Uroview FD II

{0}------------------------------------------------ April 12, 2018 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. Pausch Medical GmbH % Oliver Eikenberg, Ph.D. Senior Consultant, QA & RA EMERGO Global Consulting LLC 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746 Re: K180651 Trade/Device Name: Uroview FD II Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 23, 2018 Received: March 13, 2018 Dear Dr. Eikenberg: 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}------------------------------------------------ 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. 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, Michael D. O'Hara 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) #### K180651 Device Name Uroview FD II #### Indications for Use (Describe) The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional xray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: - · Querying and retrieving patient information and /or images from other modalities. - · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. - · Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. - · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). - · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). - · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction. varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - · Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> 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. 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." {3}------------------------------------------------ # Section 5 – 510(k) Summary # Uroview FD II K 180651 #### 1. Submission Sponsor Pausch Medical GmbH Graf-Zeppelin-Straße 1 Erlangen Bavaria, D-91056 Germany Office Ph: +49 (0)9131 / 99 92 - 0 Contact: Christian Stoian Title: CEO ## 2. Submission Correspondent Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Ph: (512) 327.9997 Contact: Dr. Oliver Eikenberg, Senior Consultant, RA/QA Email: project.management@emergogroup.com ## 3. Date Prepared February, 23 2018 #### 4. Device Identification | Trade/Proprietary Name: | Fluoroscopic, Image Intensified X-ray System | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | X-ray System | | Classification Name: | Image-intensified fluoroscopic x-ray system | | Regulation Number: | 892.1650 | | Product Code: | JAA | | Device Class: | Class II | | Classification Panel: | Radiology | | Guidance: | FORM FDA 3626 (1/14), A Guide for the Submission of Initial Reports on<br>Diagnostic X-Ray Systems and Their Major Components | {4}------------------------------------------------ ## 5. Legally Marketed Predicate Device Uroview FD (K161019) from Pausch Medical GmbH, Germany #### 6. Device Description The Uroview FD II is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient the Uroview FD Skeleton, which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD II X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD II X-ray system includes the following major components: - . Uroview FD Skeleton (urological table incl. tilting table) - High Frequency RF X-ray generator - X-ray tube incl. housing - Collimator - . Measuring chamber - . Grid - Dynamic flat panel detector - Digital imaging workstation - . Video monitors - Accessories The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics. The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33. {5}------------------------------------------------ ## 7. Indication for Use Statement The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures, including but not limited to: - Querying and retrieving patient information and/or images from other modalities . - . X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. - Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. - . Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). - Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy) ● - . Laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis detection/correction, varicocele) - . Application of fistula (kidney/bladder) - Simple procedures (e.g. urethra, testis, phimosis) - Intracorporeal shock wave lithotripsy ● - . Uroflow/urodynamics - Pediatric radiological and therapeutic applications ## 8. Substantial Equivalence Discussion The update of the model Uroview FD to the new X-ray system Uroview FD II is identical by technological characteristics, design and mode of operation for the components "Tube, Measuring Chamber, Anti Scatter Grid". The Uroview FD II further shares optimized component features or equivalent X-ray components to that of the predicate Uroview FD for Urological Table Uroview FD Skeleton, Generator, Digital Imaging System and Monitor beam- limiting device flat detector and digital imaging processing. The changes refer to design/size variations, image resolution, workstation functionalities and use of FDA-registered or FDA-cleared commercially available X-ray components, which are specifically designed for use in X-ray systems and therefore include standardized values and settings for electrical, mechanical and radiation requirements. As such the identified differences are considered to be optimized system variations, which are adequately controlled by testing of this X-ray system. The modifications of the Uroview FD II compared to the previous model Uroview FD are within the controls and predetermined specifications and are supported with verification and validation testing. The following table compares the Uroview FD II to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison chart reveals that the technological characteristics and as such the functions performed by the Uroview FD II offer substantially the same data and technology as the Uroview FD. The subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. {6}------------------------------------------------ | | Proposed Device<br>Uroview FD II | Predicate Device<br>Uroview FD | Similarities /<br>Differences | |----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Pausch Medical GmbH | Pausch Medical GmbH | N/A | | Product/Trade Name: | Uroview FD II | Uroview FD | N/A | | 510(k): | Pending | K161019 | N/A | | Establishment<br>Registration No. | 9610903 | 9610903 | N/A | | Product Code: | JAA | JAA | Same | | Regulation Number | 21 CFR 892.1650 | 21 CFR 892.1650 | Same | | Device Classification | Solid State x-ray imager<br>(flat panel/digital imager) | Solid State x-ray imager<br>(flat panel/digital imager) | Same<br>classification | | Class | II | II | Same | | Indications for use | The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for<br>urological applications (functional x-ray-diagnostics, endourology and minimal<br>invasive urology/surgery). The system, which includes a radiologic/urologic treatment<br>table, may be used for urological, treatment, planning and diagnostic procedures<br>including but not limited to:<br>• Querying and retrieving patient information and/or images from other modalities.<br>• X-ray examinations of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter,<br>urethra) including KUB, IVP, vasovesiculography, reflux-cystogram,<br>cystourethrogram, and micturation cystourethrogram combined with uroflow<br>measurements.<br>• Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of<br>the kidney, bladder, prostate, scrotum.<br>• Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter,<br>ostium, kidney and ureter, catheter placement, penile implant placement,<br>transurethral resection of prostate or bladder, alternative treatment of the BPH<br>and brachytherapy)<br>• Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous<br>nephrostomy).<br>• Laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection,<br>abdominal testis detection/correction, varicocele).<br>• Application of fistula (kidney/bladder).<br>• Simple procedures (e.g. urethra, testis, phimosis).<br>• Intracorporeal shock wave lithotripsy.<br>• Uroflow/urodynamics.<br>• Pediatric radiological and therapeutic applications | | Same<br>The intended<br>use definition<br>is identical<br>except for the<br>device name<br>Uroview FD<br>versus<br>Uroview FD II | | Complies with<br>Applicable Voluntary<br>EC, EMC-Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | Same | | Complies with ISO 10993-1<br>for Biocompatibility | yes | yes | Same | | Sterile: | N/A | N/A | N/A | | Shelf Life (usable lifetime) | Ten years | Ten years | Same | | | Proposed Device | Predicate Device | Similarities / | | | Uroview FD II | Uroview FD | Differences | | Overview of Component Specifications | | | | | Major Components | 1. Uroview FD Skeleton | 1. Uroview FD Skeleton | Same | | Basic Unit | Basic Unit (urological table) | (basic unit, urological table) | | | | 2. X-ray Generator | 2. X-ray Generator | | | | 3. X-ray tube and housing | 3. X-ray tube and housing | | | | 4. Collimator | 4. Collimator | | | | 5. Measuring chamber | 5. Measuring chamber | | | | 6. Digital image workstation | 6. Digital image workstation | | | | 7. Detector | 7. Detector | | | Basic Unit | Uroview FD Skeleton | Uroview FD Skeleton | Similar | | (urological table) | | | Newly designed<br>with similar<br>functionality | | Basic Unit System | Optional right-handed or left-<br>handed version | Optional right-handed or left-<br>handed version | Same | | Table height | Continuously adjustable by<br>motor drive: 64 to 116.5 cm<br>(25.2 to 45.9"), floating | Continuously adjustable by motor<br>drive: 64 to 116.5 cm<br>(25.2 to 45.9"), floating | Same | | Tabletop extensions | 78 cm (30.7") x 75.9 cm (29.9") | 78 cm (30.7") x 75.9 cm (29.9") | Same | | Tabletop-detector distance | 6.4 cm (2.5") | 6.4 cm (2.5") | Same | | Source-detector distance | 115 cm (45.3") | 115 cm (45.3") | Same | | Manual / Motorized<br>movement park position to<br>exposure position | 27 cm (10.6")<br>park position 27 cm (10.6") | 27 cm (10.6") | Similar,<br>additional park<br>position function | | Tilt range | Motorized tilt: ± 88 °<br>Isocentric tilt: ± 20 °…