(112 days)
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist.
In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs.
Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist.
In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs.
Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D.
The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors.
Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports.
The user controls the exposure using a manual hand-switch, implementing the dead man functionality.
An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.
The provided document is a 510(k) Premarket Notification from FONA S.r.l. to the FDA for their Stellaris dental X-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to relevant standards.
The document does NOT describe the acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.
The Stellaris devices are dental X-ray systems (2D and 3D, with and without cephalometric capabilities). The document explicitly states:
- "The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission)..." (page 8)
- "...the 3D sensor has been replaced with a 2D sensor." (page 10)
- "The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices." (page 7)
There is no mention of any AI or machine learning components within the device itself for diagnostic or image processing purposes that would require specific performance criteria or a study as outlined in the request. The "reconstruction algorithm" mentioned is standard for CT and panoramic imaging, not an AI/ML algorithm requiring separate clinical performance validation from the device's image acquisition capabilities.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes a traditional 510(k) submission for an imaging device, demonstrating substantial equivalence through technical characteristics, safety standards (IEC, EN), software standards (EN 62304), and biocompatibility (ISO 10993-1).
In summary, none of the requested information regarding AI/ML acceptance criteria or a comparative study proving device performance against such criteria can be found in this document.
{0}------------------------------------------------
March 2, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
FONA S.r.l % Krupa Srivastava RA Consultant Via G. Galilei 11 Assago, Milan 20057 ITALY
Re: K213579
Trade/Device Name: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: January 25, 2022 Received: January 14, 2022
Dear Krupa Srivastava:
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 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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K213579
Device Name
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
Indications for Use (Describe)
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for "FONA". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the phrase "CLOSER TO YOU" written in smaller, gray letters.
510(k) SUMMARY K213975
| Date Prepared: | January 11, 2022 |
|---|---|
| Submitters Information | |
| Name | FONA s.r.l. |
| Address | Via G.Galilei 1120057 Assago (MI), Italy |
| Contact Person | Luigi Germanò |
| Contact Telephone | +39 0245712171 |
| Device Information | |
| Device/ Trade Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3Dand Stellaris 3D Ceph |
| Common Name | X-Ray, Tomography, Computed, Dental |
| Classification Name | Computed Tomography X-ray system |
| Classification Regulation | 21 CFR 892.1750 - Computed TomographyX-ray system |
| Product code | OAS |
Predicate Devices:
The following legally marketed predicate devices have been chosen for the determination of substantial equivalence:
| Primary Predicate DeviceTrade Name | ORTHOPHOS SL |
|---|---|
| 510(k) Number | K150217 |
| Classification Name | Computed Tomography X-ray system |
| Classification Regulation | 21 CFR 892.1750 |
| Product code | OAS |
Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph FONA S.r.l
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, bold, gray letters. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray letters. Above the word "FONA" is a curved yellow line.
Reference Device
| Trade Name | FONA XPan DG, XPan DG Plus, ART Plus & ART Plus C |
|---|---|
| 510(k) Number | K161131 |
| Classification Name | Extraoral Source X-Ray System |
| Classification Regulation | 21 CFR 872.1800 |
| Product code | MUH |
Indications for use
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillofacial region and in subregions, for general and pediatric dentistry.
Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subreqions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dentomaxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Device Description:
Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist.
In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs.
Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist.
In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters.
Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D.
The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors.
Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports.
The user controls the exposure using a manual hand-switch, implementing the dead man functionality.
An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.
| Stellaris 3D | Stellaris 3DCeph | Stellaris 2D | Stellaris 2DCeph | |
|---|---|---|---|---|
| X-rayPrograms | Pan: 9programs3D: 23programsCeph: N/A | Pan: 9programs3D: 23programsCeph: 4programs | Pan: 9programs3D: N/ACeph: N/A | Pan: 9 programs3D: N/ACeph:4programs |
| ExposureTimes | Pan: max14.2 s3D: max 16.9sCeph: N/A | Pan: max 14.2s3D: max 16.9 sCeph: max 4 s | Pan: max14.2 s3D: N/ACeph: N/A | Pan: max 14.2 s3D: N/ACeph: max 4 s |
| SensorTechnology | Pan/3D:CMOS sensor15x15 cmCeph: N/A | Pan/3D:CMOS sensor15x15 cmCeph: Csl flatpanel24.4x30.7 cm | Pan: CMOSsensor15x0.6 cmCeph: N/A | Pan: CMOSsensor 15x0.6cmCeph: Csl flatpanel 24.4x30.7cm |
| SensorCharacteristics | Pan: pixelsize 100 μm3D: voxel sizedown to 79μmCeph: N/A | Pan: pixel size100 μm3D: voxel sizedown to 79 μmCeph: pixelsize 120micron | Pan: pixelsize 100 μm3D: N/ACeph: N/A | Pan: pixel size100 μm3D: N/ACeph: pixel size120 micron |
| IECClassification | Class I, Type B | |||
| Nominal line | 230 V ± 10%, 115 V ± 10%, |
The following table describes the functionality of each model.
Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r.
FONA S.r.l. – Socio Unico - Sede legale e operativa: Via Galilei, 11 - 20057 Assago (MI) Italia - Capitale Sociale 93.000 Euro - Codice Fiscale, Partita I.V.A.: 12983700159 - Iscrizione Registro Imprese di Milano REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for FONA, a company with the tagline "Closer to You". The word "FONA" is displayed in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the tagline "CLOSER TO YOU" in smaller, gray letters.
| Stellaris 3D | Stellaris 3D Ceph | Stellaris 2D | Stellaris 2D Ceph | |
|---|---|---|---|---|
| voltage | ||||
| Nominal line frequency | 50/60 Hz | |||
| Nominal current absorption | MAX 10 A @ 230 V, MAX16 A @ 115 V | |||
| Line fuse | T8 A 250V for 230 V version; T15 A 250V for 115 V version | |||
| Mains Resistance | ≤ 0.8 Ohm at 230 V, ≤ 0.4 Ohm at 115 V | |||
| Rating | 1450W | |||
| Curve form of high voltage | High frequency multi-pulse, ripple ≤ 4% | |||
| X-ray Tube | OPX/105 | |||
| Tube voltage | 60 - 86 kV ± 5%, constant potential | |||
| Tube current | 2.5 - 10 mA ± 10%, direct current (DC) | |||
| Focal spot | 0.5 IEC 60336 | |||
| Total filtration | > 2.5 mm Al /70 kV IEC 60522 | |||
| Maximum duty cycle | 1/8 | |||
| Anatomical selection | 4 Patient size levels: Small, Medium, Large, Extra Large | |||
| kV setting | 14 positions in 2 kV steps: from 60 to 86kV | |||
| mA setting | 7 positions according to R'10 scale: 2.5, 3.2, 4, 5, 6.3, 8, 10 mA | |||
| Aiming lights | 3 laser planes: Median Sagittal Vertical, Canine and FrankfurtHorizontal | |||
| Laser beam Class | I | |||
| Laser wavelength | 650 nm | |||
| Laser Output Power | < 0.15 mW at 100 mm |
FONA provides technical and maintenance support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.
Substantial Equivalence:
The FONA Stellaris 3D has a rotating arm which performs motor-driven rototranslatory movements that drive the tube housing assembly and the image detector around the patient head according to different orbits that follow the morphologic profile of the patient.
Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r.l
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for FONA. The word "FONA" is in large, gray, sans-serif font. Above the word is a yellow swoosh. Below the word "FONA" is the text "CLOSER TO YOU" in a smaller, gray, sans-serif font.
The tube housing assembly includes an X-ray generator that generates a beam of X-ray as per the inputs selected by the user. Depending on the imaging selection i.e. 2D/panoramic, cephalometric or 3D volume reconstructions, the sensors transform the X-rays into electrical signals.
The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices contain the same type of X-rav tube as the FONA XPan DG. FONA XPan DG Plus, FONA ART Plus and FONA ART Plus C devices. The X-ray generator in the ORTHOPHOS SL device is similar in technology as compared to the FONA Stellaris devices.
The construction of the panoramic image of the dental arch is made with a thin X-ray vertical beam from the left to the right of the patient. 3D volume reconstruction is obtained from the acquisition of two-dimensional radiographic images (15x15 cm) via the cone-beam technology, then elaborated with a reconstruction algorithm.
Stellaris 2D is equipped with a CMOS sensor that allows the acquisition of panoramic images. The reconstruction is obtained from the acquisition of twodimensional radiographic images (15x 0.6 cm) then elaborated with a reconstruction algorithm.
Stellaris 2D Ceph and Stellaris 3D Ceph, in addition, is equipped with a cephalometric arm mountable on Stellaris 2D/ Stellaris 3D respectively, which includes a one shot X-Ray sensor and a cephalostat to hold the patient in position during the examination.
Accessories like bite block, chin rest, nasal support, temporal resting bars are provided to permit correct patient positioning.
The cephalometric models come with nasion reference and side bars with ear plugs to stabilize the head during exposure.
These patient positioning items are likely to enter in contact with the patient during the normal use of the device. The use of standard hygienic protective sleeves (not included in the scope of this submission) to avoid crosscontamination among patients, operators and other persons, is mandatory.
The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices with its associated accessories fulfil the biocompatibility requirements of ISO 10993-1:2018.
The panoramic and cephalometric exposures are obtained by standard technology that have been used in dental medicine for a very long time. The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices.
Traditional 510(k)- Stellaris 2D, Stellaris 2D Ceph, Stellari 3D & Stellaris 3D Ceph FONA S.r.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The logo features the word "FONA" in large, bold, gray letters. Above the word "FONA" is a curved, yellow line that resembles a smile or an arc. Below the word "FONA" is the slogan "CLOSER TO YOU" in smaller, gray letters.
The ORTHOPHOS SL predicate device utilises the SIDEXIS software tool for image acquisition, administration, analysis & diagnosis and the images can be stored in the SIDEXIS database.
The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission), same as the FONA XPan DG, FONA XPan DG Plus, FONA ART Plus and FONA ART Plus C devices.
The use of this software is not mandatory. Any software that allows the viewing and management of radiographic images in DICOM format can also be used.
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices have more volume sizes, positions and collimations than the predicate devices. This results in more possibilities to get an exposure of relevant dento maxillofacial areas.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C |
| ManufacturerName | FONA S.r.l | Sirona Dental Systems GmbH | FONA S.r.l |
| DeviceClassificationRegulation | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 872.1800 |
| ClassificationName | Computed Tomography X-raysystem | Computed tomography x-ray system | Extraoral Source X-Ray System |
| Product Code(s) | OAS | OAS | MUH |
| Regulatory Class | 2 | 2 | 2 |
| 510(k) | K213579 | K150217 | K161131 |
| Indications for Use | Stellaris 2D: Extraoral sourcedental X-ray system intended toperform panoramic exams withproduction of diagnostic images inthe dento-maxillo-facial regionand in subregions, for general andpediatric dentistry.Stellaris 2D Ceph: Extraoralsource dental X-ray systemintended to perform panoramicand cephalometric exams withproduction of diagnostic images inthe dento-maxillo-facial regionand in subregions, for general andpediatric dentistry, as well ascarpal images for dental clinicalinvestigation. | The X-ray system creates data for digitalexposures in the maxillofacial area andin subareas for dentistry, includingpediatric dentistry, for hard-tissuediagnostics within ENT medicine, andfor carpus exposures. | The FONA Pan/Ceph device, comprisingmodels FONA XPan DG, FONA XPanDG Plus, FONA ART Plus, and FONAART Plus C, is an extraoral sourcedental X-ray system intended to performpanoramic or cephalometric exams withproduction of diagnostic images in thedento-maxillo-facial region and insubregions, for general and pediatricdentistry, as well as carpal images. |
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C |
| Stellaris 3D: Extraoral sourcedental X-ray system intended toperform 3D and panoramic examswith production of diagnosticimages in the dento-maxillo-facialregion and in subregions, forgeneral and pediatric dentistry. | |||
| Stellaris 3D Ceph: Extraoralsource dental X-ray systemintended to perform 3D,panoramic and cephalometricexams with production ofdiagnostic images in the dento-maxillo-facial region and insubregions, for general andpediatric dentistry, as well ascarpal images for dental clinicalinvestigations. | |||
| PanoramicPrograms | P1: Adult FullP2: Child FullP3: Adult Partial FrontP4: Adult Partial LeftP5: Adult Partial RightP6: Adult DentitionP7: SinusesP8: BitewingP9: TMJ Open/Closed Mouth | P1: Panoramic exposureP1A: Panoramic exposure, artifact-reducedP1C: Panoramic exposure, constant1.25x magnificationP2: Panoramic exposure, withoutascending ramiP2A: Artifact-reduced panoramicexposure without ascending rami | P1 Standard Panoramic AdultP2 Panoramic ChildP3 Left DentitionP4 Right DentitionP5 Anterior DentitionP6 TMJ lateral view open/closed mouthP7 Frontal View of Maxillary SinusesP8 Bitewing (only FONA Art Plus /FONA ART Plus C) |
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C |
| P2C: Panoramic exposure withoutascending rami at a constantmagnification of 1.25x | |||
| P10: Panoramic exposure for children | |||
| P10A: Panoramic exposure for children,without ascending rami, artifact-reduced | |||
| P10C: Panoramic exposure for children,without ascending rami, constant 1.25xmagnification | |||
| P12: Thick slice, anterior tooth region | |||
| BW1: Bitewing exposures in theposterior tooth region | |||
| BW2: Bitewing exposures in the anteriortooth region | |||
| TM1.1/TM1.2: Temporomandibular jointsfrom a lateral aspect with the mouthopen and closed, two-part exposure | |||
| TM3: Temporomandibular joints lateral,ascending rami | |||
| S1: Paranasal sinuses | |||
| S3: Paranasal sinuses, linear sliceorientation | |||
| CephalometricPrograms | C1: LL (Latero-Lateral) large viewC2: LL (Latero-Lateral) small viewC3: AP (Anterior-Posterior) / PA(Postero-Anterior) viewC4: CEPH Carpus | C1: Posterior-anterior exposure,symmetricalC2: Anterior-posterior exposure,symmetricalC3: Lateral exposureC3F: Full-format exposure, lateral | FONA XPan DG Plus:• P8 Antero-posterior• P9 Letro-lateral• P10 CarpusFONA ART Plus C• P9 Antero-posterior |
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG PlusFONA ART Plus & FONA ART Plus C |
| C4: Carpus view, symmetrical | P10 Latero-lateral P11 Carpus | ||
| 3DReconstructions(for 3D model only) | V1: Adult Full View | VOL1 (HS, SD, Low): Volume exposurewith a diameter of approx. 8 cm and aheight of approx. 8 cm or 5.5 cmcollimated. | Not Available |
| V2: Adult Upper Jaw – Surgical/Implant | VOL2 (HS, SD, Low): Volume exposurewith a diameter of about 5 cm and aheight of about 5.5 cm for upper or lowermandible. | ||
| V3: Adult Lower Jaw - Surgical/Implant | VOL3 (HS, SD, Low) (optional): Volumeexposure with a diameter of about 11cm and a height of about 10 cm orselection of upper quadrant collimated to7.5 cm and selection lower quadrantcollimated to8.0 cm | ||
| V4: Adult Sinuses | |||
| V5: Child Full | |||
| V6: Child Upper Jaw - Surgical/Implant | |||
| V7: Child Lower Jaw - Surgical/Implant | |||
| V8: Child Sinuses | |||
| V9: Upper+Lower Jaws -Surgical/Implant Front | |||
| V10: Upper+Lower Jaws -Surgical/Implant Left | |||
| V11: Upper+Lower Jaws -Surgical/Implant Right | |||
| V12: Upper Hemi-Arc Left (1quadrant) | |||
| V13: Upper Hemi-Arc Right (1quadrant) | |||
| V14: Lower Hemi-Arc Left (1quadrant) | |||
| V15: Lower Hemi-Arc Right (1quadrant) | |||
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C |
| V16: Upper Jaw Endo FrontV17: Upper Jaw Endo LeftV18: Upper Jaw Endo RrightV19: Lower Jaw Endo FrontV20: Lower Jaw Endo LeftV21: Lower Jaw Endo RightV22: TMJ LeftV23: TMJ Right | |||
| DAP Pan DoseArea Product(approx. values) | Complete range (Ceph, 3D and2D): 7 - 4411 mGy*cm². | Complete range (Ceph, 3D and 2D): 1.2 - 3056 mGy*cm². | Complete range : 3-247 mGy cm2 |
| Image AcquisitionTechnology | Pan/2D: CMOS sensor 15 x 0.6cmPan/3D: CMOS sensor 15 x 15cmCeph: Csl flat panel 24.4 x 30.7cm | Pan: CMOS sensor 14.6 x 0.6 cm3D: Flat Panel sensor 16 x 16 cmCeph: CCD sensor 23 x 0.648 cm | FONA ART Plus/FONA ART Plus C -Multi-element Cd(Zn)Te-CMOS sensorPan-15.1 x 0.64cmCeph- 22.66 x 0.64 cmFONA XPan DG/ FONA XPan DG Plus-Digital TDI CCD line sensorPan- 15.06x 0.69cmCeph- 22.1 x 0.69cm |
| Sensorcharacteristics | Pan: 100 µmCeph: 120 µm3D: voxel size down to 79 µm | Pan: 0.1 mmCeph: 0.027 mm3D: voxel size 80 - 220 µm | FONA ART Plus/ FONA ART Plus C:100 µmFONA XPan DG/ FONA XPan DG Plus:108 µm3D: N/A |
| Spatial Resolution | Pan Sensor: 5 lp/mm3D/Pan Sensor: 5 lp/mm | Pan sensor: 5 lp/mm3D/Pan sensor: 4 lp/mm | FONA XPan DG/ FONA XPan DGplus sensor: 7 lp/mm |
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C |
| Ceph Sensor: 3.1 lp/mm | Ceph sensor: 2.5 lp/mm | FONA ART Plus/ FONA ART Plus Csensor: 5 lp/mm | |
| A/D Conversion | Pan sensor: 14 bits3D/Pan sensor: 14 bitsCeph sensor: 16 bits | Pan sensor: 12 bits3D/Pan sensor: 16 bitsCeph sensor: 12 bits | FONA Xpan DG/ FONA XPAN DG plus:16 bitsFONA ART Plus/ FONA ART Plus C: 12bits |
| Nominal voltage | 230 V ± 10%, 115 V ± 10% | 200 – 240 V ± 10% | 230 V ± 10%, 115 V ± 10% |
| Mains Resistance | ≤ 0.8 ohm at 230 V, ≤ 0.4 ohm at115 V | max. 0.8 ohms | ≤ 0.8 ohm at 230 V, ≤ 0.4 ohm at 115V |
| Nominal frequency | 50 / 60 Hz | 50 / 60 Hz | 50 / 60 Hz |
| Tube Voltage | 60 - 86 kV ± 5% | 60 – 90 KV | 61 - 85 kV± 5% |
| Tube current | 2.5 - 10 mA ± 10%, DC | 3 – 16 mA | 4 - 10 mA± 10%, DC |
| Exposure times | Pan: max 14.2 sCeph: max 4 s3D: max 16.9 s | Pan: max 14.4 sCeph: max 14.9 s3D: max 14.9 s | Pan: 14.2 sCeph: 10 s3D: N/A |
| Curve form of highvoltage | High frequency multi-pulse, ripple≤ 4% | High-frequency multipulseripple ≤ 4 kV | High frequency multi-pulse, ripple ≤ 4% |
| Focal Spot | 0.5 as per IEC 60336 | 0.5 as per IEC 60336 | 0.5 as per IEC 60336 |
| X-ray insert | OPX/105 | Siemens SR 90/15 FN | OPX/105 |
| Principles ofOperation | Stellaris 3D has a rotating armmounted on a column support.The rotating arm performs motor-driven roto-translatory movementsthat allow moving the X-rayemission system and the imagedetector around the patientaccording to different orbits that | The device comprises image receptorsfor cephalometric exposures, 2Dpanoramic radiographs and 3D volumeexposures. The combination of sensorsin the device varies depending on theinstalled options and the regions ofinterest can be altered. | The models FONA XPan DG and FONAART Plus feature panoramic projectionsonly (type Pan Solo) and are thusequipped with a fixed image receptormounted on the rotating arm.The models FONA XPan DG Plus andFONA ART Plus C feature panoramicand cephalometric projections (type Pan |
| Subject Device | Predicate Device | Reference Device | |
| Device Name | Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG PlusFONA ART Plus & FONA ART Plus C |
| follow the morphologic profile ofthe patient. Stellaris 3D Ceph, inaddition, is equipped with a tele-X-ray arm coupled to the columnsupport. The arm hosts a one-shot X-Ray sensor for thedetection of X-Ray image and acephalostat to hold the patient inposition during the examination.Stellaris 2D and Stellaris 2D Cephderive directly from the Stellaris3D and Stellaris 3D Ceph devices,in which only the 3D sensor hasbeen replaced with a 2D sensor. | Ceph) and are equipped with adetachable image receptor to be placedon the rotating arm, for the panoramicmodality, or on the cephalometric arm,for the cephalometric modality. | ||
| Sterilization | Not sterile. Disinfect and use | Not sterile. Disinfect and use | Not sterile. Disinfect and use |
| Connection toimaging practicePC | Ethernet cable | Ethernet cable | Ethernet cable |
| OperatingConditions | Temperature:10 to 40 °CHumidity: 30 to 75%Pressure: 700 to 1060 hPa | Temperature:18 to 31 °CHumidity: 30 to 85%Pressure: 700 to 1060 hPa | Temperature:10 to 40 °CHumidity: 30 to 75%Pressure: 700 to 1060 hPa |
| PerformanceStandards | IEC 60601-1 (Electrical Safety)IEC 60601-1-2 (EMC)IEC 60601-1-3 (RadiationProtection)EN 60601-2-63 (Performance)EN 60336 (Focal Spots)EN 62304 (Software) | EN 60601-1 (Electrical Safety)IEC 60601-1-2 (EMC)IEC/EN 60601-1-3 (RadiationProtection)IEC 60601-2-63 (Performance)IEC 60601-1-6 & IEC 62366 (Usability)IEC 60336 (Focal Spots) | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)IEC 60601-1-3 (Radiation Protection)EN 60601-2-63 (performance)IEC 60336 (Focal spots)EN 62304 (Software)IEC 60601-1-6 & IEC 62366-1 |
| Device Name | Subject Device | Predicate Device | Reference Device |
| Stellaris 2D, Stellaris 2D Ceph,Stellaris 3D and Stellaris 3DCeph | ORTHOPHOS SL 2D, ORTHOPHOSSL 2D Ceph, ORTHOPHOS SL 3D andORTHOPHOS SL 3D Ceph | FONA XPan DG, FONA XPan DG Plus,FONA ART Plus & FONA ART Plus C | |
| IEC 60601-1-6 & IEC 62366-1(Usability)EN 60825-1 (Laser Safety)ISO 10993-1 (Biocompatibility) | EN 62304 (Software)IEC 60825-1(Laser Safety)IEC 62471 (Lamps Photobiologicalsafety)ISO 10993-1(Biocompatibility) | (Usability)EN 60825-1 (Laser Safety)ISO 10993-1 (Biocompatibility) |
Page 7 of 15
Il FONA S.r.l. - Socio Unico - Sece legale, 1 - 2007 Assag (MI) talia - Capide Sociale 90.00 Euro - Codice Fradia II A.: 129070169 - Iscriane Registo Inprese di Miano REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a yellow arc. Below the word "FONA" is the slogan, "CLOSER TO YOU", written in smaller, gray letters.
Page 8 of 15
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for FONA, which is a company that provides communication services. The logo consists of the word "FONA" in large, gray, sans-serif letters, with the tagline "CLOSER TO YOU" in smaller, gray letters below it. Above the word "FONA" is a yellow swoosh that curves over the letters. The logo is simple and modern, and the colors are muted and professional.
Page 9 of 15
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for FONA, a company with the tagline "CLOSER TO YOU". The logo features the word "FONA" in large, bold, gray letters. Above the word "FONA" is a curved, yellow line that resembles a smile or an arc. Below the word "FONA" is the tagline "CLOSER TO YOU" in smaller, gray letters.
Page 10 of 15
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image contains the logo for FONA, a company whose slogan is "Closer to You". The logo features the word "FONA" in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the slogan "CLOSER TO YOU" in smaller, gray letters.
Page 11 of 15
II FONA S.r. – Socie legale e creativa: Via Galle, 11 - 2005 Assago (M) halia - Cariale 9.000 Euro - Codice Fisale, Partia I.V.A. 1298700199 - sozione Registr Innese di REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters.
Page 12 of 15
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for FONA, a company whose slogan is "Closer to You". The logo consists of the word "FONA" in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" is the slogan "CLOSER TO YOU" in smaller, gray letters.
Page 13 of 15
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for FONA, a company that is "Closer to You". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray letters.
Page 14 of 15
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters.
Summary of Non Clinical Testing:
IEC standards have been employed for Electrical Safety, Electromagnetic Compatibility, performance and usability. Additionally, the CMOS area image sensor manufacturer has conducted performance testing according to the FDA quidance document for solid state digital X-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Labelling was developed to comply with the FDA solid state panel guidance document.
Summary of Clinical Testing:
Sample clinical images from the FONA device were evaluated as per the FDA guidance document for solid state digital X-ray panels and found to be clinically adequate.
Conclusion:
After analysing non-clinical data, electrical safety and performance as well as clinical evaluation, it can be concluded that the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices are as safe and effective as the predicate device, has few technological differences, and has no new intended use, thus rendering it substantially equivalent to the predicate device.
N/A