MULTIX Impact

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Siemens Medical Solutions USA, Inc. % Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code: 65-1A MALVERN PA 19355 Re: K182517 Trade/Device Name: MULTIX Impact Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: November 28, 2018 Received: November 29, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for January 11, 2019 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182517 Device Name MULTIX Impact #### Indications for Use (Describe) The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pedianc, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography. The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. X 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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To the right of the word "Healthineers" is a cluster of orange dots. # 510(k) Summary: MULTIX Impact Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Date Prepared: September 11, 2018 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, 65-1A Malvern, PA 19355 Establishment Registration Number 2240869 #### Location of Manufacturing Site Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318. China Establishment Registration Number 3003202425 Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 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 610-448-6139 adams.denise@siemens-healthineers.com Siemens Medical Solutions USA, Inc. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. # 3. Device Name and Classification | Trade Name: | MULTIX Impact | |----------------------------|-------------------------| | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | ## 4. Legally Marketed Predicate Device | Trade Name: | Multix Fusion Max | |-----------------------|-------------------------| | 510(k) #: | K162971 | | Clearance Date: | November 22, 2016 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | #### 5. Device Description The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact: - A new 43×35cm Wireless detector, 3543DR 1. - 2. A new X-ray tube and a new generator - 3. An optional 40 line grid with grid suppression algorithm - 4. Wireless Remote Control Console - ર. An optional All-in-one PC containing touch screen function - An optional positioning assistance camera 6. - Upgrade software to VA10 7. - 8. Upgrade operator system from Windows XP to Windows 10 ## 6. Indications for Use The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a pattern of orange dots. The MULTIX Impact uses digital detectors for generating diagnostic images by converting Xrays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. # 7. Substantial Equivalence The MULTIX Impact is a modification to the predicate device the Multix Fusion Max cleared via K162971. It is within the same classification with similar indications for use and the same mechanical design as the predicate device. The MULTIX Impact is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence. # 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device The MULTIX Impact is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available Siemens' Multix Fusion Max. It uses the same or similar components cleared in the Multix Fusion Max (e.g. collimator, patient table, Bucky wall stand). The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are several technological characteristics that differ slightly as shown in the comparison tables. Testing and validation have been successfully completed and test results show that the subject device MULTIX Impact with all of its components are comparable to the predicate device and therefore is substantially equivalent to the predicate device. The modifications made to the subject device MULTIX Impact do not affect the intended use of the device nor do they alter its fundamental scientific technology from the 510(k) cleared predicate device the Multix Fusion Max. The following tables compare the main performance data of the subject device with the predicate device to substantiate equivalence. | Attribute | MULTIX Impact<br>(subject) | Multix Fusion Max<br>K162971<br>(predicate) | Comparison<br>Results | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Indications<br>for Use | The MULTIX Impact system<br>is a radiographic system used<br>in hospitals, clinics, and<br>medical practices. MULTIX<br>Impact enables radiographic<br>exposures of the whole body | The Multix Fusion Max<br>system is a radiographic<br>system used in hospitals,<br>clinics, and medical<br>practices. Multix Fusion Max<br>enables radiographic | Intended use is<br>the same.<br>Indications for<br>use have been<br>reworded to | ## Table 1: Indications for Use Comparison Siemens Medical Solutions USA, Inc. 40 I iberty Boulevard Malvern PA 19355-9998 USA Tel.: +1-888-826-9702 usa.siemens.com/healthineers {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern. | including: skull, chest,<br>abdomen, and extremities<br>and may be used on<br>pediatric, adult and bariatric<br>patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone<br>position. The MULTIX<br>Impact system is not meant<br>for mammography.<br><br>The MULTIX Impact uses<br>digital detectors for<br>generating diagnostic images<br>by converting X-rays into<br>image signals.<br><br>The MULTIX Impact is also<br>designed to be used with<br>conventional film/screen or<br>Computed Radiography (CR)<br>cassettes. | exposures of the whole body<br>including: skull, chest,<br>abdomen, and extremities<br>and may be used on<br>pediatric, adult and bariatric<br>patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone<br>position. The Multix Fusion<br>Max system is not meant for<br>mammography.<br><br>The Multix Fusion Max uses<br>a mobile (wired), or fixed<br>(integrated) or wireless<br>digital detector for<br>generating diagnostic images<br>by converting X-rays into<br>image signals.<br><br>The Multix Fusion is also<br>designed to be used with<br>conventional film/ screen or<br>Computed Radiography (CR)<br>cassettes. | simplify. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| 40 Liberty Boulevard Malvern, PA 19355-9998 USA {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are a series of orange dots that are arranged in a pattern. | Attribute | MULTIX Impact<br>(subject) | Multix Fusion Max<br>K162971<br>(predicate) | Comparison<br>Results | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operating<br>System | Windows 10 | Windows XP | New operating<br>system, does<br>not affect safety<br>or effectiveness | | Suppression<br>algorithm for<br>low line grid | The new 40 low line grid<br>requires a suppression<br>algorithm to suppress line<br>artifacts | N/A | Performance<br>testing<br>concluded does<br>not affect image<br>quality. | | Post-<br>processing<br>software | -Contrast<br>-Detail<br>-Latitude<br>-Noise<br>-WLShift<br>-WWShift | -Amplification<br>-Edge Enhancement<br>-Harmonization<br>-Noise Reduction<br>-Center Shift<br>-Width Factor | Performance<br>testing<br>concluded does<br>not affect image<br>quality. | | Floor<br>mounted<br>support | Mechanical | N/A | Does not affect<br>safety or<br>effectiveness | | X-ray tube<br>assembly | 80 kW<br><br>Two-focus | 80 kW<br><br>Two-focus | Same | | Collimator | Standard collimator (ACSS) | Standard collimator(ACSS) | Same | | Optional<br>collimator | Manual collimator | N/A | Does not affect<br>safety or<br>effectiveness | | Optional<br>digital<br>camera | Camera on collimator to aid<br>in patient positioning | N/A | Does not affect<br>safety or<br>effectiveness | | Attribute | MULTIX Impact<br>(subject) | Multix Fusion Max<br>K162971<br>(predicate) | Comparison<br>Results | | Patient Table | Radiographic table<br>motorized with floating table<br>top and motorized Bucky<br>tray with charging in tray<br>function (wireless detector) | Radiographic table<br>motorized with floating table<br>top and manual Bucky tray<br>with charging in tray<br>function (wireless detector) | Improvement of<br>Bucky<br>movement to<br>motorized.<br>Does not affect<br>safety or<br>effectiveness | | | Radiographic table<br>motorized with floating table<br>top and motorized Bucky<br>tray (wireless detector) | Radiographic table<br>motorized with floating table<br>top and manual Bucky tray<br>with charging in tray<br>function (wireless detector) | Improvement of<br>Bucky<br>movement to<br>motorized<br>without<br>charging<br>function in tray<br>Does not affect<br>safety or<br>effectiveness | | | Fixed radiographic table with<br>floating table top and manual<br>Bucky tray (portable wireless<br>detector) | N/A | Does not affect<br>safety or<br>effectiveness | | Bucky Wall<br>Stand | BWS for wireless detector<br>Vertical motorized and<br>charging in tray | BWS for wireless detector<br>Vertical motorized and<br>charging in tray | Same | | | BWS for wireless detector<br>Vertical motorized | BWS for wireless detector<br>Vertical motorized and<br>charging in tray | No charging<br>tray. Does not<br>affect safety or<br>effectiveness | | | BWS for wireless detector<br>Manual movement in z-axis | N/A | Does not affect<br>safety or<br>effectiveness | | Attribute | MULTIX Impact<br>(subject) | Multix Fusion Max<br>K162971<br>(predicate) | Comparison<br>Results | | Touch<br>Interface | Graphical user interface | Graphical user interface | Same | | X-ray<br>generator | 55kW, 65kW or 80kW | 55kW, 65 kW or 80 kW | Same | | Operating<br>modes | RAD Single Exposure | RAD Single Exposure | Same | | Imaging<br>System | All in one PC based<br>high resolution digital<br>touch screen function as<br>option | Fluorospot Compact PC<br>based<br>high resolution digital | Addition of<br>touch screen<br>function as<br>option. Does<br>not affect safety<br>or effectiveness | | Display | Black & White<br>Color<br>Size Ratio 16:9 | Black & White<br>Color<br>Size Ratio 4:3 | Different size<br>ratio. Does not<br>affect safety or<br>effectiveness | | DICOM 3<br>Functions | Send, StC, Print,<br>Query/Retrieve, Get<br>Worklist, MPPS | Send, StC, Print,<br>Query/Retrieve, Get<br>Worklist, MPPS | Same | | Radiographic<br>Grid | 92-line grid<br>(ratio 13:1)<br>40-line grid<br>(ratio 13:1) | 92-line grid<br>(ratio 13:1)<br>85-line grid<br>(ratio 5:1) (optional) | Same ratio<br>with new<br>addition of 40-<br>line grid.<br>Performance<br>testing<br>concluded that<br>combined with<br>suppression<br>algorithm does<br>not affect image<br>quality | | Accessory | Wireless Remote Control<br>Console via bluetooth | Remote Control console | Improvement of<br>wireless<br>function. Does | #### Table 2: Subject Device Compared to the Predicate {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that form a curved line. 40 Liberty Boulevard Malvern, PA 19355-9998 USA {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots. Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355-9998 USA Tel.: +1-888-826-9702 usa.siemens.com/healthineers {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots. | Attribute | MULTIX Impact<br>(subject) | Multix Fusion Max<br>K162971<br>(predicate) | Comparison<br>Results | |-----------|----------------------------|---------------------------------------------|---------------------------------------| | | | | not affect safety<br>or effectiveness | 40 Liberty Boulevard Malvern, PA 19355-9998 USA {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern. | Table 3: Comparison of Trixell Pixium 3543 DR to the Predicate Trixell Pixium | | | |-------------------------------------------------------------------------------|--|--| | 3543 EZh | | | | Technical<br>Specifications | Trixell Pixium<br>3543 DR<br>detector<br>(wireless)<br>(subject) | Trixell Pixium<br>3543 EZh<br>detector<br>(wireless)<br>(subject) | Trixell Pixium<br>3543 EZh<br>detector<br>(wireless)<br>(predicate) | Comparison<br>Results | |----------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------| | Dimensions | 345 mm x 426 mm | 348 mm x 424 mm | 349 mm x 425 mm | Difference not significant | | Resolution | 2156 x 2662 pixels | 2350 x 2866 pixels | 2356 x 2872 pixels | Difference not significant | | Pixel size | 160 $ \mu $ m | 148 $ \mu $ m | 148 $ \mu $ m | Difference not significant/<br>Same | | Semiconductor<br>Material | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Same | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | Acquisition<br>depth | 16 bit | 16 bit | 16 bit | Same | | DQE (Detective<br>Quantum<br>Efficiency) | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | Same | | MTF<br>(Modulations<br>transfer<br>function) | MTF @ 1 lp/mm,62% | MTF @ 1 lp/mm, 63% | MTF @ 1 lp/mm,63% | Difference not significant/<br>Same | ## 9. Nonclinical Performance Testing Non-clinical tests were conducted for the MULTIX Impact during product development. The modifications described in this Premarket Notification are supported with verification and validation testing. MULTIX Impact conforms to the following standards: IEC 60601-1:2012; IEC 60601-1-2:2014; IEC 60601-1-3:2008+A1:2013; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2010-03; IEC 60601-2-54:2015-04; NEMA PS 3.1 - 3.20 (2016) and ISO 10993-1:2009. Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact during product development. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence. ## 10. General Safety and Effectiveness Concerns 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 MULTIX Impact Radiography X-ray system is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed. Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. #### 11. Conclusion as to Substantial Equivalence The MULTIX Impact has similar indications for use as the predicate Multix Fusion Max. The operating environment and mechanical design are similar. It is Siemens opinion, that the MULTIX Impact is substantially equivalent to the Multix Fusion Max, cleared in K162971 on November 22, 2016. Verification and validation testing demonstrates that the MULTIX Impact should perform as intended. The non-clinical test data demonstrate that the MULTIX Impact device performance is comparable to the predicate device that is currently marketed for the same intended use. In summary, Siemens is of the opinion that the MULTIX Impact does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device. #### 12. Guidance documents The following FDA guidance documents were utilized in the documentation of this Premarket Notification: - 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