(240 days)
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.
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).
Here's a summary of the acceptance criteria and study information for the Rotograph Prime 3D (and I-MAX 3D) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Predicate Device (I-MAX Touch 3D) Performance | Subject Device (Rotograph Prime 3D) Performance | Notes |
|---|---|---|---|---|
| 2D Panoramic Mode | Spatial resolution | 2.2 lp/mm | 3 lp/mm | Subject device shows improved spatial resolution. |
| Contrast resolution (visible holes in IEC 61223-3-4 phantom) | 4 | 4 | Equivalent contrast resolution. | |
| DAP (@80kV 9mA 13.8s) | 13.0 uGy·m² | 15.7 uGy·m² (@80kV 9mA 14.0s) | Slightly higher DAP for the subject device in panoramic mode, attributed to a larger field of view due to a higher detector. | |
| 3D Mode | Nyquist Frequency | 2.7 lp/mm | 2.85 lp/mm | Subject device shows improved Nyquist Frequency. |
| Contrast to Noise Ratio | 17.9 | 15.3 | Lower CNR for the subject device. This is explained as a choice to prioritize dose containment, with the option for users to increase radiological parameters for higher contrast. | |
| Homogeneity (Metrics defined in DIN6868-161) | 7.0 | 8.6 | Subject device shows improved homogeneity. | |
| MTF on axial slices (10% modulation) | 1.31 lp/mm | 1.37 lp/mm | Subject device shows improved MTF at 10% modulation. | |
| MTF on axial slices (50% modulation) | 0.57 lp/mm | 0.72 lp/mm | Subject device shows improved MTF at 50% modulation. | |
| Acceptance Index ((mGy·cm²)-1, defined in DIN6868-161) | 86 | 247 | Significantly higher Acceptance Index for the subject device, indicating overall better performance relative to the delivered dose. This parameter considers dose, resolution, and contrast. | |
| DAP (3D full dentition, @80kV 8mA 11.2s for predicate) | 196.7 uGy·m² | 108 uGy·m² (@84kV 5mA 7s) | Significantly lower DAP for the subject device in 3D mode, achieved by prioritizing dose containment with respect to the predicate device. | |
| Other Considerations | Electrical safety, EMC/EMI | Conformity with IEC 60601-1, IEC 60601-1-2 | Conformity with IEC 60601-1, IEC 60601-1-2 | Tested to established international standards. |
| Biocompatibility | Conformity with ISO 10993 series | Conformity with ISO 10993 series | Patient-contacting components assessed. | |
| Software Validation | Conformity with IEC 62304, FDA Guidance | Conformity with IEC 62304, FDA Guidance | Device software considered "Moderate Level of Concern". | |
| Usability | Conformity with IEC 60601-1-6, IEC 62366 | Conformity with IEC 60601-1-6, IEC 62366 | Confirmed through testing. | |
| Radiation Protection | Conformity with IEC 60601-1-3 | Conformity with IEC 60601-1-3 | Confirmed through testing. | |
| Dental Extra-oral X-ray Equipment | Conformity with IEC 60601-2-63 | Conformity with IEC 60601-2-63 | Confirmed through testing. | |
| Image Quality Equivalence (2D) | Equivalence assessed | Equivalence assessed | Equivalence of 2D image quality between proposed and primary predicate device assessed with image comparison tests. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size of real patient data or phantoms used for "image comparison tests" or "performance and image quality testing". It refers to "image comparison tests" and "specific technical data provided by the supplier of the detector." The evaluation appears to be based on physical measurements and comparisons against a phantom (e.g., IEC 61223-3-4, DIN6868-161) rather than a clinical trial with a population of patients. There's no mention of the country of origin or whether the data was retrospective or prospective in the context of image quality or performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications for establishing ground truth for the image quality and performance tests. The evaluation relies on standardized phantom measurements and objective metrics rather than human interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as the evaluation methods described involve objective measurements against phantoms and direct comparison of quantitative metrics, not expert adjudication of images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes technical performance comparisons and image quality metrics, not studies evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance data presented is for the standalone device (algorithm only for image reconstruction and processing, but without a human-in-the-loop performance study for diagnostic efficacy). The table above provides various image quality metrics demonstrating the device's capabilities without human interaction.
7. The Type of Ground Truth Used:
The ground truth for the performance and image quality evaluations appears to be based on:
- Standardized Phantoms: Metrics like spatial resolution, contrast resolution, Nyquist Frequency, CNR, Homogeneity, MTF, and Acceptance Index are derived from measurements of these phantoms, which serve as objective ground truth.
- Physical Measurements: DAP values are direct physical measurements of radiation dose.
- Technical Specifications: Some comparisons relate to detector technology (CMOS vs. Amorphous Silicon), pixel size, and bit depth, which are inherent technical specifications.
8. The Sample Size for the Training Set:
The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is an X-ray imaging system, and its software (firmware functions, reconstruction algorithms, image acquisition/correction) is a deterministic system, not an adaptive one that learns from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no apparent training set for an AI/ML model for this device. The software functions are described as being designed by Villa/Owandy and implementing standard algorithms like Feldkamp for reconstruction.
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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
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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
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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 320090 Buccinasco (MI)ITALYPhone: +39 02 488591Registration # 8021091 | |
|---|---|---|
| Contact Person: | Paolo Casagrande SantinQA ManagerPhone: +39 02 48859 239Fax: +39 02 48859 303Email: p.casagrande@villasm.com | |
| Designated Agent: | Elizabeth LaneVilla Radiology Systems199 Park Road ExtensionSuite 107Middlebury, CT 06762ph 203 2628836e-mail admin@villaus.com | |
| Date Prepared: | October 12, 2018 | |
| Subject Device | 510(k) number: K180601Trade 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, dentalRegulation Number: 21 CFR 892.1750Regulation Name: Computed tomography x-ray systemRegulatory Class: Class IIProduct Code: OAS | |
| Primary Predicate Device | Trade Name: I-MAX Touch 3DManufacturer: Owandy Radiology510(k) clearance: K130443 (June 14, 2013)Device Type: x-ray, tomography, computed, dentalRegulation Number: 21 CFR 892.1750Regulation Name: Computed tomography x-ray systemRegulatory Class: Class IIProduct 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-oraldental panoramic and CBCT (aka CBVT)X-ray unit to take either two dimensional(panoramic, TMJ and sinus exams) orthree dimensional radiographic exams ofteeth, jaw and oral structures.Two dimensional images are taken usingthe narrow beam technique. Threedimensional exams are taken using coneshaped x-ray beam technique; both ofthem are well known techniques.The device is operated and used bydentists, radiologists and other legallyqualified health care professionals.It can be used with both pediatric andadult patients. | I-MAX Touch 3D, panoramic x-rayimaging system with cephalostat, is anextraoral source x-ray system, which isintended for dental radiographicexamination of the teeth, jaw, and oralstructures, specifically for panoramicexaminations and implantology and forTMJ studies and cephalometry, and ithas the capability, using the CBVTtechnique, to generate dento-maxillofacial 3D images.The device uses cone shaped x-raybeam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations.2D Images are obtained using thestandard narrow beam techniqueThe device is to be operated and usedby dentists, radiologists and otherlegally qualified health careprofessionals. | Rotograph Prime is an extra-oraldental panoramic X-ray unit toradiograph teeth, jaw and oralstructures.The device is operated and usedby dentists, radiologists andother legally qualified healthcare professionals.It can be used with bothpediatric 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 Prime3D) | Primary predicatedevice(I-MAX Touch 3D) | Additional PredicateDevice(Rotograph Prime) | |
|---|---|---|---|
| 2D Examination programs | |||
| Panoramic exam | Yes | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes | Yes |
| Segmented Panoramic (Halfpanoramic, frontal dentition,bitewings) | Yes | Yes | Yes |
| Proposed device(Rotograph Prime3D) | Primary predicatedevice(I-MAX Touch 3D) | Additional PredicateDevice(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 15x30cm film | equivalent to 13x30cm film | equivalent to 15x30 cmfilm |
| 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 degreerotation (except for3D TMJ)Single 180 degreerotation (for 3D TMJ) | Single 200 degreerotation (except for 3DTMJ)Single 180 degreerotation (for 3D TMJ) | n/a |
| Reconstruction algorithm | Feldkamp with theoption of MAR (MetalArtifact Removal) | Feldkamp with theoption of MAR (MetalArtifact Removal) | n/a |
| Generator/tubecharacteristics | |||
| 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 Prime3D) | Primary predicatedevice(I-MAX Touch 3D) | Additional PredicateDevice(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, biteblock, chin support,head strip | temple clamps, biteblock, chin support,head strip | temple clamps, biteblock, chin support |
| Height of chin support from thefloor | 975-1635 mm | 920-1755 mm | 975-1635 mm |
| Patient positioning orientation vsthe operator | face to face | lateral with adjustablemirror | face to face |
| User interface | |||
| Real time visualization | YES | YES | YES |
| User interface | Onboard keyboardand virtual controlpanel (on PC) | Onboard keyboard andO-LED display, plusvirtual control panel(on PC) | Onboard keyboard andvirtual 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 mmx 953 mm | 2450 mm x 1260 mm x1040 mm | 2184mm x 1107 mm x953 mm |
| Proposed device(Rotograph Prime 3D) | Primary predicate device(Rotograph Evo 3D) | Additional PredicateDevice(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 (3Ddentition, 3D TMJs, 3D sinus) | 85 mm x 93 mm | 85 mm x 85 mm | n/a |
| 3D Imaging detector | |||
| Technology | CMOS flat panel withCesium Iodide (CsI)scintillator screen | Amorphous Silicon withCesium Iodide (CsI)scintillator screen | n/a |
| Sensor active area (Height xWidth) | 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/tubecharacteristics | |||
| 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 deviceRotograph Prime 3DPanoramic mode | Primary predicate deviceI-MAX Touch 3D | ||
|---|---|---|---|
| Spatial resolution | 3 lp/mm | 2.2 lp/mm | |
| Contrast resolution (number ofvisible holes in the phantomdefined 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 instandard 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: 196.7uGy·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 deviceRotograph Prime 3D | Primary predicate deviceI-MAX Touch 3D | ||
|---|---|---|---|
| System architecture | Based on multiple CPUsconnected via Can Busplus Ethernetconnection to PC | Based on multiple CPUsconnected via Can Busplus Ethernet connectionto PC.In this case, the devicehas two more CPUs forcontrolling the onboardGUI and vertical column | The firmwarearchitecture is the sameas the PredicateDevices.The architecture andnumber of CPUS of theProposed Device aresimplified compared tothe primary predicatedevice due to:- Elimination ofonboard GUI- Replacement ofcolumn movementdevice with acomponent notrequiring a CPU(fully hardware-implemented) |
| Proposed deviceRotograph Prime 3D | Primary predicate deviceI-MAX Touch 3D | ||
| Firmware functions(of MCU and DSPU ControlProcessing Units) forcontrolling movementsand imageacquisition/synchronization | Firmware functions aredesigned to managethe panoramic/3Dversion, which isconsidered a subset ofthe versions in theprimary predicatedevice. The number of3D exams is greater,but their managementis the same in terms offirmware. Somedifferences are relatedto specific hardwaresolutions or differentmicroprocessors fromthe Primary PredicateDevice. | Firmware functions aredesigned to manage thefollowing configurations:Film Version, digitalpanoramic version,panoramic/3D version,cephalometric option | The firmware functionsof the proposed deviceare equivalent to thoseof the Primary Predicatedevice, some functionshave been eliminatedsince the proposeddevice has just amachine version.The fact that proposeddevice has more 3Dexams available doesn'tadd complexity to thefirmware. |
| X-ray generator boardfirmware functions | X-ray parameters (kV,mA, pulsed / continuousemission) management,X-ray start and stop,errors control.Can Buscommunication. | X-ray parameters (kV,mA, pulsed / continuousemission) management,X-ray start and stop,errors control.Can Bus communication. | Firmware functions andCan Bus protocol arethe same as in thePrimary Predicate device |
| Communication protocolbetween the computerand DSPU board. | Proprietary TCP/IPprotocol | Proprietary TCP/IPprotocol | The communicationprotocol is the same asthe Primary PredicateDevice one. |
| Software functions (on PC) | Graphical use interface(GUI) to control themachine, TCP/IPcommunication, imageacquisition andcorrection; imagereconstruction. | Graphical use interface(GUI) to control themachine, TCP/IPcommunication, imageacquisition andcorrection; imagereconstruction | Software functions arethe same as PrimaryPredicate Device one;the GUI is different inthe graphics respect tothe Primary Predicatedevice but is the sameto the AdditionalPredicate Device, with awider selection of examoptions. |
| Proposed deviceRotograph Prime 3D | Primary predicate deviceI-MAX Touch 3D | ||
| Image acquisition | Integration of thespecific detectormanufacturer SDK; PCmemory and disk spacemanagement andcontrol. | Integration of the specificdetector manufacturerSDK; PC memory anddisk space managementand control. | Proposed Device andPrimary PredicateDevice use imagingdetector of differentmanufacturers so SDKare different but PCmemory and disk spacemanagement andcontrol is the same asPrimary PredicateDevices |
| Image correction (defectmap, offset and flat field) | Correction functions fordetector in area modeare designed by Villa /Owandy. Offsetcorrection is donebefore each acquisition | Correction functions areprovided by the detectormanufacturer. Offsetcorrection is done beforeeach acquisition | Correction functionsimplemented arestandard functions ofoffset subtraction, flatfield correction anddefect map correctionand they are equivalentto those provided by thePrimary PredicateDevice detectormanufacturer. |
| 2D examination programs'final image | The frames acquired bythe Flat panel detectorin area mode after thecorrections, areelaborated with a shiftand add procedure toform the final image | The frames acquired bythe Flat panel detector inarea mode are after thecorrection, are elaboratedwith a shift and addprocedure to form thefinal image | Same as predicatedevice |
| 2D examination programs'image pre-processing | GUI provides basicimage pre-processingcapabilities that theuser can enable ordisable. By default theyare disabled. | No image processing isavailable | This function has beenadded respect to thePrimary PredicateDevice but it is alreadypresent on theAdditional PredicateDevice. |
| Proposed deviceRotograph Prime 3D | Primary predicate deviceI-MAX Touch 3D | ||
| 3D examination imagereconstruction | The frames acquired bythe Flat panel detectorin area mode after thecorrection, areelaborated with aFeldkamp algorithm -and eventually with theMAR algorithm- to get aset of axial slices; thena dicom header is addedto each slice file. Dicomdataset is then saved todisk for transfer toexternalvisualization/processingprograms.The 3D reconstruction isdone using PC GPU orCPU. | The frames acquired bythe Flat panel detector inarea mode after thecorrection, are elaboratedwith a Feldkampalgorithm —andeventually with the MARalgorithm- to get a set ofaxial slices; then a dicomheader is added to eachslice file. Dicom datasetis then saved to disk fortransfer to externalvisualization/processingprograms.The 3D reconstruction isdone using PC CPU. | The algoritm tocalculate the slices ofthe 3D studies is thesame as the predicatedevice one. Smalldifferences are relatedto the algorithm tuningfor the different pixelsize, detector size anddetector response andfor the presence ofpartial and highresolution volumes.The algorithm has beenimplemented to run onthe computer CPU andon the graphic cardGPU. The algorithm onGPU verification isreported in PANOVA -N135C - GPU processingtime 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.
§ 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.