ProVecta 3D Prime Ceph

K193139 · Durr Dental SE · OAS · Mar 5, 2020 · Radiology

Device Facts

• Record ID: K193139
• Device Name: ProVecta 3D Prime Ceph
• Applicant: Durr Dental SE
• Product Code: OAS · Radiology
• Decision Date: Mar 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Cone beam CT (CBCT) dental X-ray system; acquires 3D, panoramic, and cephalometric images. X-ray tube and sensor rotate 180°-540° around seated/standing patient; emits conical X-ray beam; captures series of 2D images. Reconstruction computer calculates 3D volume model (voxels) from 2D series; enables generation of sectional tomograms and 3D views. Operated by dentists, physicians, or X-ray technicians in clinical settings. Output viewed by clinicians for diagnostic assessment of maxillofacial structures to support treatment planning. Benefits include precise anatomical visualization for dental procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including compliance with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-63, and DIN 6868-151/161 standards for image quality assurance and radiation safety.

Technological Characteristics

CBCT dental X-ray system; 60-99 kV tube voltage; 4-16 mA tube current; 0.5 mm focal spot; 2.5 mm Al filtration. Uses Xmaru imaging sensors. Chin holder (PBT material) tested for cytotoxicity (EN ISO 10993-5). Software: VistaSoft (DICOM 3.0 compatible). Connectivity: Networked. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for adult and pediatric patients requiring 3D, panoramic, or cephalometric X-ray imaging of the maxillofacial area for dental treatment planning. Not for mammography.

Regulatory Classification

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.

Predicate Devices

• PaX-i3D Smart (PHT-30LFO) (K152106)

Reference Devices

• ProVecta 3D Prime with VistaSoft (K181432)
• DBSWIN and VistaEasy Imaging Software (K190629)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen<br>Germany<br>Phone: + 49 (0) 7142 70 5-0<br>Fax: + 49 (0) 7142 705-500<br>E-Mail: [e-mail]<br>www.duerrdental.com | Establishment Registration<br>Name in FURLS:<br>Duerr DENTAL SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration<br>Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange<br>Director of Quality Management<br>DÜRR DENTAL SE<br>Höpfigheimer Str. 17<br>74321 Bietigheim-Bissingen,<br>Germany<br>Phone: + 49 (0) 7142 70 5-190<br>Email: [e-mail] | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski<br>Director of Quality and Regulatory<br>Air Techniques, Inc.<br>1295 Walt Whitman Road<br>Melville, NY 11747, USA<br>U.S. Phone: [phone]<br>E-Mail: [e-mail] | |

#### 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<br>(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime Ceph | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Indications for Use | PHT-30LFO is a computed<br>tomography x-ray system<br>intended to produce panoramic,<br>cephalometric or cross-sectional<br>images of the oral anatomy on a<br>real time basis by computer<br>reconstruction of x-ray image<br>data from the same axial plane<br>taken at different angles. It<br>provides diagnostic details of the<br>anatomic structures by acquiring<br>360° rotational image sequences<br>of oral and maxillofacial area for<br>a precise treatment planning in<br>adult and pediatric dentistry. The<br>device is operated and used by<br>physicians, dentists, and x-ray<br>technicians. | ProVecta 3D Prime Ceph is a<br>computed tomography x-ray<br>unit intended to generate<br>3D, panoramic and<br>cephalometric X-ray images<br>in dental radiography for<br>adult and pediatric patients.<br>It provides diagnostic details<br>of the maxillofacial areas for<br>a dental treatment. The<br>device is operated and used<br>by physicians, dentists, and<br>x-ray technicians. Not<br>intended for mammography<br>use.<br>SAME, equivalent language. | |
| Image Acquisition Modes | Panoramic, cephalometric<br>and computed tomography | SAME | |
| Imaging Software | EasyDent: 2D viewer and patient<br>management software<br>Ez3D Plus : 3D viewer and image<br>analysis software | VisionX, includes 2D and 3D.<br>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<br>(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<br>and headrest | |
| Mechanical | Compact design | Compact design | |
| Electrical | LDCP logic circuit (Low Dark<br>Current Processing) | LDCP logic circuit (Low<br>Dark Current<br>Processing) | |
| Software | DICOM 3.0 Format<br>compatible | VistaSoft, DICOM 3.0<br>compatible | |
| 2D Image Viewing<br>Program | EasyDent | VisionX | |
| 3D Image Viewing<br>Program | Ez3D Plus | VisionX | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| Image<br>Receptor | Computed<br>Tomography | Xmaru1404CF | Xmaru1404CF (SAME) |
| | Panoramic | Xmaru1404CF | Xmaru1404CF (SAME) |
| | Cephalometric | Xmaru2301CF<br>1210SGA<br>910SGA<br>Xmaru2301CF-O | Xmaru 2602CF |
| | Size of Imaging Volume<br>(cm) | Xmaru1404CF : Max. 10x8.5 | Xmaru1404CF: Max.<br>10x8.5 (SAME) |
| Pixel<br>Resolution | Computed<br>Tomography | Xmaru1404CF:<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | 2.5 lp/mm - 4x4 binning<br>Does not support:<br>5.0 lp/mm - 2x2 binning |
| | Panoramic | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | 2.5 lp/mm - 4x4 binning<br>Does not support:<br>5.0 lp/mm - 2x2 binning |
| | Cephalometric | Xmaru2301CF: 5 lp/mm<br>1210SGA: 3.9 lp/mm<br>910SGA: 3.9 lp/mm<br>Xmaru2301CF-O: 5 lp/mm | Xmaru 2602CF |
| Pixel Size<br>Computed<br>Tomography | Xmaru1404CF :<br>- 99 m- 2x2 binning<br>- 198 m- 4x4 binning | Xmaru1404CF :<br>99 µm - 2x2 binning<br>198 µm- 4x4 binning | |
| Descriptive Information | | K152106, PaX-i3D Smart<br>(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime Ceph |
| | Panoramic | Xmaru1404CF :<br>- 99 μm- 2x2 binning<br>- 198 μm- 4x4 binning | Xmaru1404CF :<br>99 μm - 2x2 binning<br>198 μm- 4x4 binning |
| | Cephalometric | Xmaru2301CF: 100 x 100 μm | Xmaru 2602CF<br>200 x 200 μm The<br>predicate uses 2x2<br>binning, so the<br>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<br>safety and essential performance |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2: General requirements for<br>basic safety and essential performance. Collateral Standard:<br>Electromagnetic Compatibility |
| IEC 60601-1-3 | General Requirements for Radiation Protection in Diagnostic X-Ray<br>Equipment |

{8}------------------------------------------------

| Standard: | Standard Title: |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-6 | General requirements for basic safety and essential performance –<br>Collateral standard: Usability |
| IEC 60601-2-63 | Particular requirements for the basic safety and essential<br>performance of dental extra-oral X-ray equipment |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and<br>requirements |
| IEC 62304 | Medical Device Software Life-cycle processes |
| IEC 62366 | Medical devices – Application of usability engineering to medical<br>devices |
| DIN 6868-151 | Image quality assurance in diagnostic X-ray departments - Part 151:<br>Acceptance testing of dental radiographic equipment accordance to<br>ROEV - Rules for the inspection of image quality after installation,<br>maintenance and modification. Acceptance testing was performed<br>for both the panoramic and cephalometric modes. Line pair and<br>contrast was evaluated using a phantom designed for this purpose. |
| DIN 6868-161 | Image Quality Assurance In Diagnostic X-Ray Departments - Part 161:<br>ROEV Acceptance Testing Of Dental Radiographic Equipment For<br>Digital Cone-Beam Computed Tomography |
| Software: | |
| Firmware: | The firmware was evaluated in accordance with the FDA Guidance<br>for the Content of Premarket Submissions for Software Contained in<br>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) | |

- 11. Clinical Data Clinical data is not required for a finding of substantial equivalence.
- 12. 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.