Clio Prime and Clio Pedo

{0}------------------------------------------------ November 6, 2020 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 seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text. Sota Precision Optics, Inc. dba SOTA Imaging % Mr. Ed Johansen Official Correspondent W. Edward Johansen 1239 Stanford Street. #205 SANTA MONICA CA 90404 #### Re: K202664 Trade/Device Name: Clio Prime and Clio Pedo Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 12, 2020 Received: September 14, 2020 #### Dear Mr. Johansen: 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 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) K202664 Device Name Clio Prime and Clio Pedo #### Indications for Use (Describe) Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient. 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 510(k) Premarket Notification No. K202664 October 29, 2020 #### I. Corporation Information Name: Sota Precision Optics, Inc. dba SOTA Imaging Address: 1073 North Batavia Street, Suite B Orange, California 92867 Telephone: (714) 532-6100 Official Correspondent: W. Edward Johansen Telephone: (310) 795-7425 E-mail address: wedjohansen@msn.com - Main address: <info@namecheap.com> Address: 1600 Stewart Street, #905, Santa Monica, California Address: 1239 Stanford Street, #205, Santa Monica, California 90404 #### II. Identification of New Device Owner/Operator: Sota Precision Optics, Inc. dba SOTA Imaging Establishment Registration Number: 3000190675 Trade Name: Clio Prime and Clio Pedo 510(k) Premarket Notification Number: K202664 Common Name: Dental digital x-ray sensor Classification Name: Extra-oral source x-ray system Product Code: MUH Class: II Panel: Radiology Regulation Number: 21 C.F.R. §872.1800 Manufacturer: SOTA Imaging Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE Systems Inc. Sterilization Facility: Not Applicable {4}------------------------------------------------ ### III. Identification of Predicate Device Owner/Operator/Manufacturer: Dental Imaging Technologies Corporation Establishment Registration Number: 2530069 510(k) Premarket Notification Number: K090458 Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE Systems Inc. Trade Name: DEXIS Platinum sensor and GENDEX GXS-700 sensors Common Name: Dental intraoral x-rav sensor Classification Name: Extra-oral source x-ray system Product Code: MUH Classification: Class II Panel: Radiology Requlation Number: 21 C.F.R. §872.1800 ### IV. Device Description Clio Prime and Clio Pedo are USB-driven digital sensors designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation. Clio Pedo is a smaller version of Clio Prime and is for pediatric use. The Clio Prime and Clio Pedo design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Clio Prime or Clio Pedo is positioned in the patient's mouth in the same manner as intra-oral film is positioned. Each of Clio Prime and Clio Pedo has a CMOS x-ray imager that creates a digital imaqe from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Clio Prime or Clio Pedo through the standard USB port. Image analysis software is not part of the submission. For Clio Prime or Clio Pedo to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. {5}------------------------------------------------ Clio Prime and Clio Pedo capture x-ray imaqes suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient. # V. Indications for Use Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which is intended to acquire dental intraoral radiography imaqes. Clio Prime or Clio Pedo shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient. ### VI. Intended Use Clio Prime and Clio Pedo are intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When Clio Prime or Clio Pedo is to be used in a dental practice, an optional software will be necessary. # VII. Performance Testing-Animal Study SOTA Imaging did not perform an animal study performance testing. # VIII. Performance Testing-Clinical Study SOTA Imaging a clinical study performance testing to determine that Clio Prime, and Clio Pedo performed as well or better than did the DEXIS Platinum sensor and GENDEX GXS-700 sensors. SOTA Imaging has provided clinical images. These clinical images provide further evidence in addition to the laboratory performance data that shows that the complete system works as intended. # IX. Performance Testing-Bench Study On behalf of SOTA Imaging Intertek performed an extensive bench testing on Clio Prime and Clio Pedo. {6}------------------------------------------------ ## X. Comparison Table The following comparison table compares Clio Prime and Clio Pedo to the predicates, the DEXIS Platinum sensor and the GENDEX GXS-700 sensors with respect to intended use, indications of use, environment of use, limitations of use, technical performance and technological characteristics, and provides more detailed information regarding the basis for the determination of substantial equivalence. {7}------------------------------------------------ # Comparison Table | Descriptive<br>Information | DEXIS Platinum<br>sensor and GENDEX<br>GXS-700 sensors | Clio Prime and Clio<br>Pedo | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K090458 | K202664 | | Manufacturer | Dental Imaging<br>Technologies<br>Corporation | Sota Precision Optics,<br>Inc. doing business as<br>SOTA Imaging | | Trade Name | DEXIS Platinum<br>sensor and GENDEX<br>GXS-700 sensors | Clio Prime and Clio<br>Pedo | | Classification Name | System, x-ray,<br>extraoral source | System, x-ray,<br>extraoral source | | Classification Panel | Radiology | Radiology | | Classification | Class II | Class II | | Regulation Number | 21 C.F.R. § 872.1800 | 21 C.F.R. § 872.1800 | | Indication for Use | The DEXIS Platinum<br>sensor or the GENDEX<br>GXS-700 sensors are<br>USB-driven, digital<br>intraoral x-ray sensors<br>which are intended to<br>acquire dental intraoral<br>radiography images.<br>The DEXIS Platinum<br>sensor or the GENDEX<br>GXS-700 sensors shall<br>be operated by<br>healthcare<br>professionals who are<br>educated and<br>competent to perform<br>the acquisition of dental<br>intraoral radiographs.<br>The DEXIS Platinum<br>sensor or the GENDEX<br>GXS-700 sensors can<br>be used either in<br>combination with | Clio Prime and Clio<br>Pedo are USB-driven,<br>digital intraoral x-ray<br>sensors which are<br>intended to acquire<br>dental intraoral<br>radiography images.<br>Clio Prime or Clio<br>Pedo shall be operated<br>by healthcare<br>professionals who are<br>educated and<br>competent to perform<br>the acquisition of<br>dental intraoral<br>radiographs. Clio<br>Prime or Clio Pedo can<br>be used either in<br>combination with<br>special positioning | | | GXS-700 sensors can<br>be used either in<br>combination with | devices to facilitate<br>positioning and<br>alignment with an x-ray<br>beam, or Clio Prime or | | | | | | | special positioning<br>devices to facilitate<br>positioning and<br>alignment with an x-ray<br>beam or the intraoral<br>radiography images.<br>The DEXIS Platinum<br>sensor or the GENDEX<br>GXS-700 sensors shall<br>be operated by<br>healthcare<br>professionals who are<br>educated and<br>competent to perform<br>the acquisition of<br>dental intraoral<br>radiographs. The<br>DEXIS Platinum<br>sensor or the GENDEX<br>GXS-700 sensors can<br>be used either in<br>combination with<br>special positioning<br>devices to facilitate<br>positioning and<br>alignment with an x-ray<br>beam, or the DEXIS<br>Platinum sensor or the<br>GENDEX GXS-700<br>sensors can also be<br>positioned by hand<br>with the assistance of<br>the patient. | Clio Pedo can also be<br>positioned by hand<br>with the assistance of<br>the patient. | | Intended Use | The DEXIS Platinum<br>sensor and the<br>GENDEX GXS-700<br>sensors are indirect<br>converting x-ray<br>detectors, e.g.<br>incident x-rays are | Clio Prime and Clio<br>Pedo are USB-driven<br>digital sensors which<br>are intended to<br>acquire dental<br>intraoral radiography | | converted by a | images. Clio Prime or | | | scintillating material | Clio Pedo shall be | | | into (visible) light, this | operated by healthcare | | | light is coupled | professionals who are | | | optically to a light | educated and | | | detection imager | competent to perform | | | based on CMOS | the acquisition of | | | technology. The | dental intraoral | | | design of the sensor | radiographs. Clio | | | assembly supports the | Prime or Clio Pedo can | | | automatic detection of | be used either in | | | the incident x-rays to | combination with | | | generate digital images | positioners | | | for dental intra-oral | manufactured to | | | applications. The | facilitate the | | | DEXIS Platinum | positioning and | | | sensor or the | alignment with an x- | | | GENDEX GXS-700 | ray beam, or it may | | | sensors supports USB | also be positioned by | | | 2.0 and USB 1.1 | hand with the | | | connectivity to | assistance of the | | | personal computers | patient. Clio Prime or | | | using a dedicated | Clio Pedo can be used | | | electronic assembly | with patients of any | | | and a sensor software | age, providing the | | | driver. The DEXIS | correct positioning of | | | Platinum sensor and | the sensor in the | | | the GENDEX GXS-700 | patient mouth can be | | | sensors are USB- | realized. Using Clio | | | driven digital sensors | Prime or Clio Pedo is | | | which are intended to | a suitable diagnostic | | | acquire dental intra- | method and may offer | | | oral radiography | reduced radiation | | | images. The DEXIS | exposure compared to | | | Platinum sensor and | analog procedures. | | | GENDEX GXS-700 | Furthermore, available |…