(24 days)
No
The summary describes a standard X-ray imaging system and its performance characteristics, with no mention of AI or ML capabilities for image processing, analysis, or other functions.
No.
The device is an extraoral X-ray system for diagnostic imaging, not a therapeutic device.
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 to "produce X-ray images... in support of cephalometric examinations," and "carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones". These statements clearly indicate its use in diagnosis.
No
The device description explicitly states it is a "radiological system" equipped with an "X-ray tube generator and detectors (sensors)," indicating it includes significant hardware components for image acquisition.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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 hyperion X5 is an extraoral X-ray system that produces images of the maxillofacial region and other anatomical structures. It works by emitting X-rays through the patient's body and capturing the resulting image. This is an in vivo process (occurring within a living organism), not an in vitro process (occurring outside of a living organism, typically in a lab setting).
- Intended Use: The intended use clearly states that the device is for producing images and carrying out diagnostic examinations on the patient's body (teeth, dental arches, cranium, etc.). It does not mention analyzing biological specimens.
Therefore, the hyperion X5 is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, 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:
-
produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);
-
produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with 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 (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement.
The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT).
The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are:
- hyperion X5 - myray - CEFLA S.C.
- NewTom GO - NewTom - CEFLA S.C.
- X-RADIUS COMPACT - Castellini - CEFLA S.C.
Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
maxillofacial region, teeth, dental arches, oral cavity, cranium parts, carpus, cranial bones.
Indicated Patient Age Range
Adult, Paediatric
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 data:
- Safety and EMC test in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60825-1. Results demonstrated compliance to the standards.
- Comparison with QUART Technical Phantom (DIN 6868-5) for Spatial resolution and Low contrast resolution between hyperion X5 and X5 3D version (K161900) for Standard Panoramic X-Rays, and between hyperion X5 and hyperion X9 pro (K190496) for the Standard Lateral Ceph X-rays. Results demonstrated substantial equivalence in spatial resolution and low contrast resolution.
- Geometrical comparison performance of hyperion X5 (PAN and CEPH projection) with hyperion X5 3D version (K161900) and teleradiograph projections with hyperion X9 pro (K190496) using specific technical phantoms. Devices are comparable in terms of distortion performance.
- CBCT geometrical performance of the proposed device using a specific phantom. Results demonstrated that all measured CBCT parameters fall within the acceptance range, similar to the reference device hyperion X5 3D version (K161900). This validates the performance of hyperion X5 in terms of noise and geometric distortion.
- Evaluation image quality of the PAN, CEPH and CBCT of hyperion X5 performed by comparing images obtained on anthropomorphic and technical phantoms with corresponding tests of hyperion X5 3D version and hyperion X9 pro. Performance validated by QA analysis with a cylindrical phantom.
Image quality comparison:
- Comparative Clinical Evaluation of 2D Panoramic X-rays taken on different hyperion X5 and hyperion X9 pro (K190496) devices.
- Comparative Clinical Evaluation of CBCT X-ray images taken on different patients with hyperion X5, hyperion X9 pro (K190496) and hyperion X5 3D version (K161900).
- Comparative Clinical Evaluation of 2D Panoramic ORTO X-rays taken on the Same Patient with hyperion X5, hyperion X9 pro (K190496).
- Comparative Clinical Evaluation of Tele-radiography X-rays taken on different patients with hyperion X5 and hyperion X9 pro (K190496).
- Identification of main marker points of a Quick latero-lateral tele radiography acquired with hyperion X5.
- On-field Clinical Evaluation of hyperion X5 and end-users feedback report.
Obtained results are able to demonstrate the substantial equivalence in performance.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 9, 2020
CEFLA S.C. % Lorenzo Bortolotti Regulatory Affairs Via Selice Provinciale 23/A Imola, Bologna 40026 ITALY
Re: K200688
Trade/Device Name: hyperion X5, NewTom GO, X-RADiUS COMPACT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: March 9, 2020 Received: March 16, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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) K200688
Device Name
hyperion X5, NewTom GO and X-RADiUS COMPACT
Indications for Use (Describe)
hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, 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:
-
produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);
-
produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
hyperion X5 K200688
510(k) Summary
hyperion X5, NewTom GO and X-RADiUS COMPACT
This 510(k) Summary of Safety and Effectiveness information is prepared according to the requirements of 21 CFR Part 807.92.
1. General Information
| Submitter: | CEFLA S.C.
Via Selice Prov.le 23/a
Imola, BO 40026 ITALY
Tel. +39 0542 653441
Fax +39 0542 653607 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent Contact: | Lorenzo Bortolotti
CEFLA S.C.
Via Bicocca 14/c
Imola, BO 40026 ITALY
Tel. +39 0542 654024
Email: regulatory@cefla.it |
| Date 510K summary prepared: | March 9, 2020 |
2. Names
| Trade/ Device name: | hyperion X5,
NewTom GO,
X-RADIUS COMPACT |
|-----------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Extra oral source, Panoramic, Cephalometric, Tomography X-ray system |
| Regulatory Name: | Computed tomography X-ray system |
| Regulation number: | 21 CFR 892.1750 |
| Regulation Class: | Class II |
| Product Codes: | OAS |
| Subsequent code: | MUH |
4
3. Predicate Devices
Proposed device is substantially equivalent to the following legally marketed predicate devices:
| Applicant | Device Name | 510(k) Number | Product Code |
|---|---|---|---|
| CEFLA S.C. | hyperion X9 pro | K190496 | OAS |
| MUH |
Furthermore, the devices indicated in the table below, already cleared by FDA, has been considered in this submission as reference device.
| Applicant | Device Name | 510(k) Number | Product Code |
|---|---|---|---|
| CEFLA S.C. | hyperion X5 3D version | K161900 | OAS |
| MUH | |||
| CEFLA S.C. | hyperion X5 2D version | K152162 | MUH |
4. Device Description
The proposed device is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement.
The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT).
The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are:
| # | Device Name | Brand | manufacturer |
|---|---|---|---|
| 1 | hyperion X5 | myray | CEFLA S.C. |
| 2 | NewTom GO | NewTom | CEFLA S.C. |
| 3 | X-RADIUS COMPACT | Castellini | CEFLA S.C. |
Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT.
5
5. Indications for Use
hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to:
- produce orthopanoramic images of the maxillofacial region and carry out diagnostic 1. examination on teeth, dental arches and other structures in the oral cavity;
-
- produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);
-
- produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with CBCT option.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Comparison of technological characteristics with the predicate and reference devices 6.
The proposed device hyperion X5 (PAN, CEPH, CBCT) is a simplified version of the predicate device hyperion X9 pro (K190496), and also a further development of the reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162).
Both proposed device and predicate device hyperion X9 pro (K190496), permit the acquisition of panoramic images (PAN), cephalometric images (CEPH) and CBCT images (3D).
Compared to hyperion X9 pro (K190496), the proposed device is not intended to create tomographic images of the full head; ear, nose and throat (ENT); other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support.
For panoramic acquisitions the proposed device provides similar technological characteristic, operating principles and features of the predicate device hyperion X9 pro (K190496) and the reference devices hyperion X5 2D version (K152162) and hyperion X5 3D version (K161900).
The cephalometric acquisitions of hyperion X5 are performed through a CMOS detector, similarly to the predicate device hyperion X9 pro (K190496): the quality of the images acquired by the two devices are substantially equivalent as demonstrated through performance tests.
For CBCT image acquisition and 3D processing the proposed device provides the same operating principles and similar technology of hyperion X9 pro device (K190496) and hyperion X5 3D version (K161900).
Main Difference:
Indication for use: Compared to predicate device hyperion X9 pro (K190496), the proposed device is NOT intend to create tomographic images of the full head, the ear, nose and throat (ENT) and neck with sections of the cervical spine mainly due from the available FOVs and mechanical dimensions. Thus, proposed device is a simplified version of the predicate device.
6
hyperion X5
CEFLA S.C. 510(K) PREMARKET NOTIFICATION
The following cross reference table shows similarity and diversity aspects between the proposed device and the Predicate / Reference devices:
| Proposed Device | Predicate Device | Reference Devices | |||
|---|---|---|---|---|---|
| Product Name | hyperion X5, | ||||
| NewTom GO, | |||||
| X-RADIUS COMPACT | hyperion X9 pro | hyperion X5 | |||
| 3D version | hyperion X5 | ||||
| 2D version | |||||
| Manufacturer | CEFLA S.C. | CEFLA S.C. | CEFLA S.C. | CEFLA S.C. | |
| 510(K) No. | - | K190496 | K161900 | K152162 | |
| Classification and indications for use | |||||
| Regulation | |||||
| Number | 892.1750 | 892.1750 | 892.1750 | 872.2100 | |
| Regulation | |||||
| Name | Computed | ||||
| tomography x-ray | |||||
| system | Computed | ||||
| tomography x-ray | |||||
| system | Computed | ||||
| tomography x-ray | |||||
| system | Extraoral Source X- | ||||
| Ray System | |||||
| Regulatory Class | Class II | Class II | Class II | Class II | |
| Classification | |||||
| Product Code | OAS (Classification | ||||
| Product Code) | |||||
| MUH (Subsequent | |||||
| Product code) | OAS (Classification | ||||
| Product Code) | |||||
| MUH (Subsequent | |||||
| Product code) | OAS (Classification | ||||
| Product Code) | |||||
| MUH (Subsequent | |||||
| Product code) | MUH | ||||
| Indication for use | The hyperion X5 is an | The hyperion X9 pro is | The hyperion X5 | The hyperion X5 | |
| extraoral X-ray system | a digital panoramic, | device, 3D version | device, 2D version | ||
| for digital panoramic | cephalometric and | machine, is an image | machine, is an | ||
| exams, tele-X-rays and | tomographic extra-oral | reproducer, for | extraoral X-ray | ||
| tomographies, | X-ray system, intended | expert professionals, | system for digital | ||
| intended to: | to: | intended to: | panoramic X-Rays | ||
| (l)produce | (I)produce | suitable for: | |||
| orthopanoramic | (I)produce | orthopanoramic | (l)produce | ||
| images of the | orthopanoramic | images of the | orthopanoramic | ||
| maxillofacial region | images of the | maxillofacial region | images of the | ||
| and carry out | maxillofacial region | and carry out | maxillofacial region, | ||
| diagnostic | and carry out | diagnostic | diagnostic | ||
| examination on teeth, | diagnostic examination | examination on | examination of the | ||
| dental arches and | on teeth, dental arches | teeth, dental arches | dentition (teeth), | ||
| other structures in the | and other structures in | and other structures | arches and other | ||
| oral cavity; | the oral cavity; | in the oral cavity; | structures of the | ||
| (II) produce X-ray | (II) produce | (II) produce | oral cavity. | ||
| images of dental | radiographs of jaws, | tomographic images | |||
| arches, cranium parts, | parts of the skull and | of the oral cavity and | |||
| and carpus in support | carpus for the purpose | maxillofacial | |||
| of cephalometric | of cephalometric | structures and carry | |||
| examinations, if | examination, when | out diagnostic | |||
| Indication for | equipped with tele-X- | equipped with tele- | examination on | ||
| use | ray arm (CEPH); | radiographic arm | teeth, dental arches, | ||
| (CEPH); | structures of the oral | ||||
| (III) produce | (III) produce | cavity and some | |||
| tomographic images | tomographic images | cranial bones. | |||
| of the oral cavity and | of the head, including | The system performs | |||
| maxillofacial | the ear, nose and | tomographic exams | |||
| structures and carry | throat (ENT), of the | with the acquisition | |||
| out diagnostic | dento-maxillo-facial | of X-ray | |||
| examination on teeth, | complex, teeth, | images through a | |||
| dental arches, | mandible and maxilla, | rotating sequence | |||
| structures of the oral | temporomandibular- | and the | |||
| cavity and some | articular joint (TMJ), | reconstruction of a | |||
| cranial bones, if | other areas of the | three-dimensional | |||
| equipped with CBCT | human skull and neck | matrix of the | |||
| option. | with sections of the | examined volume, | |||
| cervical spine for use | thus producing two- | ||||
| The device is | in diagnostic support, | and three | |||
| operated and used by | if equipped with the | dimensional views of | |||
| physicians, dentists, x- | CBCT option. | the volume itself. | |||
| ray technologists and | The device is operated | This technique is | |||
| other legally qualified | and used by | known as CBCT. | |||
| professionals. | physicians, dentists, x- | ||||
| ray technologists and | |||||
| other legally qualified | Page 5 of 10 | ||||
| professionals. | |||||
| Performance features | |||||
| Performance | |||||
| specification | Panoramic | ||||
| Cephalometric | |||||
| Computed | |||||
| tomography | Panoramic | ||||
| Cephalometric | |||||
| Computed | |||||
| tomography | Panoramic | ||||
| Computed | |||||
| tomography | Panoramic | ||||
| Patient | |||||
| population | Adult | ||||
| Paediatric | Adult | ||||
| Paediatric | Adult | ||||
| Paediatric | Adult | ||||
| Paediatric | |||||
| Exposition | |||||
| selectable | 2D: | ||||
| PAN, DENT, SIN, TMJ, | |||||
| PAN BITEWING, CEPH | |||||
| 3D: | |||||
| Computed Tomography | |||||
| (CBCT) | 2D: | ||||
| PAN, DENT, SIN, TMJ, | |||||
| PAN BITEWING, CEPH | |||||
| 3D: | |||||
| Computed Tomography | |||||
| (CBCT) | 2D: | ||||
| PAN, DENT, SIN, TMJ, | |||||
| PAN BITEWING | |||||
| 3D: | |||||
| Computed | |||||
| tomography (CBCT) | 2D: | ||||
| PAN, DENT, SIN, TMJ | |||||
| 3D: | |||||
| N/A | |||||
| DAP reduction | |||||
| between | |||||
| Panoramic | |||||
| Standard Child / | |||||
| Panoramic | |||||
| Standard Adult | 0.7 | 0.7 | 0.7 | 0.7 | |
| Technical & Functional features comparison: (A) 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 | PAN: 60 – 85 kV - | ||||
| continuous emission | |||||
| CBCT: 90kV pulsed | |||||
| mode | PAN: 60 - 85 kV - | ||||
| continuous emission | |||||
| Tube current | 4 – 15 mA. | 2 – 16 mA | 4 - 15 mA | 4 – 15 mA | |
| Exposure Time | Panoramic (PAN) and | ||||
| Cephalometric | |||||
| (CEPH): 1s - 15s | |||||
| continuous emission | Panoramic (PAN) and | ||||
| Cephalometric | |||||
| (CEPH): 1s - 18s | |||||
| continuous emission | Panoramic: 1s - 15s | ||||
| continuous radiation | Panoramic: 1s - 15s | ||||
| continuous radiation | |||||
| CBCT: 1 s - 10 s | |||||
| pulsed mode, | |||||
| effective emission | |||||
| time | CBCT: 1s - 10.4 s | ||||
| pulsed emission, | |||||
| effective emission time | CBCT: 6.4 s - 16.8 s | ||||
| pulsed mode, | |||||
| effective emission | |||||
| time | |||||
| Shape of X-Ray | |||||
| Beam | PAN and CEPH: Fan- | ||||
| shaped beam | |||||
| CBCT: cone beam | PAN and CEPH: Fan- | ||||
| shaped beam | |||||
| CBCT: cone beam | PAN: Fan-shaped | ||||
| beam | |||||
| CBCT: cone beam | PAN: Fan-shaped | ||||
| beam | |||||
| Focal Spot | PAN, CEPH: 0.5, 0.6 | ||||
| mm | |||||
| CBCT: 0.6 mm | PAN, CEPH, CBCT: 0.5 mm | PAN: 0.5 mm, 0.6 mm | |||
| CBCT: 0.6 mm | PAN: 0.5 mm | ||||
| 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. | One collimator, | ||||
| adjustable in function | |||||
| of selected projection. | One collimator, | ||||
| fixed. | |||||
| FOV | Max 10x10 | ||||
| Min: 6x6 | Max 16x18 | ||||
| Min: 8x6 | Max: 10x10 | ||||
| Min: 6x6 | NA | ||||
| Technical & Functional features comparison: (B) SSD Detector & IMAGE acquisition | |||||
| Image Detector | |||||
| Technology | Panoramic (PAN) and | ||||
| Cephalometric (CEPH) | |||||
| exams: CMOS detector | |||||
| CBCT: Amorphous | |||||
| Silicon | |||||
| PAN and CEPH Image | |||||
| detectors are | |||||
| interchangeable. | Panoramic (PAN) and | ||||
| Cephalometric (CEPH) | |||||
| exams: CMOS detector | |||||
| CBCT: Amorphous | |||||
| Silicon | |||||
| PAN and CEPH Image | |||||
| detectors are | |||||
| interchangeable. | PAN: CMOS detector | ||||
| CBCT: Amorphous | |||||
| Silicon | PAN: CMOS linear | ||||
| detector | |||||
| Image detectors | |||||
| dimension | PAN:6 x 148 mm | ||||
| CEPH: 6 x 223 mm | |||||
| CBCT: 162 x 162 mm | PAN:6 x 148 mm | ||||
| CEPH: 6 x 223 mm | |||||
| CBCT: 162 x 162 mm | PAN: 6 x 146 mm | ||||
| CBCT:146 x 146 mm | PAN: 6 x 151 mm | ||||
| Detector Pixel | |||||
| size | PAN: 100, 127 μm² | ||||
| CEPH: 100 μm² | |||||
| CBCT: 127 μm² | PAN: 100 μm² | ||||
| CEPH: 100 μm² | |||||
| CBCT: 127 μm² | PAN: 127 μm² | ||||
| CBCT: 127 μm² | PAN: 100 μm² | ||||
| PAN (CEPH) | |||||
| Conversion | |||||
| Screen | |||||
| (scintillator) | Csl | Csl | Csl | Csl | |
| CBCT | |||||
| Conversion | |||||
| Screen | |||||
| (scintillator) | Csl | Csl | Csl | N/A | |
| MTF | 57% @ 1 lp/mm (1x1) | 57% @ 1lp/mm (1x1) | 58% @ 1lp/mm (1x1) | 58% @ 1lp/mm | |
| DQE | 70% @ 0 lp/mm (1x1) | 70% @ 0lp/mm (1x1) | 70% @ 0lp/mm (1x1) | 70% @0lp/mm | |
| Source to image | |||||
| detector | |||||
| distance (SID) | PAN: 500 mm | ||||
| CEPH: 1610 mm | |||||
| CBCT: 500 mm | PAN: 550 mm | ||||
| CEPH: 1554 mm | |||||
| CBCT: 650 mm | PAN: 500 mm | ||||
| CBCT: 500 mm | PAN: 500 mm | ||||
| Acquisition path | 2 axis – CBCT scan: | ||||
| 210° | 3 axis - CBCT scan: | ||||
| 360° and 210° | 2 axis - 210° | 2 axis - 210° | |||
| Technical & Functional features comparison: (C) Laser & positioning | |||||
| Number of laser | |||||
| pointer | 3 | 4 | 3 | 3 | |
| Laser optical | |||||
| class | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | Class 1 for IEC | ||
| 60825-1 | Class 1 for IEC | ||||
| 60825-1 | |||||
| Number of | |||||
| point of | |||||
| cephalostat | 3 (adjustable) | 3 (adjustable) | 3 (adjustable along | ||
| X-axis) | 2 (fixed) | ||||
| Technical & Functional features comparison: (D) Control & Viewing Software | |||||
| Control SW | Firmware (on board) | Firmware (on board) | Firmware (on board) | Firmware + VKB (on | |
| PC) | |||||
| Graphical User | |||||
| interface | VKB (on PC or Tablet) | VKB (on board or | |||
| Tablet or PC) | VKB (on PC or Tablet) | ||||
| Viewing & | |||||
| reconstruction | |||||
| software | NNT / iRYS | NNT / IRYS | NNT / iRYS | NNT / iRYS | |
| (optional) | |||||
| Software | |||||
| validation | IEC 62304 |
- Guidance FDA on MD
SW | IEC 62304 - Guidance FDA on MD
SW | IEC 62304 - Guidance FDA on
MD SW | IEC 62304 - Guidance FDA on
MD SW | |
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CEFLA S.C. 510(K) Premarket Notification
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CEFLA S.C. 510(K) Premarket Notification
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CEFLA S.C. 510(K) Premarket Notification
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According to the table above, the proposed device has similar technology and features as the predicate device hyperion X9 pro (K190496) and the reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162), pointing out only few differences that have been addressed by dedicated performance tests demonstrating that the proposed device is able to produce images with comparable performances. In conclusion, the different features of proposed system will not affect its classification, working principle, intended use, indications for use and target population and will not rise up new safety and effectiveness questions making proposed system equivalent to predicate device hyperion X9 pro (K190496) and reference devices hyperion X5 3D version (K161900) and hyperion X5 2D version (K152162).
7. Performance Data
The following performance test were executed in support of the substantial equivalence:
Non-clinical performance data: 1)
- A. Safety and EMC test in compliance with:
- IEC 60601-1,
- IEC 60601-1-2, ●
- IEC 60601-1-3, ●
- IEC 60601-2-63,
- IEC 60601-1-6,
- IEC 62366-1,
- IEC 62304,
- IEC 60825-1.
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Obtained results demonstrate compliance to the standards listed.
- B. Comparison with QUART Technical Phantom (DIN 6868-5) between hyperion X5 and X5 3D version (K161900) for Standard Panoramic X-Rays and between hyperion X5 and hyperion X9 pro (K190496) for the Standard Lateral Ceph X-rays. In both cases, the tested performances are: Spatial resolution and Low contrast resolution. The results obtained demonstrated a substantial equivalence in spatial resolution and in low contrast resolution, both in the comparison of the hyperion X5 with hyperion X5 3D version, and in the comparison between hyperion X5 and hyperion X9 pro.
- C. Geometrical comparison performance: The proposed device hyperion X5 (PAN and CEPH projection) was tested in comparison with the reference device hyperion X5 3D version (K161900) and the teleradiograph projections with the predicate device hyperion X9 pro (K190496) using the specific technical phantoms. In the both case, we consider the two devices to be comparable in terms of distortion performance.
- D. CBCT geometrical performance: the proposed device was tested using a specific phantom. Obtained results demonstrated that all the measured parameters fall between the acceptance range the same of reference device hyperion X5 3D version (K161900). Hence, that the performances of the proposed device hyperion X5 in terms of noise and geometric distortion are validated.
Obtained results demonstrated the substantial equivalence in geometrical performances.
- E. The evaluation image quality of the PAN, CEPH and CBCT of hyperion X5, hyperion X9 pro (K190496) and hyperion X5 3D version (K161900). The quality of the evaluation image is performed in two steps.
The images obtained with hyperion X5 on anthropomorphic and technical phantom, both in the 2D and 3D case, are compared with the corresponding tests of the reference device hyperion X5 3D version and the predicate device hyperion X9 pro.
The performance of the system is validated by performing QA analysis with a suitable cylindrical phantom, with a positive result. It therefore concludes that the verification and validation of images originating from hyperion X5 has a positive outcome.
2) Image quality comparison:
In addition to the above summarized bench tests, the following comparison of clinical images of Image quality comparison has been performed:
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- a) Comparative Clinical Evaluation of 2D Panoramic X-rays taken on different hyperion X5 and hyperion X9 pro (K190496);
- b) Comparative Clinical Evaluation of CBCT X-ray images taken on the different patient with hyperion X5, hyperion X9 pro (K190496) and hyperion X5 3D version (K161900);
- c) Comparative Clinical Evaluation of 2D Panoramic ORTO X-rays taken on the Same Patient with hyperion X5, hyperion X9 pro (K190496);
- d) Comparative Clinical Evaluation of Tele-radiography X--rays taken on different patients with hyperion X5 and hyperion X9 pro (K190496);
- e) Identification of main marker points of a Quick latero-lateral tele radiography acquired with hyperion X5;
- f) On-field Clinical Evaluation of hyperion X5 and end-users feedback report.
Obtained results are able to demonstrate the substantial equivalence in performance.
Furthermore, the following FDA Guidance documents have been applied:
- Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices September 1*, -2016
- Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005
- Content of premarket submissions for Management of Cybersecurity in Medical Devices -October 2, 2014
- Pediatric Information for X-ray Imaging Device Premarket Notifications January 28, 2017 -
8. Conclusions
In conclusion of the tests summarized above and based on classification, intended use, technological characteristics and performance data, the device proposed with the trade names hyperion X5, NewTom GO and X-RADiUS COMPACT can be found substantially equivalent to the predicated devices hyperion X9 pro (K190496) and reference devices hyperion X5 3D version (K161900), hyperion X5 2D version (K152162).