PreXion3D Excelsior

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PreXion Corporation % Mr. Katsumi Hayashi Director 1-14-1 Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN January 19, 2018 Re: K173878 Trade/Device Name: PreXion3D Excelsior Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 19, 2017 Received: December 21, 2017 Dear Mr. Hayashi: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {1}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K173878 Device Name PreXion3D Excelsior #### Indications for Use (Describe). PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment. 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FORM FDA 3881 (7/17) {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92. 510(k) Number: K173878 # Applicant Information | Date Prepared: | Jan. 15th, 2018 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Name and<br>Address: | PreXion Corporation<br><br>1-14-1 Kandasuda-cho, Chiyoda-ku<br>Tokyo, 101-0041<br>Japan | | Contact Person: | Mr. Katsumi Hayashi<br>Director, Quality Assurance and Regulatory Division<br>Phone: +81-3-5297-7551<br>FAX: +81-3-5297-7552<br>Email: hayashi@prexion.co.jp | # Device Information | Type of 510(k) Submission | Special | |---------------------------|--------------------------------------| | Device Type: | Dental Cone-beam Computed Tomography | | Regulation Description: | Computed Tomography X-Ray System | | Review Panel: | Radiology | | Regulation Number: | 21 CFR 892.1750 | | Product Code: | OAS | | Device Class: | II | | Device Name: | PreXion3D Excelsior | # Predicate Device Information The legally marketed devices to which substantial equivalence is being claimed are: | 510(k) Number: | K161881 | |-------------------------|--------------------------------------| | Device Type: | Dental Cone-beam Computed Tomography | | Regulation Description: | Computed Tomography X-Ray System | | Review Panel: | Radiology | | Regulation Number: | 21 CFR 892.1750 | | Product Code: | OAS | | Device Class: | II | | Device Name: | PreXion3D Excelsior | {4}------------------------------------------------ # Device Description PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure. ## Intended Use/Indications for Use PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. # Comparison to the Predicate Device We added a Complete mode of CT Scan to the Predicate Device(K161881). That function simulatively creates a widen FOV. FOV height is extended from 81mm to 130mm. FOV width is same as one of Wide mode in CT Scan. | Device | Predicate Device(K161881) | Modified Device | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | PreXion3D Excelsior | PreXion3D Excelsior | | | Intended<br>Use/Indications for<br>Use | PreXion3D Excelsior is intended to<br>produce two dimensional digital<br>panoramic and cephalometric<br>images, and three dimensional<br>digital x-ray images of the<br>maxillofacial, and ENT (Ear, Nose<br>and Throat) region at the direction<br>of healthcare professionals as<br>diagnostic support for adult and<br>pediatric patients.<br>Cephalometric imaging also<br>includes the hand and wrist to<br>obtain carpus images for growth<br>and maturity assessment. | Same | | | X-ray<br>Gene | Tube<br>Voltage<br>60-110KV | Same | | | Device | | Predicate Device(K161881)<br>PreXion3D Excelsior | Modified Device<br>PreXion3D Excelsior | | ration<br>Devic<br>e | Pulse<br>Exposure<br>function | Yes | Same | | | Tube<br>Current | 1-6mA | Same | | | Focal Spot<br>Size | 0.3mm | Same | | | Detector | FPD (TFT) | Same | | | Pixel Size | 125 μm x125μm,125µm<br>x250µm(CT)<br><br>125 μm x 125µm(Panoramic)<br><br>140 μm x 140µm (Ceph) | Same | | X-ray<br>Imag<br>e<br>Capt<br>uring<br>Devic<br>e | Pixel<br>Number | 1280x1024 (CT)<br><br>128x1280 (Panoramic)<br><br>2112x1754 (Cephalometric) | Same | | | Size of<br>Area<br>Receiving<br>X-ray | 160mm x 128mm (CT)<br><br>160mm x 12.5mm (Panoramic)<br><br>295.68 x 245.56mm (Ceph) | Same | | | Number of<br>Bits | 16bits (CT, Panorama)<br><br>14bits (Ceph) | Same | | | SID/SOD | 700mm/ 470mm (CT, Panoramic)<br><br>1735mm / 1500mm (Ceph) | Same | | Scan<br>ner | Dimension<br>(WxDxH) | 930 mm x 1230 mm x<br>2220 mm (CT, Panoramic)<br><br>1816 mm x 1230 mm x<br>2220 mm (with Ceph) | Same | | | Weight | 165 kg (CT, Panoramic)<br><br>200kg (Ceph) | Same | | | Imaging Mode | CT scan, Panoramic scan,<br>Cephalometric radiography | Same | | | Panoramic Scan<br>Performance (Scan<br>Time) | 8-16sec | Same | | | Cephalometric<br>Radiography (Scan | 0.5-0.8 sec | Same | | Device | | Predicate Device(K161881)<br>PreXion3D Excelsior | Modified Device<br>PreXion3D Excelsior | | Time) | CT Scan Performance | Scan Time 5.2-23.6sec | Same | | | FOV (Voxel Size) | Diameter 100mm x H81mm<br>(0.100 - 0.200mm) | Diameter 100mm x H81mm<br>(0.100 - 0.200mm) | | | | Diameter 150mm<br>Diameter 100mm x H50mm<br>(0.100 - 0.200mm)<br>Diameter 50mm x H50mm<br>(0.100 - 0.200mm) | Diameter 150mm x H81 (0.200mm)<br>Diameter 100mm x H50mm<br>(0.100 - 0.200mm)<br>Diameter 50mm x H50mm<br>(0.100 - 0.200mm)<br>Diameter 150mm x H130mm<br>(0.100 - 0.200mm) | | Volume Size | | 512x512x512<br>1024x1024x816 | 512x512x512<br>512x512x950<br>1024x1024x816<br>1024x1024x1515 | | Dose Level<br>(CTDIw) | | Standard (110KV, 2.4mA, 9.6s)<br>10cm: 2.9mGy<br>5cm: 1.9mGy | Standard (110KV, 2.4mA, 9.6s)<br>10cm: 2.9mGy<br>5cm: 1.9mGy | | | | Rapid (110KV, 2.4mA, 5.2s)<br>10cm: 0.9mGy<br>5cm: 0.8mGy | Rapid (110KV, 2.4mA, 5.2s)<br>10cm: 0.9mGy<br>5cm: 0.8mGy | | | | High Definition (110KV, 2.4mA,<br>12.8s)<br>10cm: 4.9mGy<br>5cm: 3.2mGy | High Definition (110KV, 2.4mA,<br>12.8s)<br>10cm: 4.9mGy<br>5cm: 3.2mGy | | | | Ultra High Definition (110KV,<br>2.4mA, 23.6s)<br>10cm: 8.7mGy<br>5cm: 4.3mGy | Ultra High Definition (110KV,<br>2.4mA, 23.6s)<br>10cm: 8.7mGy<br>5cm: 4.3mGy | | | | Standard Child (95KV, 1.6mA, 9.6s)<br>10cm: 1.4mGy<br>5cm: 1.0mGy | Standard Child (95KV, 1.6mA, 9.6s)<br>10cm: 1.4mGy<br>5cm: 1.0mGy | | | | Rapid Child (95KV, 1.6mA, 5.2s)<br>10cm: 0.5mGy<br>5cm: 0.4mGy | Rapid Child (95KV, 1.6mA, 5.2s)<br>10cm: 0.5mGy<br>5cm: 0.4mGy | | | | | Complete<br>(110KV, 2.4mA, 19.2s)<br>15cm: 5.8mGy | | | | | Complete Child<br>(95KV, 1.6mA, 19.2s) | | Device | Predicate Device(K161881)<br>PreXion3D Excelsior | Modified Device<br>PreXion3D Excelsior | | | | | 15cm: 2.9mGy | | | Performance<br>Standards | ANSI/AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 62366<br>IEC 62304<br>IEC 60601-2-63<br>IEC 61223-3-4<br>IEC 61223-3-5<br>IEC 60825-1<br>ISO 14971<br>NEMA PS 3.1 - 3.20<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Same | | The subject device compares to the legally marketed devices as follows: {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ # Summary of Performance Testing Verification/validation testing were performed to support the software modifications. Electrical safety, EMC/EMI testing were not performed because there are not any hardware modifications. The assessment of 3D MTF for the subject device was performed to the stitching area of the volume data of Complete mode and confirmed that the results met the predicate device criteria. # Conclusions The subject device has the same intended use/Indications for use as the predicate device. The subject and predicate device also almost same such as specifications of X-ray Generation Device, Xray Image Capturing Device and Scanner, Imaging Mode, Panoramic Scan Performance, Cephalometric Radiography, Spatial Resolution and conformance with performance standards. The subject and predicate device also have differences in technological characteristics, such as FOV (Voxel Size), Volume Size and Dose Level (CTDIw) in CT Scan Performance. Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and performance testing that the subject device is substantially equivalent to the legally marketed device identified in this submission.