ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

K152489 · Panoramic Corp. · OAS · Feb 4, 2016 · Radiology

Device Facts

• Record ID: K152489
• Device Name: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
• Applicant: Panoramic Corp.
• Product Code: OAS · Radiology
• Decision Date: Feb 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended 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

Device Story

ENCOMPASS Eagle 3D is a 3-in-1 dental imaging system; performs tomography, digital panoramic, and cephalometric profiles. Device uses CCD/CMOS sensor technology with scintillator; features three movement axes (two orthogonal, one rotational) for complex imaging profiles around dental arch. System includes radiographic emission compensation for spinal region; reconstructs dental arch into plane images. Operated by dental healthcare professionals in clinical settings. Device provides various imaging modes (e.g., standard, low dose, high definition) to prioritize diagnostic needs or dose reduction. Output consists of digital radiographic images used by dentists for advanced diagnosis; aids in clinical decision-making by providing detailed anatomical visualization of dento-maxillo-facial region.

Clinical Evidence

Clinical evaluation involved comparing images acquired by the subject device and the predicate device. A licensed dentist reviewed the images and determined that the ENCOMPASS Eagle 3D images are comparable in diagnostic ability, sharpness, and quality to those produced by the predicate device.

Technological Characteristics

3-in-1 dental X-ray system; high-frequency (100 kHz) generator. Detectors: CMOS (CT), CCD (Panoramic/Ceph). Imaging modes: CBCT, Panoramic, Cephalometric. Connectivity: Digital output. Standards: IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), IEC 60601-1-3, 2-7, 2-28, 2-32 (X-ray performance), 21 CFR 1020.30, 31, 33. Software includes auto image processing for workflow optimization.

Indications for Use

Indicated for patients requiring 2D digital panoramic/cephalometric or 3D CBCT imaging of the dento-maxillo-facial region for advanced diagnosis by qualified dental healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Prexion3d Eclipse (K122199)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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 <i>one</i> or <i>both</i> , as applicable) |
|----------------------------------------------------------------|
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 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

1. Company and Correspondent making the submission: Name - Panoramic Corp. Address - 4321 Goshen Rd., Fort Wayne, IN 46818 Telephone - 800-654-2027 Contact - Doug Pack

2. 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

- 3. 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.
- 4. 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.
- 5. 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.
- 6. 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.

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| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE<br>K122199 | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications for use | ENCOMPASS Eagle 3D is intended to<br>acquire two-dimensional digital<br>panoramic and cephalometric<br>radiographies, and multi-field of view 3D<br>computed tomography images of dento-<br>maxillofacial region for the purpose of<br>advanced diagnosis at the direction of<br>qualified dental healthcare professionals. | PREXION 3D ECLIPSE is intended<br>to produce two dimensional<br>digital panoramic and<br>cephalometric images, and three-<br>dimensional digital X-ray images<br>of dento-maxillofacial region at<br>the direction of healthcare<br>professionals as diagnostic<br>support. | |
| X Ray<br>Generation<br>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<br>capturing device | Detector | CMOS (CT)<br>CCD (Panoramic)<br>CCD (Ceph) | FPD |
| | Pixel Size | 100 μm (CT)<br>108 μm (Panoramic)<br>108 μm (Ceph) | 200 μm (CT)<br>100 μm (Panoramic)<br>54 μm (Ceph) |
| | Pixel Number | 1316 x 1312 (CT)<br>64 x 1395 (Panoramic)<br>64 x 2040 (Ceph) | 640 x 656 (CT)<br>80 x 1312 (Panoramic)<br>128 x 4080 (Ceph) |
| | Size of Area<br>receiving X-Ray | 131.6 x 131.2 mm (CT)<br>6.9 x 151 mm (Panoramic)<br>6.9 x 221 mm (Ceph) | 128.1 x 131.3 mm (CT)<br>8 x 131.3 mm (Panoramic)<br>6.9 x 312 mm (Ceph) |
| | Number of Bit | 14 bits (CT,)<br>16 bits (Ceph, Panoramic) | 14 bits (CT, Panoramic)<br>16 bits (Ceph) |
| | SID/SOD | 634mm/400mm(CT)<br>564mm/400mm (Panoramic)<br>1681mm/1511mm (Ceph) | 620mm/400mm(CT, Panoramic)<br>1650 mm/1500 mm (Ceph) |
| Scanner | Dimension (WxDxH) | 1511mm x 1074mm x 1742mm | 1245mm x 1288mm x 2045mm<br>(CT, Panoramic)<br>1805mm x 1288mm x 2045mm<br>(Ceph) |
| | Weight | 115kg (CT, Panoramic)<br>152kg (Ceph) | 260kg (CT, Panoramic)<br>300kg (Ceph) |
| Imaging Mode | | CT scan, Panoramic scan, Cephalometric<br>radiography | CT scan, Panoramic scan,<br>Cephalometric radiography |
| Panoramic Scan Performance | | Standard Panoramic: 14 sec<br>TMJ Panoramic: 14 sec<br>Maxillary Sinus: 8 sec<br>Improved Orthogonality Panoramic: 14<br>sec | Standard Mode : 14 sec |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE K122199 | |
| | Low Dose Panoramic: 11 sec<br>Child Panoramic: 10.5 sec<br>Bitewing: 7.6 sec<br>Improved Bitewing: 7.6 sec | | |
| Cephalometric Radiography | LA, PA, Carpus, Oblique:<br>6.6, 10, 11, 16.5 sec | LA, PA, Carpus:<br>8, 10, 12, 15 sec | |
| | Low Dose: 16.5 sec<br>Standard Dose: 20.5 sec<br>High Definition: 25.5 sec<br>Ultra High Definition: 32.0 sec | Light Mode: 8.7 sec<br>High Definition Mode: 8.7 sec<br>Ultra High Definition Mode: 17.4 sec<br>Wide Mode: 9.1 sec x 2 | |
| | Scan Time | | |
| | | | |
| CT Scan<br>Performance | Low Dose, Standard Dose, High Definition, Ultra High Definition:<br>φ50mm x H50 mm (0.08, 0.10, 0.13, 0.16 mm)<br>φ80mm x H60 mm (0.13, 0.16, 0.20, 0.25 mm)<br>φ80mm x H80 mm (0.13, 0.16, 0.20, 0.25 mm) | Light Mode, High Definition Mode, Ultra High Definition Mode:<br>Diameter 81mm, H75mm | |
| | FOV<br>(voxel size) | | |
| | Low Dose, Standard Dose, High Definition, Ultra High Definition:<br>φ80mm x H120 mm (0.16, 0.20, 0.25, 0.32 mm)<br>φ80mm x H160 mm (0.25, 0.32, 0.40, 0.50 mm) | Wide Mode:<br>Diameter 113mm, H72mm | |
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| 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<br>(50/60 HZ) | 230/240 Vac ±10% / 115<br>Vac (50/60 HZ) | |
| Power consumption | 1.4 kVA | Not Stated | |
| ITEM | ENCOMPASS Eagle 3D K152489 | PREXION 3D ECLIPSE<br>K122199 | |
| Operation Mode | CBCT, Panoramic or Cephalometric | SAME | |
| Generator type | High Frequency 100 kHz High | High Frequency 40 kHz | |

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- 7. 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.
- 8. 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.
- 9. 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.