Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. % Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355 April 2, 2018 ## Re: K173639 Trade/Device Name: Luminos Agile Max. Luminos dRF Max. Uroskop Omnia Max. Multitom Rax Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: March 9, 2018 Received: March 13, 2018 ## Dear Ms. Adams: 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}------------------------------------------------ 510(k) Number (if known) K173639 Device Name Luminos Agile Max Indications for Use (Describe) Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos Agile Max is not for mammography examinations. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;">X</span> 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. 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 {3}------------------------------------------------ 510(k) Number (if known) Device Name Luminos dRF Max Indications for Use (Describe) Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos dRF Max is not for mammography examinations. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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 {4}------------------------------------------------ 510(k) Number (if known) Device Name Multitom Rax Indications for Use (Describe) Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Multitom Rax is not for mammography examinations. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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 {5}------------------------------------------------ 510(k) Number (if known) Device Name Uroskop Omnia Max ### Indications for Use (Describe) Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract. The table supports endourological and minimal invasive surgery in urology as there are transurethral interventions (e.g. ureterorenoscopy (URS), double stent placement, cystoscopy, transurethral resection of bladder tumors (TURB), transurethral resection of the prostate (TURP)), percutaneous urological procedures (e.g. percutaneous nephrostomy (PCN), percutaneous nephrolitholapaxy (PCNL)), urological X-ray diagnosis (e.g. survey imaging of the kidney, ureter, and bladder (KUB), intravenous pyelogram (IVP), retrograde pyelography), micturition cystourethrogram (MCU), videourodynamics, laparoscopic procedures and minor open urological interventions. The system may be used on pediatric, adult and bariatric patients. Uroskop Omnia Max is not for mammography examinations. Type of Use (Select one or both, as applicable) | <div><span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-------------------------------------------------------------------------------------------------| | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ### 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 {6}------------------------------------------------ ## K173639 510(k) Summary: Software Update VF10 for Luminos Agile Max, Luminos dRF Max, Multitom Rax, Uroskop Omnia Max | Company: | Siemens Medical Solutions USA, Inc. | |----------|-------------------------------------| | | 40 Liberty Boulevard | | | Malvern, PA 19355 | March 9, 2018 Date Prepared: This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. - 1. General Information: Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869 Location of Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Denise Adams, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355 adams.denise@siemens-healthineers.com ## Alternate Contact Person: Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355 patricia.d.jones@siemens-healthineers.com {7}------------------------------------------------ #### 3. Device Names and Classifications: Trade Names: Luminos Agile Max Luminos dRF Max Uroskop Omnia Max Multitom Rax Product Code: OWB Secondary Product Code: JAA Classification Names: System, x-ray, fluoroscopic, image-intensified, Interventional fluoroscopic x-ray system Classification Panel: Radiology Regulation: 21 CFR §892.1650 Device Class: II | Table 1: Legally Marketed Predicate Devices | | | | | |---------------------------------------------|------------------------------------------------|------------------------------------------|------------------------------------------------|------------------------------------------| | Trade Name | Luminos Agile | AXIOM Luminos dRF | Uroskop Omnia | Multitom Rax | | 510(k) Number | K111292 | K062623 | K101491 | K152928 | | Device Classification Name | System, x-ray, fluoroscopic, image-intensified | interventional fluoroscopic x-ray system | System, x-ray, fluoroscopic, image-intensified | interventional fluoroscopic x-ray system | | Regulation Medical Specialty | Radiology | Radiology | Radiology | Radiology | | Review Panel | Radiology | Radiology | Radiology | Radiology | | Product Code | JAA | OWB | JAA | OWB | | Subsequent Product Codes | IZI | JAA, OXO | MQB | JAA | | Regulation Number | 892.1650 | 892.1650 | 892.1650 | 892.1650 | | Device Class | 2 | 2 | 2 | 2 | #### Table 1: Legally Marketed Predicate Devices 4. #### 5. Device Description: All four radiology imaging devices are stationary X-ray systems for radiography and fluoroscopy. They use the same X-ray generator, the same X-ray tube and similar collimators. They also share the same imaging and system control device: The Fluorospot Compact. The reason for this submission is the upgrade of all systems to the software VF10. This new software will bring the following new features to the devices: {8}------------------------------------------------ | Product<br>Name | IEC<br>4th<br>for<br>EMC | Windows<br>10 | Cyber-<br>security<br>package | Pediatric<br>package | Use<br>hospital<br>IT (e.g.<br>RIS) on<br>modality | 16<br>fps<br>mode<br>for<br>3D | SSXI<br>update | |-------------------------|--------------------------|---------------|-------------------------------|----------------------|----------------------------------------------------|--------------------------------|----------------| | Luminos<br>Agile Max | √ | √ | √ | √ | √ | | √ | | Luminos<br>dRF Max | √ | √ | √ | √ | √ | | √ | | Uroskop<br>Omnia<br>Max | √ | √ | √ | √ | √ | | √ | | Multitom<br>Rax | √ | √ | √ | √ | √ | √ | √ | ### Table 2: New Features The image processing algorithms (Diamond View Plus) will be used for exposures without grid and fluoroscopy image processing algorithms will be enhanced and called "Clearview" Also the name suffix "Max" is being established as an addition to the product name of Luminos Agile, Luminos dRF and Uroskop Omnia. #### 6. Indications for Use: The Indications for use have been revised for clarity and alignment. Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos Agile Max is not for mammography examinations. Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction {9}------------------------------------------------ angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos dRF Max is not for mammography examinations. Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients Multitom Rax is not for mammography examinations. Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract. The table supports endourological and minimal invasive surgery in urology as there are transurethral interventions (e.g. ureterorenoscopy (URS), double stent placement, cystoscopy. transurethral resection of bladder tumors (TURB), transurethral resection of the prostate (TURP)), percutaneous urological procedures (e.g. percutaneous nephrostomy (PCN), percutaneous nephrolitholapaxy (PCNL)), urological X-ray diagnosis (e.g. survey imaging of the kidney, ureter, and bladder (KUB), intravenous pyelogram (IVP), retrograde pyelography), micturition cystourethrogram (MCU), videourodynamics, laparoscopic procedures and minor open urological interventions. The system may be used on pediatric, adult and bariatric patients. Uroskop Omnia Max is not for mammography examinations. #### 7. Substantial Equivalence: The new system software VF10 does not alter the fundamental indication for use nor does it change the technology being used for X-ray imaging. The devices remain within the same classification regulation for the same indication for use as the predicate devices. The new system software design was completed in accordance with Siemens Quality Management System Design Controls comparable to the processes available for the predicate devices. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software. Verification and Validation testing were the same or similar to the testing being used with the predicate devices. The new system software VF10 controls solid state X-ray imagers (SSXI) similar to the imagers being used with the predicate devices. The SSXIs have been improved for mechanical robustness. {10}------------------------------------------------ - The edges of the mobile detectors were reinforced with steel caps to increase the ● mechanical robustness. - The handle of the MAX wi-D will not be coated anymore with white film and will . appear in a black carbon fiber look. The following tables compare the performance changes of the detectors being used with the VF10 to the predicate detectors. The changed data are highlighted in bold letters. | Table 3: Comparison of Detector 4343-F Subject and Predicate | | | |--------------------------------------------------------------|-----------------------------|-----------------------------| | | VE 20 / K152928 | VF 10 K173639 | | Fluoroscopy detector | Pixium 4343-F | Pixium 4343-F | | Field of view (Max) | 42 cm x 42.6cm | 42.0 cm x 42.5 cm | | Matrix size | Up to 2840 x 2874 pixel | Up to 2840 x 2874 pixel | | DQE; 200 nGy | 65 % at 0.05 lp/mm | 65 % at 0.05 lp/mm | | | 51 % at 1 lp/mm | 51 % at 1 lp/mm | | | 41 % at 2 lp/mm | 41 % at 2 lp/mm | | | 25 % at 3 lp/mm | 25 % at 3 lp/mm | | | 16 % at 3.4 lp/mm (Nyquist) | 16 % at 3.4 lp/mm (Nyquist) | | MTF | 66 % at 1 lp/mm | 66 % at 1 lp/mm | | | 35 % at 2 lp/mm | 35 % at 2 lp/mm | | | 19 % at 3 lp/mm | 19 % at 3 lp/mm | | | 16 % at 3.4 lp/mm (Nyquist) | 15 % at 3.4 lp/mm (Nyquist) | Table 3: Comparison of Dotoctor 4343-F Subject and Prodicate ## Table 4: Comparison of Detector MAX wi-D Subject and Predicate | Mobil Rad detector | VE 20 / K152928 | VF 10 | |--------------------|--------------------|--------------------| | Siemens Name | MAX wi-D | MAX wi-D | | Trixell name | Pixium 3543 EZh | Pixium 3543 EZh | | Dimensions | 34.9 cm x 42.5 cm | 34.8 cm x 42.4 cm | | Matrix size | 2356 x 2872 | 2350 x 2866 | | DQE; 2 μ Gy | 66 % at 0.05 lp/mm | 70 % at 0.05 lp/mm | | | 50 % at 1 lp/mm | 51 % at 1 lp/mm | | | 40 % at 2 lp/mm | 42 % at 2 lp/mm | | | 24 % at 3 lp/mm | 29 % at 3 lp/mm | | | 17 % at Nyquist | 19 % at Nyquist | | MTF | 61 % at 1 lp/mm | 63 % at 1 lp/mm | | | 31 % at 2 lp/mm | 35 % at 2 lp/mm | | | 15 % at 3 lp/mm | 19 % at 3 lp/mm | | | 12 % at Nyquist | 12 % at Nyquist | ## Table 5: Comparison of Detector MAX mini Subject and Predicate | Mobil Rad detector | VE 20 / K152928 | VF 10 | |--------------------|-----------------|---------------| | Siemens Name | MAX mini | MAX mini | | Trixell name | Pixium 2430EZ | Pixium 2430EZ | {11}------------------------------------------------ | Dimensions (active<br>area) | 28.4 cm x 22.8 cm | 28.4 cm x 22.5 cm | |-----------------------------|--------------------|--------------------| | Matrix size | 1920 x 1538 | 1920 x 1520 | | DQE; 2 $\mu$ Gy | 66 % at 0.05 lp/mm | 66 % at 0.05 lp/mm | | | 50 % at 1 lp/mm | 50 % at 1 lp/mm | | | 40 % at 2 lp/mm | 40 % at 2 lp/mm | | | 24 % at 3 lp/mm | 24 % at 3 lp/mm | | | 17 % at Nyquist | 17 % at Nyquist | | MTF | 61 % at 1 lp/mm | 61 % at 1 lp/mm | | | 31 % at 2 lp/mm | 31 % at 2 lp/mm | | | 15 % at 3 lp/mm | 15 % at 3 lp/mm | | | 12 % at Nyquist | 12 % at Nyquist | ### Summary of Technological Characteristics of the Subject Device as Compared 8. with the Predicate Devices: The subject devices with the new software VF10 use the same X-ray generator, the same X-ray tube and the similar SSXI with the same digital imaging system and similar image processing software as the predicate devices. There are no changes in the patient environment or the type of user interface. The following table compares the main performance data of the subject devices with the predicate devices to substantiate equivalence of the subject device and predicate devices. | | Subject Devices | Predicate Devices | Compariso<br>n/<br>Comments | |------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------| | Feature | Luminos Agile Max<br>Luminos dRF Max<br>Uroskop Omnia Max<br>Multitom Rax | Luminos Agile<br>AXIOM Luminos dRF<br>Uroskop Omnia<br>Multitom Rax | | | X-ray | | | | | Generator | Polydoros<br>65/80 kW | Polydoros<br>65/80 kW | | | X-ray tube | OPTITOP<br>150/40/80/HC-100 | OPTITOP<br>150/40/80/HC-100 | X-ray | | Collimator | Digital Multileaf<br>Collimator N | Digital Multileaf<br>Collimator N | Imaging | | Air kerma | Kerma X | Kerma X | | | X-ray techniques | Radiography<br>Pulsed fluoroscopy<br>DSA and series<br>exposure | Radiography<br>Pulsed fluoroscopy<br>DSA and series<br>exposure | components<br>are the same | | Organ programs | X-ray parameters<br>Imaging processing<br>parameters | X-ray parameters<br>Imaging processing<br>parameters | | | Testing | | | | | IEC Compliance<br>for 60601-1-2<br>EMC | IEC 4th edition | IEC 3rd edition | Testing<br>according to<br>current IEC<br>test scope | | Digital Imaging | | | | | Fluoroscopic<br>SSXI integrated<br>into system | Trixell Pixium 5100<br>Max Dynamic =<br>4343F-4 | Trixell Pixium 5100<br>Max Dynamic =<br>4343F-3 | Image Chain<br>is similar to<br>predicate<br>devices. | | SSXI for Rad<br>imaging | Trixell Pixium<br>MAX wi-D =<br>3543EZh<br>MAX mini = 2430EZ | Trixell Pixium<br>MAX wi-D =<br>3543EZh<br>MAX mini = 2430EZ | Detector<br>Performance<br>data<br>according To<br>SSXI | | Digital imaging<br>system | Fluorospot Compact | Fluorospot Compact | guidance are<br>provided | | Image processing | Diamond View Plus<br>Clearview | Diamond View Plus<br>Application specific<br>organ programs | Same<br>processing<br>made user<br>friendly | | MS Operating<br>system | Windows 10 | Windows 7 | New<br>Operating<br>system | | Cybersecurity | Security package<br>based on MS Win 10 | Security package<br>based on MS Win 7 | Improved | | Integration of<br>hospital IT | Hospital/Radiology<br>Information System | Hospital/Radiology<br>Information System | Improved | | Maximum Frame<br>rate (acquisition) | 16 Frames/second* | 8 Frames/second | Improved<br>dynamic<br>resolution | | *For Multitom Rax only | | | | | Pediatric package | Increased number of<br>organ programs | Organ programs | Increased<br>number and<br>variability | ## Table 6: Technical Comparison with the Predicates {12}------------------------------------------------ #### 9. Summary of Non-Clinical Test Data: The devices operating with software VF10 comply with the voluntary standards as listed in the following table: {13}------------------------------------------------ ## Table 7: Compliance with Standards | Development<br>Organization and<br>Reference Number | Standard Title | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2012,<br>Edition 3.1 | Medical Electrical Equipment - Part 1: General<br>Requirements for Safety | | IEC 60601-1-2:2007<br>Edition 4.0 | Medical Electrical Equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic Compatibility --<br>Requirements and Tests | | IEC 60601-1-3: 2012,<br>Edition 2.1 | Medical electrical equipment - Part 1-3: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Radiation protection in diagnostic X-<br>ray equipment | | IEC 62366:2014<br>Edition 1.1 | Medical devices – Application of usability engineering to<br>medical devices | | ISO 14971, 2007 | medical devices – application of risk management to<br>medical devices | | IEC 62304 Ed. 1.0, 2006 | Medical device software - Software life cycle processes | | IEC 60601-2-28:2010<br>Edition 2.0 | Medical electrical equipment - Part 2-28: Particular<br>requirements for the basic safety and essential performance<br>of X-ray tube assemblies for medical diagnosis | | IEC 60601-2-54, 2009<br>Edition 1.0 | Medical electrical equipment - Part 2-54: Particular<br>requirements for the basic<br>safety and essential performance of X-ray equipment for<br>radiography and<br>radioscopy | | IEC 61910-1, 2014 | Medical electrical equipment - Radiation dose<br>documentation - Part 1: Radiation dose structured reports<br>for radiography and radioscopy (IEC 61910-1:2014) | | NEMA PS 3.1 - 3.20,<br>2011 | Digital Imaging and Communications in Medicine<br>(DICOM) Set | | ISO 10993-1, 2009 | Biological evaluation of medical devices -- Part 1:<br>Evaluation and testing within a risk management process | | IEC 60601-2-43:2010<br>Edition 2.0 | Medical electrical equipment - Part 2-43: Particular<br>requirements for the safety of X-ray equipment for<br>interventional procedures | The following international standards were used in the development of the VF10: The Software VF10 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. Non-clinical performance data are provided for the updated detectors. All radiology and fluoroscopy systems use the same software. Certain {14}------------------------------------------------ features of the software are enabled or disabled depending on the system and its indications for use (i.e. 16 frames per second for Multitom Rax versus 8 frames per second for all other systems. The new IEC 4th edition has been applied for the compliance to the IEC 60601-1-2 electromagnetic compatibility standard. The tests were performed on the new software VF10 demonstrating that the devices are safe and effective, perform comparably to the predicate devices, and are substantially equivalent to the predicate devices. Documentation provided demonstrates compliance of the subject devices to all FDA requirements stated in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests of software requirements and software risk hazards. Performance testing confirmed that the five devices comply with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment. The applicable sections include: | 1020.30(c) | Manufacturer's Responsibility (Certification) | |-------------|------------------------------------------------------| | 1020.30(e) | Identification of X-ray components | | 1020.30(g) | Information to be provided to assemblers | | 1020.30(h) | Information to be provided to users | | 1020.31(k) | Leakage Radiation | | 1020.30(m) | Beam Quality | | 1020.32(d) | Fluoroscopic Entrance exposure rate | | 1020.32 (a) | Primary Protective Barrier Transmission | | 1020.31(a) | Peak Tube Potential | | 1020.32(b) | Alignment of edges of the X-ray field with the edges | | | of the fluoroscopic image receptor | | 1020.32(k) | Display of values of AKR and cumulative air kerma | | 1040.10 | Laser products | The software VF10 controls solid state X-ray imagers (SSXI) that are similar in performance to the predicates. Performance data are provided according to the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on: September 1, 2016". Together, the verification/validation activities successfully confirmed that the software requirements have been fulfilled and that system functionality is consistent with the user needs and intended uses. The VF10 software correctly performs as designed and raises no new questions regarding safety or effectiveness. Therefore, when compared to the predicate devices the devices with the new software VF10 support a determination of substantial equivalence. {15}------------------------------------------------ #### 10. Summary of Clinical Tests: For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as x-ray technology; geometry and SSXI changes are minor. #### General Safety and Effectiveness Concerns: 11. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the devices are continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed. Furthermore the operators are health care professionals familiar with and responsible for the x-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. #### 12. Conclusion as to Substantial Equivalence: The radiology and fluoroscopy devices with VF10 software are intended for the same indications for use as the predicate devices. The operating environment is the same and the technology is effectively unchanged. Siemens concludes via the documentation provided in this 510(k) submission that the radiology and fluoroscopy devices Luminos Agile Max, Luminos dRF Max, Uroskop Omnia Max and Multitom Rax with VF10 software are substantially equivalent to the predicate devices Luminos Agile, AXIOM Luminos dRF, Uroskop Omnia, Multitom Rax. #### 13. Guidance documents The following FDA guidance documents were utilized in the documentation of this Premarket Notification: - Guidance for Industry and FDA Staff . Bundling Multiple Devices or Multiple Indications in a Single Submission Document issued on: June 22, 2007 - . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014 - Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016. The draft of this document was issued on November 2, 2015. - Pediatric Information for X-ray . Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff {16}------------------------------------------------ Document issued on November 28, 2017. - . Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices 1 Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016 - Guidance for Industry and FDA Staff ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 - Guidance for Industry and FDA Staff Recognition and Use of Consensus Standards Document issued on: September 17, 2007 - . The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014 - Radio Frequency Wireless Technology in Medical Devices ● Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013