Orthophos S

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July 16, 2019 Dentsply Sirona % Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W YORK PA 17401 Re: K191616 Trade/Device Name: Orthophos S Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: June 17, 2019 Received: June 18, 2019 Dear Mr. Nittinger: 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 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-reporting {1}------------------------------------------------ combination-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 medical devices and radiation-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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K191616 Device Name Orthophos S Indications for Use (Describe) The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 # 510(k) SUMMARY K191616 Orthophos S #### 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404 | Contact Person: | Karl Nittinger | |-------------------|-----------------------------------| | Telephone Number: | 717-849-4424 | | Fax Number: | 717-849-4343 | | Email Address: | karl.nittinger@dentsplysirona.com | Date Prepared: 15 July 2019 - 2. Device Name: | Proprietary Name: | Orthophos S | |----------------------|----------------------------------| | Classification Name: | Computed Tomography X-ray system | | CFR Number: | 21 CFR 892.1750 | | Device Class: | Class II | | Product Code: | OAS | ### 3. Predicate Device: The predicate and reference devices identified relating to the substantial equivalence of the Orthophos S are: {4}------------------------------------------------ | Primary Predicate Device Name | 510(k) | Company Name | |-------------------------------|---------|-----------------------------------------------------------------------| | Orthophos SL | K150217 | Sirona Dental Systems GmbH<br>(Owner Operator: Dentsply Sirona, Inc.) | Product Code: OAS | Reference Device | 510(k) | Company Name | | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--| | SIDEXIS 4 | K132773 | Sirona Dental Systems GmbH<br>(Owner Operator: Dentsply Sirona, Inc.) | | | CFR Number:<br>Device Class:<br>Product Code: | Classification Name: Picture archiving and communication system<br>21 CFR 892.2050<br>Class II<br>LLZ | | | 4. Description of Device The proposed Orthophos S is a dental cone-beam CT system (CBCT), which comprises sensor units for 2D cephalometric exposures, 2D panoramic radiograph and 3D volume exposure. The combination of sensors varies depending on the installed device configuration. In the proposed device, the 3D sensor, as well as the 2D cephalometric sensor, are identical to the corresponding sensors utilized in the predicate device (K150217). However, with respect to the 2D panoramic exposures, the proposed Orthophos S device utilizes a CMOS (scintillation) sensor whereas the predicate Orthophos SL (K150217) utilizes a CMOS (direct conversion) sensor. Orthophos S uses an x-ray beam that rotates around the patient's head. Detectors acquire twodimensional x-ray images at varying radiographic angles. An enhanced software algorithm generates the 2D panoramic and 2D cephalometric images and the reconstruction algorithm reconstructs the 3D volumetric image from the raw image data. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the sensor/x-ray source movement. Furthermore, the radiation dose can be adapted by various parameters such as program types and exposure technique factors. These functions are available for CBCT, cephalometric and panoramic exposures. A Class I laser beam is utilized to define reference lines for the correct patient position. The patient is stabilized through different bite blocks and the motoric driven forehead and temple supports. The obtained digital image data is processed to provide a reconstructed image to the operator/user. The reconstructed images are transferred to the currently marketed SIDEXIS 4 imaging processing software (K132773) and stored in the SIDEXIS 4 software database. The proposed Orthophos S device uses the same SIDEXIS 4 image processing software (K132773) as does the predicate device {5}------------------------------------------------ (K150217) and there are no changes to the SIDEXIS 4 software (K132773) introduced in this premarket notification. The proposed Orthophos S device includes metal artifact reduction software feature which automatically reduces image artifacts caused by radiopaque objects. This identical software feature is also included in the predicate Orthophos SL (K150217) device and remains unchanged in the proposed device. A user control panel allows user actions as e.g. height adjustment, selection of programs and exposure parameters and delivers information about the unit status. For 3D imaging, the proposed Orthophos S allows the user to select volume sizes, within which multiple fields of view, anatomic positions, and collimation may be selected. This is intended to allow the clinician to select the field of view based on the diagnostic need and to minimize the dose exposed to the patient. The table below summarizes the selectable 3D imaging choices available to the clinician. | | Diameter in cm | Height in cm | Collimation: Upper jaw | | Collimation: Lower jaw | | |-------|----------------|--------------|------------------------|--------------|------------------------|--------------| | | | | Diameter in cm | Height in cm | Diameter in cm | Height in cm | | Vol1 | 8 | 8 | 8 | 5.5 | 8 | 5.5 | | Vol 2 | - | - | 5 | 5.5 | 5 | 5.5 | | Vol 3 | 11 | 10 | 11 | 7.5 | 11 | 8.0 | The main components of the proposed Orthophos S device components are: - X-ray source ● - X-ray detector (flat panel and/or PAN sensor) - . Operator panel - . Laser locator - . Cephalometric arm with detector (Ceph sensor) - . Remote control (only by wire). #### 5. Indications for Use The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures. {6}------------------------------------------------ ### 6. Substantial Equivalence The subject Orthophos S has the same intended use as the predicate device Orthophos SL (K150217). Both the Orthophos S and the primary predicate device are intended as Computed Tomography X-ray systems under 21 CFR 892.1750. The proposed Orthophos S device and predicate Orthophos SL (K150217) incorporate the same functional imaging capabilities (2D panoramic, 2D cephalometric, and 3D volumetric imaging). The principles of operation and patient fixation features of both the proposed and predicate (K150217) devices are identical as is the overall workflow principals. The primary differences between the proposed Orthophos S and predicate (K150217) devices is the difference in 2D panoramic image sensor technology. The proposed device utilizes a CMOS scintillation method image sensor for 2D panoramic imaging, while the predicate Orthophos SL device utilizes a CMOS direct conversion sensor (DCS) for 2D panoramic imaging. In addition, the proposed Orthophos S does not include image visualization with lingual-buccal exploration, while the predicate device (K150217) includes this functionality. ### Indications for Use | Proposed Device | Predicate Device | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Orthophos S | Orthophos SL<br>(K150217) | | The X-ray system creates data for digital<br>exposures in the maxillofacial area and in<br>subareas for dentistry and pediatric dentistry,<br>for hard-tissue diagnostics within ENT<br>medicine, and carpus exposures. | The X-ray system creates data for digital<br>exposures in the maxillofacial area and in<br>subareas for dentistry and pediatric<br>dentistry, for hard-tissue diagnostics within<br>ENT medicine, and carpus exposures. | {7}------------------------------------------------ # Technological Comparison | Device | Proposed Device<br>Orthophos S | Predicate Device<br>Orthophos SL<br>(K150217) | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Unit data | | | | Nominal voltage | 200 -240 V | 200 -240 V | | Rated current | 12A | 12A | | Nominal frequency: | 50/ 60 Hz | 50/ 60 Hz | | Power output of tube<br>assembly | $90 kV/12 mA = 1080 W$<br>with any radiation time | $90 kV/12 mA = 1080 W$ with any<br>radiation time | | Tube voltage | 60 - 90kV (for 90 kV max.<br>12 mA) | 60 - 90kV (for 90 kV max. 12 mA) | | Tube current | 3 - 16 mA (for 16 mA max.<br>69 kV) | 3 - 16 mA (for 16 mA max. 69 kV) | | Tube setting 3D | SD: 7-13 mA; HD: 4-12 mA | SD: 7-13 mA; HD: 4-12 mA | | Maximum setting range | 60 kV / 3 mA to 90 kV / 12 mA | 60 kV / 3 mA to 90 kV / 12 mA | | Program duration | 11.6-23 sec | 11.6-23 sec | | Exposure time | 2.2-14.9 sec | 2.2-14.9 sec | | Max. FOV<br>(Size of the presentable<br>anatomical area) | Cylinder with a diameter of<br>approx. 11 cm and a height<br>of approx. 10 cm | Cylinder with a diameter of approx.<br>11 cm and a height of approx. 10 cm | | Slice pitch (voxel size) | 80-220μm | 80-220μm | | Exposure time for a<br>cephalometric image | 4.6 - 14.9 sec | 4.6 - 14.9 sec | | Device | Proposed Device<br>Orthophos S | Predicate<br>Device<br>Orthophos | | Number of single exposures | SD: 200<br>HD: 800 | SD: 200<br>HD: 800 | | Total filtration of X-ray<br>tube assembly | > 2,5 AI / 90 IEC 60522<br>0,3 mm Cu for volume<br>exposures<br>1 mm Cu for Low Dose<br>exposures | > 2,5 AI / 90 IEC 60522<br>0,3 mm Cu for volume<br>exposures 1 mm Cu for Low<br>Dose exposures | | Focal spot size acc. to IEC<br>60336, measured in the central X-<br>ray beam | Nominal focal spot value (f): 0.5<br>Width (max): 0.75 mm<br>Length (max): 1.10 mm | Nominal focal spot value (f): 0.5<br>Width (max): 0.75 mm<br>Length (max): 1.10 mm | | Imaging programs | Panorama,<br>transverse,<br>cephalometric,<br>3D, different<br>collimations | Panorama, transverse,<br>cephalometric, 3D, different<br>collimations | | X-ray tube | Siemens SR 90/15 FN | Siemens SR 90/15 FN | | PAN Sensor | CMOS | CMOS (Direct Conversion Sensor) | | Active sensor area Pan<br>type: | 145.152 mm x 6.48 mm | 146 mm x 6 mm | | Detail resolution | 0.1 mm | 0.1 mm | | Focus-sensor distance | 493 mm | 497 mm | | Digital flat panel 3D | 3D Hamamatsu 16x16 Flatpanel<br>with amorphous silicon | 3D Hamamatsu 16x16 Flatpanel<br>with amorphous silicon | | Active sensor area 3D | 160 mm x 160 mm | 160 mm x 160 mm | | Detail resolution | 0.12 mm | 0.12 mm | | Focus-sensor distance | 524 mm | 524 mm | | Ceph sensor | Digital CCD line sensor for Ceph<br>exposure technique | Digital CCD line sensor for Ceph<br>exposure technique | | Active sensor area | 230 mm x 6.48 mm | 230 mm x 6.48 mm | | Detail resolution | 0.027 mm pixel size | 0.027 mm pixel size | | Focus-sensor distance | 1714 mm | 1714 mm | | Dose Area Product (DAP) | | | | Complete range (Ceph, 3D<br>and 2D) | approx. 1.2-3056mGycm² | approx. 1.2-3056mGycm² | | Device | Proposed Device<br>Orthophos S | Predicate Device<br>Orthophos SL<br>(K150217) | | Default 3D maximum | approx. 1771mGycm² | approx. 1771mGycm² | | Visualization/<br>processing | Uses SIDEXIS 4 image<br>process software | Uses SIDEXIS 4 image process<br>software | | Image reconstruction | | | | 2D Image types | Panoramic, bite wing,<br>temporomandibular joint,<br>sinus view | Panoramic, bite wing,<br>temporomandibular joint, sinus view | | Cephalometric main types | A/P, P/A, Lateral view,<br>Carpus | A/P, P/A, Lateral view, Carpus | | Panoramic images | Full frame pan-technology<br>with Autofocus for Pan<br>Images | Full frame pan-technology with<br>Autofocus and lingual-buccal<br>exploration | | 3D | Volumes as chosen by the<br>user before the exposure | Volumes as chosen by the user before<br>the exposure | | User interface | | | | Exposure settings | At the operator panel of the<br>device: kV, mA, sec,<br>program, height adjustment,<br>laser locator on/off, rotation<br>of the ring, options | At the operator panel of the device:<br>kV, mA, sec, program, height<br>adjustment, laser locator on/off,<br>rotation of the ring, options | | Patient fixation | Bite block, chin rest, contact<br>segment for subnasal,<br>supports if necessary | Bite block, chin rest, contact segment<br>for subnasal, supports if necessary | | | Cephalometer without bite<br>block and chin rest | Cephalometer without bite block and<br>chin rest | | Localization of exposure<br>area | Given through the geometry<br>of the device and due the<br>help of laser | Given through the geometry of the<br>device and due the help of laser | | | Additional laser for<br>improvement of mid sagittal<br>head positioning | Additional laser for improvement of<br>mid sagittal head positioning | | Device | Proposed Device<br>Orthophos S | Predicate Device<br>Orthophos SL<br>(K150217) | | Calibration / Adjustment | Calibration/ adjustment is ensured for sensor (including shading, blemish and gain), geometric, panoramic, volume and Ceph | Calibration/ adjustment is ensured for sensor (including shading, blemish and gain), geometric, panoramic, volume and Ceph | | | Monthly constancy check | Monthly constancy check | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Functional testing as well as performance testing of the proposed device Orthophos S has been performed to verify the design output met the design input requirements and to validate that the device confirm to the intended user needs and the intended use as defined. Based on the comparison of the intended use, the indication for use as well as of technical and technological characteristics of the subject Orthophos S with the predicate device Orthophos SL (K150217) it has been shown that the device is substantially equivalent to its predicate device. ## 7. Non-Clinical Performance Data The Testing to verify the performance requirements of the subject Orthophos S was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence. Tests included in this premarket notification verify the conformity of the proposed Orthophos S with the requirements of: - . IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance. - . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. - IEC 60825-1: Safety of laser products Part 1: Equipment classification and ● requirements. - IEC 60601-1-3: Medical electrical equipment Part 1-3: General requirements for basic ● safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. - IEC 62366: Medical devices Application of usability engineering to medical devices. ● - ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. - IEC 62304: Medical device software Software lifecycle processes. ● - . IEC 60601-2-63: Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment - IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic ● safety and essential performance - Collateral Standard: Usability, (with third edition of 60601-1) {11}------------------------------------------------ - . Verification activities for confirmation of the image quality of the proposed device has been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device. #### 8. Clinical Performance Data Given the differences from the predicate device, no clinical data is necessary to support substantial equivalence. #### Conclusion Regarding Substantial Equivalence 9. The information included in this premarket notification supports the substantial equivalence of the subject Orthophos S. The subject device has the identical intended use as the legally marketed predicate device. The subject device also has the same indications for use and incorporates the same fundamental technology as the predicate device. Performance data are included in this premarket notification to demonstrate the performance of the subject Orthophos S against its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.