Orthopantomograph OP 3D

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 7th, 2018 PaloDEx Group Oy % Terho Turkumaki QA&RA Manager Nahkelantie 160 Tuusula. 04300 FINLAND Re: K180947 Trade/Device Name: ORTHOPANTOMOGRAPH OP 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 6, 2018 Received: April 11, 2018 Dear Terho Turkumaki: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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. {1}------------------------------------------------ K180947 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, Jeff Balyer for 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) K180947 Device Name ORTHOPANTOMOGRAPH™ OP 3D Indications for Use (Describe) ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals. | 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. 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. 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The logo is simple and clean, with a focus on the company name. ### 510(k) SUMMARY for ORTHOPANTOMOGRAPH™ OP 3D #### Submitter Information: Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland | Contact Person: | Terho Turkumäki | |-------------------|------------------| | Telephone Number: | +358 10 270 2000 | | Fax Number: | +358 50 320 9113 | | Date Prepared: | April 6, 2018 | #### Device Name: Proprietary Name: Common Name: CFR Number: Device Class: Product Code: ORTHOPANTOMOGRAPH™ OP 3D X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system 892.1750 -OAS #### Predicate Device: | Proprietary Name: | ORTHOPANTOMOGRAPH™ OP300 | |----------------------|-------------------------------------| | 510(k) Number | K133544 | | Common Name: | X-ray, Tomography, Computed, Dental | | Classification Name: | Computed tomography x-ray system | | CFR Number: | 892.1750 | | Device Class: | II | | Product Code: | OAS | ### Description of Device ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, pediatric, TMJ, bitewing and partial), cephalometric programs (lateral and PA, also including carpus imaging) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support, ceph attachment (containing ceph tube head and patient support) and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "Palodex Group". The word "Palodex" is on the top line, and the word "Group" is on the bottom line. The words are in a sans-serif font and are black in color. The background is white. The following guidances were followed when preparing this 510k submission: -Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 -Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices, November 28, 2017. -Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, September 1, 2016 -Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices. July 11, 2016. -Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999 -Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2, 2014" -FDA Guidance "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk management process". | | Concept | Proposed device<br>(ORTHOPANTOMOGRAPHTM<br>OP 3D) | Predicate device<br>(ORTHOPANTOMOGRAPHTM<br>OP300, K133544) | |-----|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Indications for Use/<br>Intended Use | ORTHOPANTOMOGRAPHTM OP 3D<br>is an x-ray device that is intended to<br>be used for imaging of adult and<br>pediatric patients. The device can be<br>configured to take panoramic,<br>cephalometric, or 3D images of the<br>cranio-maxillofacial complex for use<br>in diagnostic support. The device can<br>also be configured to take carpus<br>images.<br>ORTHOPANTOMOGRAPHTM OP 3D<br>must only be used and operated by<br>dentist and other qualified<br>professionals. | The OP300 dental panoramic,<br>cephalometric and cone beam<br>computed tomography x-ray device is<br>intended for dental radiographic<br>examination of teeth, jaw and TMJ<br>areas by producing conventional 2D x-<br>ray images as well as x-ray projection<br>images of an examined volume for the<br>reconstruction of a 3D view. The<br>device is operated and used by<br>qualified healthcare professionals. | | 2. | Imaging modes | Panoramic, TMJ, BW, 3D (CBCT),<br>cephalometric | Panoramic, TMJ,BW, 3D (CBCT),<br>Cephalometric | | 3. | X-ray source | 3D mode: 95kV<br>Pan mode: 60-90 kV<br>Ceph mode: 60-95kV<br>kV accuracy: +/-5kV<br>mA range: 1-16 mA<br>3D power mode: continuous/pulsed | 3D mode: 90kV<br>Pan/ceph mode: 57-90 kV<br>kV accuracy: +/-5kV<br>mA range: 3.2-16 mA<br>3D power mode: continuous/pulsed | | 4. | Focal spot | 0.5mm | 0.5mm | | 5. | Image detector(s) | three detectors (3D flat panel, pan<br>and ceph) | three detectors (3D flat panel, pan and<br>ceph) | | 5.1 | CBCT imaging<br>mode | 3D CMOS Flat Panel | 3D CMOS Flat Panel | | 5.2 | Panoramic imaging<br>mode | 3D CMOS Flat Panel / CMOS pan &<br>ceph detectors | CMOS pan & ceph detectors | | 5.3 | Cephalometric<br>imaging mode | CMOS ceph detector | CMOS ceph detector | | 6. | 3D imaging<br>technique | Reconstruction from 2D images | Reconstruction from 2D images | | 7. | 3D's Field Of View | 5 x 5<br>6 x 9<br>9 x 11<br>9 x 14 (optional) | 5x5<br>6x8<br>8x8<br>8x15<br>13x15 (optional) | | 8. | 3D's total viewing<br>angle | 360° | 360 ° | | 9. | Pixel size | CMOS PAN & 3D combo flat panel:<br>3D pixel size: 198 µm<br>pan/ceph pixel size: 99µm | CMOS flat panel for 3D: pixel size 200 µm<br>CMOS for pan/ceph imaging: pixel size<br>100 µm | | 10. | Voxel size | 80-400 µm | 85-420 µm | | 11. | Reconstruction<br>Software | Filtered Back Projection (FBP) | Filtered Back Projection (FBP) | | 12. | 3D's effective<br>exposure time | 1,7 - 20 s | 1.2 - 12.5 s | | 13. | Ceph exposure<br>time Time | 8.1-10.5 s | 6.9-20s | | 14. | Patient's Position | Standing and wheelchair | Standing and wheelchair | | 15. | System footprint<br>(includes the<br>operator) | H167-247cm x D124-149cm x W167<br>cm | H161-241cm x D139cm x W97-193 cm | | 16. | Weight | App. Pan/3D 120 kg<br>Ceph 155 kg | App. Pan/3D 205 kg<br>Ceph 240 kg | | 17 | Classification | OAS | OAS | | 18 | 3D resolution | Low, standard, high, endo | Low, standard, high, endo | | 19 | 2D imaging<br>programs | Adult Pan, Pediatric Pan, TMJ, BW,<br>Segmented Pan, ceph PA/LAT,<br>carpus | Adult Pan, Pediatric Pan, TMJ, BW,<br>Segmented Pan, ceph PA/LAT | | 20 | MTF @10% (5x5<br>HiRes) | 2.2lp/mm | 2.25lp/mm | ### Description of Substantial Equivalence {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Palodex Group. The word "Palodex" is written in a large, bold, sans-serif font. The word "Group" is written in a smaller, sans-serif font and is located to the lower right of the word "Palodex". The logo is simple and modern. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the words "Palodex Group" in a simple, sans-serif font. The word "Palodex" is in a larger font size and is placed above the word "Group." The word "Group" is slightly offset to the right, creating a visual hierarchy. ## Indications for Use ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals. The proposed ORTHOPANTOMOGRAPH™ OP 3D has similar Intended Use/Indications for Use as the predicate device ORTHOPANTOMOGRAPH™ OP300 (K133544) and is based on the already cleared ORTHOPANTOMOGRAPH™ OP 3D (K170813) intended Use statement with the addition of cephalometric imaging and the related carpus imaging is used to define the bone age and skeletal maturity for the timing of orthodontic treatment to the pubertal growth spurt. Reference device ORTHOPHOS SL (K150217) is included to justify the usage of carpus imaging as an application of the cephalometric imaging for orthodontics. # Principle of Operation The proposed ORTHOPANTOMOGRAPH™ OP 3D shares similar architectural components and principle of operation as the predicate device ORTHOPANTOMOGRAPH™ OP300 (K133544). Both devices utilize cone beam x-ray technology to acquire volumetric data. Conical x-ray beam rotates around the patient's head and incident upon the receptor and the system generates volumetric data from the 2D projection images, similarly to the predicate device. The reconstruction of 3D images from 2D image data in the proposed device is made using the same reconstruction techniques as in the predicate device. Additionally the interfaces to 2D/3D image viewing software are similar. There is no substantial difference in the functionality for the data acquisition, data/image display nor integration with 2D/3D imaging software of ORTHOPANTOMOGRAPH™ OP 3D, when compared to the predicate device. The proposed and the predicate device utilize the similar format for interfacing with the 2D and/or 3D imaging software. ### Technological Characteristics The technical characteristics of the proposed device and predicate device, including imaging technology (X-ray sources and image detectors), available Field of Views, technical resolution (MTF) and other basic technological characteristics are substantially equivalent to the predicate device ORTHOPANTOMOGRAPH™ OP300. The proposed ORTHOPANTOMOGRAPH™ OP 3D can produce 2D and 3D images of the cranio-maxillofacial areas of equivalent diagnostic quality as the images with the predicate device ORTHOPANTOMOGRAPH OP300 (K133544). Differences in technical characteristics are minor and the device performance is equivalent as evidenced through verification and validation testing. ### Non-Clinical Performance Data As part of the design control activities, the ORTHOPANTOMOGRAPH™ OP 3D device has successfully passed internal design verification and validation. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is larger than the word "Group" which is on the bottom line. The word "Group" is slightly offset to the right. Electrical, mechanical, safety and performance testing according to standards IEC 60601-1: 2005, IEC 60601-1-6:2013, IEC 62366:2014, IEC 60601-2-63:2012, IEC 60601-2-28:2010, and IEC 60601-1-3:2007 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2014. Testing was completed by 3rd party test house, and the proposed ORTHOPANTOMOGRAPH™ OP 3D has passed all tests. Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-1. Software for ORTHOPANTOMOGRAPH™ OP 3D has been categorized as Moderate Level of Concern and documented according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use. ### Clinical Performance Data No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence. #### Conclusion as to Substantial Equivalence There are no significant differences between the proposed ORTHOPANTOMOGRAPH™ OP 3D and predicate ORTHOPANTOMOGRAPH™ OP300 (K133544). Minor differences have been shown not to affect the substantial equivalence of the device. The proposed device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent with regards to safety and effectiveness. All internal verification and validation has been completed successfully. In summary, the proposed ORTHOPANTOMOGRAPH™ OP 3D device is substantially equivalent to the predicate ORTHOPANTOMOGRAPH™ OP300 device.