BI IMAGE-X EVOLUTION

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 20, 2016 Radiotecnologia Industrial S.A. De C.V. % Claude Berthoin, President Denterprise International, Inc./ 510k FDA Consulting 100 East Granada Blvd Suite 219 Ormond Beach, FL 32176 Re: K160458 Trade/Device Name: BI IMAGE-X EVOLUTION Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: May 6, 2016 Received: May 10, 2016 Dear Claude Berthoin: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert Oaks 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160458 Device Name BI IMAGE-X EVOLUTION Indications for Use (Describe) The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The eagle's feathers are detailed, and the overall image is well-drawn. # 510k FDA Consulting ### Medical Device Clearance 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 386-506-8711 # 510(k) Summary #### Submitter/Applicant Radiotecnologia Industrial S.A. de C.V. Calle Puebla Sur, Manzana 4 Lote 5 Colonia Jardin Industria Ixtapaluca, Estado de Mexico, Mexico 56535 Contact: Marcelo Mojica, Engineering Manager Telephone: (01) 800-681-05-38 Date Prepared: February 15, 2016 #### Preparer/Consultant Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 Phone: 386-506-8711 Fax: 855-235-7902 | Primary Contact: | Joyce St. Germain, Regulatory Executive | |---------------------|-----------------------------------------| | | Joyce@510kFDA.com | | Secondary Contract: | Claude Berthoin, President | | | Claude@510kFDA.com | #### Device Classification | Trade Name: | |----------------------| | Common Name: | | Classification Name: | | Regulation Number: | | Product Code: | | Regulatory Class: | | 510k Review Panel: | BI IMAGE-X EVOLUTION Extraoral Source X-ray System Unit, X-Ray, Extraoral with Timer 21 CFR 872.1800 EHD 2 Dental {4}------------------------------------------------ #### Predicate Device The subject device claims equivalence to the following legally marketed predicate: | 510(k) Number: | K122582 | |----------------------|-----------------------------------| | Date Cleared | December 7, 2012 | | Trade Name: | Dental X-Ray Z70 | | Common Name: | Extraoral Source X-ray System | | Classification Name: | Unit, X-Ray, Extraoral with Timer | | Regulation Number: | 21 CFR 872.1800 | | Product Code: | EHD | | Regulatory Class: | 2 | | 510k Review Panel: | Dental | #### Indication for Use The BI IMAGE-X EVOLUTION is an extraoral x-ray generator system is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor. #### Intended Use The BI IMAGE -X EVOLUTION device is an extroral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made. #### Device Description The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand. Choice of model is a matter of functional utility in the dental operatory and personal preference by the medical professional. The type of model used does not change the performance of the device. Different models neither affect the device's indications for use nor raise differing issues of safety or effectiveness. #### Comparison of Technological data on next page {5}------------------------------------------------ # Characteristics with Predicate The following table compares technological and other characteristics of the subject and predicate device. # Table 5 -- Technological Comparison | | Subject Device | Predicate Device<br>K122582 | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | BI IMAGE-X | Dental X-Ray Z70 | | 510(k) Owner | Radiotecnologia<br>Industrial S.A. de C.V.<br>(Mexico) | XZeal Technologies, Inc.<br>(Kissimmee, FL) | | Classification & Product<br>Code | 872.72.1800; EHD | 872.1800; EHD | | Device Description | Extroral x-ray system<br>used for dental<br>radiographic<br>examinations and<br>diagnosising. | Extroral x-ray system<br>used for dental<br>radiographic<br>examinations and<br>diagnosising. | | Common Name | Extraoral Source X-ray<br>System | Extraoral Source X-ray<br>System | | Models | Wall Mount, Mobile<br>and Column Units | Wall Mount, Mobile<br>and Column Units | | Indication for Use | The BI IMAGE-X<br>EVOLUTION is an<br>extraoral x-ray<br>generator system is<br>designed to be used by<br>dental professionals for<br>radiographic<br>examinations to assist<br>with diagnosis of<br>diseases of the teeth,<br>jaw, and oral structure<br>in combination with an<br>intraoral image<br>receptor. | TheDental X-ray Z70<br>device is an X-Ray<br>generator that<br>provides the radiation<br>necessary for the<br>formation of a<br>radiographic image<br>from which a<br>radiographic diagnosis<br>may be made. | | Intended Use | The BI IMAGE -X<br>EVOLUTION device is an<br>extraoral x-ray<br>generator that provides<br>the radiation necessary<br>for the formation of a<br>radiographic image<br>from which a | Extraoral source X-ray<br>system for dental<br>radiographic<br>examination and<br>diagnosis of diseases<br>of the teeth. | | | radiographic diagnosis<br>may be made. | | | Electric Power Voltage | 108-132 VAC Monophase<br>rectified | 120 VAC ± 10% or<br>230 VAC ± 10% | | Rated Current | 10A max (120V) | 9 A (120V) - 4A (230V) | | Type of Power Supply | 50/60 Hz | 50/60 Hz | | kVp (kilovolt peak) | 70 kVp +/- 15% with 108-<br>132 V | 70 kVp ± 10% | | Exposure Time | 0.01-2.2 sec | 0.06 — 2.50 sec | | Current to Tube | 10 mA +/- 20% | 7 mA ± 1.40 | | Maximum Radiation Field | Ø 60 mm | Ø 60 mm | | Focal Point | 0.8mm (IEC366) | 0.8 mm x 0.8 mm<br>(IEC 336) | | X-Ray Generator | AC - Alternate Current | AC - Alternate Current | | Operator Exposure Control | Deadman Switch | Deadman Switch | | Exposure Interval<br>(Duty Cycle) | 1:32 | 1:60 | | Minimum Distance<br>between the source and<br>the skin - SSD | 20 cm | 20 cm | | Fuses | 10A 250V | 10A 230V | | Operatiang Temperature<br>Range | -20°C - + 70°C | -20°C - + 55°C | | Fixed Arm | 27.56 inches (70 cm) | 27.56 inches (70 cm) | | Standards of Conformity | IEC 60601-1<br>IEC 60601-6<br>IEC 60601-3<br>IEC 60601-2-28<br>EN 60601-1-2 | EN 60601-1<br>EN 60601-2-28<br>EN 60601-2-54<br>EN 60601-1-3<br>EN 60601-1-2 | {6}------------------------------------------------ The above comparison shows the subject and predicate devices have substantially similar technology characteristics. {7}------------------------------------------------ #### Performance Data The following performance data were provided in support of the substantial equivalence determination. EMC and Electrical Safety – IEC 60601-1 3rd Edition (which include IEC test specifications: 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2. The testing data reports for the subject device are provided in this petition. Tests were conducted by independent laboratory (Met Laboratories, Inc. 33439 Western Avenue, Union city, CA 94587. This device conforms to all applicable performance standards in 21CFR 1020.030 and 1020.31. Software - Software verification and validation testing and risk analysis assessment were performed by Radiotech and is a part of this submission. #### 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. #### Conclusion The subject and the predicate device have the same intended use and the same technological features. The BI IMAGE – X and the Dental X-Ray Z70 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. The BI IMAGE - X warrants a finding of substantial equivalence to the legally marketed Dental X-Ray Z70 and thus clearance for premarket activities in the United States.