3D Accuitomo 150N

{0}------------------------------------------------ February 18, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. J. Morita USA, Inc. % Mr. Keith Barritt Attorney Fish & Richardson P.C. 1000 Maine Avenue. S.W., Suite 1000 WASHINGTON DC 20024 Re: K201378 Trade/Device Name: 3D Accuitomo 150N Model X800N Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: December 30, 2020 Received: December 31, 2020 Dear Mr. Barritt: 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. 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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 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. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201378 Device Name 3D Accuitomo 150N Model X800N #### Indications for Use (Describe) The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients. Type of Use (Select one or both, as applicable) | <div style="display:flex; align-items:center;"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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}------------------------------------------------ #### K#201378 ## 510(k) Summary J. Morita USA Inc. 3D Accuitomo 150N Model X800N X-ray system for Panoramic, Cephalometric and CBCT imaging The following information is provided pursuant to 21 CFR 807.92. #### 807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date #### (i) 510(k) Submitter Registration No. 2081055 J. Morita USA, Inc. 9 Mason, Irvine, CA 92618, USA Phone: 949-581-9600 Fax: 949-581-9688 #### (ii) 510(k) Submitter Contact Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington DC 20024, USA Phone: (202) 626-6433 Fax: (202) 783-2331 Email: barritt@fr.com #### (iii) Preparation Date February 17, 2021 ### 807.92(a)(2): Name of Device | Trade or Proprietary Name: | 3D Accuitomo 150N Model X800N | |-----------------------------|-------------------------------------------------| | Common Name: | Dental Computed Tomography X-ray System imaging | | Device Classification Name: | System, X-Ray, Tomography, Computed | | Review Panel: | 892 Radiology device | | Product Code: | OAS, MUH | | Regulation: | 21 CFR 892.1750 Class II | | Device Class: | Traditional | | 510(k) Type: | | {4}------------------------------------------------ ### 807.92(a)(3): Predicate Device This device is substantially equivalent for purposes of FDA medical device regulations to the following predicate device: | Trade or Proprietary Name: | Veraview X800 (K#171012) | |------------------------------|-------------------------------------------------| | Common Name: | Dental Computed Tomography X-ray System imaging | | Classification Name: | Computed tomography x-ray system | | Device Classification Panel: | Class II, Radiology | | Product Code: | OAS | | Regulation: | 21 CFR 892.1750 | As discussed further below, the following J. Morita reference devices were used to confirm the suitability of the images of the 3D Accuitomo 150N Model X800N (the "X800N") for the general examination and diagnostic ENT indication being added: Veraviewepocs X550 (K#073696) and MCT-1 (K#073695). #### 807.92(a)(4): Device Description The purpose of this 510(k) application is to obtain clearance from FDA for a new ENT indication for J. Morita's already cleared device, the Veraview X800 (K#171012). The new indication is for general examination and diagnosis of the skull including the ENT. The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction. The X800N has three main radiographic modes as follows: - Panoramic tomography including linear tomography and scanogram - - Cephalometric radiography - - -Cone beam computed tomography #### 807.92(a)(5): Intended Use The intended use of the X800N is: - Panoramic tomography including linear tomography and scanogram - - Cephalometric radiography - - Cone beam computed tomography - - General examination and diagnosis of the skull including the ENT. - {5}------------------------------------------------ ## Indication for Use X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients. ## 807.92(a)(6): Technological Characteristics The predicate device Veraview X800 (K#171012) is identical in regards to mechanical performance, imaging area, and the other safety and efficacy related parameters. For the X800N, exactly the same image as the dental application for the X800 is taken and utilized for the ENT application. | Item | Device submitted in this 510(k) | Predicate device | | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Product name | 3D Accuitomo 150N | Veraview X800 | | | | Model | X800N | X800 | | | | Manufacturer | J. MORITA MFG. CORP. | Same as left | | | | Indications for use | X800N is intended to be used for<br>panoramic tomography including<br>linear tomography and scanogram,<br>cephalometric radiography, and<br>cone beam computed tomography.<br>X800N is an extraoral source X-<br>ray unit that is used for dental and<br>head radiographic examination<br>and diagnosis of teeth, jaw, oral<br>structure, temporomandibular<br>joint, skull including the ENT,<br>dento-maxillofacial areas, and<br>hand for maturity assessment, by<br>exposing an X-ray image receptor<br>to ionizing radiation.<br>The device uses a cone shaped X- | Veraview X800 is intended to be<br>used for panoramic tomography<br>including linear tomography and<br>scanogram, cephalometric<br>radiography, and cone beam<br>computed tomography.<br>Veraview X800 is an extraoral<br>source X-ray unit that is used for<br>dental and head radiographic<br>examination and diagnosis of<br>teeth, jaw, oral structure,<br>temporomandibular joint, skull<br>including the dento-maxillofacial<br>areas, and hand for maturity<br>assessment, by exposing an X-<br>ray image receptor to ionizing | | | | | Item | Device submitted in this 510(k) | Predicate device | | | | | ray beam projected on to a flat<br>panel detector, and the examined<br>volume image is reconstructed to<br>be viewed in 2D or 3D viewing<br>stations.<br>The device is to be operated and<br>used by medical doctors, dentists,<br>and other legally qualified<br>professionals for pediatric and<br>adult patients. | radiation.<br>The device uses a cone shaped<br>X-ray beam projected on to a flat<br>panel detector, and the examined<br>volume image is reconstructed to<br>be viewed in 2D or 3D viewing<br>stations.<br>The device is to be operated and<br>used by dentists and other<br>legally qualified professionals<br>for pediatric and adult patients. | | | | Energy used and/or<br>delivered | AC 120 V, 60 Hz | Same as left | | | Design | Loading factors | Tube Potential: 60-100kV<br>Tube Current: 2-10mA<br>Loading time: max. 18.5s | Same as left | | | | X-ray tube<br>assembly | Nominal focal spot: 0.5 at target<br>angle<br>Inherent filtration min. 2.5mmAL | Same as left | | | | X-ray detector 1 | Internal parts code: D001-15038-<br>50*<br>See column in predicate device. | Same as left | | | | X-ray detector 2 | Internal parts code: D001-16044-<br>50*<br>CMOS flat panel<br>Scintillator: CsI<br>Pixel size for Pan: 0.1 mm<br>Pixel size for CBCT: 0.1 mm,<br>0.2 mm | Same as left | | | | Item | Device submitted in this 510(k) | Predicate device | | | | X-ray detector 3 | Internal parts code: D001-04188-<br>50*<br>See column in predicate device. | Same as left- | | | Soft-<br>ware | Viewer<br>(general purpose<br>viewer: not<br>included in this<br>submission of<br>the device) | Viewer software:<br>510K number: K073704<br>Device name: i-Dixel | Same as left | | | | Perfor<br>mance | Panoramic<br>- spatial<br>resolution | Line pair resolution on IEC<br>61223-3-4: min. 2.5 LP/mm | Same as left | | | | Panoramic<br>- noise | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.0 mm<br>at High speed mode, min.<br>diameter 1.0 mm at High<br>resolution mode | Same as left | | Cephalometric<br>- spatial<br>resolution | | Line pair resolution on IEC<br>61223-3-4: min. 2.5 LP/mm | Same as left | | | Cephalometric<br>- noise | | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.5 mm | Same as left | | | CBCT<br>- spatial<br>resolution | | min. 10% MTF at 2.0 LP/mm at<br>standard mode<br>min. 10% MTF at 2.5 LP/mm at<br>high resolution mode | Same as left | | | CBCT<br>- noise | | The standard deviation of the gray<br>scale of the center region of the<br>Contrast phantom shall be less<br>than 12.5 (10% of the full scale). | Same as left | | A comparison table of the X800N to the predicate device is shown below: {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## 807.92(b)(1): Non-clinical Testing The new X800N has been tested for compliance and developed in accordance with the following international standards: | IEC/ISO Standard | FDA Recognition number | |-------------------------------|------------------------| | IEC 60601-1:2005+A.MD1:2012 | 19-4 | | IEC 60601-1-2:2014 | 19-8 | | IEC 60601-1-3:2008+AMD1:2013 | 12-269 | | IEC 60601-1-6:2010+AMD1:2013 | 5-89 | | IEC 60601-2-54:2009+AMD1:2015 | 12-296 | | IEC 60601-2-63:2017 | 12-310 | | IEC 61223-3-4:2000 | 12-221 | | IEC 62304:2006+AMD1:2015 | 13-79 | | IEC 62366:2015 | 5-114 | | ISO 10993-1:2009/Cor1:2010 | 2-220 | | ISO 14971:2007 | 5-40 | The software changes were validated pursuant to the FDA's 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." ## 807.92(b)(2): Clinical Testing Clinical evaluation was performed to evaluate if the CT image obtained by the X800N for general examination and diagnosis of the ENT area is substantially equivalent to that obtained by J. Morita's reference devices, the X550 (K#073696) and MCT-1 (K#073695), which are FDAauthorized for "dental radiographic examination and diagnosis of teeth, jaw, oral structure, TMjoints and skull, including the ENT and dento-maxillofacial areas" and for taking x-ray images "of the head and neck areas, including the ENT and dento-maxillofacial areas, for use in diagnostic support," respectively. ### Methods: Experienced doctors who are using CBCT for their ENT medical practice subjectively evaluated images taken by the X800N, X550, and MCT-1. The images they evaluated were obtained in J. Morita's facility from adult and child human skull phantoms made from resin molding on real human dry skulls. The use of phantom image for evaluation was judged to be appropriate in the majority of cases and no evaluator judged it is not suitable to use the phantom image. The images were then ranked by the evaluators according to five categories: "Excellent Quality for Diagnosis," "Acceptable Quality for Diagnosis," Not Acceptable Quality for Diagnosis," "Not reviewed," and "Other." {9}------------------------------------------------ ## Results: All the evaluators ranked the images of the X800N as "Excellent Quality for Diagnosis" or "Acceptable Quality for Diagnosis." The overall results were better than that of the X550. Thus, the images of the X800N are comparable to the images from the X550. And the results of the X800N were comparable to the MCT-1. # 807.92(b)(3): Conclusions from Testing The clinical evaluation results show that the image quality of the X800N is comparable to the images quality of both the X550 and MCT-1. Thus, the images taken by X800N are sufficient to use for general examination and diagnosis of the ENT area. As the only changes from the previous device are indication for use, change of display icon from dental figure, and the description of operation instructions for the ENT application, the X800N is substantially equivalent to the predicate device.