(60 days)
Not Found
No
The summary describes a standard computed tomography system and its image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The focus is on the hardware, image acquisition, reconstruction, and basic image processing.
No.
The device is described as an "x-ray imaging system" used "for use in diagnostic support," indicating it is for imaging and diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for use in diagnostic support."
No
The device description explicitly states it is a computed tomography X-ray system equipped with an X-ray tube generator, X-ray sensor, and other hardware components like laser pointers and a patient support. While it includes software for image processing, it is not solely software.
Based on the provided information, the NewTom 7G is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the NewTom 7G is an X-ray imaging system that acquires images of the human body (head, spine, extremities, etc.). It does not analyze biological samples like blood, urine, or tissue.
- The device's function is imaging and reconstruction. It uses X-rays to create 2D and 3D images of anatomical structures for diagnostic support. This is a characteristic of medical imaging devices, not IVDs.
Therefore, the NewTom 7G falls under the category of a medical imaging device, specifically a computed tomography (CT) system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray (Cone-beam)
Anatomical Site
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.
Indicated Patient Age Range
Adult, Pediatric; particularly designed for use with patients more than 11 kg (24 lb) in weight and more than 87 cm (34.25") in height; these height and weight measurements approximately correspond to that of an average 3-year-old child.
Intended User / Care Setting
doctors, dentists, radiologists and other legally qualified professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance testing was conducted to 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.
- Verification 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 clinical studies have been considered necessary to support substantial equivalence. The proposed device showed comparable basic safety and essential performance to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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)
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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 |
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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 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 | Increased available X-ray load
factors with proposed device
required more input power.
However electromagnetic
compatibility and electrical
safety of both proposed and
predicate devices have found
in compliance with consensus
standard IEC 60601-1 and
particular and collateral
applicable standards. |
| Technical & Functional features comparison: X-ray emission | | | |
| Type of X-ray
emission | Pulsed | Pulsed | No difference. |
| Anode material | RTM | RTM | No difference. |
| Nominal tube
voltage | 130 kV | 120 kV | The X-ray tube assembly of
NewTom 7G is designed to
manage higher X-ray loading
factors than NewTom 5G XL
(K183448). |
| Rotating anode
speed | 10.000 rpm | 10.000 rpm | No difference. |
| Focal spot (IEC
60336) | 0.3 / 0.6 mm | 0.3 / 0.6 mm | No difference. |
| Max used tube
voltage | 120 kV | 110 kV | The increase in the maximum
available kV compensates the
increased dimensions, increased
beam filtration and gives the
possibility to select higher X-ray
load factors especially with high
density parts or big-size patients. |
| Max continuous
heat dissipation | 750 W | 300 W | The X-ray tube assembly of
NewTom 7G is designed to
manage higher X-ray loading
factors than NewTom 5G XL
(K183448). |
| Anode angle | 10° | 15° | No significant difference. It
depends to NewTom 7G
geometry. |
| Type of
collimator | Motorized variable collimator | Motorized variable collimator | No difference. |
| Shape of X-ray
beam | 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 of
NewTom 7G compared to
NewTom 5G XL (K183448) allows
to obtain a better X-ray beam
quality reducing useless dose
contribution of low-energy X-ray
beam. |
| Typical Range
CDTIw (mGy)
measured
according IEC
60601-2-44 | 17,61 [15x6] Best Quality - 1,23 [17x12] Low
Dose | 24,2 [15x5] HiRes, Enhanced - 1,5 [8x8] Eco | The typical CDTIw values
obtained with NewTom 7G are
comparable or lower than the
typical CTDIw values measured
with the NewTom 5G XL
(K183448). |
| Additional fixed
acquisition | Ray2D (it allows acquiring a single X-ray
image saved on an image file),
CineX / CineScout (it allows for the dynamic
acquisition of a set sequence of X-ray images
saved on a video) | Ray2D (it allows acquiring a single X-ray
image saved on an image file),
CineX (it allows for the dynamic acquisition of
a set sequence of X-ray images saved on a
video) | No difference. |
| Technical & Functional features comparison: SSD X-ray sensor & IMAGE Acquisition | | | |
| | | | |
| Detector
technology | Amorphous Silicon flat panel X-ray detector | Amorphous Silicon flat panel X-ray detector | No difference. |
| Detector
dimensions | 300 mm x 300 mm | 260 mm x 300 mm | The size of active area on the
Solid State Detector available
with proposed device is greater
than the one available with the
predicate device.
This
fact
combined with the slightly bigger
geometry of the NewTom 7G
allows to achieve larger FOVs
than those available with the
NewTom 5G XL (K183448). |
| Image detector
conversion
screen
(scintillator
material) | Csl | Csl | No difference. |
| Detector pixels | 1956x1956 pixels | 1560x1440 pixels | A higher pixels number of the
SDD's matrix depends from the
size of active area and the pixel
size. |
| Detector pixel
size | 154 µm | 184 μm | The size of the pixel of the Solid
State Detector available with
proposed device is smaller than
available with the
the one
NewTom
5G XL
(K183448).
Smaller
pixel
size potentially
allows to obtain an higher image
resolution. |
| Quantization
depth | 16 bits | 16 bits | No difference. |
| Communication /
image transfer | Ethernet cable | Ethernet cable | No difference. |
| Reconstruction
Voxel sizes
min-MAX | $90 \div 600$ μm
(available voxels depend from the FOV and
scan mode) | $100 \div 300$ μm
(available voxels depend from the FOV and
scan mode) | The NewTom 7G allows to obtain
reconstructed volume data with a
minimum voxel size of 90μm
(high resolution images) instead
with the predicate device
NewTom 5G XL (K183448) the
minimum voxel size achievable is
100μm. |
| Gantry Aperture
size | 770 mm | 580 mm | Bigger gantry aperture size allows
an easier patient positioning and
increases the patient confort. |
| Minimum focal
spot to skin
distance (source-
object) | 200 mm | 150 mm | The NewTom 7G focal spot to
skin distance is greater than
NewTom 5G XL (K183448). Both
values are according to the
requirements of the recognized
consensus standard IEC 60601-2-
44. |
| Sampling angle
or 3D's total view
angle | 360° | 360° | No difference. |
| Technical & Functional features comparison: Laser & positioning | | | |
| Number of laser
pointer | 2 lasers volumetric pointers | 2 lasers volumetric pointers | No difference. |
| Laser optical
class | 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 &
Reconstruction
software | NNT | NNT | The software has been updated
to include the management of
NewTom 7G. Changes have been
managed according to the
recognized consensus standard
IEC 62304 and the FDA Guidance
on Medical Device Software. |
| Software
validation | 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. |
| Electromagnetic
compatibility | Complies IEC 60601-1-2:2014 | Complies IEC 60601-1-2:2014 | No difference. |
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8
9
10
11
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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.