X TWIN SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem depicts a stylized caduceus, a symbol often associated with healthcare, with a triple helix design representing the interconnectedness of health and human services. The text is arranged in a circular fashion around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 3, 2014 Roesys GmbH % Mr. Jochen Dyszbalis Quality Manager Dr .- Max-Ilgner-Str. 2 Espelkamp, Nordrhein-Westfalen 32339 GERMANY Re: K133496 Trade/Device Name: X Twin System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 22, 2014 Received: October 24, 2014 Dear Mr. Dyszbalis: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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}------------------------------------------------ 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/Resourcesfor You/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 A Ochs for Janine M. Morris 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) K133496 Device Name X Twin System #### Indications for Use (Describe) The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position. The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary #### Name and Address of manufacturer: Roesys GmbH Dr.-Max-Ilgner-Straße 2 32339 Espelkamp Germany Owner/Operator Number: 10045270 Name, title and phone number of official correspondent: Jochen Dyszbalis Quality Manager +49 5772 91555 00 | Date of preparation: | November 11, 2013 | |----------------------|-------------------| |----------------------|-------------------| #### Device Identification: | Device Trade Name: | X Twin | |--------------------|---------------------------------------| | Common Name: | General purpose diagnostic X-ray unit | #### Classification of the device: | Device Classification Name: | System, X-ray, Stationary | |-----------------------------|---------------------------| | Product Code: | KPR | | Device Classification No.: | Part 892.1680 | | Panel: | Radiology | | Regulatory Status: | Class II | #### Predicate device: Device Trade Name: Applicant: 510(k) No.: Essenta DR Philips Medical Systems DMC GmbH K070528 #### Device Description: #### X Twin The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing {5}------------------------------------------------ assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator. ## Imaqinq Device An essential part of the X-ray system X Twin is the digital Flat Panel Image Detector. In the X Twin System is mounted the Digital X-ray Detector DFP4343C7. The Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a highresolution digital imaging detector, designed for general radiography. The X-ray Conversion Layer consists of Cesium lodide (Csl) with Amorphous Silicon (a-Si) Photodiode. The active area has a size of 430(H)x439(V)mm (16.9×17.3 inch), the Pixel Matrix has a size of 3008(H)x3072(V) with a Pixel Pitch of 143 µm. The Cycle Time from Shot to Shot is 6sec. The Digital X-ray Detector DFP4343C7 is released by the FDA in a 510 (k) process. The Release Number is K122589. ## Software The software used in the X Twin consists of two systems: #### X Twin Control Software ● The X Twin Control Software controls only the motorized adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. These movements are only possible if corresponding switches are manually operated. When the switch is released, the movement is stopped immediately. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. This function is also only possible during manually operated switches. The angle and the SID is displayed on the control unit on the support arm of the X Twin. The control software controls also the emergency stop buttons ant the collision protection of the X Twin. The control software neither provides automatically movement actions nor does it take influence on the diagnosis. Failures or latent design flaws are unlikely to cause any injury to the patient or operator. In accordance to the Guidance for Software used in Medical Devices Roesys has determined the Level of Concern of the X Twin Control software as Moderate. {6}------------------------------------------------ #### Imaging Software DXRS . DXRS software is intended for acquisition, processing, viewing, printing, saving and transmittance of X-ray images to PACS server. DXRS software can retrieve patient data from other information systems (HIS/RIS). DXRS software includes a main application (below referred to as SW application), its modules and utilities. SW application provides declared functionality. Modules and utilities provide additional functionality. ## Brief description of the operation scenario Operation scenario includes a sequence of actions described below. Manual input of patient data or its automatic retrieval using Worklist function. Acquisition of X-ray image by the detector manufacturer's service software, supplied with the detector. SW application displays recommended values of exposure parameters which operator can use to acquire an X-ray image of a specific body part. Recommended values are only displayed and do not define or influence exposure process in practice in any way. Image processing is carried out manually to prepare images for diagnostics. Image processing includes zoom, navigation, flip and rotation, inversion, usage of collimators (program shutters) and adjustment of Window Width/Level. SW application also provides lateralization and a rollback function which removes results of actions applied to the image and brings image back to the initial state. As a result of post-processing operations, the image is ready to be displayed or to be used for diagnostic purposes. Sending acquired X-ray images to a PACS server for storage Printing images or creation of Patient Disks (if necessary) In accordance to the Guidance for Software used in Medical Devices the Level of Concern for our device is Moderate. DXRS Software and the accompanying Digital X-Ray Detector DFP4343C7 are designed only for general radiographic systems. They are used neither in X-ray surgery nor mammography nor in life supporting systems. The DXRS software was part of the 510(k) Premarket Notification No. K122589. ## Intended Use: The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic examinations including specialist areas like trauma or pediatric work, excluding mammography. X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position. The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres. {7}------------------------------------------------ # Table 1: Substantial Equivalence Chart | | Substantial Equivalent Device | Predicate Device | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | | X Twin | Essenta DR (K070528) | | | Intended Use | The X Twin is intended to be used<br>as a digital multifunctional x-ray<br>system, suitable for all radiographic<br>exams, including specialist areas<br>like trauma or pediatric work,<br>excluding mammography.<br>X Twin shall only be operated by<br>qualified, trained professionals. The<br>patient can be in sitting, lying or<br>standing position.<br>The device is a permanently<br>installed device and is intended to<br>be operated in medical rooms with<br>appropriate radiation protection<br>only. It is not intended to be used<br>with flammable anesthetic agents<br>or in potentially explosive<br>atmospheres. | The ESSENTA DR is a digital<br>multifunctional X-ray system,<br>suitable for all routine<br>radiographic exams, including<br>specialist areas like trauma or<br>pediatric work, excluding<br>mammography. It is designed<br>for radiographic examination of<br>the standing or seated patient<br>or the recumbent patient in<br>combination with a mobile x-<br>ray table (trolley). The system<br>is intended for direct digital<br>imaging using the built in flat<br>panel detector and in addition<br>for free exposures on<br>radiographic cassettes. | Similar | | Target<br>population | Adult and pediatric subjects | Adult and pediatric subjects | Equivalent | | Operator | Qualified trained professionals | Qualified/trained doctor or<br>technicians | Equivalent | | Energy<br>Source | 400 V / 480 V ± 10%, 50/60 Hz | 400 V / 480 V ± 10%, 50/60 Hz | Equivalent | | Power<br>consumption | 24 - 44 kVA | 50 - 80 kVA | Advanced, the<br>power<br>consumption is<br>reduced, but the<br>X-Ray<br>parameters are<br>similar | | Maximum<br>output | Depends on chosen generator<br>model. | Depends on model of<br>generator chosen.<br>Models are available from 50<br>kW to 80 kW. | Equivalent | | User<br>Interface | Software Driven Touch Panel LCD<br>+ two individual control units<br>located at each support arm (one is<br>a wired remote control) | Software Driven Touch Panel<br>LCD,<br>+ remote control unit | Similar | | Columns | Two columns (tube & receptor).<br>Guide frame mounted on floor | One main column.<br>Floor or wall mounted support | Different, but<br>does not<br>concern safety<br>or efficacy | | Tube mount | Fixed to a tube column, arm can<br>rotate<br>Automatic focusing by an integrated<br>control system | Fixed with respect to receptor,<br>arm can rotate | Advanced | | Receptor<br>mount | Fixed to a receptor column, arm<br>can rotate<br>Automatic focusing by an integrated<br>control system | Fixed on same column as tube<br>head | Difference:<br>Fixed to a<br>separate<br>column;<br>Does not<br>concern safety<br>or efficacy | | Method of<br>control | Software Driven Touch Panel LCD,<br>+ two individual control units<br>located at each support arm<br>(one is a wired remote control) | Software Driven Touch Panel<br>LCD,<br>+ remote control unit<br>+ Detector control unit | Similar | | Electrical<br>safety | IEC 60601-1 | IEC 60601-1 | Equivalent | | Source-to-<br>image<br>distance<br>(SID) | vertical: 40 -110 cm (16-44")<br>horizontal: 100-200 cm (40-79")<br>(also continuously adjustable and<br>dual speed motorized) | 110-200 cm (43-79")<br>continuously adjustable<br>(dual speed motorized<br>movement) | Advanced | | Vertical<br>travel | 1,600 mm (63") | 1,330 mm (4' 4.4") | Equivalent | | Longitudinal<br>travel | 100 cm (40")<br>(each column) | None | Advanced | | Rotation<br>angle | ± 100°<br>(each arm) | -30° to +135° | Different, but<br>does not<br>concern safety<br>or efficacy | | Total weight | 175 kg +410 kg = 585 kg<br>(1x 1290 lb)<br>(Guide frame with column + Vertical<br>pillar) | 300 kg (661.5 lb) | Different, but<br>does not<br>concern safety<br>or efficacy | | Image<br>Detector | Electronic flat detector with High<br>Stability Scinitillator<br>Active detector area: 35 cm x 43<br>cm (14" x 17") with rotatable<br>detector carrier<br>lmage matrix size: 1920 pixel x<br>2367 pixel<br>Pixel size: 182 µm, with a pixel<br>depth of 14 bits | Flat Panel Detector with<br>Cesium lodide (Csl) for X-ray<br>scintillator<br>Active detector area: 43 cm x<br>43 cm (16.9" x 17.3") with<br>rotatable detector carrier<br>Image matrix size: 3008(H)<br>pixel x 3072(V) pixel<br>Pixel size: 143 µm, with a pixel<br>depth of 14 bits | Different, but<br>does not<br>concern safety<br>or efficacy | {8}------------------------------------------------ {9}------------------------------------------------ # Detailed description of the main differences between X Twin and the predicate Essenta DR: | Power consumption: | The power consumption of the X Twin is lower than of the predicate<br>Essenta DR (24-44 kVA against 50-80 kVA).<br>This means that the twin X has better energy efficiency. The X-Ray<br>parameters are similar with the parameters of the Essenta DR, therefore<br>the difference does not concern safety or efficacy. | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Columns: | The difference of both systems is that the X Twin contains two moveable<br>columns and the Essenta DR has only one column.<br>The columns of the X Twin are motorized, positioned on floor mounted<br>guide frames. The column of the Essenta DR is fix floor or wall mounted.<br>The advantage of the X Twin is a higher flexibility for the positioning of<br>the system. Since the X-Ray imaging process is not affected from this<br>difference, it does not concern safety or efficacy. | | Tube and Receptor<br>Mount: | The main difference in mounting the tube and the receptor is that these<br>components are fixed on an adjustable U-arm at the Essenta DR. The X<br>Twin uses separate arms, one for the tube and one for the receptor.<br>This allows the occasionally necessary recording with a beam path which<br>is not aligned at 90° to the Receptor. The advantage of the X Twin is a<br>higher flexibility for the positioning of the system. Since the X-Ray<br>imaging process is not affected from this difference, it does not concern<br>safety or efficacy. | | Rotation Angle: | Both X-Ray systems have different rotation angles. The Essenta DR has<br>a rotation angle range of 165°, the X Twin has a rotation angle range of<br>200° (applicable for standard images: 180°). The advantage of this<br>difference is a higher flexibility for a wide range of examinations. Since<br>the X-Ray imaging process is not affected from this difference, it does<br>not concern safety or efficacy. | | Total Weight: | The total weight of the X Twin is higher than the total weight of the<br>Essenta DR (difference: 285 kg / 628.5lb). The reason for this difference<br>is the second column with the second arm and the floor mounted guide<br>frames. Since these units are floor mounted, this difference does not<br>concern safety or efficacy. | | Image Detector: | There are two differences between the used Image Detectors. The first<br>difference is the active detector area. The Predicate Essenta DR uses a<br>14" x 17" detector; the X Twin uses a 16.9″ x 17.3″ detector. This has the advantage<br>that even large organs such as thorax can be recorded on one image.<br>The second difference is the higher pixel resolution (Predicate 182 um -<br>X Twin 143 µm). This allows the creation of images with higher<br>resolution. An illustration of finer tissue structures is thus more feasible.) | {10}------------------------------------------------ These main differences do concern safety or efficacy of the X Twin System neither individually nor in combination with each other. # Summary of Non-Clinical Performance Testing: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-3 Test clauses: 7.6 Test for half-value layer 8.5.2 Focal spot to image receptor distance 12.4 Leakage radiation IEC 60601-2-54 ISO 10993 Result of the biocompatibility Tests: There was no evidence found that the surfaces of the X Twin system may cause skin irritations or similar negative effects on the patient. The observed surface coatings are used on similar medical devices for 10 years, during this time was no case regarding skin irritation was known. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices The documentation and testing of the X Twin Control Software was classified and performed as Moderate in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The documentation and testing of the Imaging Software DXRS was also performed in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This software is part of the Image Detector DFP4343C7, therefore the software is already released (see K122589). Reqarding the Image Detector DFP4343C7 a separate Non-Clinical performance testing was performed by NIPK Electron as 510(k) Applicant. The performance testing was performed according to Section VI of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory. {11}------------------------------------------------ # Summary of Clinical Performance Testing: Roesys GmbH did not perform any clinical testing for the X Twin. Regarding the Image Detector DFP4343C7 a Clinical Performance Testing was performed by NIPK Electron as 510(k) Applicant. The performance testing was performed according to Section VII of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory. {12}------------------------------------------------ # Conclusion: Roesys GmbH believes that the X Twin system is substantially equivalent to the currently legally marketed device. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.