(156 days)
Not Found
No
The summary mentions "auto image processing" but provides no details suggesting the use of AI/ML algorithms for this processing. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as an imaging system intended for advanced diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "the purpose of advanced diagnosis."
No
The device description explicitly details hardware components, including a 3-in-1 system for dental imaging, a CCD sensor, movement axes, and radiographic emission compensation. The performance studies also include electrical, mechanical, and environmental safety testing, which are relevant to hardware.
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 ENCOMPASS Eagle 3D is an imaging device that uses X-rays to create images of the dento-maxillo-facial region. It does not analyze biological samples.
- Intended Use: The intended use is for acquiring radiographic images for advanced diagnosis, which is a function of medical imaging, not in vitro diagnostics.
Therefore, the ENCOMPASS Eagle 3D falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
ENCOMPASS Eagle 3D is 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.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. 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. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
Mentions image processing
Auto image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, Computed Tomography, Radiography
Anatomical Site
Dento-maxillo-facial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified dental healthcare 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)
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001; IEC 60601-2-7/2001; 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: MTF and DOE measurements were taken and compared to the predicate. 3D performance testing was performed yielding the MTF curve and the NPS, noise power spectrum. Accuracy testing and software validation was performed. All test results were satisfactory.
Clinical Data: In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device. They were compared by a licensed dentist. The Images from the Encompass machine are comparable in diagnostic ability, sharpness and quality to images from the Predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: 70% 1.05 lp/mm
MTF: 40% 2.2 lp/mm
DQE@0 lp/mm 46.9%
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
Panoramic Corp. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K152489
Trade/Device Name: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: January 18, 2016 Received: January 22, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152489
Device Name
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
Indications for Use (Describe)
ENCOMPASS Eagle 3D is 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
| 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)
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
510(k) Summary K152489
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: January 18, 2016
-
Company and Correspondent making the submission: Name - Panoramic Corp. Address - 4321 Goshen Rd., Fort Wayne, IN 46818 Telephone - 800-654-2027 Contact - Doug Pack
-
Device:
Device trade name, ENCOMPASS Eagle 3D Device common name. CBCT/Panoramic/Cephalometric Dental X-Ray Regulation number, 21 CFR §892.1750 Regulation name, Computed tomography x-ray system Classification: 2 Product code) OAS
-
- Predicate Device: The Encompass 3D is substantially equivalent to the following legally marketed device: K122199, Prexion3d Eclipse made by The Yoshida Dental Mfg. Co., Ltd. 21 CFR§ 892.1750, Class 2 Product code OAS.
-
- Description: The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. 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. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). The Encompass Eagle 3D complies with applicable aspects of 21CFR 1020.30,31, and 33.
-
- Indications for use: ENCOMPASS Eagle 3D is 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.
-
- Comparison with predicate devices: The PREXION 3D ECLIPSE consists of scanner intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support. The new device ENCOMPASS Eagle 3D is a digital capture type CBCT/Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical. A comparison table follows.
4
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE
K122199 | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications for use | ENCOMPASS Eagle 3D is intended to
acquire two-dimensional digital
panoramic and cephalometric
radiographies, and multi-field of view 3D
computed tomography images of dento-
maxillofacial region for the purpose of
advanced diagnosis at the direction of
qualified dental healthcare professionals. | PREXION 3D ECLIPSE is intended
to produce two dimensional
digital panoramic and
cephalometric images, and three-
dimensional digital X-ray images
of dento-maxillofacial region at
the direction of healthcare
professionals as diagnostic
support. | |
| X Ray
Generation
Device | Tube Voltage | 60-85 kV | 50-90 kV |
| | Tube Current | 4-8 mA | 1-4 mA |
| | Focal Spot Size | 0.5 mm | 0.2 mm |
| X Ray image
capturing device | Detector | CMOS (CT)
CCD (Panoramic)
CCD (Ceph) | FPD |
| | Pixel Size | 100 μm (CT)
108 μm (Panoramic)
108 μm (Ceph) | 200 μm (CT)
100 μm (Panoramic)
54 μm (Ceph) |
| | Pixel Number | 1316 x 1312 (CT)
64 x 1395 (Panoramic)
64 x 2040 (Ceph) | 640 x 656 (CT)
80 x 1312 (Panoramic)
128 x 4080 (Ceph) |
| | 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) | 128.1 x 131.3 mm (CT)
8 x 131.3 mm (Panoramic)
6.9 x 312 mm (Ceph) |
| | Number of Bit | 14 bits (CT,)
16 bits (Ceph, Panoramic) | 14 bits (CT, Panoramic)
16 bits (Ceph) |
| | SID/SOD | 634mm/400mm(CT)
564mm/400mm (Panoramic)
1681mm/1511mm (Ceph) | 620mm/400mm(CT, Panoramic)
1650 mm/1500 mm (Ceph) |
| Scanner | Dimension (WxDxH) | 1511mm x 1074mm x 1742mm | 1245mm x 1288mm x 2045mm
(CT, Panoramic)
1805mm x 1288mm x 2045mm
(Ceph) |
| | Weight | 115kg (CT, Panoramic)
152kg (Ceph) | 260kg (CT, Panoramic)
300kg (Ceph) |
| Imaging Mode | | CT scan, Panoramic scan, Cephalometric
radiography | CT scan, Panoramic scan,
Cephalometric radiography |
| Panoramic Scan Performance | | Standard Panoramic: 14 sec
TMJ Panoramic: 14 sec
Maxillary Sinus: 8 sec
Improved Orthogonality Panoramic: 14
sec | Standard Mode : 14 sec |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE K122199 | |
| | Low Dose Panoramic: 11 sec
Child Panoramic: 10.5 sec
Bitewing: 7.6 sec
Improved Bitewing: 7.6 sec | | |
| Cephalometric Radiography | LA, PA, Carpus, Oblique:
6.6, 10, 11, 16.5 sec | LA, PA, Carpus:
8, 10, 12, 15 sec | |
| | Low Dose: 16.5 sec
Standard Dose: 20.5 sec
High Definition: 25.5 sec
Ultra High Definition: 32.0 sec | Light Mode: 8.7 sec
High Definition Mode: 8.7 sec
Ultra High Definition Mode: 17.4 sec
Wide Mode: 9.1 sec x 2 | |
| | Scan Time | | |
| | | | |
| CT Scan
Performance | Low Dose, Standard Dose, High Definition, Ultra High Definition:
φ50mm x H50 mm (0.08, 0.10, 0.13, 0.16 mm)
φ80mm x H60 mm (0.13, 0.16, 0.20, 0.25 mm)
φ80mm x H80 mm (0.13, 0.16, 0.20, 0.25 mm) | Light Mode, High Definition Mode, Ultra High Definition Mode:
Diameter 81mm, H75mm | |
| | FOV
(voxel size) | | |
| | Low Dose, Standard Dose, High Definition, Ultra High Definition:
φ80mm x H120 mm (0.16, 0.20, 0.25, 0.32 mm)
φ80mm x H160 mm (0.25, 0.32, 0.40, 0.50 mm) | Wide Mode:
Diameter 113mm, H72mm | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| MTF: 70% | 1.05 lp/mm | 1.2 lp/mm | |
| MTF: 40% | 2.2 lp/mm | 2.2 lp/mm | |
| DQE@0 lp/mm | 46.9% | 51.7% | |
| Photo | Image: ENCOMPASS Eagle 3D K152489 | Image: PREXION 3D ECLIPSE | |
| Operating temperature | +15°C to + 30°C | Not stated | |
| Mains voltage supply | 110/127/220 or 240 Vac
(50/60 HZ) | 230/240 Vac ±10% / 115
Vac (50/60 HZ) | |
| Power consumption | 1.4 kVA | Not Stated | |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE
K122199 | |
| Operation Mode | CBCT, Panoramic or Cephalometric | SAME | |
| Generator type | High Frequency 100 kHz High | High Frequency 40 kHz | |
5
6
-
- Safety, EMC, Biocompatibility (N/A) and Performance Data: Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001; IEC 60601-2-7/2001; 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: MTF and DOE measurements were taken and compared to the predicate. See table above. 3D performance testing was performed yielding the MTF curve and the NPS, noise power spectrum. Accuracy testing and software validation was performed. The Encompass Eagle 3D complies with applicable aspects of 21CFR 1020.30,31, and 33. All test results were satisfactory.
-
- Clinical Data: In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device. They were compared by a licensed dentist. The Images from the Encompass machine are comparable in diagnostic ability, sharpness and quality to images from the Predicate device.
-
- Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Panoramic Corp. concludes that the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric X-Ray is safe and effective and substantially equivalent to predicate devices as described herein.