(112 days)
No
The summary describes a standard dental X-ray system with image acquisition, processing, and storage capabilities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is described as an "Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "production of diagnostic images."
No
The device description clearly indicates it is a dental X-ray system with mechanical, electrical, and hardware components (X-ray source, sensors, control panel, hand-switch, laser aiming lights, patient positioning aids). While it includes software for image acquisition, processing, and storage, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stellaris devices are dental X-ray systems. They use X-rays to create images of the dento-maxillo-facial region and carpal bones. This is an imaging modality, not a test performed on a biological sample.
- Intended Use: The intended use is to perform panoramic, cephalometric, and 3D exams to produce diagnostic images. This is for visualization and diagnosis based on anatomical structure, not on the analysis of biological markers in a sample.
The device is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAS
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial region and in subregions
Indicated Patient Age Range
general and pediatric dentistry
Intended User / Care Setting
Not Found
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)
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 guidance 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.
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.
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.
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) |
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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 11 |
| 20057 Assago (MI), Italy | |
| Contact Person | Luigi Germanò |
| Contact Telephone | +39 0245712171 |
| Device Information | |
| Device/ Trade Name | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D |
| and Stellaris 3D Ceph | |
| Common Name | X-Ray, Tomography, Computed, Dental |
| Classification Name | Computed Tomography X-ray system |
| Classification Regulation | 21 CFR 892.1750 - Computed Tomography |
| X-ray system | |
| Product code | OAS |
Predicate Devices:
The following legally marketed predicate devices have been chosen for the determination of substantial equivalence:
| Primary Predicate Device
| Trade 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.
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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 3D
Ceph | Stellaris 2D | Stellaris 2D
Ceph |
|---------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------|
| X-ray
Programs | Pan: 9
programs
3D: 23
programs
Ceph: N/A | Pan: 9
programs
3D: 23
programs
Ceph: 4
programs | Pan: 9
programs
3D: N/A
Ceph: N/A | Pan: 9 programs
3D: N/A
Ceph:4
programs |
| Exposure
Times | Pan: max
14.2 s
3D: max 16.9
s
Ceph: N/A | Pan: max 14.2
s
3D: max 16.9 s
Ceph: max 4 s | Pan: max
14.2 s
3D: N/A
Ceph: N/A | Pan: max 14.2 s
3D: N/A
Ceph: max 4 s |
| Sensor
Technology | Pan/3D:
CMOS sensor
15x15 cm
Ceph: N/A | Pan/3D:
CMOS sensor
15x15 cm
Ceph: Csl flat
panel
24.4x30.7 cm | Pan: CMOS
sensor
15x0.6 cm
Ceph: N/A | Pan: CMOS
sensor 15x0.6
cm
Ceph: Csl flat
panel 24.4x30.7
cm |
| Sensor
Characteristics | Pan: pixel
size 100 μm
3D: voxel size
down to 79
μm
Ceph: N/A | Pan: pixel size
100 μm
3D: voxel size
down to 79 μm
Ceph: pixel
size 120
micron | Pan: pixel
size 100 μm
3D: N/A
Ceph: N/A | Pan: pixel size
100 μm
3D: N/A
Ceph: pixel size
120 micron |
| IEC
Classification | 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
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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 Frankfurt | |||
| Horizontal | ||||
| Laser beam Class | I | |||
| Laser wavelength | 650 nm | |||
| Laser Output Power |