Who is the manufacturer of NewTom 7G?

Cefla S.C. filed the 510(k) submission for NewTom 7G (K220664).

What is the FDA product code for NewTom 7G?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for NewTom 7G?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NewTom 7G?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NewTom 7G

K220664 · Cefla S.C. · JAK · May 6, 2022 · Radiology

Device Facts

Record ID	K220664
Device Name	NewTom 7G
Applicant	Cefla S.C.
Product Code	JAK · Radiology
Decision Date	May 6, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMI), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, hand, relative joints and of lower extremities including hip, upper leg, midfoot, forefoot, relative joints, 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 managed and used by doctors, dentists, radiologists and other legally qualified professionals.

Device Story

NewTom 7G is a cone-beam computed tomography (CBCT) system; acquires X-ray image sequences by rotating around patient; uses solid-state amorphous silicon flat panel detector; collimated X-ray beam adapts to region of interest; patient lies on motorized 3-axis support; laser pointers aid positioning. System reconstructs 3D matrix from acquired data; produces 2D and 3D images for diagnostic support. Operated by doctors, dentists, and radiologists in clinical settings. Output viewed on computer via NNT software; assists in clinical diagnosis and treatment planning. Benefits include high-resolution imaging with dose-optimization parameters.

Clinical Evidence

Bench testing only. No clinical studies were conducted. Performance verified through compliance with consensus standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-44, IEC 60825-1, IEC 62304) and image quality reviews comparing the subject device to the predicate.

Technological Characteristics

CBCT system; amorphous silicon flat panel detector (300x300 mm, CsI scintillator); pulsed X-ray emission; RTM rotating anode (10,000 rpm); 130 kV nominal voltage; motorized variable collimator; 3-axis motorized patient bed; Class 1 laser positioning; Ethernet connectivity; NNT software for reconstruction/viewing.

Indications for Use

Indicated for diagnostic imaging of head (ENT, dento-maxillofacial, teeth, mandible, jaw, TMJ), skull, neck, cervical spine, spine sections, and upper/lower extremities. Suitable for adult and pediatric patients (minimum weight 11 kg/24 lb, height 87 cm/34.25").

Regulatory Classification

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.

Predicate Devices

NewTom 5G XL (K183448)

Related Devices

K183448 — NewTom 5G XL · Cefla S.C. · Mar 8, 2019
K193139 — ProVecta 3D Prime Ceph · Durr Dental SE · Mar 5, 2020
K110260 — NEWTOM 5G / NEWTOM 5G VERSION FP · Qr S.R.L. · Apr 6, 2011
K142222 — NewTom 5G · Qr S.R.L. · Jan 26, 2015
K130297 — SCANORA 3DX · Palodex Group OY · May 29, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ May 6, 2022 Image /page/0/Picture/1 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. Cefla S.c. % Lorenzo Bortolotti Managing Director Via Selice Prov.le 23/ Imola, Bologna 40026 ITALY Re: K220664 Trade/Device Name: NewTom 7G Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, OAS Dated: March 2, 2022 Received: March 17, 2022 #### Dear Lorenzo Bortolotti: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220664 Device Name NewTom 7G #### Indications for Use (Describe) The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMI), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, hand, relative joints and of lower extremities including hip, upper leg, midfoot, forefoot, relative joints, 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 managed and used by doctors, dentists, radiologists 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) #### 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}------------------------------------------------ ## K220664 ## CEFLA S.C. Traditional 510(k) Premarket Notification # 510(k) SUMMARY as required by 21 cfr 807.92 | Submitter's Name: | CEFLA S.C. | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Via Selice Provinciale 23/a | | | Imola, BO 40026 ITALY | | | Tel. +39 0542 653111 | | | Fax +39 0542 653444 | | Establishment Registration No. : | 3006610845 | | Contact Person: | Lorenzo Bortolotti, Regulatory Affairs | | Telephone Number: | +39 0542 653441 | | Email Address: | regulatory@cefla.it | | Date prepared: | March 02nd, 2022 | | Device name: | NewTom 7G | | Device: | System, X-Ray, Tomography, Computed | | Regulatory description: | Computed tomography X-ray system | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | 2 | | Classification | JAK | | Product Code: | | | Subsequent Product Code: | OAS | | Device Description: | NewTom 7G is a computed tomography X-ray system using the cone-beam technology manufactured by CEFLA S.C. The proposed device NewTom 7G is a further development of the predicate device NewTom 5G XL (K183448) manufactured by CEFLA S.C. Like the predicate device NewTom 5G XL the proposed device NewTom 7G is equipped with X-ray tube generator and X-ray sensor (solid state X-ray imaging detector) for radiological images acquisition. The proposed device permits to acquire radiological images at varying radiographic angles by rotating around the patient. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible. This is achieved by collimating the X-ray beam. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to aid the patient positioning. The patient stay lie down on the patient support for a good stabilization. Control panel allow user actions as: patient support adjustment, selection of examination, selection of exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer. The software used to manage the images is NNT, a radiological imaging software developed by CEFLA S.C. | | Indication for Use: | NewTom 7G is a computed tomography X-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, 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 managed and used by doctors, dentists, radiologists and other legally qualified professionals. | | Identification of Predicate Device | The predicate device identified relating the substantial equivalence of the proposed device is: Device Name: NewTom 5G XL 510(k) Number: K183448 Device: System, X-Ray, Tomography, Computed Regulation Description: Computed tomography x-ray system Applicant: CEFLA S.C. Via Selice Provinciale 23/A Imola, IT 40026 Regulation Number: 21 CFR §892.1750 Device Class: Class II Classification Product Code: JAK Subsequent Product Code: OAS | {4}------------------------------------------------ {5}------------------------------------------------ Substantial Equivalence NewTom 7G is a further development of the NewTom 5G XL (K183448). The devices have intended use, same clinical conditions, the same target population and the same operating principles. Both devices have requirements from technical standards. The NewTom 7G technology has no innovative aspects compared to the predicate device NewTom 5G XL, but represents an increment of technical performances and usability. The aim of these improvements is giving to the professionals a tool to better answer the improvements are based on the client's feedback and on more than twenty years' experience in R&D, production and world-wide distribution of CBCT devices. The following cross reference table shows similarity aspects between the proposed device and the predicate device: | Characteristic | Proposed Device | Predicate Device | Differences discussion | |----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | NewTom 7G | NewTom 5G XL | | | Manufacturer | CEFLA S.C. | CEFLA S.C. | | | 510(K) No. | - | K183448 | | | Figure | Image: NewTom 7G | Image: NewTom 5G XL | Equivalent shape: toroidal gantry with patient bed. | | Regulation Number | 892.1750 | 892.1750 | No difference. | | Regulation Description | Computed tomography X-ray system | Computed tomography X-ray system | No difference. | | Device Class | 2 | 2 | No difference. | | Classification Product Code | JAK (Classification Product Code) OAS (Subsequent Product code) | JAK (Classification Product Code) OAS (Subsequent Product code) | No difference. | | Acquisition technique | X-ray cone beam computed tomography | X-ray cone beam computed tomography | No difference. | | Indication for use | The NewTom 7G is a computed tomography X-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, 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 managed and used by doctors, dentists, radiologists and other legally qualified professionals. | 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-mandibular joint (TMJ), other areas of the human skull and neck with sections of upper cervical spine and of the 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. | Indications for use are equivalent. The anatomical elements have been better listed in the indications for use of the NewTom 7G. | | Anatomical parts | Maxillofacial Dental Ear-Nose-Throat (ENT) Temporomandibular Joint (TMJ) Human skull Neck Section of spine Upper and lower extremities | Maxillofacial Dental Ear-Nose-Throat (ENT) Temporomandibular Joint (TMJ) Human skull Neck Section of spine Upper and lower extremities | No significant difference. The NewTom 7G allows to visualized sections of the whole spine. It is due by increased radiological parameters: kV, mA available and bigger gantry opening size. | | Performance features | | | | | Patient population | Adult, Pediatric | Adult, Pediatric | No difference. | | Minimum patient size | Particularly designed for use with patients more than 11 kg (24 lb) in weight and more than 87 cm (34.25") in eight; these height and weight measurements approximately correspond to that of an average 3-year-old child. | Particularly designed for use with patients more than 11 kg (24 lb) in weight and more than 87 cm (34.25") in eight; these height and weight measurements approximately correspond to that of an average 3-year-old child. | No difference. | | Selectable parameters | Anatomical position, scan protocol types, Field of View (FOV) | Anatomical position, scan protocol types, Field of View (FOV) | No difference. | | Scan modes | LOW DOSE SCAN REGULAR SCAN ENHANCED SCAN BEST SCAN | ECO SCAN REGULAR SCAN ENHANCED SCAN | An additional scans mode "BEST SCAN" has been added due to extended range of radiological parameters available with NewTom 7G. For children LOW DOSE SCAN is recommended like ECO SCAN is recommended with the predicate device NewTom 5G XL (K183448). | | Rated input | 16A @ 230 V~ 50/60 Hz | 20A @ 115V~ 12A @ 240V~ 50/60 Hz…