(240 days)
Not Found
No
The summary describes standard X-ray imaging techniques and image processing, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on traditional imaging metrics and software validation according to standard FDA guidance, not AI/ML specific validation.
No
The description states the device is an X-ray unit to take radiographic exams, which are diagnostic in nature, not therapeutic.
Yes
The device is described as an X-ray unit used to take radiographic exams of teeth, jaw, and oral structures, which directly falls under the definition of a diagnostic device as it is used to capture images for the purpose of diagnosis.
No
The device description explicitly states it is a "complete 3D and 2D panoramic X-ray system" and includes components like a CMOS Flat Panel detector and an X-ray unit, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Rotograph Prime 3D and I-MAX 3D are X-ray units that take images of the internal structures of the teeth, jaw, and oral cavity. This is an in vivo (within the living body) imaging procedure.
- Intended Use: The intended use is to take radiographic exams for diagnostic purposes, not to perform tests on biological samples.
The device is a medical imaging device, specifically an extra-oral dental panoramic and CBCT X-ray unit.
N/A
Intended Use / Indications for Use
Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is a complete 3D and 2D panoramic X-ray system. It performs:
2D standard examination programs
- Standard Panoramic: adult/child panoramic exam
- -TMJ open and closed mouth
- Sinus P/A projection
- Half Panoramic (left/right)
- Ortho Rad Panoramic
- -Frontal Dentition
- -Low Dose Panoramic
- -Bitewing (Left/Right/Left and Right
3D standard examination programs
- 3D Full Dentition
- 3D Single Jaw (Maxillary, Mandibular)
- 3D Mandibular Teeth (Frontal, Premolars and Molars)
- -3D Maxillary Teeth (Frontal, Premolars and Molars)
- 3D TMJ ( ( ( right/left)
- 3D Sinus
The images are acquired by a CMOS Flat Panel detector with CsI scintillator and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and oral structures
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
dentists, radiologists and other legally qualified health care professionals.
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)
Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to substantial equivalence determination. All standards applied were FDA recognized international standards. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Moderate Level of Concern".
Non-clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" (September 1, 2016) were performed in order to assess the image quality and the relevant analysis has been supplied, together with specific technical data provided by the supplier of the detector (see Appendix L).
Non-clinical testing demonstrates that the device performs in a substantially equivalent manner to the predicate devices with regard to imaging and dose performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
COMPARISON OF KEY IMAGE QUALITY METRICS along with dose between the subject and primary predicate device
Panoramic mode:
- Spatial resolution: 3 lp/mm (Proposed device), 2.2 lp/mm (Primary predicate)
- Contrast resolution (number of visible holes in the phantom defined in IEC 61223-3-4): 4 (Proposed device), 4 (Primary predicate)
- DAP: @80kV 9mA 14.0s: 15.7 uGy·m² (Proposed device), @80kV 9mA 13.8s: 13.0 uGy·m² (Primary predicate)
3D mode:
- Nyquist Frequency: 2.85 lp/mm (Proposed device), 2.7 lp/mm (Primary predicate)
- Contrast to Noise Ratio: 15.3 (Proposed device), 17.9 (Primary predicate)
- Homogeneity (Metrics defined in standard DIN6868-161): 8.6 (Proposed device), 7.0 (Primary predicate)
- MTF on axial slices
- 10% modulation: 1.37 lp/mm (Proposed device), 1.31 lp/mm (Primary predicate)
- 50% modulation: 0.72 lp/mm (Proposed device), 0.57 lp/mm (Primary predicate)
- Acceptance Index: 247 (mGy·cm²)-1 (Proposed device), 86 (mGy·cm²)-1 (Primary predicate)
- DAP (3D full dentition): @84kV 5mA 7s: 108 uGy·m² (Proposed device), @80kV 8mA 11.2s: 196.7 uGy·m² (Primary predicate)
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.
Not Found
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Villa Sistemi Medicali S.p.A. Paolo Casagrande Santin Quality Assurance Manager via delle Azalee 3 20090 BUCCINASCO (MI) ITALY
November 2, 2018
Re: K180601
Trade/Device Name: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: October 12, 2018 Received: October 19, 2018
Dear Paolo Casagrande Santin:
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
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Michael D. O'Hara
For
Robert 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) K180601
Device Name Rotograph Prime 3D, I-MAX 3D
Indications for Use (Describe)
Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either twc dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
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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Image /page/3/Picture/0 description: The image features a logo with a stylized white letter 'N' set against a blue square background. Below the blue square, the word 'VILLA' is written in white, bold, sans-serif letters on a white rectangular background. The logo appears clean and modern, with a simple color scheme.
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Villa Sistemi Medicali S.p.A.
via delle Azalee 3
20090 Buccinasco (MI)
ITALY
Phone: +39 02 488591
Registration # 8021091 | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Contact Person: | Paolo Casagrande Santin
QA Manager
Phone: +39 02 48859 239
Fax: +39 02 48859 303
Email: p.casagrande@villasm.com | |
| Designated Agent: | Elizabeth Lane
Villa Radiology Systems
199 Park Road Extension
Suite 107
Middlebury, CT 06762
ph 203 2628836
e-mail admin@villaus.com | |
| Date Prepared: | October 12, 2018 | |
| Subject Device | 510(k) number: K180601
Trade Name: Rotograph Prime 3D (under trade mark Villa Sistemi Medicali)
I-MAX 3D (under Trade mark Owandy Radiology as Private Labeler)
Device Type: x-ray, tomography, computed, dental
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: OAS | |
| Primary Predicate Device | Trade Name: I-MAX Touch 3D
Manufacturer: Owandy Radiology
510(k) clearance: K130443 (June 14, 2013)
Device Type: x-ray, tomography, computed, dental
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: OAS | |
| Additional Predicate Device | Trade Name: | Rotograph Prime |
| | Manufacturer: | Villa Sistemi Medicali S.p.A. |
| | 510(k) clearance: | K162190 (July 6, 2017) |
| | Device Type: | System, x-ray, extraoral source, digital |
| | Regulation Number: | 21 CFR 872.1800 |
| | Regulation Name: | Extraoral Source X-Ray System |
| | Regulatory Class: | Class II |
| | Product Code: | MUH |
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Image /page/4/Picture/0 description: The image features a logo with a blue square background. Inside the square, there is a stylized white letter "N" that appears to be interconnected. Below the square, there is a white rectangle with the word "VILLA" written in a bold, sans-serif font.
Device Description
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is a complete 3D and 2D panoramic X-ray system. It performs:
2D standard examination programs
- Standard Panoramic: adult/child panoramic exam ।
- -TMJ open and closed mouth
- Sinus P/A projection ।
- । Half Panoramic (left/right)
- । Ortho Rad Panoramic
- -Frontal Dentition
- -Low Dose Panoramic
- -Bitewing (Left/Right/Left and Right
3D standard examination programs
- 3D Full Dentition l
- 3D Single Jaw (Maxillary, Mandibular) ।
- 3D Mandibular Teeth (Frontal, Premolars and Molars) ।
- -3D Maxillary Teeth (Frontal, Premolars and Molars)
- । 3D TMJ ( ( ( right/left)
- । 3D Sinus
The images are acquired by a CMOS Flat Panel detector with CsI scintillator and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
Installation mode
The subject device is sold in wall or floor mounted version.
Accessories and components
The device can be equipped with different accessories to fulfill different diagnostic needs, such as three different chin supports with bite stick or with special removable appendix for edentulous patients, specific support for 2D TMJ exam, head strips for 3D exams and X-ray push button with extensible.
The device contains the following materials and/or components:
।
Tube-head: dielectric oil, copper, iron, aluminum, glass, tungsten.
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Image /page/5/Picture/0 description: The image features a logo with a blue square background. Inside the square, there is a stylized white letter 'N' with a curved design. Below the 'N', the word 'VILLA' is written in white, block letters. The logo appears to be for a company or organization named Villa, with the 'N' possibly representing a stylized initial.
- -Collimator: lead
- -Other parts of the device: non-biodegradable plastic materials, metal materials, printed circuits, iron-plastic materials, lead
The patient contacting components are:
- temple support rods
- chin supports
- bite sticks
- head strips
- handles
Chin supports, bite sticks are unchanged from primary predicate device, and temple support rods and handles are unchanged from additional predicate device.
Head strips and all other parts in contact with patient have been assessed according to ISO 10993.
Contact duration is in the range of seconds to few minutes and contact type is surface-contacting.
Indication for Use
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
It can be used with both pediatric and adult patients.
Rationale for Substantial Equivalence
Here below a summing up the main features of the proposed and predicate devices in order to point out the significant similarities and differences.
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is based on a well-known technology and it has the same indication for use as the predicate devices as reported here below.
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Image /page/6/Picture/0 description: The image is a logo for Villa. The logo consists of a white stylized letter "N" on a blue square background. Below the "N" is the word "VILLA" in white, also on a blue background.
| Proposed device: | Primary predicate device: | Additional predicate device: | |
|---|---|---|---|
| Rotograph Prime 3D and I-Max 3D | I-MAX Touch 3D | Rotograph Prime | |
| Intended Use | Rotograph Prime 3D is an extra-oral | ||
| dental panoramic and CBCT (aka CBVT) | |||
| X-ray unit to take either two dimensional | |||
| (panoramic, TMJ and sinus exams) or | |||
| three dimensional radiographic exams of | |||
| teeth, jaw and oral structures. | |||
| Two dimensional images are taken using | |||
| the narrow beam technique. Three | |||
| dimensional exams are taken using cone | |||
| shaped x-ray beam technique; both of | |||
| them are well known techniques. | |||
| The device is operated and used by | |||
| dentists, radiologists and other legally | |||
| qualified health care professionals. | |||
| It can be used with both pediatric and | |||
| adult patients. | I-MAX Touch 3D, panoramic x-ray | ||
| imaging system with cephalostat, is an | |||
| extraoral source x-ray system, which is | |||
| intended for dental radiographic | |||
| examination of the teeth, jaw, and oral | |||
| structures, specifically for panoramic | |||
| examinations and implantology and for | |||
| TMJ studies and cephalometry, and it | |||
| has the capability, using the CBVT | |||
| technique, to generate dento- | |||
| maxillofacial 3D images. | |||
| The device uses cone shaped x-ray | |||
| beam projected on to a flat panel | |||
| detector, and the examined volume | |||
| image is reconstructed to be viewed in | |||
| 3D viewing stations. | |||
| 2D Images are obtained using the | |||
| standard narrow beam technique | |||
| The device is to be operated and used | |||
| by dentists, radiologists and other | |||
| legally qualified health care | |||
| professionals. | Rotograph Prime is an extra-oral | ||
| dental panoramic X-ray unit to | |||
| radiograph teeth, jaw and oral | |||
| structures. | |||
| The device is operated and used | |||
| by dentists, radiologists and | |||
| other legally qualified health | |||
| care professionals. | |||
| It can be used with both | |||
| pediatric and adult patients. |
The following tables list the similarities and the differences between the subject device (Rotograph Prime 3D under trade mark Villa Sistemi Medicali and I-MAX 3D under trade mark Owandy Radiology) and the primary predicate device I-MAX Touch 3D, and the additional predicate device Rotograph Prime.
A detailed discussion about the differences is reported in section "Substantial Equivalence Discussion"
Similarities
| Proposed device
(Rotograph Prime
3D) | Primary predicate
device
(I-MAX Touch 3D) | Additional Predicate
Device
(Rotograph Prime) | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| 2D Examination programs | | | |
| Panoramic exam | Yes | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes | Yes |
| Segmented Panoramic (Half
panoramic, frontal dentition,
bitewings) | Yes | Yes | Yes |
| | Proposed device
(Rotograph Prime
3D) | Primary predicate
device
(I-MAX Touch 3D) | Additional Predicate
Device
(Rotograph Prime) |
| Low dose panoramic | Yes | Yes | Yes |
| TMJ Open/Closed mouth | Yes | Yes | Yes |
| TMJ single phase | Yes | Yes | Yes |
| Sinus | Yes | Yes | Yes |
| Cephalometric option available | NO | YES | NO |
| 2D Exam characteristics | | | |
| Panoramic max image size | equivalent to 15x30
cm film | equivalent to 13x30
cm film | equivalent to 15x30 cm
film |
| 3D examination programs | | | |
| 3D Full dentition | Yes | Yes | n/a |
| 3D TMJ Left | Yes | Yes | n/a |
| 3D TMJ Right | Yes | Yes | n/a |
| 3D sinus | Yes | Yes | n/a |
| 3D Single Jaw
(maxillary / mandibular) | YES | NO | n/a |
| 3D teeth only (maxillary /
mandibular) | YES | NO | n/a |
| 3D High resolution mode | YES | NO | n/a |
| 3D exam characteristics | | | |
| X-ray beam | cone beam | cone beam | n/a |
| Acquisition trajectory | Single 200 degree
rotation (except for
3D TMJ)
Single 180 degree
rotation (for 3D TMJ) | Single 200 degree
rotation (except for 3D
TMJ)
Single 180 degree
rotation (for 3D TMJ) | n/a |
| Reconstruction algorithm | Feldkamp with the
option of MAR (Metal
Artifact Removal) | Feldkamp with the
option of MAR (Metal
Artifact Removal) | n/a |
| Generator/tube
characteristics | | | |
| X-ray generator | High frequency | High frequency | High frequency |
| Focal spot value | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) |
| | Proposed device
(Rotograph Prime
3D) | Primary predicate
device
(I-MAX Touch 3D) | Additional Predicate
Device
(Rotograph Prime) |
| Independent kV-mA regulation | YES | YES | YES |
| DAP Software | YES | YES | YES |
| kV Range | 60 - 86 kV step 2kV | 60 - 86 kV step 2kV | 60 - 70 kV step 2kV |
| Total filtration | 2.5 mm Al eq | 2.5 mm Al eq | 2.0 mm Al eq |
| Collimator | Automatic | Automatic | Fixed |
| Patient positioning | | | |
| Height adjustment | motorized | motorized | motorized |
| Positioning lights | 2 laser pointers | 2 laser pointers | 2 laser pointers |
| Patient position | Standing | Standing | Standing |
| Patient positioning tools | temple clamps, bite
block, chin support,
head strip | temple clamps, bite
block, chin support,
head strip | temple clamps, bite
block, chin support |
| Height of chin support from the
floor | 975-1635 mm | 920-1755 mm | 975-1635 mm |
| Patient positioning orientation vs
the operator | face to face | lateral with adjustable
mirror | face to face |
| User interface | | | |
| Real time visualization | YES | YES | YES |
| User interface | Onboard keyboard
and virtual control
panel (on PC) | Onboard keyboard and
O-LED display, plus
virtual control panel
(on PC) | Onboard keyboard and
virtual control panel
(on PC) |
| Installation | | | |
| Power supply voltage | 110-120 V, 50/60 Hz | 110-120 V, 50/60 Hz | 110-120 V, 50/60 Hz |
| Current rating | 14.5 A | 15 A | 7 A |
| Type of installation | wall or floor mount | Wall or floor mount | Wall mount |
| Weight (wall mount version) | 67 kg | 161 kg | 62 kg |
| Dimensions (wall mount version) | 2184mm x 1107 mm
x 953 mm | 2450 mm x 1260 mm x
1040 mm | 2184mm x 1107 mm x
953 mm |
| | Proposed device
(Rotograph Prime 3D) | Primary predicate device
(Rotograph Evo 3D) | Additional Predicate
Device
(Rotograph Prime) |
| 3D examination programs | | | |
| 3D Single Jaw
(maxillary / mandibular) | YES | NO | n/a |
| 3D teeth only (maxillary /
mandibular) | YES | NO | n/a |
| 3D High resolution mode | YES | NO | n/a |
| 3D exam characteristics | | | |
| Biggest FOV (Ø x H) mm (3D
dentition, 3D TMJs, 3D sinus) | 85 mm x 93 mm | 85 mm x 85 mm | n/a |
| 3D Imaging detector | | | |
| Technology | CMOS flat panel with
Cesium Iodide (CsI)
scintillator screen | Amorphous Silicon with
Cesium Iodide (CsI)
scintillator screen | n/a |
| Sensor active area (Height x
Width) | 144 mm x 119.5 mm | 130 mm x 130 mm | n/a |
| Pixel size | 120 μm x 120 μm | 127 μm x 127 μm | n/a |
| Bit depth | 16 bit | 14 bit | n/a |
| Generator/tube
characteristics | | | |
| mA range | 2 - 12.5 mA | 6 - 10 mA | 2 - 7.1 mA |
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Image /page/7/Picture/0 description: The image is a logo for Villa. The logo is a blue square with a white stylized letter "V" in the center. Below the letter "V" is the word "VILLA" in white, block letters. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image is a logo featuring a stylized white letter 'N' on a blue square background. Below the square, the word "VILLA" is written in white, block letters. The overall design is simple and modern, with a clear contrast between the white elements and the blue background.
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Image /page/9/Picture/0 description: The image is a logo for Villa. The logo consists of a blue square with a white stylized letter "N" inside. Below the "N" and still within the blue square, the word "VILLA" is written in white, block letters.
Differences
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) has the same functions in the same environment as the primary predicate device I-MAX Touch 3D and the additional predicate device Rotograph Prime (and I-MAX under trade mark Owandy Radiology).
Specifically, the proposed device performs the same projections for the 2D examination of teeth, jaw and oral structures as both I-MAX Touch 3D and Rotograph Prime (and I-MAX under trade mark Owandy Radidlogy) and in addition has the capability to perform three dimensional exams as I-MAX Touch 3D device. On the proposed device, in addition to the exams present on I-MAX Touch 3D, has been added some new smaller field of view 3D examinations derived from the correspondent examinations with full field of view.
The proposed device uses a high frequency x-ray generator with the same electronics and x-ray exposure control as Rotograph Prime (and I-MAX under trade mark Owandy Radiology), with a range of exposure parameters similar to that of I-MAX Touch 3D. The focal spot value is the same as both predicate devices. The range of mA has been extended to the lower values allowing further dose reduction and to higher values allowing a reduction of the exam exposure time (still preserving the overall patient's dose).
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Image /page/10/Picture/0 description: The image is a logo for Villa. The logo features a stylized white letter "N" on a blue square background. Below the square is the word "VILLA" in white, set against the same blue background.
In the proposed device the patient positioning is assured by two laser pointers that allow to locate the patient reference planes as in both predicate devices and is frontal as in Rotograph Prime. The range of chin support height is the same as Rotograph Prime one.
The proposed device's detector is based on the same principle of the primary predicate device I-MAX Touch 3D (large area flat panel detector), however it's a more recent product: small differences are in the pixel size and active area. The equivalence of the image quality of both two dimensional radiographic exams of the proposed device vs the primary predicate device has been assessed with image comparison tests.
The user interface of the proposed device is the same as in Rotograph Prime and equivalent to that of I-MAX Touch 3D.
| | | Proposed device
Rotograph Prime 3D
Panoramic mode | Primary predicate device
I-MAX Touch 3D |
|---------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------|--------------------------------------------|
| Spatial resolution | | 3 lp/mm | 2.2 lp/mm |
| Contrast resolution (number of
visible holes in the phantom
defined in IEC 61223-3-4) | | 4 | 4 |
| DAP | | @80kV 9mA 14.0s: 15.7 uGy·m² | @80kV 9mA 13.8s: 13.0 uGy·m² |
| 3D mode | | | |
| Nyquist Frequency | | 2.85 lp/mm | 2.7 lp/mm |
| Contrast to Noise Ratio | | 15.3 | 17.9 |
| Homogeneity | Metrics defined in
standard DIN6868-161 | 8.6 | 7.0 |
| MTF on axial slices | | 10% modulation: 1.37 lp/mm | 10% modulation: 1.31 lp/mm |
| | | 50% modulation: 0.72 lp/mm | 50% modulation: 0.57 lp/mm |
| Acceptance Index | | 247 (mGy·cm²)-1 | 86 (mGy·cm²)-1 |
| DAP (3D full dentition ) | | @84kV 5mA 7s: 108 uGy·m² | @80kV 8mA 11.2s: 196.7
uGy·m² |
COMPARISON OF KEY IMAGE QUALITY METRICS along with dose between the subject and primary predicate device
In the panoramic mode of operation the DAP value is slightly higher for the subject device. This is substantially due to the higher vertical size of the detector (14.2mm high, compared to 12.8mm of the primary predicate device), allowing to have a larger field of view and anatomic coverage.
In the 3D mode of operation instead, on the subject device the default parameters for a standard adult patient are chosen so to give priority to the dose containment with respect to the predicate device, at the cost of a slightly higher
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image noise that results in a lower Contrast to Noise Ratio as explained in the Test Report RT336_2018-08-31_rev0_imageQuality included in Annex L. The user can anyway increase the radiological parameters in order to obtain higher contrast, should the need arise. This choice is also supported by the fact that the Acceptance Index is much higher in value, indicating an overall better performance. Index (defined in the standard DIN6868-161) is a parameter that indicates that the overall imaging performance, taking into account both the delivered dose, the image resolution and image contrast. The higher is the device performance vs the delivered dose. Additional details are given in above mentioned annex.
| | Proposed device
Rotograph Prime 3D | Primary predicate device
I-MAX Touch 3D | |
|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System architecture | Based on multiple CPUs
connected via Can Bus
plus Ethernet
connection to PC | Based on multiple CPUs
connected via Can Bus
plus Ethernet connection
to PC.
In this case, the device
has two more CPUs for
controlling the onboard
GUI and vertical column | The firmware
architecture is the same
as the Predicate
Devices.
The architecture and
number of CPUS of the
Proposed Device are
simplified compared to
the primary predicate
device due to:
- Elimination of
onboard GUI - Replacement of
column movement
device with a
component not
requiring a CPU
(fully hardware-
implemented) |
| | Proposed device
Rotograph Prime 3D | Primary predicate device
I-MAX Touch 3D | |
| Firmware functions
(of MCU and DSPU Control
Processing Units) for
controlling movements
and image
acquisition/synchronization | Firmware functions are
designed to manage
the panoramic/3D
version, which is
considered a subset of
the versions in the
primary predicate
device. The number of
3D exams is greater,
but their management
is the same in terms of
firmware. Some
differences are related
to specific hardware
solutions or different
microprocessors from
the Primary Predicate
Device. | Firmware functions are
designed to manage the
following configurations:
Film Version, digital
panoramic version,
panoramic/3D version,
cephalometric option | The firmware functions
of the proposed device
are equivalent to those
of the Primary Predicate
device, some functions
have been eliminated
since the proposed
device has just a
machine version.
The fact that proposed
device has more 3D
exams available doesn't
add complexity to the
firmware. |
| X-ray generator board
firmware functions | X-ray parameters (kV,
mA, pulsed / continuous
emission) management,
X-ray start and stop,
errors control.
Can Bus
communication. | X-ray parameters (kV,
mA, pulsed / continuous
emission) management,
X-ray start and stop,
errors control.
Can Bus communication. | Firmware functions and
Can Bus protocol are
the same as in the
Primary Predicate device |
| Communication protocol
between the computer
and DSPU board. | Proprietary TCP/IP
protocol | Proprietary TCP/IP
protocol | The communication
protocol is the same as
the Primary Predicate
Device one. |
| Software functions (on PC) | Graphical use interface
(GUI) to control the
machine, TCP/IP
communication, image
acquisition and
correction; image
reconstruction. | Graphical use interface
(GUI) to control the
machine, TCP/IP
communication, image
acquisition and
correction; image
reconstruction | Software functions are
the same as Primary
Predicate Device one;
the GUI is different in
the graphics respect to
the Primary Predicate
device but is the same
to the Additional
Predicate Device, with a
wider selection of exam
options. |
| | Proposed device
Rotograph Prime 3D | Primary predicate device
I-MAX Touch 3D | |
| Image acquisition | Integration of the
specific detector
manufacturer SDK; PC
memory and disk space
management and
control. | Integration of the specific
detector manufacturer
SDK; PC memory and
disk space management
and control. | Proposed Device and
Primary Predicate
Device use imaging
detector of different
manufacturers so SDK
are different but PC
memory and disk space
management and
control is the same as
Primary Predicate
Devices |
| Image correction (defect
map, offset and flat field) | Correction functions for
detector in area mode
are designed by Villa /
Owandy. Offset
correction is done
before each acquisition | Correction functions are
provided by the detector
manufacturer. Offset
correction is done before
each acquisition | Correction functions
implemented are
standard functions of
offset subtraction, flat
field correction and
defect map correction
and they are equivalent
to those provided by the
Primary Predicate
Device detector
manufacturer. |
| 2D examination programs'
final image | The frames acquired by
the Flat panel detector
in area mode after the
corrections, are
elaborated with a shift
and add procedure to
form the final image | The frames acquired by
the Flat panel detector in
area mode are after the
correction, are elaborated
with a shift and add
procedure to form the
final image | Same as predicate
device |
| 2D examination programs'
image pre-processing | GUI provides basic
image pre-processing
capabilities that the
user can enable or
disable. By default they
are disabled. | No image processing is
available | This function has been
added respect to the
Primary Predicate
Device but it is already
present on the
Additional Predicate
Device. |
| | Proposed device
Rotograph Prime 3D | Primary predicate device
I-MAX Touch 3D | |
| 3D examination image
reconstruction | The frames acquired by
the Flat panel detector
in area mode after the
correction, are
elaborated with a
Feldkamp algorithm -
and eventually with the
MAR algorithm- to get a
set of axial slices; then
a dicom header is added
to each slice file. Dicom
dataset is then saved to
disk for transfer to
external
visualization/processing
programs.
The 3D reconstruction is
done using PC GPU or
CPU. | The frames acquired by
the Flat panel detector in
area mode after the
correction, are elaborated
with a Feldkamp
algorithm —and
eventually with the MAR
algorithm- to get a set of
axial slices; then a dicom
header is added to each
slice file. Dicom dataset
is then saved to disk for
transfer to external
visualization/processing
programs.
The 3D reconstruction is
done using PC CPU. | The algoritm to
calculate the slices of
the 3D studies is the
same as the predicate
device one. Small
differences are related
to the algorithm tuning
for the different pixel
size, detector size and
detector response and
for the presence of
partial and high
resolution volumes.
The algorithm has been
implemented to run on
the computer CPU and
on the graphic card
GPU. The algorithm on
GPU verification is
reported in PANOVA -
N135C - GPU processing
time estimation |
COMPARISON OF SOFTWARE between the subject and predicate device
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Image /page/14/Picture/0 description: The image is a logo for Villa. The logo consists of a blue square with a white stylized letter "V" inside. Below the square, the word "VILLA" is written in white, block letters. The logo is simple and modern, and the blue and white color scheme is clean and professional.
Performance Data And Testing Evidence
Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to substantial equivalence determination. All standards applied were FDA recognized international standards. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Moderate Level of Concern".
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) has been designed to be in conformity with the following international standards:
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007): Medical electrical equipment Part 1: General י requirements for basic safety and essential performance
- -IEC 60601-1-2:2007: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601–1-3:2008: Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in l Diagnostic X-Ray Equipment
- IEC 60601-2-63:2012: Medical electrical equipment Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
- -IEC 62304:2006: Medical device software - Software life-cycle processes
- -ANSI/AAMI ES60601-1: 2005 / A2:2010 - Medical electrical equipment, Part 1: General Requirements
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- -CAN/CSA-C22.2 No. 60601-1:08: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC 60601-1-6:2010: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability
- IEC 62366:2007: Medical devices Application of usability engineering to medical devices -
- -ISO 10993-2:2006: Biological evaluation of medical devices- part 2: animal welfare requirements
- ISO 10993-5:2009: Biological evaluation of medical devices- part 5: tests for in vitro cytotoxicity -
- ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization -
- ISO 10993-12:2012: Biological evaluation of medical devices- part 12: sample preparation and reference materials -
In the submission are provided all the test reports including test protocol, methods, pass/fail criteria, and results in conformity with the standards here above.
A risk analysis was performed to analyze the hazards associated with the changes.
Non-clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" (September 1, 2016) were performed in order to assess the image quality and the relevant analysis has been supplied, together with specific technical data provided by the supplier of the detector (see Appendix L).
Substantial Equivalence Conclusion
The intended use of the proposed device is the same of the predicate device. Concerning the technical characteristics, it has been demonstrated that Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) does not introduce innovative aspects and does not arise different considerations regarding the relevant risks linked to the device. Non-clinical testing demonstrates that the device performs in a substantially equivalent manner to the predicate devices with regard to imaging and dose performance. Despite some minor technological differences, Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) can be considered as safe and as effective as the predicate devices and therefore substantially equivalent to the predicates I-MAX Touch 3D and Rotograph Prime.