(86 days)
The NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandbular joint (TMI), other areas of the human skull and neck with sections of upper cervical spine and lower extremities for use in diagnostic support.
The NewTom 5G XL is a volumetric Cone Beam Computed Tomography (CBCT) system intended for diagnostic use. It obtains geometrical and x-ray information through digital 2D and 3D images of the objects in the area being examined.
The NewTom 5G XL is able to analyze the regions of the head, including the dental and maxillofacial and the otorhinolaryngology areas, the cervical spinal column and upper and lower limbs.
Particularly, the NewTom 5G XL can be used in the following fields:
- maxillofacial surgery, orthodontics, implants, endodontics, otorhinolaryngology, prosthetics, and orthopedics.
The NewTom 5G XL CBCT device acquires a sequence of x-ray images by performing a rotation around the patient's head then, starting from these images, reconstructs a 3D matrix of the examined volume and produces 2D views of it.
From these views it is possible to reconstruct other 2D images on which 3D images, angle and distance measurements can be taken. Each image can be printed and/or stored in a magnetic/optical media (CD, hard disk, network, USB pen or other mass storage device).
NewTom 5G XL consists of three main components: the scanner unit, the motorized patient support and the main workstation (secondary workstations could be also available as optional) that supports the dedicated software, enabling data acquisition.
The software requires a Microsoft Windows OS (version 7 or later).
I am sorry, but the provided text does not contain the detailed information needed to construct the complete table of acceptance criteria and reported device performance, nor does it provide a full study description as requested.
The document discusses the substantial equivalence of the NewTom 5G XL device to predicate devices (NewTom 5G and NewTom VGi Evo) based on safety, non-clinical performance, and clinical performance tests. However, it does not explicitly state acceptance criteria as specific numerical thresholds that the device was required to meet for each performance metric. It generally states that the device's performance is "comparable" or "able to fulfill the main standard reference."
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Metric | Acceptance Criteria (Not explicitly stated as numerical thresholds in the document) | Reported Device Performance (Comparative statements) |
|---|---|---|
| SNR (Signal-to-Noise Ratio) | Comparable to predicate device NewTom 5G (K142222) and reference device NewTom VGi Evo (K151612) | NewTom 5G XL has SNR comparable to the values given by the predicate device NewTom 5G (K142222) and by the reference device NewTom VGi Evo (K151612). |
| Spatial Resolution | Comparable to predicate device NewTom 5G (K142222) and reference device NewTom VGi Evo (K151612) | NewTom 5G XL has spatial resolution comparable to the values given by the predicate device NewTom 5G (K142222) and by the reference device NewTom VGi Evo (K151612). |
| MTF (Modulation Transfer Function) | Comparable to predicate device NewTom 5G (K142222) | NewTom 5G XL has modulation transfer function (MTF) comparable to the values obtained using the predicate device NewTom 5G (K142222). Additionally, specific MTF values are listed in the comparison table: MTF50 > 6, MTF10 > 12. |
| NPS (Noise Power Spectrum) | Comparable to predicate device NewTom 5G (K142222) | NewTom 5G XL has noise power spectrum (NPS) comparable to the values obtained using the predicate device NewTom 5G (K142222). |
| CTDIw (Weighted Computed Tomography Dose Index) | Comparable to predicate device NewTom 5G (K142222) for similar FOVs, or lower | The CTDIw dose value given by NewTom 5G XL are comparable to the values obtained using the predicate device NewTom 5G (K142222). Generally speaking, considering similar FOVs, the CTDIw value measured with the NewTom 5GXL is lower than the CDTIw value measured with the NewTom 5G. |
| Image Quality (DIN 6868-161) | "Quality level" evaluated according to German standard DIN6868-161 | Test report according to standard DIN 6868-161 has been performed to evaluate the quality level of images obtained using the device NewTom 5G XL, according to the German standard DIN6868-161. (Implicitly, the results met the standard's requirements for image quality). |
| Image Quality (NEMA XR 29-2013 / MITA Smart Dose) | Diagnostic quality images while optimizing radiation use | Test report according to standard NEMA XR 29-2013 (MITA Smart Dose) has been performed to evaluate that patient undergoing CT exams by means of the proposed device NewTom 5G XL, are subjected to procedures that produces images having diagnostic quality expected while optimizing the use of ionizing radiation. (Implicitly, the device produces such images). |
| Image Quality (IEC 61223-3-5) | Performance parameters (image quality, patient dose, positioning) evaluated and met | With this performance test, the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning have been evaluated. (Implicitly, the device met the requirements of this standard). |
| Clinical Image Resolution and Quality | Diagnostic reliability and utility based on clinical experience | On the subject device have been performed clinical evaluation in order to judge the images resolution and quality during CBCT acquisition. The quality evaluation has been done considering different anatomical sites and different patient population. Based on clinical experience, the test results can show the diagnostic reliability and utility of the radiographic images produced by the NewTom 5G XL CBCT scanner. |
Missing information for a complete study description:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "clinical evaluation" and "different anatomical sites and different patient population" but does not specify the number of cases/patients, the origin of the data, or if it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "clinical evaluation" and "clinical experience" but does not specify the number of experts or their qualifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No information provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a CBCT imaging system, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in this context (and not mentioned). The studies described are assessing the performance of the imaging device itself rather than a CAD/AI component for interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as it's an imaging device, not a standalone algorithm. The "clinical evaluation" mentioned is of the images generated by the device, not an algorithm's output.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical evaluation, the ground truth seems to be based on "clinical experience" and the ability of the images to show "diagnostic reliability and utility." It's not explicitly stated as expert consensus, pathology, or outcomes data. For the non-clinical tests, physical phantoms were used as the reference.
- The sample size for the training set:
- Not applicable; this is an imaging device, not an algorithm that requires a training set in the typical machine learning sense. The software updates and functionalities are compared to previous versions, but no "training set" for an AI algorithm is referenced.
- How the ground truth for the training set was established:
- Not applicable.
In summary: The provided text focuses on demonstrating the substantial equivalence of a new CBCT imaging device (NewTom 5G XL) to existing predicate devices by comparing technical specifications and performance metrics using phantoms and general clinical evaluation. It does not describe an AI/CAD algorithm validation study with specific acceptance criteria, sample sizes, and expert adjudication details typical for such submissions.
{0}------------------------------------------------
March 8, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CEFLA S.C. % Ms. Elena Arcangeli Regulatory Affairs Via Selice Provinciale 23/A Imola, (Bo) 40026 ITALY
Re: K183448
Trade/Device Name: NewTom 5G XL Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, OAS Dated: November 30, 2018 Received: December 12, 2018
Dear Ms. Arcangeli:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D.'Hara
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183448
Device Name NewTom 5G XL
Indications for Use (Describe)
The NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandbular joint (TMI), other areas of the human skull and neck with sections of upper cervical spine and lower extremities for use in diagnostic support.
The device accomplishes this task by reconstructing a 3D matrix of the examined volume and producing two-dimensional views of this volume, displaying both two and three dimensional images.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
This 510(k) Summary is being submitted as required by 21 CFR 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 | |
| Contact: | Elena Arcangeli |
| CEFLA S.C. | |
| Via Selice Prov.le 23/a | |
| Imola, BO 40026 ITALY | |
| Tel. +39 0542 654024 | |
| Fax +39 0542 653607 | |
| Email: regulatory@cefla.it |
Summary Prepared Date:
November 30, 2018
2. NAMES
| Device Name: | NewTom 5G XL |
|---|---|
| Common Name: | System, X-Ray, Tomography, Computed |
| Regulation Name: | Computed tomography x-ray system |
| Product Code: | JAK (primary), OAS (secondary) |
| Classification: | 21CFR 892.1750; Class II |
{4}------------------------------------------------
PREDICATE AND REFERENCE DEVICES 3.
The NewTom 5G XL is substantially equivalent to the following device:
Predicate device
| Applicant / Manufacturer | QR s.r.l. |
|---|---|
| Trade / Device Name | NewTom 5G |
| Classification product code | JAK, OAS |
| Device classification name | System, X-Ray, Tomography, Computed |
| 510(k) Number | K142222 |
Reference device
| Applicant / Manufacturer | QR s.r.l. |
|---|---|
| Trade / Device Name | NewTom VGi Evo |
| Classification product code | OAS |
| Device classification name | X-Ray, Tomography, Computed, Dental |
| 510(k) Number | K151612 |
4. Device Description
The NewTom 5G XL is a volumetric Cone Beam Computed Tomography (CBCT) system intended for diagnostic use. It obtains geometrical and x-ray information through digital 2D and 3D images of the objects in the area being examined.
The NewTom 5G XL is able to analyze the regions of the head, including the dental and maxillofacial and the otorhinolaryngology areas, the cervical spinal column and upper and lower limbs.
Particularly, the NewTom 5G XL can be used in the following fields:
- maxillofacial surgery, orthodontics, implants, endodontics, otorhinolaryngology, prosthetics, and orthopedics.
The NewTom 5G XL CBCT device acquires a sequence of x-ray images by performing a rotation around the patient's head then, starting from these images, reconstructs a 3D matrix of the examined volume and produces 2D views of it.
From these views it is possible to reconstruct other 2D images on which 3D images, angle and distance measurements can be taken. Each image can be printed and/or stored in a magnetic/optical media (CD, hard disk, network, USB pen or other mass storage device).
NewTom 5G XL consists of three main components: the scanner unit, the motorized patient support and the main workstation (secondary workstations could be also available as optional) that supports the dedicated software, enabling data acquisition.
The software requires a Microsoft Windows OS (version 7 or later).
NewTom 5G XL is intended for all people who usually undergo radio-diagnostic examinations like the ones performed by this device, in compliance with the use instructions, the medical praxis and the local regulations.
NewTom 5G XL has been specially designed for patients from 3 years of age [87 cm (34.25 in) standing height] to the 99th percentile of the U.S. adult male chart [193.92 cm (76.35 inches)
{5}------------------------------------------------
standing height]. The device may also be used for pediatric or small patients. The features available for this purpose are:
- o automatic calculation of minimum X-ray parameters required to carry out an examination, according to the size and the density of the volume to be examined;
- o indication of the values of the dose administered during the examination, before the actual scanning;
- necessity of carrying out examinations with the patient seated or lying on the patient table, thus reducing the risk of movement;
- . availability of adjustable fixing and centering tools, to secure the patient's head and/or limbs and allow a correct positioning;
- . possibility of using fields of view with reduced dimensions, such as: 6x6 (6 cm volume diameter, 6 cm height), 8x6, 8x8. Possibility of scanning in Eco Scan mode, a low-dose protocol characterised by reduced scanning time.
Studies have shown that pediatric patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients. For this reason detailed information are reported on the user manual in order to safeguard children and small-sized patient, particularly recommending the use of the Eco Scan mode, a low-dose protocol characterized by reduced scanning time.
The device must be managed and used by doctors, dentists, radiologists and other legally qualified professionals.
5. Indications for Use
The NewTom 5G XL is a cone beam computed tomography (CBCT) X-Ray Imaging System that acquires sequences of images of the head, including ear, nose and throat (ENT), of dentomaxillofacial complex, teeth, mandible and jaw, temporomandibular joint (TMJ), other areas of the human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support.
The device accomplishes this task by reconstructing a 3D matrix of the examined volume and producing two-dimensional views of this volume, displaying both two and three dimensional images.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
6. Comparison of technological characteristics with the predicate device
NewTom 5G XL Computed tomography x-ray system manufactured by CEFLA s.c. is substantially equivalent to the following devices legally marketed in the US:
| Device | Applicant [Note] | Device Name | Pre-market notificationNumber | Product code |
|---|---|---|---|---|
| Predicatedevice | QR s.r.l. | NewTom 5G | K142222 | JAK, OAS |
| Referencedevice | QR s.r.l. | NewTom VGi Evo | K151612 | OAS |
The NewTom 5G XL device is a variant of the Predicate device NewTom 5G (cleared K142222). Compared to this version, NewTom 5G XL features some changes concerning the power
{6}------------------------------------------------
supply, the image acquisition panel, the x-ray tube, the software revision, the electronic boards revision and aesthetic changes to the cover.
The software of proposed NewTom 5G XL is substantially equivalent to the NewTom 5G computed tomography x-ray system already cleared and described in the submission NewTom 5G K142222. The functionalities of the proposed device NewTom 5G XL were already included in the previous version of the software already approved (K142222). The major changes introduced starting from the previous system can be summarized as follows:
| Scanmodes: | Additional Field of Views (as detailed in the table below)Different ranges of selectable Exposure time - Scan time (as detailed in thetable below) |
|---|---|
| Userinterface: | New tools for 2D and 3D image management and visualization: additionalgrid, show/hide overlays, popup of information, extended implants library,multiple image rotation. |
| Introduction of specific application modes that are different combinations ofsoftware tools and functions available in the NNT workspace. Applicationmodes: Oral & Maxillo facial surgery, Medical Specialties, ENT specialties,Imaging Center. | |
| Update the software GUI: colors, icons, buttons size. | |
| Added patient dose verification tool (dose book). |
For CBCT image acquisition and 3D processing (also referred to as "3D mode"), panoramic x-ray exposures (also referred to as "2D mode") and mechanical construction, the subject NewTom 5G XL, provides similar characteristic, operating principles and components adopted in Predicate device NewTom 5G (K142222). NewTom 5G XL allows 3D images having a detected area bigger than the one granted by NewTom 5G.
On the other hand, the subject device NewTom 5G XL version, presents similarity to the cleared reference device NewTom VGi Evo (K151612) because it uses the same 3D image area detector, while it differs due to the mechanical construction.
Therefore, as it appears from the comparison table here below reported, considering the intended use, the characteristics of the predicate devices K142222 and of the reference device K151612 and the results of functional and security test performed, the subject device NewTom 5G XL may be found substantially equivalent to the cleared predicate and reference device.
{7}------------------------------------------------
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
|---|---|---|---|
| GENERALFEATURES | |||
| ApplicantManufacturer | CEFLA s.c. | QR s.r.l. | QR s.r.l. |
| Trade / DeviceName | NewTom 5G XL | NewTom 5G | NewTom VGi Evo |
| Figure | |||
| Regulation name | Computed Tomography X-Ray System | Computed Tomography X-Ray System | Computed Tomography X-Ray System |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Regulatory Class | II | II | II |
| Classif. productcode | JAK (primary), OAS (secondary) | JAK, OAS | OAS |
| Deviceclassificationname | System, X-Ray, Tomography, Computedand X-Ray, Tomography, Computed,Dental | System, X-Ray, Tomography, Computedand X-Ray, Tomography, Computed,Dental | X-Ray, Tomography, Computed, Dental |
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| Indications for usestatement | The NewTom 5G XL is cone beamcomputed tomography x-ray imagingsystem that acquires sequences of theimages of the head, including ear, noseand throat (ENT), of dento-maxillofacialcomplex, teeth, mandible and jaw,temporo-mandibular joint (TMJ), otherareas of the human skull and neck withsections of upper cervical spine and ofthe upper and lower extremities for usein diagnostic support.The device accomplishes this task byreconstructing a 3D matrix of theexamined volume and producing two-dimensional views of this volume,displaying both two and threedimensional images.The device is operated and used byphysicians, dentists, x-ray technologistsand other legally qualified professionals. | The NewTom 5G is a cone beamcomputed tomography x-ray imagingsystem that acquires sequences of theimages of the head including the ear,nose and throat (ENT), dento-maxillofacial complex, teeth, mandibleand jaw, temporo-mandibular joint(TMJ), other areas of the human skull andneck with sections of upper cervicalspine, and upper and lower extremitiesfor use in diagnostic support.The device accomplishes this task byreconstructing a 3D matrix of theexamined volume and producing twodimensional views of this volume,displaying both two and threedimensional images.The device is operated and used byphysicians, dentists, x-ray technologistsand other legally qualified professionals. | The NewTom VGi Evo is a cone beamcomputed tomographic x-ray imagingsystem that acquires sequences of thehead including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas ofhuman skull and neck with sections ofupper cervical spine for use in diagnosticsupport.The device accomplishes this task byreconstructing a 3D matrix of theexamined volume and producing twodimensional views (tomographicsections, pan and ceph projections)displaying both two and threedimensional images.The device is operated and used byphysicians, dentists, x-ray technologistsand other legally qualified professionals. |
| Acquisitiontechnique | x-ray cone beam computed tomography | x-ray cone beam computed tomography | x-ray cone beam computed tomography |
| PERFORMANCE FEATURES | |||
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| Patient population | Adult - Pediatric | Adult - Pediatric | Adult - Pediatric |
| Selectableparameter | anatomical position, scan protocol types,Field of View (FOV) | anatomical position, scan protocol types,Field of View (FOV) | anatomical position, scan protocol types,Field of View (FOV) |
| Expositionselectable | 3D: Computed tomography - (CBCT) | 3D: Computed tomography - (CBCT) | 3D: Computed tomography - (CBCT) |
| Scan modes | REGULAR SCANENHANCED SCANECO SCAN MODE (Approximatively-60 to -30% compared to Reg. scan) | REGULAR SCANENHANCED SCAN | REGULAR SCANENHANCED SCANECO SCAN MODE (For childrenrecommended ECO SCAN mode andfastest scanning mode) |
| Dose reduction forchild/adult male -std exposition | |||
| Anatomical sites | maxillofacialdentalENT - TMJhuman skull,neck with sections of upper cervicalspineupper and lower extremities | maxillofacialdentalENT - TMJhuman skull,neck with sections of upper cervicalspineupper and lower extremities | maxillofacialdentalENT - TMJhuman skull,neck with sections of upper cervicalspineupper and lower extremities |
| Sampling angle or3d's total viewangle | 360° | 360° | 360° |
| TECHNICAL & FUNCTIONAL FEATURES COMPARISON: (A) X-RAY EMISSION | |||
| Type of x-rayemission | Pulsed | Pulsed | Pulsed |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
|---|---|---|---|
| Model of x-rayTube | IAE RTM 30 HS | IAE X22 | IAE RTM 30 HS |
| Anode Material | RT-TZM | RTM | RT-TZM |
| Tube Voltage (KV) | 110 kV | 110 kV | 110 kV |
| Tube current (mA) | 32mA | 20 mA | 32mA |
| Focal spot size(IEC60336) | 0.3/ 0.6 mm | 0.3 mm | 0.3/ 0.6 mm |
| Anode angle | 15° | 15° | 15° |
| Type of collimator | motorized variable collimator | motorized variable collimator | motorized variable collimator |
| Shape of X-RayBeam | CBCT SQUARED | CBCT SQUARED | CBCT SQUARED |
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| FOVs CBCT:Std. Res. Mode:$18 \div 36$ sec (scan time)$0.9 \div 5.4$ sec (x-ray exposure time) | FOVs CBCT:Std. Res. Mode:$18 \div 36$ sec; (scan time)$2.4 \div 6.7$ sec (x-ray exposure time). | FOVs CBCT:Std. Res. Mode:$15 \div 20$ sec; (scan time)$0.9 \div 3.5$ sec (x-ray exposure time). | |
| HiRes Mode:$18 \div 36$ sec (scan time)$3.24 \div 9.0$ sec (x-ray exposure time) | HiRes Mode:$26.7 \div 36$ sec; (scan time)$5.4 / 7.3$ sec (x-ray exposure time). | HiRes Mode:$18 \div 25$ sec; (scan time)$4.3 \div 6.0$ sec (x-ray exposure time). | |
| exposure time;scan time | Ray2D:$0.064 \div 3.2$ s$0.01 \div 0.5$ s (x-ray time) | Hi-Res Mode, only FOV 6x6:$22.5 / 36$ sec;$4.5 / 7.3$ sec (x-ray time).( $3.6 / 4.5 / 6.7 / 7.3$ sec,effective radiation times) | Sharp 2D Mode:19.2 sec; (scan time)2.4 sec (x-ray exposure time) |
| CineX:1÷20s at 20fps; $0.2\div4$ s (x-ray time)21÷36s at 15fps; $3.15\div5.4$ s (x-ray time) | CineX1÷20s @ 20fps; $0.2\div4$ s (x-ray time)21÷36s @15fps; $3.15\div5.4$ s (x-ray time) | ||
| field of views(FOVs) image area | 21x1918x16 | 18x16 | 24x1916x16 |
| size (ØxH cm) | 15x22 - 15x12 - 15x512x810x10 - 10x58x8 - 8x56x6 | 15x22 - 15x12 - 15x512x88x86x6 | 15x15 - 15x12 - 15x512x810x10 - 10x58x8 - 8x55x5 |
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| Image detectortechnology | Amorphous Siliconflat panel X-ray detector(THALES manufacturer) | Amorphous Siliconflat panel X-ray detector(VARIAN manufacturer) | Amorphous Siliconflat panel X-ray detector(THALES manufacturer) |
| Detectordimension | 260 x 300 mm | 200x250 mm | 260 x 300 cm |
| Scintillatormaterial | Direct deposition CsI | Direct deposition CsI | Direct deposition Csl |
| Detector pixel | 1560 x 1440 pixels | 1920 x 1536 pixels | 1560 x 1440 pixels |
| Detector Pixel size | 184 μm | 127 μm | 184 μm |
| Possibleresolution | 0.368 x 0.368 mm for StdRes0.184 x 0.184 mm for HiRes | 0.254 x 0.254 mm for StdRes0,127 x 0,127 mm for HiRes | 0.368 x 0.368 mm for StdRes0.184 x 0.184 mm for HiRes |
| Voxel size | 75/100/125/150/200/250/300 μm | 75/100/125/150/200/250/300 μm | 75/100/125/150/200/250/300 μm |
| MTFModulation TransferFunction | MTF50 > 6MTF10 > 12 | MTF50 > 7MTF10 > 13 | MTF50 > 6MTF10 > 12 |
| DQEDetective QuantumEfficiency | 70% @ 0lp/mm (datasheet flat panel) | 70% @ 0lp/mm (1x1) | 70% @ 0lp/mm (datasheet flat panel) |
| Rotating anodespeed | 10 Krpm | 3 Krpm | 10 Krpm |
| Total filtration | 11.2 mm Al @ 70kV | 4.4 mm Al @ 70 kV | 12 mm Al @ 70Kv |
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| Source to imagedetector distance(SID) | 970 mm | 970 mm | 721 mm |
| Minimum sourceto skin distance(source-object) | 150 mm | 150 mm | 150 mm |
| Image transfer toPC | Direct Giga Ethernet | Direct Giga Ethernet | Direct Giga Ethernet |
| Patient centering | Positioning laser | Positioning laser | Positioning laser |
| Number of laserpointer | 2 lasers volumetric pointers | 2 lasers volumetric pointers | 2 lasers volumetric pointers |
| Laser optical classIEC 60825-1 | Class 1 | Class 1 | Class 1 |
| Standardaccessories | Phantom QACalibration support:Prosthesis support | Phantom QACalibration support:Prosthesis support | Phantom QACalibration support:Prosthesis support |
| TECHNICAL & FUNCTIONAL FEATURES COMPARISON: (C) CONTROL & VIEWING SOFTWARE | |||
| Control & ViewingSoftware | NNT | NNT | NNT |
| User Interface | NNT | NNT | NNT |
| Subject DeviceCEFLA S.C. - NewTom 5G XL | Predicate Device - K142222QR s.r.l. - NewTom 5G | Reference Device - K151612QR s.r.l. - NewTom VGi Evo | |
| Softwarevalidation | IEC 62304 + Guidance FDA on MD SW | IEC 62304 + Guidance FDA on MD SW | IEC 62304 + Guidance FDA on MD SW |
| REFERENCE STANDARDS | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | |
| IEC 60601-1-3 | IEC 60601-1-3 | IEC 60601-1-3 | |
| IEC 60601-1-6 | IEC 60601-1-6 | IEC 60601-1-6 | |
| IEC 60601-2-28 | IEC 60601-2-28 | IEC 60601-2-28 | |
| Standardreferences | IEC 60601-2-44 | IEC 60601-2-44 | IEC 60601-2-63 |
| IEC 62366 | IEC 62366 | IEC 62366 | |
| IEC 62304 | IEC 62304 | IEC 62304 | |
| IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | |
| 21 CFR 1010.3 | 21 CFR 1010.3 | 21 CFR 1010.3 | |
| 21 CFR 1020.30 | 21 CFR 1020.30 | 21 CFR 1020.30 | |
| 21 CFR 1020.33 | 21 CFR 1020.33 | 21 CFR 1020.33 |
{11}------------------------------------------------
NewTom 5G XL
CEFLA S.C.
510(k) PREMARKET NOTIFICATION
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
According to table above, the subject device has similar technology and features than the Predicate device NewTom 5G (K142222) and Reference device NewTom VGi Evo (K151612), pointing out only few differences that have been addressed by dedicated performance tests demonstrating that the subject device is able to produce images with comparable performances.
7. Safety and performance Data
Several safety and performance tests, have been performed in order to compare the performances of the subject device NewTom 5G XL with the predicate device NewTom 5G (K142222) and the reference device NewTom VGi Evo (K151612).
Safety and EMC tests
- A. Safety and EMC tests performed on subject device in compliance with
- IEC 60601-1 + USA Deviations + Canadian Deviations ●
- IEC 60601-1-2
- IEC 60601-1-3 ●
- IEC 60601-1-6
- IEC 62366
- IEC 60601-2-28
- IEC 60601-2-44
- IEC 62304
- 21 CFR 1010.3
- 21 CFR 1020.30
- 21 CFR 1020.33
In particular, IEC 60601-2-44 "Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography" has been applied with the main exclusions of Sensitivity profile statement, Geometric efficiency in the Z direction and the 21 CFR 1020.33 "Performance standards for ionizing emitting products, Computed tomography (CT) equipment" has been applied with the main exclusions of Sensitivity profile statement, control of xray emission with a shutter, scan increment accuracy.
The exclusions are based on the principles of operation CBCT (Cone Beam Computed Tomography) technology that allows the user to obtain all the necessary data for the volumetric reconstruction of the examined area through one complete rotation of the X-ray generator and detector around the patient's head, neck and limbs. The device doesn't use a shutter to control the x-ray emission. The patient support is fixed during the X-ray emission.
Non-clinical performance tests
- B. Performance parameters comparison between NewTom 5G XL vs NewTom 5G vs NewTom VGi Evo have been performed using a phantom reference and were addressed to demonstrate that subject device NewTom 5G XL has SNR (signal to noise ratio) and spatial resolution comparable to the values given by the predicate device NewTom 5G (K142222) and by the reference device NewTom VGi Evo (K151612).
- ﻥ 3D performance parameters comparison between NewTom 5G XL vs NewTom 5G have been performed using a phantom reference and were addressed to demonstrate that NewTom 5G
{16}------------------------------------------------
XL has modulation transfer function (MTF) and noise power spectrum (NPS) comparable to the values obtained using the predicate device NewTom 5G (K142222).
- Comparison of Weighted Computed Tomography Dose Index (CDTIw) between NewTom 5G D. XL vs NewTom 5G have been performed to demonstrate that by varying the size of the Field of View (FOV) the CDTIw dose value given by NewTom 5G XL are comparable to the values obtained using the predicate devicesNewTom 5G (K142222). Generally speaking, considering similar FOVs, the CTDIw value measured with the NewTom 5GXL is lower than the CDTIw value measured with the NewTom 5G.
- Test report according to standard DIN 6868-161 has been performed to evaluate the quality ய் level of images obtained using the device NewTom 5G XL, according to the German standard DIN6868-161.
- F. Test report according to standard NEMA XR 29-2013 (MITA Smart Dose) has beeb performed to evaluate that patient undergoing CT exams by means of the proposed device NewTom 5G XL, are subjected to procedures that produces images having diagnostic quality expected while optimizing the use of ionizing radiation.
- G. Test report according to standard IEC 61223-3-5 -Imaging performance of computed tomography X-ray equipment. With this performance test, the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning have been evaluated. The test methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during the installation or after the device has been completed.
Clinical performance test
-
H. Evaluation of Cone Beam CT Image Quality by the NewTom 5G XL On the subject device have been performed clinical evaluation in order to judge the images resolution and quality during CBCT acquisition. The quality evaluation has been done considering different anatomical sites and different patient population. Based on clinical experience, the test results can show the diagnostic reliability and utility of the radiographic images produced by the NewTom 5G XL CBCT scanner.
All above mentioned tests (Safety and EMC / Non clinical / Clinical) allow to demonstrate that: -
o images produced by NewTom 5G XL have performances that can be compared to the ones given by the predicate device and by the reference device;
-
The image quality performances are able to fulfill the main standard reference which can be ● considered to evaluate and qualify a CBCT device.
For these reasons the results of the non-clinical performance, together with the clinical evaluation of the NewTom 5GXL images quality, allow to demonstrate the substantial equivalence of the NewTom 5G XL to the predicate device and to the reference device. .
Reference FDA guidelines
The NewTom 5G XL has been developed in accordance with the applicable international standards and following the indications provided by FDA's guidelines listed here below:
- . Guidance for the content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
{17}------------------------------------------------
- Content of premarket submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)
- Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016)
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device (October 25, 2017)
- Pediatric Information for X-ray Imaging Device Premarket Notifications (November 28,2017)
8. Conclusions
Due to all above summarized evidence and referring to classification, intended use, technological characteristics, and performance data, the subject device may be found substantially equivalent to the predicate device K142222 and to the reference deviceK151612.
§ 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.