(24 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 (TMI), 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 andiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:
Like the predicate device hyperion X9 pro (K190496) 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 cone beam 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.
The provided text describes a 510(k) premarket notification for a dental X-ray system, comparing a proposed device (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) to a predicate device (hyperion X9 pro, K190496). The submission focuses on demonstrating substantial equivalence, particularly related to the introduction of new 2D X-ray sensors.
Based on the provided text, the device in question is not an AI-powered device; it is a general dental X-ray imaging system. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML-based medical devices (such as MRMC studies, sample sizes for test/training sets, expert adjudication, or ground truth establishment for AI performance) are not applicable or reported in this document.
The "acceptance criteria" discussed in this document relate to the performance and safety standards that the medical device must meet to demonstrate substantial equivalence to a legally marketed predicate device. The text does not detail specific performance thresholds or how the device as an AI would be evaluated. Instead, it confirms compliance with general medical device standards.
Here's a breakdown of what is available and what is not for the requested points, given that this is not an AI device:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (as implied by the document for a general medical device): Compliance with recognized consensus standards for medical electrical equipment, radiation protection, and software.
- IEC 60601-1: Medical electrical equipment (basic safety and essential performance)
- IEC 60601-1-2: Electromagnetic compatibility
- IEC 60825-1: Safety of laser products
- IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
- IEC 62366: Application of usability engineering
- IEC 62304: Medical device software Software lifecycle processes
- IEC 60601-2-63: Dental extra-oral X-ray equipment (particular requirements)
- IEC 60601-1-6: Usability
- Demonstration of equivalent or lower radiation dose (DAP values).
- Demonstration of equivalent image quality.
- Reported Device Performance (against these criteria):
- Radiation Dose: The Proposed Device showed "similar or lower measured DAP values than Predicate Device for the same selected exams."
- Proposed Device (Sensors with scintillator): 11 mGy*cm2 to 126 mGy*cm2
- Proposed Device (Direct conversion sensors): 7 mGy*cm2 to 103 mGy*cm2
- Predicate Device (Sensor with scintillator): 13.01 mGy*cm2 to 229.81 mGy*cm2
- Mechanical & Technical Features: Largely identical or with justified differences that do not negatively affect safety or performance (e.g., new direct conversion sensors, updated firmware/software to manage new sensors, but conforming to standards).
- Image Quality: "The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device." (No specific metrics or quantitative values are provided for image quality beyond this statement).
- Software Validation: Updated firmware and viewing software for new sensors were managed according to IEC 62304 and FDA Guidance on Medical Device Software.
- Electrical Safety & EMC: Complies with IEC 60601-1:2012 and IEC 60601-1-2:2014.
- Radiation Dose: The Proposed Device showed "similar or lower measured DAP values than Predicate Device for the same selected exams."
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified for AI performance. This document describes non-clinical performance testing (e.g., electrical safety, EMC, radiation output, image quality review) of the X-ray system itself, not a test set for an AI algorithm.
- The document states "The results of the Non-clinical performance testing support substantial equivalence." No specific "test set" sample size in the context of diagnostic performance (e.g., number of patient images) is mentioned.
- Data Provenance: Not explicitly stated, but the testing would likely have been conducted by the manufacturer (CEFLA S.C.) in Italy, given their location. The nature of the testing (bench testing, phantom imaging, etc.) suggests it's not patient data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no mention of a "test set" requiring expert-established ground truth for diagnostic performance, as this is not an AI device. The "image quality review" is mentioned, but without details on experts or methodology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as this is not an AI device or a study involving human reader performance evaluation in a diagnostic context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." Therefore, no MRMC study was performed, and no AI assistance is part of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not feature a standalone algorithm in the context of AI. It is an X-ray imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI context. Ground truth in this submission pertains to the physical and technical specifications of the device, confirmed through engineering measurements, compliance with standards, and comparison to the predicate device's established performance parameters. For image quality, it's inferred that the review was against expected image characteristics for such a system, rather than diagnostic outcomes.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so no training set for an algorithm is mentioned or relevant.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
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January 20, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name "U.S. Food & Drug Administration" in a smaller font size.
CEFLA S.C. % Mr. Lorenzo Bortolotti Via Selice Provinciale 23/a Imola, BO 40026 ITALY
Re: K214084
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, MUH Dated: December 20, 2021 Received: December 27, 2021
Dear Mr. 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 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
{1}------------------------------------------------
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 medical devices and radiation-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,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214084
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 (TMI), 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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CEFLA S.C. Special 510(k) Premarket Notification
510(k) SUMMARY as required by 21 cfr 807.92
Submitter's Name: CEFLA S.C. Address: Via Selice Provinciale 23/a Imola, BO 40026 ITALY Tel. +39 0542 653111 Fax +39 0542 653444 Establishment Registration Number: 3006610845 Lorenzo Bortolotti, Regulatory Affairs Contact Person: Telephone Number: +39 0542 653441 Email Address: regulatory@cefla.it December 15th, 2021 Date prepared: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Device name: Common Name: Extra oral source, Panoramic, Cephalometric, Computed tomography X-ray system Device Classification Computed Tomography X-ray System Name: Regulation Number: 21 CFR §892.1750 Device Class: Class II Classification OAS Product Code: Subsequent Product MUH Code: The Proposed device is a panoramic, cephalometric andiological system developed and manufactured by CEFLA S.C. The proposed device Device Description: is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features: Manufacturer Device Name Brand # CEFLA S.C. ਜ |hyperion X9 pro myray 2 NewTom GiANO HR CEFLA S.C. NewTom 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, NewTom GiANO HR and X-RADiUS TRiO PLUS.
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| Like the predicate device hyperion X9 pro (K190496) the proposed device is equipped with X-ray tube generator and X-ray sensors (solid state X-ray imagingdetectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device permits toacquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patientfollowing different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep theradiation 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 exposuretechnique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient, stabilized through adjustable patientsupports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and deliversinformation about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to acomputer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCTacquisitions, 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:(I) 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: K190496Device 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 hyperion X9 pro (K190496) permit the aquisition of panoramic images (CEPH) Equivalence
and cone beam computed tomography images (CBCT).
The proposed device is a change of the Cefla's own legally marketed predicate device: hyperion X9 pro (K190496). This device change makes available for the acquisition of 2D images (PAN, CEPH) alternative X-ray Direct conversion sensors in addition to the X-ray
Scintillator sensors (detectors) already used in the predicate device hyperion X9 pro (K190496).
The following cross reference table shows similarity and diversity aspects between the proposed device and the Predicate device.
| Device Name | Proposed Device | Predicate Device (A) | Justification for Differences |
|---|---|---|---|
| hyperion X9 pro,NewTom GiANO HR,X-RADIUS TRIO PLUS | hyperion X9 proNewTom GiANO HR,X-RADIUS TRIO PLUS | ||
| Manufacturer | CEFLA S.C. | CEFLA S.C. | |
| 510(K) No. | K214084 | K190496 | |
| 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-raySystem | Computed Tomography X-raySystem | No difference. |
| Indication for use | The device is a digital panoramic,cephalometric and tomographicextra-oral X-ray system, intended to:(I) produce orthopanoramic imagesof the maxillofacial region and carryout diagnostic examination on teeth,dental arches and other structures inthe oral cavity;(II) produce radiographs of jaws,parts of the skull and carpus for thepurpose of cephalometricexamination, if equipped with tele-radiographic arm (CEPH);(III) the production of tomographicimages of the head, including theear, nose and throat (ENT), of thedento-maxillo-facial complex, teeth,mandible and maxilla,temporomandibular-articular joint(TMJ), other areas of the human skulland neck with sections of the cervicalspine for use in diagnostic support, ifequipped with the CBCT option.The device is operated and used byphysicians, dentists, x-raytechnologists and other legallyqualified professionals. | The device is a digital panoramic,cephalometric and tomographicextra-oral X-ray system, intended to:(I) produce orthopanoramic imagesof the maxillofacial region and carryout diagnostic examination on teeth,dental arches and other structures inthe oral cavity;(II) produce radiographs of jaws,parts of the skull and carpus for thepurpose of cephalometricexamination, if equipped with tele-radiographic arm (CEPH);(III) the production of tomographicimages 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 skulland neck with sections of the cervicalspine for use in diagnostic support, ifequipped with the CBCT option.The device is operated and used byphysicians, dentists, x-raytechnologists and other legallyqualified 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, CEPH3D: Computed Tomography (CBCT) | 2D: PAN, BTW (bitewing), DENT,SIN, TMJ, CEPH3D: Computed Tomography (CBCT) | No difference. |
| Technical & Functional features comparison: Rated input | |||
| Rated input | 20A @ 115V~12A @ 240V~50/60 Hz | 20A @ 115V~12A @ 240V~50/60 Hz | No difference. |
| Technical & Functional features comparison: X-Ray emission | |||
| Tube voltage | Panoramic (PAN) andCephalometric (CEPH) exams: 60 -85 kV - continuous emissionCBCT: 90 kV pulsed mode | Panoramic (PAN) and Cephalometric(CEPH) exams: 60 - 85 kV -continuous emissionCBCT: 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 significant 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, adjustablein function of selected projection.One secondary collimator for CEPH.Correspondence between X-rayfield and effective image receptionarea According to IEC 60601-2-63. | One primary collimator, adjustablein function of selected projection.One secondary collimator for CEPH.Correspondence between X-ray fieldand effective image reception areaAccording to IEC 60601-2-63. | The beam limiter structure and functioningare identical between Proposed Device andPredicate Device.Only the beam limiter windows size has beenchanged on Proposed Device when 2D DirectConversion X-ray sensors are installed.However the correspondence between X-rayfield and effective image reception area isconforming the same recognized consensusstandard 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 significant difference between ProposedDevice and Predicate device on declared 2Dequivalent filtration. |
| 2D operating modesmin and MAX DoseArea Product DAP(mGy*cm2), TypicalRange | 1) Sensors with scintillator:11 mGycm2 (exam: CEPH Lat.Short reduced Quick, Small PatientSize) - 126 mGycm2 (exam PANOrtho, Large Patient Size)2) Direct conversion sensors:7 mGycm2 (exam: CEPH Lat. Shortreduced Quick, Small Patient Size) -103 mGycm2 (exam: PAN OrthoLarge Size Patient) | Sensor with scintillator:13.01 mGycm2 (exam: CEPH Lat.Short reduced Quick, Small PatientSize) - 229,81 mGycm2 (exam: PANOrtho, Large Patient Size) | The Proposed Device showed similar or lowermeasured DAP values than Predicate Devicefor the same selected exams. |
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | |||
| Image X-ray sensorsTechnology | 2D X-ray imaging:1) CMOS X-ray sensor withscintillator Direct Deposition CSI;2) Direct conversion CMOS sensor. | 2D X-ray imaging:CMOS X-ray sensor with scintillatorDirect Deposition CSI. | The Proposed Device is available with thesame 2D CMOS X-ray sensors with scintillatorused on Predicate Device or with DirectConversion 2D CMOS X-ray sensors.Both Proposed Device and Predicate Deviceuse the same CBCT Flat Panel X-ray sensor. |
| CBCT Image X-ray sensor:Amorphous Silicon Flat Panel. | CBCT Image X-ray sensor:Amorphous Silicon Flat Panel. | ||
| 2D X-ray imaging: | 2D X-ray imaging: | The Direct conversion X-ray sensors available | |
| 1) Sensors with scintillator | Sensors with scintillator | with Proposed Device are higher and tighter | |
| PAN: 148 mm x 6 mm | PAN: 148 mm x 6 mm | than the X-ray sensors with scintillator. The | |
| CEPH: 223 mm x 6 mm | CEPH: 223 mm x 6 mm | correspondence between X-ray field and | |
| effective image reception area is conforming | |||
| Image X-ray sensorsdimensions | 2) Direct conversion sensors. | the same recognized consensus standard IEC | |
| PAN: 153,6 mm x 4,4 mm | 60601-2-63 applied to both Proposed Device | ||
| CEPH 230,4 mm x 4,4 mm | and Predicate Device thus it doesn't involve in | ||
| different risks and safety considerations. | |||
| The 3D X-ray sensor dimensions are identical | |||
| 3D Image X-ray sensor: | 3D Image X-ray sensor: | between Proposed Device and Predicate | |
| CBCT: 162 x 162 mm | CBCT: 162 x 162 mm | Device because both devices use the same | |
| CBCT Flat Panel. | |||
| 2D X-ray imaging: | 2D X-ray imaging: | No difference between Proposed Device and | |
| 1) Sensors with scintillator | Sensors with scintillator | Predicate Device. | |
| Image X-ray sensorsPixel size | PAN and CEPH: 100x100 μm | PAN and CEPH: 100x100 μm | The 2D sensor pixel sizes are identical |
| between Proposed Device and Predicate | |||
| 2) Direct conversion sensor PAN | Device. | ||
| and CEPH: 100x100 μm | The 3D X-ray sensor pixel sizes are identical | ||
| between Proposed Device and Predicate | |||
| 3D Image X-ray sensor: | 3D Image X-ray sensor: | device because both devices use the same | |
| CBCT: 127x127 μm | CBCT: 127x127 μm | CBCT Flat Panel. | |
| Source to image X-raysensor distance (SID) | PAN: 550 mm ± 5 mm | PAN: 550 mm ± 5 mm | No difference between Proposed Device and |
| CEPH: 1554 mm ± 8 mm | CEPH: 1554 mm ± 8 mm | Predicate Device. The two devices mechanica | |
| CBCT: 650 mm ± 5 mm | CBCT: 650 mm ± 5 mm | structure is the same. | |
| 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 fixingpoints of craniostat | 6 (adjustable) | 6 (adjustable) | No difference. |
| Number of fixingpoints of 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 2D direct conversion X-raysensors. The changes have been managedaccording to the same recognized consensusIEC 62304 and FDA Guidance on MedicalDevice Software. |
| Graphical UserInterface (GUI) | VKB | VKB | No significant differences. |
| Viewing &Reconstructionsoftware | NNT / IRYS | NNT / IRYS | The viewing software has been updated tomanage also the images from 2D directconversion X-ray sensors. The changes havebeen managed according to the samerecognized consensus standard IEC 62304 andFDA Guidance on Medical Device Software. |
| Software validation | IEC 62304+ Guidance FDA on MD SW | IEC 62304+ Guidance FDA on MD SW | No difference. |
| Electrical Safety & Electromagnetic compatibility | |||
| Electrical safety | Complies with IEC 60601-1: 2012 | Complies with IEC 60601-1:2012 | No difference. |
| Electromagneticcompatibility | Complies IEC 60601-1-2:2014 | Complies IEC 60601-1-2:2014 | No difference. |
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CEFLA S.C. Special 510(k) Premarket Notification
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CEFLA S.C. Special 510(k) Premarket Notification
{9}------------------------------------------------
CEFLA S.C. Special 510(k) Premarket Notification
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CEFLA S.C. Special 510(k) Premarket Notification
Testing:
Testing to verify the performance requirements of the proposed device was conducted 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:
-
IEC 60601-1: Medical electrical equirements for basic safety and essential performance (including US National Differences, Canadian National Differences and Korean National Differences).
· IEC 60601-1-2: Medical electrical equipments 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.
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| • 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. | |
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| • 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 havedemonstrated that the device is substantially equivalent to the predicate device. | |
| 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 ofthe Cefla's own legally marketed predicate device: hyperion X9 pro (K190496). The proposed device has identical intended use and fundamental principlesof operation. The proposed device showed comparable basic safety and essential performances as the legally marketed predicate device. Differencesbetween 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.