RiX70 DC

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September 13, 2018 Trident s.r.l % Joyce St. Germain Regulatory Consultant The 510k Consulting LLC 1449 Springleaf Dr. Ormond Beach, Florida 32174 Re: K182206 Trade/Device Name: RiX70 DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: August 8. 2018 Received: August 15, 2018 Dear Joyce St. Germain: 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 mav, 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 avare 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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. Hole 2. Nils Robert A. 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) K182206 Device Name RiX70 DC Indications for Use (Describe) RiX70 DC X-ray Unit is designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-----------------------------------------------------------| | <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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 #### Submitter/Applicant Trident s.r.l. Via Artigiani 4, Castenedolo, 25014 (BS), Italy Phone: +39 0302732485 Fax: +39 0302731647 Contact: Giorgio Rizzo, President Giorgio.rizzo33@trident-dental.com Date Prepared: August 08, 2018 #### Preparer/Consultant The 510k Consulting, LLC Phone: 904-477-3203 Primary Contact: Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com #### Device Classification | Trade Name: | RiX70 DC | |--------------------|-----------------------------------| | Common Name: | Unit, X-Ray, Extraoral with Timer | | Regulation Name: | Extraoral Source X-ray System | | Regulation Number: | 21 CFR 872.1800 | | Product Code: | EHD | | Regulatory Class: | II | | 510k Review Panel: | Dental | #### Predicate Device The subject device claims equivalence to the following legally marketed predicate: | 510(k) Number: | K163519 | |--------------------|----------------------------------| | Date Cleared | January 13, 2017 | | Trade Name: | RX DC | | Common Name: | Unit, X-Ray, Extraoral with Time | | Regulation Name: | Extraoral Source X-ray System | | Regulation Number: | 21 CFR 872.1800 | | Product Code: | EHD | | Regulatory Class: | II | | 510k Review Panel: | Dental | {4}------------------------------------------------ #### Indications for Use RiX70 DC X-ray Unit is designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors. #### Intended Use The RiX70 DC is designed for the acquisition of intraoral images of the teeth, jaw and the mouth structure for diagnostic purposes. #### Device Description The subject device is RiX70 DC X-rav Unit and it is an extraoral source dental x-ray system intended for intraoral imaging. The subject device is a device comprised of a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively: - A control unit equipped with wall plate, extension arm and wired control . device. - A tube head with x-ray tube. X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique. The system can be used either with conventional film or a digital imaging system. The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp. Comparison of Technological Characteristics with Predicate on next page. The following table compares technological and other characteristics of the subiect and predicate device. {5}------------------------------------------------ ## Table 5.1 -- Technological Comparison | | Subject Device | Predicate Device | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Device | RiX70 DC | RX DC | NA | | Manufacturer | Trident s.r.l., Italy | Isemed Srl, Italy | NA | | 510(k) Number | NA | K163519 | NA | | Classification &<br>Product Code | 872.1800; EHD | 872.1800; EHD | Same | | Device Description | Dental X-ray<br>System | Dental X-ray<br>System | Same | | Common Name | Extraoral Source<br>X-ray System | Extraoral Source<br>X-ray System | Same | | Indications for use | RiX70 DC X-ray<br>Unit is designed<br>for use in dental<br>surgery to make<br>endo-oral x-rays<br>for diagnostic<br>purposes. This<br>equipment can be<br>used to produce<br>traditional x-rays<br>developed using<br>chemicals or,<br>alternatively, it<br>can be used with<br>digital x-ray<br>sensors. | RX DC x-ray unit<br>is designed for<br>use in dental<br>surgery to make<br>endo-oral x-rays<br>for diagnostic<br>purposes. This<br>equipment can be<br>used to produce<br>traditional x-rays<br>developed using<br>chemicals or,<br>alternatively, it<br>can be used with<br>digital x-ray<br>sensors. | Same | | Intended use | The RiX70 DC is<br>designed for the<br>acquisition of<br>intraoral images of<br>the teeth, jaw and<br>the mouth<br>structure for<br>diagnostic<br>purposes. | Same as<br>Indications for<br>Use Statement | Same | | Principle of use | X-ray tube | X-ray tube | Same | | Installation<br>configuration | Wall-mounted<br>standard version<br>and Stand mobile<br>version | Wall-mounted<br>standard version | Similar /<br>Subject device<br>has an<br>additional<br>option | | X-ray emission<br>control | Wired control | Remote control | Different | | HV generator | High frequency<br>Constant potential | High frequency<br>Constant<br>potential | Same | | Anode material | Tungsten | Tungsten | Same | | Tube voltage<br>(kV) | 60, 65, 70 kV | 60 kV | Different | | Tube current<br>(mA) | 7 mA fixed | 7 mA<br>3.5 mA | Similar | | Exposure time | 0.02 sec-2 sec (R'<br>so steps) | 0.01 sec - 1 sec<br>(in R 20 steps) | Different | | X-ray tube &<br>Anode angle | 16° | 12.5° | Similar | | Focal spot size | 0.4mm<br>IEC 60336/1993 | 0.4mm | Same | | Leakage<br>radiation | < 0.25 mGy/h (@<br>1 m) | < 0.25 mGy/h (@<br>1 m) | Same | | Focus film<br>distance | Standard round<br>(fix): 200 mm (8")<br>Standard<br>rectangular<br>(removable):<br>45x35mm | Short round (fix):<br>200 mm (8")<br>Long<br>rectangular<br>(removable):<br>300mm (12") | Different size | | Diameter of x-<br>ray beam cone | Short round (fix):<br>Ø 60 mm | Short round<br>(fix): Ø 60 mm<br>Long<br>rectangular<br>(removable): Ø<br>45x35mm<br>Round<br>(removable):<br>Ø 55 mm | Different size | | Exposure times<br>control | Microprocessor<br>controlled<br>exposure times | Microprocessor<br>controlled<br>exposure times | Same | | Exposure<br>modes | Preset loading<br>factors or manual<br>mode | Preset loading<br>factors or manual<br>mode | Same | | Selectable<br>parameter | Patient type,<br>anatomical<br>position, film type | Patient type,<br>anatomical<br>position | Same | | Patient type | Adult--Child | Adult--Child | Same | | Tooth type | Molar (upper and<br>lower)<br>Premolars (upper<br>and lower)<br>Incisors/canines<br>(upper and lower)<br>Bite wing | Molar (upper and<br>lower)<br>Premolars (upper<br>and lower)<br>Incisors/canines<br>(upper and lower)<br>Bite wing | Same | | Film type | Photo-stimulated<br>plate or sensor | Photo-stimulated<br>place or sensor | Same | | Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 62304<br>IEC 62366<br>ISO 14971 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 62304 | Subject device<br>performed<br>more IEC<br>standards on<br>the device.<br>Both passed<br>all standards<br>performed. | ## Table of Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ The above comparison shows the subject and predicate devices have substantially similar technology characteristics. #### Non-Clinical Performance Data The following performance data was provided in support of the substantial equivalence determination. Non clinical tests performed on the subject device: Safety and EMC tests conducted in compliance with the declared standards: - IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) . - IEC 60601-1-6:2010 - IEC 62366: 2007 - IEC 60601-1-3:2008 (Second Edition) - . IEC 60601-2-65:2012 - . IEC 60601-1-2:2007 (EMC) For all consensus standards here above all requirements have been met. Trident has obtained a CB certificate (CBTC IT-16415 2016-01-29) from IMQ ltalv. Software/Firmware quality activities were conducted as appropriate for a Moderate Level of Concern, and included activities for conformance with IEC 62304, Medical device software: Software Life Cycle Processes. #### Risk Analysis Information Risk analysis includes particular recommendations to address radiation exposure to the user under mobile operating conditions. Operators should always read the user manuals for medical devices and take the necessary precautions before using the device. Methods to reduce exposure is recommended safety precautions such as wearing personnel monitoring and protective equipment. Additional information for safety is found in the user manual for this device. Risk management was performed according to ISO 14971. This device is known as a moderate level of concern. #### Conclusion The subject and the predicate device have the same indications for use and the same intended use and the similar technological features. The RiX70 DC and the predicate, RX DC share the same principles of operation and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate. {9}------------------------------------------------ Page 7 of 7 The RiX70 DC warrants a finding of substantial equivalence to the legally marketed RX DC and thus clearance for premarket activities in the United States.