MYRAY HYPERION

{0}------------------------------------------------ # 510(k) Summary for the Cefla, s.c. - Cefla Dental Group Cefla MyRay Hyperion # 1101661 #### 1. SPONSOR SEP 1 G 2010 Cefla, s.c. - Cefla Dental Group via Selice Prov. le 23/a Imola, BO 40026 Italy | Contact: | Simona Daidone | | |------------|-----------------|--| | Telephone: | +39 0542 653111 | | Date Prepared: June 11, 2010 #### 2. DEVICE NAME Proprietary Name: Common/Usual Name: Classification Name: MyRay Hyperion Dental Panoramic X-ray system System, x-ray, extraoral, source, digital #### 3. PREDICATE DEVICES - · Instrumentarium Dental Inc., Orthopantomograph OP200D (K043612) - Sirona Dental System GmbH, Orthophos XG DS (K033073) . - Gendex, Orthoralix 9200 DDE (K032355) . #### 4. INTENDED USE The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures. #### 5. DEVICE DESCRIPTION The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the {1}------------------------------------------------ imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla). A detailed description of the components is provided below. #### Telescopic Column The telescopic column supports the patient arm at which the patient stands during X-ray exposures. It also includes the patient handles which the patient holds during imaging and a plate which contains the mid-sagittal laser beam, the bite block and chin rest. The telescopic column allows adjustment of the patient arm to the patient's height. #### Overhead Assembly The overhead assembly supports the main horizontal and rotating arm. The rotating arm holds the x-ray generator and the collimator in a fixed position opposite to the x-ray image detector. #### Console The console allows the user to select the projection mode and the exposure factors, view the machine status information, control the height of the telescopic column, adjust the reset of the Y-axis, and turn on the laser guide lights. A system emergency stop button is included on the console so the user can immediately stop the procedure. #### Control Panel The control panel serves as the user interface with the electronic control system. The layout of the controls has been designed to split the panel into 2 sections. The "Procedure programming" area is found on the left side from which the user selects the type of procedure to be performed and technical settings. The "Assisted positioning" area is found on the right side of the panel which contains the controls to move the unit to position the patient. In addition, a port for an SD card (Secure Digital Memory Card) is provided at the bottom of the control panel. If this card is inserted, the images can be saved without having to connect the unit to a computer. #### Control System The electronic components which control the system operation consist of the following: - · Main unit- providing real-time system control as well as motor drive; - · Power unit- connecting to the mains power supply and providing the 400 VDC bus for the system; - · Converter unit- controlling the power to the x-ray generator; {2}------------------------------------------------ - · Sensor unit- controlling the x-ray image detector #### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The Cefla MyRay Hyperion dental x-ray system is similar in design and materials to the Instrumentarium OP200D, subject of K043612, the Sirona Orthophos XG DS, subject of K033073, and the Gendex Orthoralix 9200 DDE subject of K032355. The similarities in intended use, operational characteristics, and functional technological characteristics between the MyRay Hyperion, OP 200D, and Orthophos XG DS dental x-ray systems lead to a conclusion of substantial equivalence between the proposed and predicate devices. A comparison between the features of the proposed device and those of the predicate devices is shown in Table 5-1 below: | Comparison Chart | Hyperion | Instrumentarium OP<br>200 D | Sirona<br>Orthophos XG 5 | Gendex<br>Orthoralix 9200 | |------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------| | Maximum total weight | 145 kg | 175 kg | 183 kg | 115-212 kg | | Nominal voltage | 230/115 VAC | 230/115 VAC | 230/115 VAC | 250-115 VAC | | Nominal frequency | 60 Hz | 60 Hz | 60 Hz | 60 Hz | | X-ray source: geometry<br>and type | Fan beam, High<br>Frequency<br>Constant Potential | Fan beam, High<br>Frequency Constant<br>Potential | Fan beam, High<br>Frequency<br>Constant Potential | Fan beam, High<br>Frequency<br>Constant Potential | | X-ray source: focal spot | 0.5mm | 0.5mm | 0.5mm | 0.5 mm | | X-ray source: max.<br>energy | 85 kVp | 85 kVp | 90 kVp | 84 kVp | | Exposure Time (std.<br>panoramic) | 9.3 s | 17.6 s | 14.2 s | 12 s | | Patient position | Lateral | Frontal | Frontal | Frontal | | Detector: type | CCD | CCD | CCD | CCD | | CCD pixel size | 48 microns | 48 microns | 27 microns | 48 microns | | Detector area | 147 x 6 mm | 147 x 6 mm | N.A. | 147 x 6 mm | | Detector: gray scale | 12 bit | 12 bit | 16 bit | 12 bit | | Image pixel size | 96 x 96 microns | 96 x 96 microns | N.A. | 96 x 96 microns | | Computer interface | LAN | Proprietary (PCI slot) | LAN | LAN | | Patient positioning | 3 laser lines | 3 laser lines | 2 laser lines | 3 laser lines | # Table 5-1. Comparison Table for Determination of Substantial Equivalence NA=Not available, LAN=Local area network, PCI=Personal Computer Instrumentation {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three wavy lines, which may represent people or services. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Cefla Dental Group % Ms. Mary McNamara-Cullinane Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 SEP 1 6 2010 Re: K101661 Trade/Device Name: Cefla MyRay Hyperion Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 11, 2010 Received: June 14, 2010 Dear Ms. McNamara-Cullinane: 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 220). This letter will allow you to begin marketing your device as described in your Section 5100%) premarket. notification. The FDA finding of substantial equivalence of your device to a legal y renatisted predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Donald J. Trump Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health #### Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K161661 Device Name: Cefla MyRay Hyperion SEP 1 6 2010 i Indications for Use: The Cefla MyRay Hyperion is indicated for use in producing panoramic X-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures. Prescription Use X (Part 21 CFR 801 Subpart D) ### AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (00) C Division Sign Only ion Sian-O Division of Radiological Dev Office of In Vitro Diagnostic Device Eva 510K KIOKIOI