(60 days)
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.
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.
The provided document describes the NewTom 7G Computed Tomography X-ray system, which is a further development of the NewTom 5G XL (K183448). The submission details the device's characteristics, indications for use, and a comparison to its predicate device to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the NewTom 7G in the way one might see for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on conforming to various established standards and demonstrating technical improvements or equivalence to the predicate device. The performance is primarily reported as compliance with regulatory standards and functional equivalence or enhancement compared to the predicate.
| Acceptance Criteria (based on compliance) | Reported Device Performance (NewTom 7G) |
|---|---|
| Safety and Electrical Standards: | |
| IEC 60601-1 (Basic Safety & Essential Performance) | Complies with IEC 60601-1: 2012 (including US National Differences). |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies with IEC 60601-1-2:2014. |
| IEC 60601-1-3 (Radiation Protection) | Complies with IEC 60601-1-3. |
| IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6. |
| IEC 60601-2-28 (X-ray Source/Tube Assemblies Safety) | Complies with IEC 60601-2-28. |
| IEC 60601-2-44 (CT X-ray Equipment Safety) | Complies with IEC 60601-2-44. Minimum focal spot to skin distance of 200 mm (predicate: 150 mm), both within standard requirements. |
| IEC 60825-1 (Laser Safety) | Class 1 for IEC 60825-1. |
| Software Standards: | |
| IEC 62304 (Medical Device Software Lifecycle) | Complies with IEC 62304 + FDA Guidance on MD SW. Software (NNT) updated to manage NewTom 7G. |
| Image Quality & Technical Performance: | |
| Image Quality Review | Demonstrated substantial equivalence to the predicate device. |
| Voxel Size (Resolution) | Achieves a minimum voxel size of 90µm (high resolution images), compared to 100µm for the predicate device. |
| Detector Size | Detector dimensions of 300 mm x 300 mm (predicate: 260 mm x 300 mm), allowing for larger Fields of View (FOVs). |
| Detector Pixel Size | 154 µm (predicate: 184 µm), suggesting potential for higher image resolution. |
| Typical Range CDTIw (Radiation Dose) | 17.61 mGy [15x6] Best Quality - 1.23 mGy [17x12] Low Dose. Values are "comparable or lower" than the predicate device (24.2 mGy [15x5] HiRes, Enhanced - 1.5 mGy [8x8] Eco). Total filtration increased to 21 mm Al eq. @ 70kV (predicate: 11.2 mm Al eq. @ 70kV) to reduce useless dose. |
| Gantry Aperture Size | 770 mm (predicate: 580 mm), allowing easier patient positioning and increased comfort. |
| Nominal Tube Voltage | Increased to 130 kV (predicate: 120 kV), with max used tube voltage 120 kV (predicate: 110 kV), managed by the X-ray tube assembly designed for higher loading factors and to compensate for increased dimensions and beam filtration. |
| Max Continuous Heat Dissipation | Increased to 750 W (predicate: 300 W), indicating the X-ray tube assembly is designed to manage higher X-ray loading factors. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This indicates that no clinical test set using patient data was employed to demonstrate the device's performance in diagnosing conditions. The testing was non-clinical, focusing on conformity to technical and safety standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no human clinical studies were performed. The "image quality review" likely referred to technical evaluation of image characteristics or phantoms, not clinical interpretation by experts with established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human clinical studies or expert-based ground truth establishment were performed for a test set.
5. 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
Not applicable. The NewTom 7G is a Computed Tomography X-ray system; there is no mention of an AI component or any MRMC study involving human readers with or without AI assistance. The submission is for the imaging device itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an imaging device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical ground truth. The "ground truth" for the performance evaluation appears to be the technical specifications and requirements of various IEC standards, against which the device's technical performance (e.g., kV, mA, filtration, dose, resolution, physical dimensions) was verified. The "image quality review" mentioned in the Conclusion section likely refers to quantitative and qualitative assessments of image characteristics against expected technical performance, rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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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
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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
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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)
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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 | |
| EstablishmentRegistration 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 |
| Regulatorydescription: | Computed tomography X-ray system |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | 2 |
| Classification | JAK |
| Product Code: | |
| Subsequent ProductCode: | 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, includingear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the humanskull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relativejoints 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, displayingboth two- and three-dimensional images.The device is managed and used by doctors, dentists, radiologists and other legally qualified professionals. |
| Identification ofPredicate Device | The predicate device identified relating the substantial equivalence of the proposed device is:Device Name: NewTom 5G XL510(k) Number: K183448Device: System, X-Ray, Tomography, ComputedRegulation Description: Computed tomography x-ray systemApplicant: CEFLA S.C.Via Selice Provinciale 23/AImola, IT 40026Regulation Number: 21 CFR §892.1750Device Class: Class IIClassification Product Code: JAKSubsequent Product Code: OAS |
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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 gantrywith 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. |
| ClassificationProduct Code | JAK (Classification Product Code)OAS (Subsequent Product code) | JAK (Classification Product Code)OAS (Subsequent Product code) | No difference. |
| Acquisitiontechnique | X-ray cone beam computed tomography | X-ray cone beam computed tomography | No difference. |
| Indication for use | The NewTom 7G is a computed tomographyX-ray imaging system using the cone-beamtechnology which acquires sequences ofimages of the head, including ear, nose andthroat (ENT), of the dento-maxillofacialcomplex, teeth, mandible, jaw andtemporomandibular joint (TMJ), of the otherareas of the human skull and neck withsections of upper cervical spine, of the spinesections, of upper extremities includingshoulder, upper arm, forearm, hand, relativejoints and of lower extremities including hip,upper leg, lower leg, midfoot, forefoot,relative joints, for use in diagnostic support.The device accomplishes this task byreconstructing a 3D matrix of the examinedvolume and producing two-dimensionalviews of this volume, displaying both two-and three-dimensional images.The device is managed and used by doctors,dentists, radiologists and other legallyqualified professionals. | The NewTom 5G XL is cone-beam computedtomography X-ray imaging system thatacquires sequences of images of the head,including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible andjaw, temporo-mandibular joint (TMJ), otherareas of the human skull and neck withsections of upper cervical spine and of theupper and lower extremities for use indiagnostic support.The device accomplishes this task byreconstructing a 3D matrix of the examinedvolume and producing two-dimensional viewsof this volume, displaying both two- andthree-dimensional images.The device is operated and used byphysicians, dentists, X-ray technologists andother legally qualified professionals. | Indications for use areequivalent. The anatomicalelements have been better listedin the indications for use of theNewTom 7G. |
| Anatomical parts | MaxillofacialDentalEar-Nose-Throat (ENT)Temporomandibular Joint (TMJ)Human skullNeckSection of spineUpper and lower extremities | MaxillofacialDentalEar-Nose-Throat (ENT)Temporomandibular Joint (TMJ)Human skullNeckSection of spineUpper and lower extremities | No significant difference.The NewTom 7G allows tovisualized sections of the wholespine. It is due by increasedradiological parameters: kV, mAavailable andbigger gantryopening size. |
| Performance features | |||
| Patientpopulation | Adult, Pediatric | Adult, Pediatric | No difference. |
| Minimum patientsize | Particularly designed for use with patientsmore than 11 kg (24 lb) in weight and morethan 87 cm (34.25") in eight; these height andweight measurements approximatelycorrespond to that of an average 3-year-oldchild. | Particularly designed for use with patientsmore than 11 kg (24 lb) in weight and morethan 87 cm (34.25") in eight; these height andweight measurements approximatelycorrespond to that of an average 3-year-oldchild. | No difference. |
| Selectableparameters | Anatomical position, scan protocol types,Field of View (FOV) | Anatomical position, scan protocol types,Field of View (FOV) | No difference. |
| Scan modes | LOW DOSE SCANREGULAR SCANENHANCED SCANBEST SCAN | ECO SCANREGULAR SCANENHANCED SCAN | An additional scans mode "BESTSCAN" has been added due toextended range of radiologicalparameters available withNewTom 7G. For children LOWDOSE SCAN is recommended likeECO SCAN is recommended withthe predicate device NewTom 5GXL (K183448). |
| Rated input | 16A @ 230 V~50/60 Hz | 20A @ 115V~12A @ 240V~50/60 Hz | Increased available X-ray loadfactors with proposed devicerequired more input power.However electromagneticcompatibility and electricalsafety of both proposed andpredicate devices have foundin compliance with consensusstandard IEC 60601-1 andparticular and collateralapplicable standards. |
| Technical & Functional features comparison: X-ray emission | |||
| Type of X-rayemission | Pulsed | Pulsed | No difference. |
| Anode material | RTM | RTM | No difference. |
| Nominal tubevoltage | 130 kV | 120 kV | The X-ray tube assembly ofNewTom 7G is designed tomanage higher X-ray loadingfactors than NewTom 5G XL(K183448). |
| Rotating anodespeed | 10.000 rpm | 10.000 rpm | No difference. |
| Focal spot (IEC60336) | 0.3 / 0.6 mm | 0.3 / 0.6 mm | No difference. |
| Max used tubevoltage | 120 kV | 110 kV | The increase in the maximumavailable kV compensates theincreased dimensions, increasedbeam filtration and gives thepossibility to select higher X-rayload factors especially with highdensity parts or big-size patients. |
| Max continuousheat dissipation | 750 W | 300 W | The X-ray tube assembly ofNewTom 7G is designed tomanage higher X-ray loadingfactors than NewTom 5G XL(K183448). |
| Anode angle | 10° | 15° | No significant difference. Itdepends to NewTom 7Ggeometry. |
| Type ofcollimator | Motorized variable collimator | Motorized variable collimator | No difference. |
| Shape of X-raybeam | CBCT (Cone Beam) SQUARED | CBCT (Cone Beam) SQUARED | No difference. |
| Total filtration | 21 mm Al eq. @ 70kV | 11.2 mm Al eq. @ 70kV | The increased total filtration ofNewTom 7G compared toNewTom 5G XL (K183448) allowsto obtain a better X-ray beamquality reducing useless dosecontribution of low-energy X-raybeam. |
| Typical RangeCDTIw (mGy)measuredaccording IEC60601-2-44 | 17,61 [15x6] Best Quality - 1,23 [17x12] LowDose | 24,2 [15x5] HiRes, Enhanced - 1,5 [8x8] Eco | The typical CDTIw valuesobtained with NewTom 7G arecomparable or lower than thetypical CTDIw values measuredwith the NewTom 5G XL(K183448). |
| Additional fixedacquisition | Ray2D (it allows acquiring a single X-rayimage saved on an image file),CineX / CineScout (it allows for the dynamicacquisition of a set sequence of X-ray imagessaved on a video) | Ray2D (it allows acquiring a single X-rayimage saved on an image file),CineX (it allows for the dynamic acquisition ofa set sequence of X-ray images saved on avideo) | No difference. |
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | |||
| Detectortechnology | Amorphous Silicon flat panel X-ray detector | Amorphous Silicon flat panel X-ray detector | No difference. |
| Detectordimensions | 300 mm x 300 mm | 260 mm x 300 mm | The size of active area on theSolid State Detector availablewith proposed device is greaterthan the one available with thepredicate device.Thisfactcombined with the slightly biggergeometry of the NewTom 7Gallows to achieve larger FOVsthan those available with theNewTom 5G XL (K183448). |
| Image detectorconversionscreen(scintillatormaterial) | Csl | Csl | No difference. |
| Detector pixels | 1956x1956 pixels | 1560x1440 pixels | A higher pixels number of theSDD's matrix depends from thesize of active area and the pixelsize. |
| Detector pixelsize | 154 µm | 184 μm | The size of the pixel of the SolidState Detector available withproposed device is smaller thanavailable with thethe oneNewTom5G XL(K183448).Smallerpixelsize potentiallyallows to obtain an higher imageresolution. |
| Quantizationdepth | 16 bits | 16 bits | No difference. |
| Communication /image transfer | Ethernet cable | Ethernet cable | No difference. |
| ReconstructionVoxel sizesmin-MAX | $90 \div 600$ μm(available voxels depend from the FOV andscan mode) | $100 \div 300$ μm(available voxels depend from the FOV andscan mode) | The NewTom 7G allows to obtainreconstructed volume data with aminimum voxel size of 90μm(high resolution images) insteadwith the predicate deviceNewTom 5G XL (K183448) theminimum voxel size achievable is100μm. |
| Gantry Aperturesize | 770 mm | 580 mm | Bigger gantry aperture size allowsan easier patient positioning andincreases the patient confort. |
| Minimum focalspot to skindistance (source-object) | 200 mm | 150 mm | The NewTom 7G focal spot toskin distance is greater thanNewTom 5G XL (K183448). Bothvalues are according to therequirements of the recognizedconsensus standard IEC 60601-2-44. |
| Sampling angleor 3D's total viewangle | 360° | 360° | No difference. |
| Technical & Functional features comparison: Laser & positioning | |||
| Number of laserpointer | 2 lasers volumetric pointers | 2 lasers volumetric pointers | No difference. |
| Laser opticalclass | Class 1 for IEC 60825-1 | Class 1 for IEC 60825-1 | No difference. |
| Patient position | Lie on the bed | Lie on the bed | No difference. |
| Patient bed | 3 motorized axes (x,y,z) | 3 motorized axes (x,y,z) | No difference. |
| Technical & Functional features comparison: Control & Viewing Software | |||
| Viewing &Reconstructionsoftware | NNT | NNT | The software has been updatedto include the management ofNewTom 7G. Changes have beenmanaged according to therecognized consensus standardIEC 62304 and the FDA Guidanceon Medical Device Software. |
| Softwarevalidation | IEC 62304+ Guidance FDA on MD SW | IEC 62304+ Guidance FDA on MD SW | No difference. |
| Electrical Safety & Electromagnetic compatibility | |||
| Electrical safety | Complies with IEC 60601-1: 2012 | Complies with IEC 60601-1:2012 | No difference. |
| Electromagneticcompatibility | Complies IEC 60601-1-2:2014 | Complies IEC 60601-1-2:2014 | No difference. |
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Testing to verformance requirements of the proposed device was conducted in this premarket notification. The results of the Non-clinical Performance performance testing support substantial equivalence. Testing: Tests included in this premarket notification verify the conformity of the proposed device with the requirements of: • IEC 60601 :: Medical electrical equipments for basic safety and essential performance (including US National Differences). • IEC 60601-2: Medical electrical equipments for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. • IEC 60601-1-3: Medical electrical equirements for basic safety and essential performance - Collateral Standard Radiation protection in diagnostic X-ray equipment. • IEC 60601-1-6: Medical electrical equirements for basic safety and essential performance - Collateral Standard: Usability. • EC 60601-2-28: Medical electrical equipment - Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis. • IEC 60601-2-44: Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray equipment for computed tomography. · IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements. · IEC 62304: Medical device software - Software lifecycle processes. · Verfication activities for confirmation of the proposed device has been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device. Given the differences from the predicate device, no human cinical studies have been considered necessary to support substantial equivalence. Clinical Testing Conclusion
The information included in this premarket notifical equivalence of the proposed device New on 7G. The proposed device is an increment of the Cefla's own legally marketed predicate device: NewTom 5G XL (K183448). The proposed device has identical intended
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use and fundamental principles of operation. The proposed device showed comparable basic safety and essential performarketed predicate device. Differences between the comparison section above do not reasonably involves in negative effects on substantial equivalence.
§ 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.