NewTom 5G XL

{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) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ## 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 notification<br>Number | Product code | |---------------------|------------------|----------------|-----------------------------------|--------------| | Predicate<br>device | QR s.r.l. | NewTom 5G | K142222 | JAK, OAS | | Reference<br>device | 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: | Scan<br>modes: | Additional Field of Views (as detailed in the table below)<br>Different ranges of selectable Exposure time - Scan time (as detailed in the<br>table below) | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User<br>interface: | New tools for 2D and 3D image management and visualization: additional<br>grid, show/hide overlays, popup of information, extended implants library,<br>multiple image rotation. | | | Introduction of specific application modes that are different combinations of<br>software tools and functions available in the NNT workspace. Application<br>modes: Oral & Maxillo facial surgery, Medical Specialties, ENT specialties,<br>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 Device<br>CEFLA S.C. - NewTom 5G XL | Predicate Device - K142222<br>QR s.r.l. - NewTom 5G | Reference Device - K151612<br>QR s.r.l. - NewTom VGi Evo | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | GENERAL<br>FEATURES | | | | | Applicant<br>Manufacturer | CEFLA s.c. | QR s.r.l. | QR s.r.l. | | Trade / Device<br>Name | NewTom 5G XL | NewTom 5G | NewTom VGi Evo | | Figure | <br> | | | | 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. product<br>code | JAK (primary), OAS (secondary) | JAK, OAS | OAS | | Device<br>classification<br>name | System, X-Ray, Tomography, Computed<br>and X-Ray, Tomography, Computed,<br>Dental | System, X-Ray, Tomography, Computed<br>and X-Ray, Tomography, Computed,<br>Dental | X-Ray, Tomography, Computed, Dental | | | Subject Device<br>CEFLA S.C. - NewTom 5G XL | Predicate Device - K142222<br>QR s.r.l. - NewTom 5G | Reference Device - K151612<br>QR s.r.l. - NewTom VGi Evo | | Indications for use<br>statement | The NewTom 5G XL is cone beam<br>computed tomography x-ray imaging<br>system that acquires sequences of the<br>images of the head, including ear, nose<br>and throat (ENT), of dento-maxillofacial<br>complex, teeth, mandible and jaw,<br>temporo-mandibular joint (TMJ), other<br>areas of the human skull and neck with<br>sections of upper cervical spine and of<br>the upper and lower extremities for use<br>in diagnostic support.<br>The device accomplishes this task by<br>reconstructing a 3D matrix of the<br>examined volume and producing two-<br>dimensional views of this volume,<br>displaying both two and three<br>dimensional images.<br>The device is operated and used by<br>physicians, dentists, x-ray technologists<br>and other legally qualified professionals. | The NewTom 5G is a cone beam<br>computed tomography x-ray imaging<br>system that acquires sequences of the<br>images of the head including the ear,<br>nose and throat (ENT), dento-<br>maxillofacial complex, teeth, mandible<br>and jaw, temporo-mandibular joint<br>(TMJ), other areas of the human skull and<br>neck with sections of upper cervical<br>spine, and upper and lower extremities<br>for use in diagnostic support.<br>The device accomplishes this task by<br>reconstructing a 3D matrix of the<br>examined volume and producing two<br>dimensional views of this volume,<br>displaying both two and three<br>dimensional images.<br>The device is operated and used by<br>physicians, dentists, x-ray technologists<br>and other legally qualified professionals. | The NewTom VGi Evo is a cone beam<br>computed tomographic x-ray imaging<br>system that acquires sequences of the<br>head including the ENT, dento-<br>maxillofacial complex, temporo-<br>mandibular-joint (TMJ), other areas of<br>human skull and neck with sections of<br>upper cervical spine for use in diagnostic<br>support.<br>The device accomplishes this task by<br>reconstructing a 3D matrix of the<br>examined volume and producing two<br>dimensional views (tomographic<br>sections, pan and ceph projections)<br>displaying both two and three<br>dimensional images.<br>The device is operated and used by<br>physicians, dentists, x-ray technologists<br>and other legally qualified professionals. | | Acquisition<br>technique | x-ray cone beam computed tomography | x-ray cone beam computed tomography | x-ray cone beam computed tomography | | PERFORMANCE FEATURES | | | | | | Subject Device<br>CEFLA S.C. - NewTom 5G XL | Predicate Device - K142222<br>QR s.r.l. - NewTom 5G | Reference Device - K151612<br>QR s.r.l. - NewTom VGi Evo | | Patient population | Adult - Pediatric | Adult - Pediatric | Adult - Pediatric | | Selectable<br>parameter | anatomical position, scan protocol types,<br>Field of View (FOV) | anatomical position, scan protocol types,<br>Field of View (FOV) | anatomical position, scan protocol types,<br>Field of View (FOV) | | Exposition<br>selectable | 3D: Computed tomography - (CBCT) | 3D: Computed tomography - (CBCT) | 3D: Computed tomography - (CBCT) | | Scan modes | REGULAR SCAN<br>ENHANCED SCAN<br>ECO SCAN MODE (Approximatively<br>-60 to -30% compared to Reg. scan) | REGULAR SCAN<br>ENHANCED SCAN | REGULAR SCAN<br>ENHANCED SCAN<br>ECO SCAN MODE (For children<br>recommended ECO SCAN mode and<br>fastest scanning mode) | | Dose reduction for<br>child/adult male -<br>std exposition | | | | | Anatomical sites | maxillofacial<br>dental<br>ENT - TMJ<br>human skull,<br>neck with sections of upper cervical<br>spine<br>upper and lower extremities | maxillofacial<br>dental<br>ENT - TMJ<br>human skull,<br>neck with sections of upper cervical<br>spine<br>upper and lower extremities | maxillofacial<br>dental<br>ENT - TMJ<br>human skull,<br>neck with sections of upper cervical<br>spine<br>upper and lower extremities | | Sampling angle or<br>3d's total view<br>angle | 360° | 360° | 360° | | TECHNICAL & FUNCTIONAL FEATURES COMPARISON: (A) X-RAY EMISSION | | | | | Type of x-ray<br>emission | Pulsed | Pulsed | Pulsed | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Subject Device<br>CEFLA S.C. - NewTom 5G XL | Predicate Device - K142222<br>QR s.r.l. - NewTom 5G | Reference Device - K151612<br>QR s.r.l. - NewTom VGi Evo | | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Model of x-ray<br>Tube | 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<br>(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-Ray<br>Beam | CBCT SQUARED | CBCT SQUARED | CBCT SQUARED | | | Subject Device<br>CEFLA S.C. - NewTom 5G XL | Predicate Device - K142222<br>QR s.r.l. - NewTom 5G | Reference Device - K151612<br>QR s.r.l. - NewTom VGi Evo | | | FOVs CBCT:<br>Std. Res. Mode:<br>$18 \div 36$ sec (scan time)<br>$0.9 \div 5.4$ sec (x-ray exposure time) | FOVs CBCT:<br>Std. Res. Mod…