(24 days)
Not Found
No
The document describes standard image processing for reconstruction but does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as an extra-oral system intended to produce orthopanoramic, cephalometric, and tomographic images for diagnostic support. It does not provide 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 an "extra-oral system" equipped with an "X-ray tube generator and X-ray sensors (solid state X-ray imaging detectors)" and "Class I lasers pointers," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as an extra-oral system for producing various types of radiographic images (panoramic, cephalometric, tomographic) of the maxillofacial region, skull, and neck for diagnostic examination and support. This involves imaging the patient directly.
- Device Description: The description details an X-ray system with an X-ray tube, sensors, and software for acquiring and processing radiological images. This is consistent with an imaging device used on a patient.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any interaction with biological samples or laboratory testing.
The device is an imaging device used for diagnostic purposes by capturing images of the patient's anatomy.
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 (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.
Product codes (comma separated list FDA assigned to the subject device)
OAS, MUH
Device Description
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:
Manufacturer Device Name Brand
CEFLA S.C. hyperion X9 pro myray
CEFLA S.C. NewTom GiANO HR NewTom
CEFLA S.C. X-RADiUS TRiO PLUS Castellini
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.
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.
Mentions image processing
Yes, "The obtained digital image data are processed to provide a reconstructed image."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray (digital panoramic, cephalometric and tomographic extra-oral system)
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, sections of the 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.
Performance Tests verified conformity with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-1-3, IEC 62366, IEC 62304, IEC 60601-2-63, and IEC 60601-1-6.
Verification activities for confirmation of the image quality of the proposed device have been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device.
No human clinical studies were considered necessary.
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 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
2
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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3
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.
4
| | 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. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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: K190496
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 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 pro | ||
| NewTom 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 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 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 | |||
| 3D: Computed Tomography (CBCT) | 2D: PAN, BTW (bitewing), DENT, | ||
| SIN, TMJ, CEPH | |||
| 3D: 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) 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 significant 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. | |||
| Correspondence between X-ray | |||
| field and effective image reception | |||
| area According to IEC 60601-2-63. | One primary collimator, adjustable | ||
| in function of selected projection. | |||
| One secondary collimator for CEPH. | |||
| Correspondence between X-ray field | |||
| and effective image reception area | |||
| According to IEC 60601-2-63. | The beam limiter structure and functioning | ||
| are identical between Proposed Device and | |||
| Predicate Device. | |||
| Only the beam limiter windows size has been | |||
| changed on Proposed Device when 2D Direct | |||
| Conversion X-ray sensors are installed. | |||
| However the correspondence between X-ray | |||
| field and effective image reception area is | |||
| conforming the same recognized consensus | |||
| standard 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 significant difference between Proposed | ||
| Device and Predicate device on declared 2D | |||
| equivalent filtration. | |||
| 2D operating modes | |||
| min and MAX Dose | |||
| Area Product DAP | |||
| (mGy*cm2), Typical | |||
| Range | 1) Sensors with scintillator: | ||
| 11 mGy*cm2 (exam: CEPH Lat. | |||
| Short reduced Quick, Small Patient | |||
| Size) - 126 mGy*cm2 (exam PAN | |||
| Ortho, Large Patient Size) |
- Direct conversion sensors:
7 mGycm2 (exam: CEPH Lat. Short
reduced Quick, Small Patient Size) -
103 mGycm2 (exam: PAN Ortho
Large Size Patient) | Sensor with scintillator:
13.01 mGycm2 (exam: CEPH Lat.
Short reduced Quick, Small Patient
Size) - 229,81 mGycm2 (exam: PAN
Ortho, Large Patient Size) | The Proposed Device showed similar or lower
measured DAP values than Predicate Device
for the same selected exams. |
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | | | |
| Image X-ray sensors
Technology | 2D X-ray imaging: - CMOS X-ray sensor with
scintillator Direct Deposition CSI; - Direct conversion CMOS sensor. | 2D X-ray imaging:
CMOS X-ray sensor with scintillator
Direct Deposition CSI. | The Proposed Device is available with the
same 2D CMOS X-ray sensors with scintillator
used on Predicate Device or with Direct
Conversion 2D CMOS X-ray sensors.
Both Proposed Device and Predicate Device
use 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 sensors
dimensions | 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 sensors
Pixel 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-ray
sensor 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 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 2D direct conversion X-ray
sensors. 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 viewing software has been updated to
manage also the images from 2D direct
conversion X-ray sensors. The 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 & Electromagnetic compatibility | | | |
| Electrical safety | Complies with IEC 60601-1: 2012 | Complies with IEC 60601-1:2012 | No difference. |
| Electromagnetic
compatibility | 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
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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.
-
· IEC 62304: Medical device software Software lifecycle processes.
11
| | • 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: hyperion X9 pro (K190496). 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. |