(307 days)
No
The document does not mention AI, ML, DNN, or any related concepts. The focus is on standard radiographic imaging and reconstruction.
No
The device is described as an X-ray imaging system intended for diagnostic examinations, not for treating conditions.
Yes
The device is intended for "dental radiographic examinations" and produces X-ray images for "reconstruction of 3D view," which are used by dentists and qualified professionals. These examinations and images are inherently diagnostic in nature, providing information to identify and understand conditions related to teeth, jaw, and TMJ areas.
No
The device description explicitly states it is a dental panoramic and cephalometric device, which are hardware components used to produce X-ray images. While it includes software (firmware), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view." This describes an imaging device used for diagnostic purposes on the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical X-ray machine with sensors and a cephalometric arm. This is consistent with an imaging device, not an IVD.
- Input Imaging Modality: The input is "X-ray," which is an imaging modality used on the body.
- Anatomical Site: The anatomical sites are parts of the body (teeth, jaw, TMJ, skull, hands, wrists).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the X-View 3D PAN/X-View 2D PAN is a medical imaging device, specifically a dental panoramic and cephalometric X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.
The device must only be operated and used by dentists and other legally qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The X-View PAN is manufactured by Trident s.r.l. and it can be sold under two different commercial names:
- X-View 3D PAN
- X-View 2D PAN
Both devices, depending on the configuration chosen, can be equipped with a cephalometric arm equipped with a 24x30 cm flat panel sensor for the execution of cephalometric radiographs of various formats and latero-lateral and antero-posterior projections. The cephalometric device can also be added in the field.
The device can be set in the configurations: Floor version with column and wall bracket and Floor version with column and standard base.
The subject dental X-ray system X-View is supported by software (firmware). The software is of Moderate Level of concern and is FDA-cleared.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
teeth, jaw and TMJ areas, maxillofacial region, parts of the skull, hands and wrists (carpus)
Indicated Patient Age Range
general populations as long as they are older than 10 years.
Intended User / Care Setting
dentists 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 testing and laboratory testing were performed according to the following standards: IEC 60601-1:2005/AC1:2006 /A1:2012/AC1:2014, IEC 60601-1-2:2014, IEC 60601-1-3:2008, IEC 60601-1-6:2010+AMD1:2013 and IEC 62366-1:2015, IEC 60601-2-63:2012, IEC 60825-1 (2007).
Software verification and validation testing were conducted.
Performance Testing was completed as a direct comparison between the subject and predicate device.
Clinical tests were performed both in Italy at the University of Genoa and the clinical judgment made by ABR, President of Dental Imaging Consultants, LLC, have demonstrated the clinical validity of the X-View systems both in the execution of PAN-type exams and 3D volumetric exams. Images were presented and approved by the ABR Consultant.
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.
K162619, K160386, K200625, K211688
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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July 10, 2023
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Trident s.r.l % Mrs. Joyce St. Germain Regulatory Consultant, owner The 510k Consulting, LLC 1449 Springleaf Drive ORMOND BEACH FL 32174
Re: K222666
Trade/Device Name: X-VIEW 3D PAN/X-VIEW 2D PAN Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: November 1, 2022 Received: November 2, 2022
Dear Mrs. St. Germain:
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/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 mediation-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.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices 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) K222666
Device Name X-VIEW 3D PAN/X-VIEW 2D PAN
Indications for Use (Describe)
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 2D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.
The device must only be operated and used by dentists 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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The 510k Consulting,LLC
Key to success in obtaining your medical device clearance 1449 Springleaf Dr., Ormond Beach, FL 32174 joyce510kfda@gmail.com
510(k) Summary K222666
I. Submitter
Trident s.r.l. Via Artigiani 4 Castenedolo (BS) Italy 25014
39-0302732485 Phone: Fax: 39-0302731647 Contact: Giorgio Rizzo Giorgio.rizzo33@gmail.com
Preparer/Consultant/Contact
The 510k Consulting, LLC
Joyce St. Germain 1449 Springleaf Dr. Ormond Beach, FL 32174 904-477-3203 Primary Contact: Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com
Date Prepared: September 2, 2022
II. Device
| Trade Name: | X-VIEW 3D PAN / X-VIEW 2D PAN |
|---|---|
| Common Name: | Dental X-ray System |
| Regulation Name: | Computed Tomography X-Ray System |
| Regulation Number: | 21 CFR 892.1750 |
| Medical Specialty: | Radiology |
| Regulation Class: | II |
| Product Code: | OAS |
| Submission Type: | 510(k) |
III. Predicate Device
| 510(k) Number: | K160166 |
|---|---|
| Date Cleared: | November 15, 2016 |
| Manufacturer: | de Gotzen S.r.l. |
| Trade Name: | X-MIND trium |
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| Common Name: | Dental X-ray System |
|---|---|
| Regulation Name: | Computed Tomography X-Ray System |
| Regulation Number: | 21 CFR 892.1750 |
| Medical Specialty: | Radiology |
| Regulatory Class: | II |
| Product Code: | OAS, MUH |
Secondary Predicate
| 510(k) Number: | K182198 |
|---|---|
| Date Cleared: | January 31, 2019 |
| Manufacturer: | Yoshida Dental Mfg. Co., Ltd. |
| Trade Name: | Panoura X-ERA PF/NF/MF |
| Common Name: | Dental X-ray System |
| Regulation Name: | Extraoral source x-ray system |
| Regulation Number: | 21 CFR 872.1800 |
| Medical Specialty: | Radiology |
| Regulatory Class: | II |
| Product Code: | MUH |
This predicate has not been subject to a design-related recall.
IV. Device Description
The X-View PAN is manufactured by Trident s.r.l. and it can be sold under two different commercial names:
- X-View 3D PAN ●
- . X-View 2D PAN
Both devices, depending on the configuration chosen, can be equipped with a cephalometric arm equipped with a 24x30 cm flat panel sensor for the execution of cephalometric radiographs of various formats and latero-lateral and antero-posterior projections. The cephalometric device can also be added in the field.
The device can be set in the configurations: Floor version with column and wall bracket and Floor version with column and standard base.
The subject dental X-ray system X-View is supported by software (firmware). The software is of Moderate Level of concern and is FDA-cleared.
| Characteristics | Value |
|---|---|
| Manufacturer | iRay Technology |
| Model | Jupi 0606X |
Sensor details for X-View 3D PAN
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| Scintillator | CsI |
|---|---|
| Sensitive area | 15,4 x 15,4 cm |
| Pixel dimensions (L=H) | 100 x 100 μm |
| Pixel Number (H x L) | 1536x 1536 |
| Voxel Dimension | 141 μm |
| Reconstructed Volume (Diameter x | |
| Height)) (max) | 105 x 105 mm |
| Frame rate | 20 (1×1) |
| 60 (2×2) | |
| > 220 (panoramic) |
Sensors details for X-View 2D PAN
The X-View 2D Pan can mount 3 different digital sensors for PAN examinations.
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Sensor 1
| Characteristics | Value |
|---|---|
| Manufacturer | iRay Technology |
| Model | Pluto 0600X |
| Scintillator | CsI |
| Active area width (H x L) | 150 x 7mm |
| Pixel dimensions (L=H) | 100 x 100 μm |
| Pixel Number (H x L) | 1500 x 68 |
| AD Conversion | 16 bit |
| Frame rate (fps) maximum | 300 (binning 1x1) |
| 600m(binning 2x2) | |
| Data interface | GigaE |
| Trigger mode | Continous or pulsed |
Sensor 2
| Characteristics | Value |
|---|---|
| Manufacturer | Teledyne Dalsa |
| Model | 1501 |
| Scintillator | CsI |
| Active area width (H x L) | 149 x 7 mm |
| Pixel dimensions (L=H) | 99 x 99 µm |
| Pixel Number (H x L) | 1505 x 71 |
| Pixel fill factor | 85 % |
| AD Conversion | 14 bit |
| Frame rate (fps) maximum | > 300 (binning 1x1) |
| Frame rate (fps) maximum | > 600m(binning 2x2) |
| Data interface | GigaE |
| Trigger mode | Continuous |
Sensor 3
| Manufacturer | Athlos |
|---|---|
| Model | UFS |
| Scintillator | CdTe |
| Active area width (H x L) | 150 x 5.2 mm |
| Pixel dimensions (L=H) | 100 x 100 um |
| Pixel Number (H x L) | 1500 x 52 |
| AD Conversion | 16 bit |
| Frame rate (fps) maximum | 300 (binning 1x1) |
| 600m(binning 2x2) | |
| Data interface | GigaE |
| Trigger mode | Steady Frame Mode |
| Dynamic Frame Modulation | |
| TDI Mode | |
| MTF | 60% @2lp/mm; |
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| >30% @5lp/mm | |
|---|---|
| DQE(0) | >80% |
| TDI scanning object speed (MAXIMUM) | 100; 200 cm/s |
| Characteristics | Value |
|---|---|
| Manufacturer | iRay Technology |
| Model | Venu 1012VD |
| Detector Technology | Amorphous Silicon |
| Scintillator | CSI |
| Sensitive area | 30 x 25 cm |
| Pixel dimensions | 125 um |
| Image format | 30 x25 and 25 x 25 |
| Image dimensions (pixel) | 2400 x 2000 for 30 x 25 cm image format |
Sensor for Cephalometric examinations
V. Indications for Use
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D Xray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.
The device must only be operated and used by dentists and other legally qualified professionals.
VI. Comparison Technological Characteristics with the Predicate Device
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | X-VIEW 3D PAN / X-VIEW | ||
| 2D PAN | X-MIND trium | NA | |
| Manufacturer | Trident s.r.l., Italy | de Götzen S.r.l. — Acteon | |
| Group | |||
| Via Roma, 45 | |||
| 21057 Olgiate Olona | |||
| VA - Italia | NA | ||
| 510(k) Number | K222666 | K160166 | NA |
| Classification & | |||
| Product Code | 892.1750, OAS. | 892.1750, OAS. | NA |
| Device Classification | |||
| Name | Computed tomography x- | ||
| ray system | Computed tomography x- | ||
| ray system | Same | ||
| Regulation Name and | |||
| Common Name | Computed tomography x- | ||
| ray system | Computed tomography x- | ||
| ray system | Same | ||
| Indication for Use | The X-View 3D PAN/X-View | ||
| 2D PAN dental panoramic | |||
| and cephalometric device | |||
| is intended for dental | |||
| radiographic examinations | |||
| of teeth, jaw and TMJ | |||
| areas by producing | |||
| conventional 2D X-ray | |||
| images as well as X-ray | |||
| projection images of | |||
| examined volume for the | |||
| reconstruction of 3D view. | |||
| The X-View 3D PAN/X-View | |||
| 2D PAN dental panoramic | |||
| and cephalometric device | |||
| is intended for general | |||
| populations as long as they | |||
| are older than 10 years. | |||
| The device must only be | |||
| operated and used by | |||
| dentists and other legally | |||
| qualified professionals. | X-MIND trium is a digital | ||
| panoramic, cephalometric | |||
| and tomographic extra-oral | |||
| X-ray system, indicated for | |||
| use in: |
- producing panoramic X-
ray images for diagnostic
examination of dentition
(teeth), jaws and oral
structures; - producing radiographs of
maxillofacial region and
parts of the skull for
cephalometric
examination, if equipped
with
CEPH arm; - producing radiographs of
hands and wrists for
carpus examination, if
equipped with CEPH arm; - producing tomographic
images of the oral and
maxillofacial region, for
diagnostic examination of
dentition (teeth), jaws,
oral structures and some
cranial bones, if equipped
with CBCT option. | Similar |
| Intended Use | Intended for dental
radiographic examinations
of teeth for general
population and to be
operated by dentist and
other legally qualified
professionals. | Intended for dental
radiographic examinations
of teeth for general
population and to be
operated by dentist and
other legally qualified
professionals. | Same |
| Characteristic | X-View 2D Pan/X-View 3D PAN | X-MIND trium | |
| | From a clinical point of view, X-View can be applied for the
following medical indications: | From a clinical point of view, X-MIND
trium can be applied for the following
medical indications: | |
| | Generic dentistry | Generic dentistry | |
| | Dental implantology | Dental implantology | |
| | Dental surgery | Dental surgery | |
| | Maxillo-facial surgery | Maxillo-facial surgery | |
| | Cephalometric analysis | Cephalometric analysis | |
| | Carpus radiology | Carpus radiology | |
| | The target patient populations as
long as they are older than 10
years anyway the sustainability to
X-ray exposure must be evaluated
by surgeons, dentists and qualified
and authorized physicians. | The target patient population includes
adults and pediatric patients from 5
years old [~21 kg (46 lb); 113 cm (44.5
in) standing height]; anyway the
sustainability to X-ray exposure must be
evaluated by surgeons, dentists and
qualified and authorized physicians. | |
| Performance
specifications | 1) Panoramic
- Cephalometric (optional)
- CBCT (optional) | 1) Panoramic
- Cephalometric (optional)
- CBCT (optional) | |
| | 1) PAN:
- standard panoramic
- child panoramic
- TMJ
- bitewing
- sectorial panoramic with
improved orthogonality - maxillary sinuses | 1) PAN:
- standard panoramic
- child panoramic
- TMJ
- bitewing
- sectorial panoramic with
improved orthogonality - maxillary sinuses | |
| Exam mode | 2) CEPH: - frontal (AP/PA)
- lateral (LL)
- hand acquisition - carpus
(special support needed) | 2) CEPH: - frontal (AP/PA)
- lateral (LL)
- hand acquisition - carpus
(special support needed) | |
| | 3) CBCT: - full view
- extended view | 3) CBCT:
- full view
- extended view | |
| | Flat Panel | Jupi0606X | C12280D-40
Different |
| | Manufacturer
Technology | iRay Technology | Hamamatsu Photonics KK
Different |
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Discussion of the same characteristics
The subject and predicate have some of the same characteristics such as the same classification and product code, same indication for use, same intended use, same mode of operations, panoramic image receptor technology, same readout circuit, scintillator, and same tube cooling method.
Discussion of main differences and secondary predicate
-
- Flat panel imager: X-View 3D systems mounts a Flat panel imager supplied by iRay Technology instead of the Hamamtsu used on the predicate. The imager of X-View 3D has the latest construction technology, also if the scintillator screen is the same. This fact will impact on the following items:
- a. Pixel size: 100u instead the 200u will allows to have more details on the reconstructed image.
- b. Larger sensitive area will allow a higher FOV.
- c. Pixel numbers of the image are different due to the larger sensitive area and the lower pixel size; this will increase the acquired image size but will give more details on the reconstruction, also increased by the pixel depth (16 bit compared with the 13 bit of the predicate).
- d. The acquisition speed of the proposed device has a multiple mode, allowing the acquisition software to drive the imager at a maximum frame rate.
-
- Tube focal spot: X-View systems are using an RX tube having a focal spot of 0.5 according to IEC 60366:2005; the predicate device has a lower focal spot; this difference does not affect the image quality as X-View compensates for this with a lower pixel size. The focal spot of X-View is stated according to the IEC standard requirements.
-
- Electrical power line resistance: X-View has a higher one but respects the IEC 60601-1 standard; this will not affect the systems' functionalities.
-
- Tube head total filtration: X-View system complies with IEC 60601-1-3, having total filtration higher than the required 3.05 mm AL eq. required at 85 kV.
-
- Leakage radiation: X-View respects the IEC standards, so declares a lower leakage radiation than the one required by 21 CFR.
-
- Up and down stroke: this data is linked to the mechanical dimensions of the units; X-View has a lower data, but its run is such that it can accommodate all types of patients.
VII. Performance Data
Summary of non-clinical testing and laboratory testing was performed according to the following standards:
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Sterilization and Shelf-Life does not apply to the subject device.
Biocompatibility
For the biocompatibility of the parts that can come into contact with the patient, ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" has been considered. The system uses plastic components made of material widely used in the medical device field (ABS).
According to the reported standard, no biocompatibility problem has been observed.
Electrical safety and electromagnetic compatibility (EMC) were conducted on the subject device. The subject device complies with the standards for safety that are listed below.
IEC 60601-1:2005/AC1:2006 /A1:2012/AC1:2014: Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance)
- All the requirements of this standard were met, except for inapplicable requirements. ■
- This standard has not been adapted for application to the device under review.
- 트 Test Reports 10SO00079 identify the requirements of this standard not applicable to the device.
- No deviations from this standard were applied.
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- All the requirements of this standard were met, except for inapplicable requirements.
- I This standard has not been adapted for application to the device under review.
- Test Reports 80SN00267 identify the requirements of this standard not applicable to the device.
- No deviations from this standard were applied.
IEC 60601-1-3:2008: Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- . All the requirements of this standard were met, except for inapplicable requirements.
- This standard has not been adapted for application to the device under review.
- . Test Report 10SN00119 identifies the requirements of this standard not applicable to the device.
- 트 No deviations from this standard were applied.
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IEC 60601-1-6:2010+AMD1:2013 and IEC 62366-1:2015: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 트 All the requirements of this standard were met, except for inapplicable requirements.
- I This standard has not been adapted for application to the device under review.
- No deviations from this standard were applied.
IEC 60601-2-63:2012 (Medical electrical equipment -- Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment)
- All the requirements of this standard were met, except for inapplicable requirements. I
- I This standard has not been adapted for application to the device under review.
- Test Report 10SN00119 Annex no.1 identifies the requirements of this standard not applicable to the device.
- . No deviations from this standard were applied.
IEC 60825-1 (2007): Safety of laser products - Part 1: Equipment classification and requirements
- . All the requirements of this standard were met, except for inapplicable requirements.
- I This standard has not been adapted for application to the device under review.
No deviations from this standard were applied.
Software and Risk Analysis
Both acquisition software Deep-View and Archimed Suite have already been FDA cleared with other devices (ref. to K162619, K160386, K200625): Archimed Suite has also been cleared by another manufacturer (K211688). The version used for this clearance is equal to the above cleared versions with the upgrade related only to digital sensor interface, where specific drivers supplied by the sensor manufacturer have been included.
Software architecture of X-VIEW PAN can be divided into two groups:
- . Main unit software. This software will be designated, in the following, as "Main firmware" and is embedded on the system.
- Software running on dedicated image acquisition PC, using standard "Windows®" . Operating System; it has been validated for Windows. It is referenced as "Acquisition software", or "Acquisition software control" or "X-VIEW interface".
The dedicated software for image acquisition is running on a dedicated PC.
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Main firmware
The Main firmware and the Acquisition software do not perform any diagnosis; the mitigation actions are not committed to the Main firmware or to the Acquisition software, so a failure in Main firmware and/or Acquisition software result in a Minor Injury, either to a patient or to a user of the device.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. " The software for this device was considered as a "Moderate" level of concern since a malfunction of, or a latent design flaw in the device software can lead to an erroneous diagnosis or a delay in delivery of appropriate medical care.
Risk Analysis Information
A risk analysis study according to ISO 14971 has been carried out on the entire system and takes into account also the software-related risks. All aspects of the X-View system have been evaluated or mitigated and all final test results are a PASS.
The analysis of the benefit / risk ratio related to the execution of radiological investigations is left to the discretion of the end user, who is a doctor or dentist radiologist and is therefore able to evaluate this relationship.
The petition was prepared in compliance with the following FDA guidance instructions and documents: "Guidance for the submission of 510(k) for Solid State X-ray Imaging Devices". Also, the "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Performance
The following performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission.
Software ... the level of concern for this device is MODERATE.
Performance Testing...was completed as a direct comparison between the subject and predicate device.
Clinical tests were performed both in Italy at the University of Genoa and the clinical judgment made by ABR, President of Dental Imaging Consultants, LLC, have demonstrated the clinical validity of the X-View systems both in the execution of PAN-type exams and 3D volumetric exams. Images were presented and approved by the ABR Consultant.
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Conclusion
The comparison of intended use and technological characteristics shows the subject device is at least as safe and effective as the predicate, and, furthermore, warrants a finding of substantial equivalence between the subject device, X-VIEW 3D PAN/X-VIEW 2D PAN and the predicate device, Panoura X-ERA NLFNF/MF. Furthermore, this finding of substantial equivalence warrants clearance from FDA for marketing activities in the United States.