 4x4 binning | |
| Cephalometric | Xmaru2301CF: 100 x 100 μm | Xmaru 2602CF200 x 200 μm Thepredicate uses 2x2binning, so theresolution is identical. | |
| 1210SGA: 127x127 μm | |||
| 910SGA: 127x127 μm | |||
| Xmaru2301CF-O: 100x100 μm | |||
| Photograph |
Summary of the Technological Characteristics
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9. Discussion of Similarities and Differences:
The two systems share certain common components including the main digital imaging panel and the X-ray tube, Monobloc, MCU, and Power boards. However the mechanical parts as well as the exterior of the device are Dürr Dental developments. The software, while functionally similar, is different, having been derived from our own software cleared in K190629, Trade/Device Name: DBSWIN and VistaEasy Imaging Software. The key performance difference between this device and our reference clearance K181432 is that we now support cephalometric testing. So BOTH devices, our new one and the predicate, offer identical modalities, including some identical components.
10. Non-Clinical Data and Performance Testing
Testing to the following IEC and DIN Standards was successfully performed:
| Standard: | Standard Title: |
|---|---|
| IEC 14971 | Medical devices - Application of risk management to medical devices |
| IEC 60601-1 | Medical Electrical Equipment, Part I: General requirements for basicsafety and essential performance |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2: General requirements forbasic safety and essential performance. Collateral Standard:Electromagnetic Compatibility |
| IEC 60601-1-3 | General Requirements for Radiation Protection in Diagnostic X-RayEquipment |
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| Standard: | Standard Title: |
|---|---|
| IEC 60601-1-6 | General requirements for basic safety and essential performance –Collateral standard: Usability |
| IEC 60601-2-63 | Particular requirements for the basic safety and essentialperformance of dental extra-oral X-ray equipment |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification andrequirements |
| IEC 62304 | Medical Device Software Life-cycle processes |
| IEC 62366 | Medical devices – Application of usability engineering to medicaldevices |
| DIN 6868-151 | Image quality assurance in diagnostic X-ray departments - Part 151:Acceptance testing of dental radiographic equipment accordance toROEV - Rules for the inspection of image quality after installation,maintenance and modification. Acceptance testing was performedfor both the panoramic and cephalometric modes. Line pair andcontrast was evaluated using a phantom designed for this purpose. |
| DIN 6868-161 | Image Quality Assurance In Diagnostic X-Ray Departments - Part 161:ROEV Acceptance Testing Of Dental Radiographic Equipment ForDigital Cone-Beam Computed Tomography |
| Software: | |
| Firmware: | The firmware was evaluated in accordance with the FDA Guidancefor the Content of Premarket Submissions for Software Contained inMedical Devices. Risk management activities were documented. |
| Biocompatibility: | |
| Chin Holder for bite block (Material PBT): | |
| EN ISO 10993-5 | Cytotoxicity |
| All other accessories have been cleared previously (refer to section 16 - Biocompatibility) |
-
- Clinical Data Clinical data is 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 ProVecta 3D Prime Ceph is substantially equivalent to the predicate device as described herein. The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.