MULTIX Impact, MULTIX Impact C

{0}------------------------------------------------ December 13, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's name on the right. The seal includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355 Re: K213700 Trade/Device Name: MULTIX Impact; MULTIX Impact C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 18, 2021 Received: November 23, 2021 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 and Part 809); medical device 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}------------------------------------------------ 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, , for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213700 Device Name MULTIX Impact; MULTIX Impact C #### Indications for Use (Describe) MULTIX Impact 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, or in the prone position. MULTIX Impact is not intended for mammography. MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact C is not intended for mammography. MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> </span> </div> | | 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 words is a graphic of orange dots arranged in a circular pattern. # 510(k) Summary: MULTIX Impact / MULTIX Impact C K213700 Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: December 7, 2021 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 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 Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 610-944-2184 adams.denise@siemens-healthineers.com {4}------------------------------------------------ Image /page/4/Picture/0 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 arranged in a circular pattern. # 3. Subject Device Name and Classification | Trade Name: | MULTIX Impact (VA21) | |----------------------------|-------------------------| | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | | Trade Name: | MULTIX Impact C (VA21) | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | # 4. Legally Marketed Predicate/Reference Devices | Trade Name: | MULTIX Impact (VA20) | |----------------------------|-------------------------| | 510(k) #: | K203345 | | Clearance Date: | January 07, 2021 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | | Trade Name: | MULTIX Impact C (VA20) | | 510(k) #: | K203340 | | Clearance Date: | January 06, 2021 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | | Trade Name: | YSIO X.pree | | 510(k) #: | K201670 | | Clearance Date: | October 21, 2020 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | Siemens Medical Solutions USA, Inc. {5}------------------------------------------------ Image /page/5/Picture/0 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 words is a graphic of orange dots arranged in a circular pattern. | Device Class: | Class II | | | |---------------|----------|--|--| | Product Code: | KPR | | | ### 5. Device Description The MULTIX Impact (VA21) Radiography X-ray system is a floor mounted, modular system of x-ray components (x-ray tube, bucky wall stand, patient table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (VA20, K203345). The MULTIX Impact C (VA21) Radiography X-ray system is a ceiling suspended, modular system of x-ray components (x-ray tube, bucky wall stand, patient table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact C (VA20, K203340). The following modifications have been made to the predicate devices: - 1. Upgrade software version from VA20 to VA21 to support the new features: Auto TOD Measurement, Auto Thorax Collimation, Virtual Collimation, Hybrid Image Documentation (HID). - 2. New mobile UI: Smart Remote Control (SRC). - 3. New accessory: myExam 3D Camera, to support the new software features. The myExam 3D Camera has been cleared in YSIO X.pree (K201670). ## 6. Indications for Use ## MULTIX Impact: MULTIX Impact 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. MULTIX Impact is not intended for mammography. MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. ### MULTIX Impact C: MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C 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. MULTIX Impact C is not intended for mammography. MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern. PA 19355 USA Tel +1-888-826-9702 usa.siemens.com/healthineers {6}------------------------------------------------ Image /page/6/Picture/0 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 words is a graphic of orange dots arranged in a circular pattern. ### 7. Substantial Equivalence ## MULTIX Impact (VA21): MULTIX Impact (VA21) is a modification of the predicate device, the MULTIX Impact (VA20), cleared via K203345. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact (VA21) is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence. ### MULTIX Impact C (VA21): MULTIX Impact C (VA21) is a modification of the predicate device, the MULTIX Impact C (VA20), cleared via K203340. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact C (VA21) 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 subject devices are substantially equivalent to the predicate devices in terms of the indications for use, design, material, functionality, technology, and energy source. The subject devices use the same or similar components cleared in the predicate devices. The components of the subject device have many of the same technological characteristics as those in the predicate device. Some technological characteristics that differ slightly are shown in attached comparison table. Verification and validation testing have been successfully completed and test results show that the subject devices with all its components, is substantially equivalent to the predicate devices. The modifications made to the subject devices do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate devices. The following tables compare the main performance data of the subject device with the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 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. | Attribute | MULTIX Impact (VA21)<br>(Subject) | MULTIX Impact (VA20)<br>K203345<br>(Predicate) | Comparison<br>Results | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Indications<br>for Use | MULTIX Impact is a radiographic<br>system used in hospitals, clinics, and<br>medical practices. MULTIX Impact<br>enables radiographic exposures of<br>the whole body including: skull,<br>chest, abdomen, and extremities and<br>may be used on pediatric, adult and<br>bariatric patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone position.<br>MULTIX Impact is not intended for<br>mammography.<br><br>MULTIX Impact uses digital<br>detectors for generating diagnostic<br>images by converting X- rays into<br>image signals.<br><br>MULTIX Impact is also designed to<br>be used with conventional film/screen<br>or Computed Radiography (CR)<br>cassettes. | MULTIX Impact is a radiographic<br>system used in hospitals, clinics, and<br>medical practices. MULTIX Impact<br>enables radiographic exposures of<br>the whole body including: skull,<br>chest, abdomen, and extremities and<br>may be used on pediatric, adult and<br>bariatric patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone position.<br>MULTIX Impact is not intended for<br>mammography.<br><br>MULTIX Impact uses digital<br>detectors for generating diagnostic<br>images by converting X- rays into<br>image signals.<br><br>MULTIX Impact is also designed to<br>be used with conventional film/screen<br>or Computed Radiography (CR)<br>cassettes | Same | # Table 1: Indications for Use Comparison: | Attribute | MULTIX Impact C (VA21)<br>(Subject) | MULTIX Impact C (VA20)<br>K203340<br>(Predicate) | Comparison Results | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Indications for Use | MULTIX Impact C is a radiographic<br>system used in hospitals, clinics, and<br>medical practices. MULTIX Impact<br>C enables radiographic exposures of<br>the whole body including: skull,<br>chest, abdomen, and extremities and<br>may be used on pediatric, adult and<br>bariatric patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone position.<br>MULTIX Impact C is not intended<br>for mammography.<br><br>MULTIX Impact C uses digital | MULTIX Impact C is a radiographic<br>system used in hospitals, clinics, and<br>medical practices. MULTIX Impact<br>C enables radiographic exposures of<br>the whole body including: skull,<br>chest, abdomen, and extremities and<br>may be used on pediatric, adult and<br>bariatric patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone position.<br>MULTIX Impact C is not intended<br>for mammography.<br><br>MULTIX Impact C uses digital | Same | | Siemens Medical Solutions USA, Inc. | | 40 Liberty Boulevard<br>Malvern, PA 19355<br>USA | Tel.: +1-888-826-9702<br>usa.siemens.com/healthineers | {8}------------------------------------------------ Image /page/8/Picture/0 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 arranged in a circular pattern. | detectors for generating diagnostic<br>images by converting X- rays into<br>image signals. | detectors for generating diagnostic<br>images by converting X- rays into<br>image signals. | |----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | MULTIX Impact C is also designed<br>to be used with conventional<br>film/screen or Computed<br>Radiography (CR) cassettes. | MULTIX Impact C is also designed to<br>be used with conventional film/screen<br>or Computed Radiography (CR)<br>cassettes. | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains 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 graphic of orange dots. | Table 2: Subject Device Compared to Predicate Device | |------------------------------------------------------| |------------------------------------------------------| | MULTIX Impact (VA21)<br>(Subject) | MULTIX Impact (VA20)<br>K203345<br>(Predicate) | Comparison<br>Results | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MULTIX Impact C (VA21)<br>(Subject) | MULTIX Impact C (VA20)<br>K203340<br>(Predicate) | | | | Polydoros RFX | Polydoros RFX | Same | | | RAY-14S_3F | RAY-14S_3F | Same | | | - Collimator ML03<br>- Collimator ML04<br>- Collimator RFU | - Collimator ML03<br>- Collimator ML04<br>- Collimator RFU | Same | | | - Collimator ML04<br>- Collimator RFU | - Collimator ML04<br>- Collimator RFU | | | | - Trixell Pixium 3543EZH<br>(MAX wi-D)<br>- iRay Mars1717VS (Core XL)<br>- iRay Venu1717X (Core Static) | - Trixell Pixium 3543EZH<br>(MAX wi-D)<br>- iRay Mars1717VS (Core XL)<br>- iRay Venu1717X (Core Static) | Same | | | Manual or motorized vertical<br>module | Manual or motorized vertical<br>module | Same | | | - Motorized vertical module<br>- Manual tilting module | - Motorized vertical module<br>- Manual tilting module | | | | Floor mounted semi-motorized -<br>- Manual tube tilting<br>- Manual longitudinal movement<br><br>Floor mounted fully motorized<br>- Manual tube tilting<br>- Motorized tube lifting<br>- Manual longitudinal movement<br>- Motorized tube tilting<br>- Motorized longitudinal | Floor mounted semi-motorized<br>- Manual tube tilting<br>- Manual longitudinal movement<br><br>Floor mounted fully motorized<br>- Manual tube tilting<br>- Motorized tube lifting<br>- Manual longitudinal movement<br>- Motorized tube tilting<br>- Motorized longitudinal | Same | | | Attribute | MULTIX Impact (VA21)<br>(Subject)<br><br>MULTIX Impact C (VA21)<br>(Subject) | MULTIX Impact (VA20)<br>K203345<br>(Predicate)<br><br>MULTIX Impact C (VA20)<br>K203340<br>(Predicate) | Comparison<br>Results | | Ceiling<br>suspension<br>tube stand<br>(MULTX<br>Impact C) | Ceiling suspension manual<br>- Manual tube tilting<br>- Motorized tube lifting<br><br>Ceiling suspension motorized<br>- Motorized tube tilting<br>- Motorized tube lifting | Ceiling suspension manual<br>- Manual tube tilting<br>- Motorized tube lifting<br><br>Ceiling suspension motorized<br>- Motorized tube tilting<br>- Motorized tube lifting | Same | | All-in-one<br>PC | - With touch screen<br>- With non-touch screen | - With touch screen<br>- With non-touch screen | Same | | Patient<br>table | Elevating patient table with tray<br>for wireless or fixed detector | Elevating patient table with tray<br>for wireless or fixed detector | Same | | Imaging<br>System | Software version: VA21<br>including new software features:<br>Auto TOD Measurement, Auto<br>Thorax Collimation, Virtual<br>Collimation, and Hybrid Image<br>Documentation (HID). | Software version: VA20 | Different<br>Improved to support<br>more operational<br>possibilities. Bench<br>testing concluded no<br>impact on safety and<br>effectiveness. | | HMI<br>(Human<br>Machine<br>Interface) | Smart Remote Control (SRC)<br>supported by Siemens provided<br>Phone that meets minimum<br>requirements. | Remote Interface supported by<br>Siemens provided tablet that<br>meets minimum requirements. | Similar<br>Same software with<br>similar hardware.<br>Bench testing<br>concluded no impact on<br>safety and<br>effectiveness. | | Attribute | MULTIX Impact (VA21)<br>(Subject)<br>MULTIX Impact C (VA21)<br>(Subject) | MULTIX Impact (VA20)<br>K203345<br>(Predicate)<br>MULTIX Impact C (VA20)<br>K203340<br>(Predicate) | Comparison<br>Results | | Camera | 3D Camera | 2D Camera | Different<br>Improved to support the<br>new features of Auto<br>TOD Measurement,<br>Auto Thorax<br>Collimation, Virtual<br>Collimation, and<br>Hybrid Image<br>Documentation (HID).<br>Bench testing<br>concluded no impact on<br>safety and<br>effectiveness. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a pattern of orange dots. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. ## Table 3: Comparison of new feature to reference device | Technical<br>Specifications | MULTIX Impact /<br>MULTIX Impact C<br>(VA21)<br>(subject) | YSIO X.pree<br>(K201670)<br>(reference) | Comparison Results | |-----------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | myExam 3D<br>Camera | - Accessory<br>- Model: Intel®<br>RealSenseTM D400<br>series | - Accessory<br>- Model: Intel®<br>RealSenseTM D400<br>series | Similar<br>Same model series;<br>Same functionality;<br>Bench testing concluded no<br>impact on safety and<br>effectiveness. | | Auto Thorax<br>Collimation | Exam range<br>automatically planned<br>for Thorax by 3D<br>camera with manual<br>adjustment | Exam range automatically<br>planned for Thorax by 3D<br>camera with manual<br>adjustment | Different<br>Same functionality;<br>Similar clinical workflow;<br>Bench testing concluded no<br>impact on safety and<br>effectiveness. | | Virtual<br>Collimation | Manually adjust<br>collimation size on<br>imaging system by 3D<br>camera | Manually adjust<br>collimation size on<br>imaging system by 3D<br>camera | Different<br>Same functionality;<br>Similar clinical workflow;<br>Bench testing concluded no<br>impact on safety and<br>effectiveness. | {12}------------------------------------------------ Image /page/12/Picture/0 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 triangular shape. ## 9. Nonclinical Performance Testing Non-clinical tests were conducted for the MULTIX Impact (VA21) and MULTIX Impact C (VA21) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing. MULTIX Impact (VA21) and MULTIX Impact C (VA21) conforms to the following standards: ANSI ES60601-1:2005/(R)2012 and A1:2012 IEC 60601-1-2 Edition 4.0 2014-02 IEC 60601-1-3 Edition 2.1 2013-04 IEC 62366-1 Edition 1.0 2015-02 ISO 14971 Second edition 2007-03-01 IEC 60601-1-6 Edition 3.1 2013-10 IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION IEC 60601-2-28 Edition 3.0 2017-06 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION NEMA PS 3.1 - 3.20 (2016) ISO 10993-1 Fifth edition 2018-08 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 (VA21) and MULTIX Impact C (VA21) during product development. The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim 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, MULTIX Impact (VA21) and MULTIX Impact C (VA21) Radiography Xray system are 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 healthcare professionals familiar with and responsible for the x-ray examinations to be performed. Siemens Medical Solutions USA, Inc. {13}------------------------------------------------ Image /page/13/Picture/0 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 arranged in a pattern. #### Conclusion as to Substantial Equivalence 11. The MULTIX Impact (VA21) / MULTIX Impact C (VA21) has the same indications for use as the predicate device, MULTIX Impact (VA20, K203345) / MULTIX Impact C (VA20, K203340). The operating environment and mechanical design are similar. Verification and validation testing demonstrate that the MULTIX Impact (VA21) and MULTIX Impact (VA21) performs as intended. The non-clinical test data demonstrate that the MULTIX Impact (VA21) and MULTIX Impact C (VA21) device performance is comparable to the predicate device that is currently marketed for the same intended use. In summary, Siemens concludes that the MULTIX Impact (VA21) and MULTIX Impact (VA21) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device, MULTIX Impact (VA20, K203345) and MULTIX Impact C (VA20, K203340). #### 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 and Food and Drug Administration Staff Document issued on July 11, 2016. - Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance ● for Industry and Food and Drug Administration Staff Document issued on November 28, 2017. - Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices ● 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 {14}------------------------------------------------ Image /page/14/Picture/0 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 words is a graphic of orange dots arranged in a circular pattern. - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 14, 2018 - • 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