(29 days)
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:
(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);
(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084). Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:
1 hyperion X9 pro myray CEFLA S.C.
2 NewTom GIANO HR NewTom CEFLA S.C.
3 X-RADIUS TRIO PLUS Castellini CEFLA S.C.
Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.
Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.
This document describes a 510(k) premarket notification for a dental X-ray system. The key aspect of this submission is that the Proposed Device is a modification of an existing, legally marketed Predicate Device. The modifications primarily involve the availability of alternative 2D X-ray detectors. Therefore, the study presented here focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel performance against a clinical ground truth.
1. Acceptance Criteria and Reported Device Performance
Since this is a submission demonstrating substantial equivalence to an existing device, the "acceptance criteria" are predominantly the adherence to various medical device standards and the maintenance of comparable performance to the predicate device. The "reported device performance" is largely framed in terms of "no significant difference" or "comparable" to the predicate, as the goal is to show the new version is as safe and effective as the old.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Device Name remains the same | hyperion X9 pro, NewTom GiANO HR, X-RADIUS TRIO PLUS (Identical) |
| Manufacturer remains the same | CEFLA S.C. (Identical) |
| External appearances and materials are identical | "The external appearances and materials between Proposed device and Predicate device are identical." |
| Regulation Number (21 CFR 892.1750) is the same | "No difference." (Identical) |
| Regulatory Class (Class II) is the same | "No difference." (Identical) |
| Classification Product Codes (OAS, MUH) are the same | "No difference." (Identical) |
| Classification Name (Computed Tomography X-ray System) is the same | "No difference." (Identical) |
| Indications for Use are identical | "No difference." (Identical to predicate: orthopanoramic images, cephalometric examination, tomographic images of head/ENT/dentomaxillofacial/TMJ, etc.) |
| Performance specifications (Panoramic, Computed tomography, Cephalometric) are the same | "No difference." (Identical) |
| Patient population (Adult, Pediatric) is the same | "No difference." (Identical) |
| Exposure selectable modes (2D: PAN, BTW, DENT, SIN, TMJ, CEPH) are the same | "No difference." (Identical) |
| Rated input is the same | "No difference." (Identical: 20A @ 115V~, 12A @ 240V~, 50/60 Hz) |
| X-Ray emission parameters (Tube voltage, Tube current range, Exposure Time range, Shape of X-Ray Beam, Focal spot size, Anode Inclination, Collimator) are the same. | "No difference." (Identical across all listed parameters) |
| FOV (3D) is the same | "No difference." (Identical: Max: 16x18 cm, min: 4x4 cm) |
| Total filtration for scansions is the same | "No difference." (Identical: 2D > 2,5 mm Al @85kV, 3D 6.5 mm Al @ 90 kV) |
| 2D operating modes MIN and MAX Dose Area Product (DAP) are comparable | "No significant difference. The Proposed Device showed comparable measured DAP values than Predicate Device for the same selected exams." (Slight variations, e.g., 12 mGycm2 vs 11 mGycm2 for CEPH Lat Short, 137 mGycm2 vs 136 mGycm2 for TMJ Lat) |
| Image X-ray sensors Technology for 2D and 3D imaging are comparable or identical | "No significant difference." (Both use CMOS with scintillator and Direct conversion CMOS for 2D, and Amorphous Silicon Flat Panel for 3D.) |
| Image X-ray sensors dimensions for 2D are documented and justified if different; 3D dimensions are identical. | For 2D CMOS with scintillator, new alternative sensors are slightly higher/wider (e.g., PAN: 152mm x 6.7mm vs 148mm x 6mm). Justified as "The new alternative X-ray sensors with scintillator available with Proposed Device are higher and wider than the X-ray sensors with scintillator available with the Predicate Device, however the Proposed Device uses the identical beam limiting system used by the Predicate Device. The correspondence between X-ray field and effective image reception area is conforming the same recognized consensus standard IEC 60601-2- 63 applied to both Proposed Device and Predicate Device thus it doesn't involve in different safety considerations." For Direct conversion CMOS and 3D, identical dimensions. |
| Image X-ray sensors Pixel size for 2D are comparable or better; 3D are identical. | "No significant difference between Proposed Device and Predicate Device. The 2D sensor pixel sizes are comparable between Proposed Device and Predicate Device. The pixel sizes of new alternative CMOS detectors with scintillator is slight better than the pixel size of the CMOS detectors with scintillator already available with Predicate Device because smaller pixel size can theoretically allow to obtain higher resolution." For 3D, identical pixel size (127x127 μm). |
| Source to image X-ray sensor distance (SID) is the same | "No difference between Proposed Device and Predicate Device. The two devices share the same mechanical structure." (Identical) |
| Laser pointers optical class is the same | "No difference." (Identical: Class 1 according to IEC 60825-1:2014) |
| Number of fixing points of craniostat and cephalostat are the same | "No difference." (Identical: 6 adjustable for craniostat, 3 adjustable for cephalostat) |
| Control software (Firmware) changes properly managed and validated | "The firmware on board has been updated to manage also the new alternative 2D X-ray sensors models. The changes have been managed according to the same recognized consensus IEC 62304 and FDA Guidance on Medical Device Software." |
| Graphical User Interface (GUI) is comparable | "No significant differences." (Identical: VKB) |
| Viewing & Reconstruction software changes properly managed and validated | "The addition of alternative 2D X-ray sensors doesn't require significant change of Viewing & Reconstruction software however specific configuration data has been added to manage the new 2D X-ray Scintillator sensor models. Software changes have been managed according to the same recognized consensus standard IEC 62304 and FDA Guidance on Medical Device Software." |
| Software validation according to IEC 62304 + FDA Guidance on MD SW | "No difference." (Identical) |
| Electrical safety complies with IEC 60601-1: 2012 | "No difference." (Complies with IEC 60601-1: 2012) |
| Electromagnetic compatibility complies with IEC 60601-1-2:2014 | "No difference." (Complies with IEC 60601-1-2:2014) |
| Other relevant standards are met (e.g., IEC 60825-1, IEC 60601-1-3, IEC 62366, IEC 60601-2-63, IEC 60601-1-6) | Performance Tests included in this premarket notification verify the conformity of the proposed device with the requirements of these standards. |
| Image quality is confirmed to be equivalent to the predicate device. | "Verification activities for confirmation of the image quality of the proposed device has been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a traditional "test set" sample size in terms of clinical cases or patient images. This submission relies on a comparison against the predicate device's established performance and adherence to engineering and safety standards. The testing described is primarily non-clinical performance testing to verify conformity with various IEC standards (electrical safety, EMC, radiation protection, software lifecycle, usability, dental x-ray specific requirements).
- Sample Size: Not specified in terms of clinical images or patient data, as the study is not based on a new clinical performance claim but on equivalence to a predicate. It indicates "Verification activities for confirmation of the image quality of the proposed device has been performed." This implies technical tests on samples, phantoms, or test patterns, rather than a large human-read image dataset.
- Data Provenance: Not explicitly stated for specific test data, but the manufacturer is CEFLA S.C. based in Imola, Italy. The testing would have been conducted as part of their device development and validation processes, likely at their facilities or certified labs. The study is a non-clinical validation comparing the proposed device's technical specifications and test results to those of the predicate device and relevant standards. It is retrospective in the sense that it relies on existing data/standards for the predicate and engineering tests for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This type of submission (510(k) for substantial equivalence based on non-clinical performance and direct comparison to a predicate) typically does not involve establishing ground truth through multiple expert clinical readers for a test set. The "ground truth" here is the established safety and performance of the predicate device and the adherence to relevant international standards.
If image quality was assessed, it would likely be through technical metrics (e.g., MTF, contrast, noise) rather than subjective clinical readings by multiple radiologists. The document references "image quality review," which could involve internal engineering and quality experts. No specific number or qualifications of experts for image review are provided in this summary.
4. Adjudication Method for the Test Set
Not applicable for this type of submission. There is no multi-reader, multi-case study or a need for clinical adjudication to establish ground truth for a diagnostic accuracy claim. The comparison is based on engineering specifications and adherence to standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This means the submission relies on non-clinical performance data and a direct comparison of features and technical specifications to the legally marketed predicate device.
Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the subject of this submission, nor is a human-in-the-loop performance study.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is an X-ray imaging system, not an AI software algorithm. Therefore, "standalone" algorithm performance testing is not applicable in this context. The core function is image acquisition, not algorithmic analysis of images.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly the already established and FDA-cleared performance and safety of the predicate device (K214084), combined with compliance with relevant international and national standards (e.g., IEC 60601 series, IEC 62304). The study aims to demonstrate that the small changes introduced do not alter this established 'ground truth' of safety and fundamental performance. It is not based on expert consensus for disease detection, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device (X-ray system), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm training set involved.
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January 17, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CEFLA S.C. % Lorenzo Bortolotti Regulatory Affairs Via Selice Provinciale 23/A Imola. BO 40026 ITALY
Re: K223794
Trade/Device Name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: December 19, 2022 Received: December 19, 2022
Dear Lorenzo Bortolotti:
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
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801); medical device 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
2023.01.17
Lu Jiang 12:32:19 -05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K223794
Device Name
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Indications for Use (Describe)
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:
(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);
(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92 | K223794 | |||||
|---|---|---|---|---|---|---|
| Submitter's Name: | CEFLA S.C. | |||||
| Address: | Via Selice Provinciale 23/a | |||||
| Imola, BO 40026 ITALY | ||||||
| Tel. +39 0542 653111 | ||||||
| Fax +39 0542 653444 | ||||||
| EstablishmentRegistration Number: | 3006610845 | |||||
| Contact Person: | Lorenzo Bortolotti, Regulatory Affairs | |||||
| Telephone Number: | +39 0542 653441 | |||||
| Email Address: | regulatory@cefla.it | |||||
| Date prepared: | December 19th, 2022 | |||||
| Device name: | hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS | |||||
| Common Name: | Extra oral source, Panoramic, Cephalometric, Computed tomography X-ray system | |||||
| Device ClassificationName: | X-Ray, Tomography, Computed, Dental | |||||
| Regulation Number: | 21 CFR §892.1750 | |||||
| Device Class: | Class II | |||||
| ClassificationProduct Code: | OAS | |||||
| Subsequent ProductCode: | MUH | |||||
| Device Description: | The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed deviceis a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084).Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, withoutchanging any of the basic safety, essential performances and functional features: | |||||
| # | Device Name | Brand | Manufacturer | |||
| 1 | hyperion X9 pro | myray | CEFLA S.C. | |||
| 2 | NewTom GIANO HR | NewTom | CEFLA S.C. | |||
| 3 | X-RADIUS TRIO PLUS | Castellini | CEFLA S.C. |
Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.
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| Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generatorand X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computedtomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varyingradiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can beadapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and theadjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameterssuch as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patientstabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, andexposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. Theimages are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images,essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C. | |
|---|---|
| Indication for Use: | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in theoral cavity;(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible andmaxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support,if equipped with the CBCT option.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. |
| Identification ofPredicate Device | The predicate device identified relating the substantial equivalence of the proposed device is:Device Names: hyperion X9 Pro, NewTom GIANO HR, X-RADIUS TRIO PLUS510(k) Number: K214084Device Classification Name: X-Ray, Tomography, Computed, DentalApplicant: CEFLA S.C.Via Selice Provinciale 23/AImola, IT 40026Regulation Number: 21 CFR §892.1750Device Class: Class IIClassification Product Code: OASSubsequent Product Code: MUH |
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Substantial Both Proposed device and Predicate device (K214084) permit the aquisition of panoramic images (CEPH) and cone beam Equivalence computed tomography images (CBCT).
The proposed device is a change of the Cefla's own legally marketed predicate device: hyperion X9 Pro, NewTom GiANO HR, X-RADUS TRO PLUS (K214084).
This device change makes available for the acquisition of 2D images (PAN, CEPH) alternative solid-state X-ray detectors already used in the predicate device hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K214084).
The following cross reference table shows similarity and diversity aspects between the proposed device and the Predicate device.
| Proposed Device | Predicate Device | Justification for Differences | |
|---|---|---|---|
| Device Name | hyperion X9 pro,NewTom GiANO HR,X-RADIUS TRIO PLUS | hyperion X9 pro,NewTom GiANO HR,X-RADIUS TRIO PLUS | |
| Manufacturer | CEFLA S.C. | CEFLA S.C. | |
| 510(K) No. | - | K214084 | |
| Figure | Image: Proposed Device | Image: Predicate Device | The external appearances and materialsbetween Proposed device and Predicatedevice are identical. |
| Classification and indication for use | |||
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | No difference. |
| Regulatory Class | Class II | Class II | No difference. |
| Classification ProductCode | OAS (Classification Product code)MUH (Subsequent Product code) | OAS (Classification Product code)MUH (Subsequent Product code) | No difference. |
| Classification Name: | Computed Tomography X-ray System | Computed Tomography X-ray System | No difference. |
| Indication for use | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | The device is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to: (I) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity; (II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH); (III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | No difference. |
| Performance features | |||
| Performancespecification | PanoramicComputed tomographyCephalometric | PanoramicComputed tomographyCephalometric | No difference. |
| Patient population | Adult, Pediatric | Adult, Pediatric | No difference. |
| Exposition selectable | 2D: PAN, BTW (bitewing), DENT, SIN,TMJ, CEPH | 2D: PAN, BTW (bitewing), DENT, SIN,TMJ, CEPH | No difference. |
| Rated input | 20A @ 115V~ | 20A @ 115V~ | No difference. |
| 12A @ 240V~ | 12A @ 240V~ | ||
| 50/60 Hz | 50/60 Hz | ||
| Technical & Functional features comparison: X-Ray emission | |||
| Tube voltage | Panoramic (PAN) and Cephalometric(CEPH) exams: 60 - 85 kV - continuousemissionCBCT: 90 kV pulsed mode | Panoramic (PAN) and Cephalometric(CEPH) exams: 60 - 85 kV - continuousemissionCBCT: 90 kV pulsed mode | No difference. |
| Tube current range | 2 - 16 mA | 2 - 16 mA | No difference. |
| Exposure Time range | 2D: 1s- 18s continuous emissionCBCT: 1s -10.4 s pulsed emission | 2D: 1s- 18s continuous emissionCBCT: 1s -10.4 s pulsed emission | No difference. |
| Shape of X-Ray Beam | PAN and CEPH: fan-shaped beamCBCT: cone beam | PAN and CEPH: fan-shaped beamCBCT: cone beam | No difference. |
| Focal spot sizeAccording IEC 60336 | PAN, CEPH and CBCT: 0.5mm | PAN, CEPH and CBCT: 0.5mm | No difference. |
| Anode Inclination | 10° | 10° | No difference. |
| Collimator | One primary collimator, adjustable infunction of selected projection.One secondary collimator for CEPH. | One primary collimator, adjustable infunction of selected projection.One secondary collimator for CEPH. | No difference. |
| Correspondence between X-ray fieldand effective image reception areaAccording to IEC 60601-2-63. | Correspondence between X-ray fieldand effective image reception areaAccording to IEC 60601-2-63. | ||
| FOV (3D) | Max: 16x18 cmmin: 4x4 cm | Max: 16x18 cmmin: 4x4 cm | No difference. |
| Total filtration forscansions | 2D > 2,5 mm Al @85kV3D 6.5 mm Al @ 90 kV | 2D > 2,5 mm Al @85kV3D 6.5 mm Al @ 90 kV | No difference. |
| 2D operating modesmin and MAX Dose AreaProduct DAP(mGy*cm2), TypicalRange | 1) Sensors with scintillator:12 $mGycm2$ (exam: CEPH Lat. Shortreduced Quick, Small Patient Size) -137 $mGycm2$ (exam TMJ Lateral L orR 3X) | 1) Sensors with scintillator:11 $mGycm2$ (exam: CEPH Lat. Shortreduced Quick, Small Patient Size) -136 $mGycm2$ (exam TMJ Lateral L orR 3X) | No significant difference.The Proposed Device showed comparablemeasured DAP values than Predicate Devicefor the same selected exams. |
| 2) Direct conversion sensors:7 $mGycm2$ (exam: CEPH Lat. Shortreduced Quick, Small Patient Size) -103 $mGycm2$ (exam: PAN OrthoLarge Size Patient) | 2) Direct conversion sensors:7 $mGycm2$ (exam: CEPH Lat. Shortreduced Quick, Small Patient Size) -103 $mGycm2$ (exam: PAN Ortho LargeSize Patient) | ||
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | |||
| Image X-ray sensorsTechnology | 2D X-ray imaging:1) CMOS detector with scintillatorDirect Deposition CSI;2) Direct conversion CMOS detector.3D Image X-ray sensorCBCT: Amorphous Silicon Flat Panel. | 2D X-ray imaging:1) CMOS sensor with scintillator DirectDeposition CSI;2) Direct conversion CMOS detector.3D Image X-ray sensorCBCT: Amorphous Silicon Flat Panel. | No significant difference. |
| Image X-ray sensorsdimensions | 2D X-ray imaging: | 2D X-ray imaging: | The new alternative X-ray sensors withscintillator available with Proposed Device arehigher and wider than the X-ray sensors withscintillator available with the PredicateDevice, however the Proposed Device usesthe identical beam limiting system used by thePredicate Device. The correspondencebetween X-ray field and effective imagereception area is conforming the samerecognized consensus standard IEC 60601-2-63 applied to both Proposed Device andPredicate Device thus it doesn't involve indifferent safety considerations. |
| 1) CMOS detector with scintillator: | 1) CMOS detector with scintillator: | ||
| A) | A) | ||
| PAN: 148 mm x 6 mm | PAN: 148 mm x 6 mm | ||
| CEPH: 223 mm x 6 mm | CEPH: 223 mm x 6 mm | ||
| B) | |||
| PAN: 152 mm x 6,7 mm | |||
| CEPH: 228 mm x 6,7 mm | |||
| 2) Direct conversion CMOS detector | 2) Direct conversion CMOS detector | The Direct conversion CMOS detectorsdimensions are identical between ProposedDevice and Predicate Device because bothdevices use the same Direct conversion CMOSdetector models. | |
| PAN: 153,6 mm x 4,4 mm | PAN: 153,6 mm x 4,4 mm | ||
| CEPH: 230,4 mm x 4,4 mm | CEPH: 230,4 mm x 4,4 mm | ||
| 3D Image X-ray sensor: | 3D Image X-ray sensor: | The 3D X-ray sensor dimensions are identicalbetween Proposed Device and PredicateDevice because both devices use the sameCBCT Flat Panel | |
| CBCT: 162 mm x 162 mm | CBCT: 162 mm x 162 mm | ||
| 2D X-ray imaging: | 2D X-ray imaging: | No significant difference between Proposed | |
| Image X-ray sensorsPixel size | 1) CMOS detector with scintillator PANand CEPH: | 1) CMOS detector with scintillator PANand CEPH: | Device and Predicate Device.The 2D sensor pixel sizes are comparable |
| A) 100 μm x 100 μm | A) 100 μm x 100 μm | between Proposed Device and PredicateDevice. The pixel sizes of new alternative | |
| B) 99 μm x99 μm | CMOS detectors with scintillator is slight | ||
| 2) Direct conversion CMOS detectorPAN and CEPH: 100 μm x 100 μm | 2) Direct conversion CMOS detectorPAN and CEPH: 100 μm x 100 μm | better than the pixel size of the CMOSdetectors with scintillator already availablewith Predicate Device because smaller pixelsize can theoretically allow to obtain higherresolution. | |
| 3D Image X-ray sensor:CBCT: 127x127 μm | 3D Image X-ray sensor:CBCT: 127x127 μm | The 3D X-ray sensor pixel sizes are identicalbetween Proposed Device and PredicateDevice because both devices use the sameCBCT Flat Panel. | |
| PAN: 550 mm ± 5 mm | PAN: 550 mm ± 5 mm | ||
| Source to image X-raysensor distance (SID) | CEPH: 1554 mm ± 8 mm | CEPH: 1554 mm ± 8 mm | No difference between Proposed Device andPredicate Device. The two devices share the |
| CBCT: 650 mm ± 5 mm | CBCT: 650 mm ± 5 mm | same mechanical structure. | |
| Technical & Functional features comparison: Laser & positioning | |||
| Laser pointers opticalclass | Class 1 according IEC 60825-1:2014 | Class 1 according IEC 60825-1:2014 | No difference. |
| Number of fixing pointsof craniostat | 6 (adjustable) | 6 (adjustable) | No difference. |
| Number of fixing pointsof cephalostat | 3 (adjustable) | 3 (adjustable) | No difference. |
| Technical & Functional features comparison: Control & Viewing Software | |||
| Control software | Firmware (on board) | Firmware (on board) | The firmware on board has been updated tomanage also the new alternative 2D X-raysensors models. The changes have beenmanaged according to the same recognizedconsensus IEC 62304 and FDA Guidance onMedical Device Software. |
| Graphical User Interface(GUI) | VKB | VKB | No significant differences. |
| Viewing &Reconstructionsoftware | NNT / iRYS | NNT / iRYS | The addition of alternative 2D X-ray sensorsdoesn't require significant change of Viewing& Reconstruction software however specificconfiguration data has been added tomanage the new 2D X-ray Scintillator sensormodels. Software changes have beenmanaged according to the same recognizedconsensus standard IEC 62304 and FDAGuidance on Medical Device Software. |
| Software validation | IEC 62304+ Guidance FDA on MD SW | IEC 62304+ Guidance FDA on MD SW | No difference. |
| Electrical safety | Complies with IEC 60601-1: 2012 | Complies with IEC 60601-1: 2012 | No difference. |
| Electromagneticcompatibility | Complies with IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 | No difference. |
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Testing to verfy the performance requirements of the was conducted and included in this premarket notification. The results of the Non-clinical performance testing support substantial equivalence. Performance Tests included in this premarket notification verify the conformity of the proposed device with the requirements of: Testing: • IEC 60601-1: Medical electrical equipments for basic safety and essential performance (including US National Differences,
Canadian National Differences and Korean National Differences).
· IEC 60601-1-2: Medical electrical equirements for basic safety and esential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60825-1: Safety of laser products Part 1: Equipment classification and requirements.
- IEC 60601-1-3: Medical electrical equirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- · IEC 62366: Medical devices Application of usability engineering to medical devices.
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| IEC 62304: Medical device software - Software lifecycle processes. IEC 60601-2-63: Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X- ray equipment. IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability. Verification activities for confirmation of the image quality of the proposed device has been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device. | |
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| Clinical Testing | Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence. |
| Conclusion | The information included in this premarket notification supports the substantial equivalence of the proposed device. The proposed device is a change of the Cefla's own legally marketed predicate device (K214084). The proposed device has identical intended use and fundamental principles of operation. The proposed device showed comparable basic safety and essential performances as the legally marketed predicate device. Differences between the devices shown in the comparison section above do not reasonably involves in negative effects on substantial equivalence. |
§ 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.