(144 days)
Not Found
No
The summary mentions "automatic image processing" and "motion artifact reduction software" and "metal artifact reduction software," but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. There is no description of training or test sets for an AI/ML model.
No.
The device is used for obtaining diagnostic images, not directly for therapy.
Yes
Explanation: The device is explicitly designed to obtain radiological images for the purpose of "speed of diagnosis" and is used by "qualified health professionals" for "dental use," indicating its role in identifying and evaluating medical conditions.
No
The device description explicitly states it is a "complete 3-in-1 dental imaging system" and mentions hardware components like "X-ray sensors" and "X-Ray units." While it includes software for image processing, 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 clearly states that the device is designed to obtain radiological images of the oral anatomy and surrounding areas. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis.
- Device Description: The description confirms it's an X-ray imaging system for generating panoramic, cephalometric, and tomographic images.
- Input Imaging Modality: The input is X-Ray, which is an imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The anatomical sites are parts of the human body being imaged, not biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to image the body directly.
N/A
Intended Use / Indications for Use
The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
EAGLE EDGE Models AXR90, AXR120 are complete 3-in-1 dental imaging systems capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography (CBCT) technique. The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes one or more X-ray sensors and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray (CBCT, Panoramic, Cephalometric)
Anatomical Site
oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified health professionals (dental use)
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
Sample X-Ray images were taken by the Eagle Edge AXR90 and AXR120 across the different operational modes, i.e. Panoramic, Cephalometric, tomographic/CBCT scans. These images were evaluated by an American Board of Radiology certified radiologist.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety, EMC, Biocompatibility and Performance Data: Safety and performance testing was conducted by an internationally recognized testing laboratory Underwriters Laboratories standard(s) for Safety: ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1 Edition 3.1 (2012), IEC 60601-1 Edition 3.1 (2012) Additional Standards applied: IEC 60601-1-3:2008 (Second Edition) + A1:2013, IEC 60601-1-6:2010 (Third Edition) + A1:2013, IEC 60601-2-63:2012 (First Edition). A different accredited laboratory "IBEC" (Instituto Brasileiro de Conformidade Ltda) tested the system according to IEC 60601-1-2 Ed. 4.0 (2014) —Collateral standard: Electromagnetic disturbance - Requirements and tests. All standards tests passed. Biocompatibility evaluation was performed in accordance with EN ISO 10993-1: 2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. These tests were conducted for irritation, sensitization, and cytotoxicity. All tests passed. Risk analysis and software validation was performed according to the FDA guidance document Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.). Consideration was given to cybersecurity via compliance with the recommendations of the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. Each unit manufactured is 100% tested for Connection to the Software, Exposure Accuracy, Tube Voltage and Exposure Time, Reproducibility, Beam Quality, Tube Efficiency, and Leakage Radiation. Image evaluation was performed by both licensed dentist and a USA Board Certified Radiologist.. Dental images were compared to the images obtained on the predicate device and found to be equivalent or better. In addition, the Radiologist evaluated the effectiveness of the motion artifact reduction software and the metal artifact reduction software. These software features were found to be effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information 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
August 10, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
Alliage S/A Industrias Médico Odontológica % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K210820
Trade/Device Name: EAGLE EDGE AXR90 and AXR120 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 9, 2021 Received: July 12, 2021
Dear Mr. Kamm:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
. for
Thalia T. Mills, Ph.D. Director 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
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Indications for Use
510(k) Number (if known) K210820
Device Name EAGLE EDGE AXR90 and AXR120
Indications for Use (Describe)
The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
| 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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Image /page/3/Picture/0 description: The image contains the title "510(k) Summary K210820" at the top. Below the title is the word "alliage" in a large, bold, dark blue font. The text "Alliage S/A Indústrias Médico Odontológica" is below the word "alliage". The address "Rodovia Abrão Assed, Km 53+450m" is on the next line.
Rodovia Abrão Assed, Km 53+450m Recreio Anhanguera, CEP 14097-500, Ribeirão Preto - São Paulo- Brazil Tel +55 16 3512-1212
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date prepared: August 6, 2021
| 1. Company and Correspondent making the submission: |
|---|
| Name: Alliage S/A Indústrias Médico Odontológica |
| Address: Rod. Abrão Assed, Km 53+450m Recreio Anhanguera, CEP 14097-500, BRAZI |
| Telephone: +55 16 3512-1212 |
| Contact: Daniel Camargo |
| 2. Trade /Proprietary Name: | EAGLE EDGE AXR90 and AXR120 |
|---|---|
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 892.1750 |
| Device Class: | 2 |
3. Legally Marketed Predicate Device Information:
| 510(k) Number: | K152489 |
|---|---|
| Manufacturer: | Panoramic Corp |
| Trade /Proprietary Name | ENCOMPASS Eagle 3D CBCT |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | 2 |
4. Description:
EAGLE EDGE Models AXR90, AXR120 are complete 3-in-1 dental imaging systems capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography (CBCT) technique. The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes one or more X-ray sensors and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
Models: (Customer decides which modalities are desired)
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Pan only Pan + Ceph (Single Sensor) Pan + Ceph (Two Sensors) CBCT + PAN CBCT + PAN + CEPH
Sensor Technology Discussion:
For Panoramic only configuration we have validated two possible detector models are: The Alliage SPB PAN (CMOS 157.5x6.4) OR the XINEOS 1501 (CMOS 152x6.8) for panoramic acquisition
For Panoramic with Cephalostat configuration it has two options it depends on the client choice if he wants one single mobile digital sensor or two fixed digital sensor. For option with one single mobile digital sensor two possible detector models are: Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for panoramic and cephalometric acquisitions
For the option with two fixed digital sensor possible detector models are: Alliage SPB PAN (CMOS 157.5x6.4) OR the XINEOS 1501 (CMOS 152x6.8) for panoramic acquisition Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for cephalometric acquisition
For Tomography configuration, the detector model is VIVIX 0606C (CMOS 153.2x153.2) for CBCT and Panoramic acquisition
For Tomography with cephalostat configuration possible detector models are: VIVIX 0606C (CMOS 153.2x153.2) for CBCT and Panoramic acquisition Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for cephalometric acquisition
5. Indications for use:
The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
6. Comparison with predicate devices:
The Encompass Eagle 3D CBCT/panoramic/cephalometric Dental X-ray consists of a configuration which implements 3D use a Cone beam Computed Tomography. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. The new device EAGLE EDGE AXR90 and AXR120 CBCT / Panoramic / Cephalometric X-Ray is digital capture type CBCT / Panoramic / Cephalometric system. The technologies employed by the predicate and our new device are almost identical.
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| ITEM | ENCOMPASS 3D K152489 | EAGLE EDGE AXR90, AXR120 | |
|---|---|---|---|
| Indications for use | Intended to acquire two-dimensional | ||
| digital panoramic and cephalometric | |||
| radiographies, and multi-field of view | |||
| 3D computed tomography images of | |||
| dento-maxillo-facial region for the | |||
| purpose of advanced diagnosis at the | |||
| direction of qualified dental | |||
| healthcare professionals. | The EAGLE EDGE AXR90 and AXR120 | ||
| are CBCT / Panoramic / Cephalometric | |||
| X-Ray units designed to obtain 2D and | |||
| 3D radiological images of the oral | |||
| anatomy, including teeth, maxillofacial | |||
| areas, oral structures, carpal images | |||
| and head-neck bone regions. This | |||
| system is exclusively for dental use and | |||
| should be handled only by qualified | |||
| health professionals. (SAME, different | |||
| wording) | |||
| X-Ray | |||
| Generation | |||
| Device | Tube | ||
| voltage | 60-85 kV | AXR90: 60- 90kV | |
| (at 90kV max. 12.5mA) | |||
| AXR120: 60-120 kV | |||
| (at 120kV max. 8mA) | |||
| (Higher kV can provide better images) | |||
| Tube | |||
| Current | 4-8 mA | 3.2-16 mA | |
| Focal spot | |||
| Size | 0.5 mm | 0.5 mm | |
| Detector | CMOS (CT) | ||
| CCD (Panoramic) | |||
| CCD (Ceph) | CMOS/a-Si (CT) | ||
| CMOS (Panoramic) | |||
| CMOS (Ceph) | |||
| Pixel Size | 100 μm (CT) | ||
| 108 μm (Panoramic) | |||
| 108 μm (Ceph) | 119 μm (CT) | ||
| 100 μm (Panoramic) | |||
| 100 μm (Ceph) | |||
| X-Ray image | |||
| capturing | |||
| device | Size of | ||
| Area | |||
| receiving | |||
| X-Ray | 131.6 x 131.2 mm (CT) | ||
| 6.9 x 151 mm (Panoramic) | |||
| 6.9 x 221 mm (Ceph) | 214.9 x 215,5 (CT) | ||
| 6.8 x 225,2 (Panoramic) | |||
| 6.8 x 228 (Ceph) | |||
| Larger panel size for CT. Otherwise | |||
| not an important difference. | |||
| Number | |||
| of Bits | 14 bits (CT) | ||
| 16 bits (Ceph, Panoramic) | 16 bits (CT) | ||
| 14 bits (Panoramic, Ceph) | |||
| Not a useful difference | |||
| SID/SOD | 634mm/400mm(CT) | ||
| 564mm/400mm (Panoramic) | |||
| 1681mm/1511mm (Ceph) | 620mm/400mm (CT) | ||
| 620mm/400mm (Panoramic) | |||
| 1732,5mm/1473,65mm (Ceph) | |||
| Scanner | Dimension | ||
| (WxDxH) | 1511mm x 1074mm x 1742mm | Main Unit: 1711 x 586 x 1318 | |
| Cephalostat: 1105 x 665 x 963mm | |||
| Base: 1215 x 770 x 300mm | |||
| Comparable dimensions | |||
| ITEM | ENCOMPASS 3D K152489 | EAGLE EDGE AXR90, AXR120 | |
| Weight | 152 Kg | 160 Kg Comparable weight | |
| Imaging Mode | CT scan, Panoramic scan, | ||
| Cephalometric radiography | CT scan, Panoramic scan, | ||
| Cephalometric radiography SAME | |||
| Panoramic Scan | |||
| Performance | Standard Panoramic: 14 sec | ||
| TMJ Panoramic: 14 sec | |||
| Maxillary Sinus: 8 sec | |||
| Improved Orthogonality Panoramic: 14 | |||
| sec | |||
| Low Dose Panoramic: 11 sec | |||
| Child Panoramic: 10.5 sec | |||
| Bitewing: 7.6 sec | |||
| Improved Bitewing: 7.6 sec | Standard Panoramic: 14 sec | ||
| Fast Panoramic: 10 sec | |||
| Improved orthogonality: 14 sec | |||
| Infant: 10 sec | |||
| Maxillary sinus: 8 sec | |||
| TMJ: 10 sec | |||
| TMJ PA: 10 sec | |||
| Bitewing: 7.6 sec | |||
| Lateral section: 6 sec | |||
| Center section: 3.5 sec | |||
| Cephalometric | |||
| Radiography | LA, PA, Carpus, Oblique: | ||
| 6.6, 10, 11, 16.5 sec | AP/PA, LL, Carpal, Oblique: 4~16,5 sec | ||
| CT Scan | |||
| Performance | Scan Time | Low Dose: 16.5 sec | |
| Standard Dose: 20.5 sec | |||
| High Definition: 25.5 sec | |||
| Ultra High Definition: 32.0 sec | Fast Scout: 0.1 sec | ||
| Full Scout: 0.2 sec | |||
| Low Dose: 10 sec | |||
| Standard: 15 sec | |||
| High Definition: 20 sec | |||
| Ultra High definition 25 sec | |||
| FOV | |||
| (Voxel | |||
| Size) | 5x5mm; 6x8mm; 8x8mm; 8x12mm | ||
| 8x16mm | 5x5mm; 6x9mm; 9x9mm; 9x16mm | ||
| 15x16mm; 21x16mm | |||
| Photo | Image: ENCOMPASS 3D K152489 | Image: EAGLE EDGE AXR90, AXR120 |
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-
- Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data: Safety and performance testing was conducted by an internationally recognized testing laboratory Underwriters Laboratories standard(s) for Safety: ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1 Edition 3.1 (2012), IEC 60601-1 Edition 3.1 (2012) Additional Standards applied:
7
IEC 60601-1-3:2008 (Second Edition) + A1:2013, IEC 60601-1-6:2010 (Third Edition) + A1:2013, IEC 60601-2-63:2012 (First Edition)
A different accredited laboratory "IBEC" (Instituto Brasileiro de Conformidade Ltda) tested the system according to IEC 60601-1-2 Ed. 4.0 (2014) —Collateral standard: Electromagnetic disturbance - Requirements and tests. All standards tests passed.
Biocompatibility evaluation was performed in accordance with EN ISO 10993-1: 2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. These tests were conducted for irritation, sensitization, and cytotoxicity. All tests passed. Risk analysis and software validation was performed according to the FDA guidance document Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.)
Consideration was given to cybersecurity via compliance with the recommendations of the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
Each unit manufactured is 100% tested for Connection to the Software, Exposure Accuracy, Tube Voltage and Exposure Time, Reproducibility, Beam Quality, Tube Efficiency, and Leakage Radiation. Image evaluation was performed by both licensed dentist and a USA Board Certified Radiologist.. Dental images were compared to the images obtained on the predicate device and found to be equivalent or better. In addition, the Radiologist evaluated the effectiveness of the motion artifact reduction software and the metal artifact reduction software. These software features were found to be effective.
-
- Clinical Testing Performed: Sample X-Ray images were taken by the Eagle Edge AXR90 and AXR120 across the different operational modes, i.e. Panoramic, Cephalometric, tomographic/CBCT scans. These images were evaluated by an American Board of Radiology certified radiologist.
9. Conclusions:
According to the Federal Food, Drug and Cosmetic Law, 21 CFR Part 807 and based on the information provided in this pre-marketing notification, Alliage S/A Indústrias Médico Odontológica concludes that EAGLE EDGE AXR90 and AXR120 CBCT / Panoramic / Cephalometric X-Ray is safe and effective and substantially equivalent to predicate devices, as described in this document.
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