(62 days)
No
The description focuses on standard image reconstruction techniques (mathematical calculation) and does not mention AI/ML terms or capabilities.
No
Explanation: The device is an x-ray unit and software intended to generate and process images for diagnostic purposes, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details of the maxillofacial areas for a dental treatment," and the "Summary of Performance Studies" mentions that the "overall impression is sufficient for dental diagnostics."
No
The device description clearly describes a hardware component (computed tomography x-ray unit) that acquires images, in addition to the software component (VistaSoft) that processes and displays them.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ProVecta 3D Prime and VistaSoft system is an imaging device that uses X-rays to create images of the maxillofacial area. It does not analyze biological samples.
- Intended Use: The intended use is for generating and analyzing X-ray images for dental diagnosis and treatment planning. This is a form of medical imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ProVecta 3D Prime:
ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic 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.
VistaSoft:
The VistaSoft software functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.
Product codes
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 X-rays 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
maxillofacial areas
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Bite block, chin rest and headrest
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
Testing to the following IEC and DIN Standards was successfully performed: IEC 60601-1 Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical Electrical Equipment, Part l-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
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
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 and 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 Assessment:
The Bite Block received the following evaluations:
Cytotoxicity Testing
Chemical Analysis Testing
Biological Safety Testing
The forehead support with cushion received the following evaluation: Cytotoxicity testing.
Other patient contact components had already received their own FDA clearances. Cleaning, Disinfection and Sterilization Testing:
Bite block manual cleaning and Disinfection Testing was performed.
Bite block mechanical cleaning and Disinfection Test was performed.
Bite Block Steam sterilization Test was performed.
Pediatric considerations: Labeling included the recommendations of the FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017." Cybersecurity considerations: Labeling also included cybersecurity strategy information based on FDA's cybersecurity guidance, "Postmarket Management of Cybersecurity in Medical Devices" dated December 28, 2016."
Clinical Data: Not required for a finding of substantial equivalence (because the same detector as the predicate is used) but performed to assure diagnostic quality of the dental images. The overall impression is sufficient for dental diagnostics. Good contrast and good resolution. Teeth, osseous structures, sinus maxillaries are clearly shown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
August 2nd, 2018
Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K181432
Trade/Device Name: ProVectra 3D Prime with VistaSoft Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 29, 2018 Received: June 1, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Rogers
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181432
Device Name ProVectra 3D Prime with VistaSoft
Indications for Use (Describe)
ProVecta 3D Prime:
ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic 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.
VistaSoft:
The VistaSoft software functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 with VistaSoft
K181432
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Date Summary Prepared:
July 26, 2018
2. Submitter's Identification:
DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Contact:
Oliver Lange Head of Quality Management Email: lange.o@@duerr.de
U.S. Contact:
Suzanne Lucas Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Tel: 516-214-5514 Email: slucas@airtechniques.com
3. Device:
Trade /Proprietary Name: Device: Regulation Description: Regulation Medical Specialty: Review Panel Product Code Regulation Number Device Class
ProVecta 3D Prime with VistaSoft X-Ray, Tomography, Computed, Dental Computed tomography x-ray system. Radiology Radiology OAS 892.1750 2
4. Predicate Device:
Legally Marketed Predicate Device Information: 510(k) Number: K152106 Manufacturer: Vatech Co. Ltd. Trade /Proprietary Name PaX-i3D Smart (PHT-30LFO) Device: X-Ray, Tomography, Computed, Dental
4
| Regulation Description: | Computed tomography x-ray system. |
|---|---|
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | 2 |
The Dental tomography x-ray system requires our VistaSoft Software, modified from what was cleared in: K161444 Trade/Device Name: DBSWIN and VistaEasy Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
5. 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 X-rays 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.
Image /page/4/Figure/4 description: The image shows a piece of equipment with several parts labeled with numbers. Number 1 is pointing to a circular object, while number 2 is pointing to a square object. Numbers 3, 4, and 5 are pointing to different parts of the equipment's structure, and numbers 6 and 7 are pointing to a screen-like component.
- 1 Emergency stop switch
- 2 On/off switch
- 3 X-ray tube
- 4 C-shaped elbow
- 5 Status LED
- 6 Operating elements
- 7 Memory card slot
5
6. Indications for use:
ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic 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.
The VistaSoft software features functions for recording, displaying, analyzing, diagnosing, managing and sending digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.
7. 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 with
VistaSoft DÜRR DENTAL SE | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 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 is computed
tomography x-ray unit intended to
generate 3D and panoramic 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. The VistaSoft software
features functions for recording,
displaying, analyzing, diagnosing,
managing and sending digital or
digitized video and X-ray images
in dental practices and specialist
dental clinics. Not intended for
mammography use.
Main difference: This unit does
not support the cephalometric
mode. | |
| Image Acquisition Modes | Panoramic, cephalometric
and computed tomography | Panoramic and computed
tomography | |
| Imaging Software | EasyDent: 2D viewer and
patient management
software
Ez3D Plus : 3D viewer and
image analysis software | VistaSoft, includes 2D and 3D | |
| Input Voltage | AC 100-240 V | AC 200-240V | |
| Tube Voltage | 50-99 kV | 50-99 kV | |
| Tube Current | 416 mA | 416mA | |
| Descriptive Information | | K152106, PaX-i3D Smart
(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime with
VistaSoft DÜRR DENTAL SE |
| Focal Spot Size | | 0.5 mm | 0,5 mm |
| Exposure Time | | Max. 18 s | Max. 16.4s |
| Slice Width | | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | | 2.8 mm Al | 2.8 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 | VistaSoft |
| 3D Image Viewing Program | | Ez3D Plus | VistaSoft |
| Anatomical Sites | | Maxillofacial | Maxillofacial |
| Image
Receptor | Computed
Tomography | Xmaru1404CF | Xmaru1404CF |
| Note: CT
and | Panoramic | Xmaru1404CF | Xmaru1404CF |
| panoramic
image
performance
is identical
because the | MTF @ 2.5
lp/mm | >8% | >8% |
| | Noise, RMS of
Dark current | ADU