(113 days)
No
The summary describes standard image reconstruction techniques ("mathematical calculation") and does not mention AI, ML, or related concepts.
No
The device is described as an X-ray unit intended to generate images for diagnostic purposes, not for treatment.
Yes
The intended use states that the device "provides diagnostic details of the maxillofacial areas for a dental treatment."
No
The device description clearly states it is a cone beam CT x-ray device, which is a hardware-based imaging system. While it includes software for image reconstruction, the core device is a physical x-ray unit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The ProVecta 3D Prime Ceph is an X-ray imaging device. It generates images of the maxillofacial area within the patient's body using radiation. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for generating X-ray images for diagnostic details in dental radiography. This is an in vivo (within the living body) diagnostic process, not in vitro.
The description focuses on the imaging technology, the anatomical site being imaged, and the users, all of which are consistent with an in vivo medical imaging device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAS
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
Maxillofacial areas
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Physicians, dentists, and x-ray technicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data and Performance Testing was successfully performed to the following IEC and DIN Standards: IEC 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63, IEC 60825-1, IEC 62304, IEC 62366, DIN 6868-151, DIN 6868-161.
Acceptance testing was performed for both the panoramic and cephalometric modes. Line pair and contrast was evaluated using a phantom designed for this purpose.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
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
1
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
2
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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3
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 SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Phone: + 49 (0) 7142 70 5-0
Fax: + 49 (0) 7142 705-500
E-Mail: info@duerr.de
www.duerrdental.com | Establishment Registration
Name in FURLS:
Duerr DENTAL SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration
Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange
Director of Quality Management
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen,
Germany
Phone: + 49 (0) 7142 70 5-190
Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski
Director of Quality and Regulatory
Air Techniques, Inc.
1295 Walt Whitman Road
Melville, NY 11747, USA
U.S. Phone: 516-214-5574
E-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 |
4
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.
5
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 computed
tomography x-ray system
intended to produce panoramic,
cephalometric or cross-sectional
images of the oral anatomy on a
real time basis by computer
reconstruction of x-ray image
data from the same axial plane
taken at different angles. It
provides diagnostic details of the
anatomic structures by acquiring
360° rotational image sequences
of oral and maxillofacial area for
a precise treatment planning in
adult and pediatric dentistry. The
device is operated and used by
physicians, dentists, and x-ray
technicians. | 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.
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.
SAME, equivalent language. | |
| Image Acquisition Modes | Panoramic, cephalometric
and computed tomography | SAME | |
| Imaging Software | EasyDent: 2D viewer and patient
management software
Ez3D Plus : 3D viewer and image
analysis 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 | 416mA | |
| 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 rest
and headrest | |
| Mechanical | Compact design | Compact design | |
| Electrical | LDCP logic circuit (Low Dark
Current Processing) | LDCP logic circuit (Low
Dark Current
Processing) | |
| Software | DICOM 3.0 Format
compatible | VistaSoft, DICOM 3.0
compatible | |
| 2D Image Viewing
Program | EasyDent | VisionX | |
| 3D Image Viewing
Program | Ez3D Plus | VisionX | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| Image
Receptor | Computed
Tomography | Xmaru1404CF | Xmaru1404CF (SAME) |
| | Panoramic | Xmaru1404CF | Xmaru1404CF (SAME) |
| | Cephalometric | Xmaru2301CF
1210SGA
910SGA
Xmaru2301CF-O | Xmaru 2602CF |
| | Size of Imaging Volume
(cm) | Xmaru1404CF : Max. 10x8.5 | Xmaru1404CF: Max.
10x8.5 (SAME) |
| Pixel
Resolution | Computed
Tomography | Xmaru1404CF:
- 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning | 2.5 lp/mm - 4x4 binning
Does 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 binning
Does not support:
5.0 lp/mm - 2x2 binning |
| | Cephalometric | Xmaru2301CF: 5 lp/mm
1210SGA: 3.9 lp/mm
910SGA: 3.9 lp/mm
Xmaru2301CF-O: 5 lp/mm | Xmaru 2602CF |
| Pixel Size
Computed
Tomography | Xmaru1404CF : - 99 m- 2x2 binning
- 198 m- 4x4 binning | Xmaru1404CF :
99 µm - 2x2 binning
198 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 binning
198 μm- 4x4 binning |
| | Cephalometric | Xmaru2301CF: 100 x 100 μm | Xmaru 2602CF
200 x 200 μm The
predicate uses 2x2
binning, so the
resolution is identical. |
| | | 1210SGA: 127x127 μm | |
| | | 910SGA: 127x127 μm | |
| | | Xmaru2301CF-O: 100x100 μm | |
| Photograph | | | |
Summary of the Technological Characteristics
6
7
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 basic |
| safety and essential performance | |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2: General requirements for |
| basic safety and essential performance. Collateral Standard: | |
| Electromagnetic Compatibility | |
| IEC 60601-1-3 | General Requirements for Radiation Protection in Diagnostic X-Ray |
| Equipment |
8
| 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 essential |
| performance of dental extra-oral X-ray equipment | |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and |
| requirements | |
| IEC 62304 | Medical Device Software Life-cycle processes |
| IEC 62366 | Medical devices – Application of usability engineering to medical |
| devices | |
| DIN 6868-151 | Image quality assurance in diagnostic X-ray departments - Part 151: |
| Acceptance testing of dental radiographic equipment accordance to | |
| ROEV - Rules for the inspection of image quality after installation, | |
| maintenance and modification. Acceptance testing was performed | |
| for both the panoramic and cephalometric modes. Line pair and | |
| contrast 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 For | |
| Digital Cone-Beam Computed Tomography | |
| Software: | |
| Firmware: | The firmware was evaluated in accordance with the FDA Guidance |
| for the Content of Premarket Submissions for Software Contained in | |
| Medical 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.