(29 days)
Not Found
No
The summary describes standard image processing for reconstruction but does not mention AI, ML, or any related concepts like training or test sets for algorithmic performance.
No
The device is described as a diagnostic imaging system, used for producing images for examination and diagnostic support, not for active treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity" and for "use in diagnostic support".
No
The device description explicitly states it is a "panoramic, cephalometric and tomographic radiological system" equipped with "X-ray tube generator and X-ray sensors," which are hardware components. While it includes software for image management, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an extra-oral system that produces images (panoramic, cephalometric, and tomographic) of the maxillofacial region and other parts of the head and neck using X-rays. It directly interacts with the patient to acquire these images.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is solely focused on generating images through radiation.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAS, MUH
Device Description
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: hyperion X9 pro (myray), NewTom GIANO HR (NewTom), X-RADIUS TRIO PLUS (Castellini).
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Computed tomography
Anatomical Site
maxillofacial region, teeth, dental arches, oral cavity, jaws, parts of the skull, carpus, head, ear, nose, throat (ENT), dento-maxillo-facial complex, mandible, maxilla, temporomandibular-articular joint (TMJ), human skull, neck, cervical spine
Indicated Patient Age Range
Adult, Pediatric
Intended User / Care Setting
physicians, dentists, x-ray technologists and other legally qualified professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted to verify the conformity of the proposed device with the requirements of:
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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
1
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
2
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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3
| 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 | ||||||
| Establishment | ||||||
| Registration 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 Classification | ||||||
| Name: | X-Ray, Tomography, Computed, Dental | |||||
| Regulation Number: | 21 CFR §892.1750 | |||||
| Device Class: | Class II | |||||
| Classification | ||||||
| Product Code: | OAS | |||||
| Subsequent Product | ||||||
| Code: | MUH | |||||
| Device Description: | 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: | ||||||
| # | 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.
4
| | 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. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |
| Identification of
Predicate 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 PLUS
510(k) Number: K214084
Device Classification Name: X-Ray, Tomography, Computed, Dental
Applicant: CEFLA S.C.
Via Selice Provinciale 23/A
Imola, IT 40026
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Classification Product Code: OAS
Subsequent Product Code: MUH |
5
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 materials |
| between Proposed device and Predicate | |||
| device 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 Product | |||
| Code | 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 | |||
| Performance | |||
| specification | Panoramic | ||
| Computed tomography | |||
| Cephalometric | Panoramic | ||
| Computed tomography | |||
| Cephalometric | 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 - continuous | |||
| emission | |||
| CBCT: 90 kV pulsed mode | Panoramic (PAN) and Cephalometric | ||
| (CEPH) exams: 60 - 85 kV - continuous | |||
| emission | |||
| CBCT: 90 kV pulsed mode | No difference. | ||
| Tube current range | 2 - 16 mA | 2 - 16 mA | No difference. |
| Exposure Time range | 2D: 1s- 18s continuous emission | ||
| CBCT: 1s -10.4 s pulsed emission | 2D: 1s- 18s continuous emission | ||
| CBCT: 1s -10.4 s pulsed emission | No difference. | ||
| Shape of X-Ray Beam | PAN and CEPH: fan-shaped beam | ||
| CBCT: cone beam | PAN and CEPH: fan-shaped beam | ||
| CBCT: cone beam | No difference. | ||
| Focal spot size | |||
| According 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 in | ||
| function of selected projection. | |||
| One secondary collimator for CEPH. | One primary collimator, adjustable in | ||
| function of selected projection. | |||
| One secondary collimator for CEPH. | No difference. | ||
| Correspondence between X-ray field | |||
| and effective image reception area | |||
| According to IEC 60601-2-63. | Correspondence between X-ray field | ||
| and effective image reception area | |||
| According to IEC 60601-2-63. | |||
| FOV (3D) | Max: 16x18 cm | ||
| min: 4x4 cm | Max: 16x18 cm | ||
| min: 4x4 cm | No difference. | ||
| Total filtration for | |||
| scansions | 2D > 2,5 mm Al @85kV | ||
| 3D 6.5 mm Al @ 90 kV | 2D > 2,5 mm Al @85kV | ||
| 3D 6.5 mm Al @ 90 kV | No difference. | ||
| 2D operating modes | |||
| min and MAX Dose Area | |||
| Product DAP | |||
| (mGy*cm2), Typical | |||
| Range | 1) Sensors with scintillator: | ||
| 12 $mGy*cm2$ (exam: CEPH Lat. Short | |||
| reduced Quick, Small Patient Size) - | |||
| 137 $mGy*cm2$ (exam TMJ Lateral L or | |||
| R 3X) | 1) Sensors with scintillator: | ||
| 11 $mGy*cm2$ (exam: CEPH Lat. Short | |||
| reduced Quick, Small Patient Size) - | |||
| 136 $mGy*cm2$ (exam TMJ Lateral L or | |||
| R 3X) | No significant difference. | ||
| The Proposed Device showed comparable | |||
| measured DAP values than Predicate Device | |||
| for the same selected exams. | |||
| 2) Direct conversion sensors: | |||
| 7 $mGy*cm2$ (exam: CEPH Lat. Short | |||
| reduced Quick, Small Patient Size) - | |||
| 103 $mGy*cm2$ (exam: PAN Ortho | |||
| Large Size Patient) | 2) Direct conversion sensors: | ||
| 7 $mGy*cm2$ (exam: CEPH Lat. Short | |||
| reduced Quick, Small Patient Size) - | |||
| 103 $mGy*cm2$ (exam: PAN Ortho Large | |||
| Size Patient) | |||
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | |||
| Image X-ray sensors | |||
| Technology | 2D X-ray imaging: |
- CMOS detector with scintillator
Direct Deposition CSI; - Direct conversion CMOS detector.
3D Image X-ray sensor
CBCT: Amorphous Silicon Flat Panel. | 2D X-ray imaging:
- CMOS sensor with scintillator Direct
Deposition CSI; - Direct conversion CMOS detector.
3D Image X-ray sensor
CBCT: Amorphous Silicon Flat Panel. | No significant difference. |
| Image X-ray sensors
dimensions | 2D X-ray imaging: | 2D X-ray imaging: | 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. |
| | 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 detectors
dimensions are identical between Proposed
Device and Predicate Device because both
devices use the same Direct conversion CMOS
detector 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 identical
between Proposed Device and Predicate
Device because both devices use the same
CBCT 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 sensors
Pixel size | 1) CMOS detector with scintillator PAN
and CEPH: | 1) CMOS detector with scintillator PAN
and 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 Predicate
Device. The pixel sizes of new alternative |
| | B) 99 μm x99 μm | | CMOS detectors with scintillator is slight |
| | 2) Direct conversion CMOS detector
PAN and CEPH: 100 μm x 100 μm | 2) Direct conversion CMOS detector
PAN and CEPH: 100 μm x 100 μm | 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. |
| | 3D Image X-ray sensor:
CBCT: 127x127 μm | 3D Image X-ray sensor:
CBCT: 127x127 μm | The 3D X-ray sensor pixel sizes are identical
between Proposed Device and Predicate
Device because both devices use the same
CBCT Flat Panel. |
| | PAN: 550 mm ± 5 mm | PAN: 550 mm ± 5 mm | |
| Source to image X-ray
sensor distance (SID) | CEPH: 1554 mm ± 8 mm | CEPH: 1554 mm ± 8 mm | No difference between Proposed Device and
Predicate 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 optical
class | Class 1 according IEC 60825-1:2014 | Class 1 according IEC 60825-1:2014 | No difference. |
| Number of fixing points
of craniostat | 6 (adjustable) | 6 (adjustable) | No difference. |
| Number of fixing points
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 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) | VKB | VKB | No significant differences. |
| Viewing &
Reconstruction
software | NNT / iRYS | NNT / iRYS | 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 | 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. |
| Electromagnetic
compatibility | 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. | |
|---|---|
| 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. |