Multix Fusion Max

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355 Re: K162971 Trade/Device Name: Multix Fusion Max Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 21, 2016 Received: October 25, 2016 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. 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Sincerely yours, Robert Oolo Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ## K162971 Device Name Multix Fusion Max #### Indications for Use (Describe) Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatic, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion Max system is not meant for mammography. Multix Fusion Max uses a mobile(wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max 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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The background is white. ## Healthcare ## 510(k) Summary: Multix Fusion Max Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Date Prepared: November 21, 2016 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, Business Unit XP 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.com 40 Liberty Boulevard Malvern, PA 19355-9998 USA {4}------------------------------------------------ #### 3. Device Name and Classification | Trade Name: | Multix Fusion Max | |----------------------------|-------------------------| | 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 Devices | Primary Predicate | | |-----------------------|-------------------------| | Trade Name: | Multix Fusion | | 510(k) #: | K142049 | | Clearance Date: | December 18, 2014 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | ### Reference Predicate | | Trade Name: | YSIO Max | |-----------------------|-------------------------| | 510(k) #: | K133259 | | Clearance Date: | January 24, 2014 | | 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 Fusion Max Radiography X-ray system is a modular system of x-ray components (ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and integrated detectors) same as the predicate the Multix Fusion. This 510(k) submission describes modifications to the predicate device the Multix Fusion cleared via K142049. The following modifications have been made to the cleared predicate device and the system will be rebranded the Multix Fusion Max: {5}------------------------------------------------ #### Hardware The following components are being integrated into the system: the Pixium 3543 EZh wireless detector, the Pixium 2430 EZ wireless detector; the Pixium 4343RCE fixed detector, a new wireless Bucky wall stand with motorized height adjustment, a new table that has a charging tray and a manual Bucky tray, and a new 92-line grid with a 13:1 ratio. ### Software The operating system is being upgraded from Windows XP to Windows 7 and the software version will now be VE21. ### 6. Indication for Use Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max 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 Fusion Max system is not meant for mammography. Multix Fusion Max uses a mobile (wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. ## 7. Substantial Equivalence The Multix Fusion Max is a modification to the primary predicate device the Multix Fusion cleared via K142049. The Multix Fusion Max utilizes the same wireless detectors as the reference device the Ysio Max cleared via K133259. It is within the same classification regulation for the same indications for use and the same mechanical design as the predicate devices. The Multix Fusion Max is substantially equivalent to the predicate devices and documentation is provided to support a claim of substantial equivalence. | | Multix Fusion Max<br>(subject) | Multix Fusion K142049<br>(primary predicate) | Comparison<br>Results | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Indications<br>for Use | 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<br>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. | The Multix Fusion system<br>is a radiographic system<br>used in hospitals, clinics,<br>and medical practices.<br>Multix Fusion enables<br>radiographic exposures of<br>the whole body including:<br>skull, chest, abdomen, and<br>extremities and may be<br>used on pediatric, adult and<br>bariatric patients.<br>Exposures may be taken<br>with the patient sitting. | Same | ### Comparison of Indications for Use {6}------------------------------------------------ | standing, or in the prone<br>position. The Multix Fusion<br>Max system is not meant for<br>mammography. | standing, or in the prone<br>position. The Multix<br>Fusion system is not meant<br>for mammography. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The Multix Fusion uses a<br>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. | The Multix Fusion uses a<br>mobile (wired), or fixed<br>(integrated) or wireless<br>digital detector for<br>generating diagnostic<br>images by converting x-<br>rays into image signals. | | The Multix Fusion is also<br>designed to be used with<br>conventional film/ screen or<br>Computed Radiography<br>(CR) cassettes. | The Multix Fusion is also<br>designed to be used with<br>conventional film/ screen<br>or Computed Radiography<br>(CR) cassettes. | # Comparison of Subject Device to the Primary Predicate Device - | Attribute | Multix Fusion Max (subject) | Multix Fusion K142049 (primary predicate) | Comparison Results | |-------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Ceiling mounted support (unchanged) | Semi-automated | Semi-automated | Same | | X-ray tube assembly (unchanged) | 80 kW<br>Two-focus | 80 kW<br>Two-focus | Same | | Collimator (unchanged) | Standard collimator(ACSS) | Standard collimator(ACSS) | Same | | Patient Table | Radiographic table motorized with floating table top (wireless detector) | Radiographic table motorized with floating table top (wireless detector) | Charging tray | | | Radiographic table motorized with floating table top (integrated detector) | Radiographic table motorized with floating table top (integrated detector) | Same | | Bucky Wall Stand | BWS for integrated detector motorized height adjustment (vertical movement) | BWS for integrated detector motorized height adjustment (vertical movement) | Same | | | BWS for wireless detector<br>motorized height adjustment<br>(vertical movement) | BWS for wireless detector<br>motorized or manual<br>height adjustment (vertical<br>movement) | Only motorized<br>height<br>adjustment | | Touch<br>Interface<br>(unchanged) | Graphical user interface | Graphical user interface | Same | | X-ray<br>generator<br>(unchanged) | 55kW, 65 kW or 80 kW | 55kW, 65 kW or 80 kW | Same | | Integrated<br>detector<br>TRIXELL | Pixium 4343RCE<br>43 cm x 43 cm | Pixium 4343RG<br>43 cm x 43 cm<br>Pixium 4343RC<br>43 cm x 43 cm | Compared to<br>the predicate<br>Pixium<br>4343RC-the<br>active area is<br>smaller but the<br>performance<br>(e.g. DQE,<br>MTF) is similar | | Portable<br>Wireless<br>Detector<br>(wi-D)<br>TRIXELL | Pixium 3543EZh<br>43 cm x 35 cm<br>Pixium 2430EZ<br>30 cm x 24 cm | PaxScan 4336W<br>43cm x 36 cm | Same<br>technology with<br>WIFI feature | | Operating<br>modes<br>(unchanged) | RAD Single Exposure | RAD Single Exposure | Same | | Imaging<br>System<br>(unchanged) | Fluorospot Compact PC<br>based,<br>high res digital | Fluorospot Compact PC<br>based,<br>high res digital | Same | | Display 19"<br>(unchanged) | Black & White<br>or Color | Black & White<br>or Color | Same | | DICOM 3<br>Functions<br>(unchanged) | Send, StC, Print,<br>Query/Retrieve, Get<br>Worklist, MPPS | Send, StC, Print,<br>Query/Retrieve, Get<br>Worklist, MPPS | Same | | Radiographi<br>c<br>Grid | 92-line grid<br>(ratio 13:1)<br>85-line grid<br>(ratio 5:1) (optional) | 80-line grid (ratio10:1)<br>50-line grid (ratio10:1) | More lines,<br>different ratio | | Accessory<br>(unchanged) | Remote Control | Remote Control | Same | {7}------------------------------------------------ - {8}------------------------------------------------ | | console | console | | |--|---------|---------|--| | | | | | | | | | Fixed Subject Detector Compared to the Fixed Primary Predicate Detector | | |------------------------------------|---------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------|--| | | | | | | | Technical<br>Specifications | Trixell Pixium<br>4343RCE detector<br>(fixed) (subject) | Trixell Pixium<br>4343RC detector<br>(fixed) (predicate) | Comparison<br>Results | | | Dimensions | 423.3 mm x 425.4 mm | 424.6 mm x 425.5 mm | Difference not<br>significant | | | Resolution | 2860 x 2874 pixels | 2869 x 2874 pixels | Difference not<br>significant | | | Pixel size | 148 um | 148 um | Same | | | Semiconductor<br>Material | Amorphous silicon, a-<br>Si | Amorphous silicon, a-<br>Si | Same | | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | | Acquisition depth | 16 bit | 16 bit | Same | | | DQE (Detective<br>Duantin | DOE @ 0.05 lp/mm (2<br>μGy), 67% | DOE @ 0.05 lp/mm (2<br>uGy), 65% | Difference not<br>significant | | | (Modulations<br>transfer function) | MTF @ 1 lp/mm, 62% | MTF @ 1 lp/mm, 63% | Difference not<br>significant | | | ## Wireless Subject Detector Compared to the Wireless Primary Predicate Detector | Technical<br>Specifications | Trixell Pixium 3543<br>EZh detector<br>(wireless) (subject) | Varian PaxScan<br>4336W detector<br>(wireless)<br>(predicate) | Comparison<br>Results | |-------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------| | Dimensions | 349 mm x 425 mm | 356 mm x 427 mm | Smaller | | Resolution | 2356 x 2872 pixels | 3032 x 2520 pixels | Difference not<br>significant | | Pixel size | 148 139 Larger | | | | Semiconductor<br>Material | Amorphous silicon, a-<br>Si | Amorphous silicon, a-<br>Si | Same | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | Acquisition depth | 16 bit | 16 bit | Same | | DQE (Detective<br>Quantum<br>Efficiency) | DQE @ 1 lp/mm (2 DQE @ 1 lp/mm (2 Difference not<br>significant | | | | MTF<br>(Modulations<br>transfer function) | MTF @ 1 lp/mm, 61% | MTF @ 1 lp/mm, 57% | Difference not<br>significant | ## Wireless Subject Detector Compared to the Wireless Reference Predicate Detector | Technical<br>Specifications | Trixell Pixium 3543<br>EZh detector<br>(wireless) (subject) | Trixell Pixium 3543<br>EZh detector<br>(wireless)<br>(reference predicate) | Comparison<br>Results | |-----------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------| | Dimensions | 349 mm x 425 mm | 349 mm x 425 mm | Same | {9}------------------------------------------------ | Resolution | 2356 x 2872 pixels | 2356 x 2872 pixels | Same | |-------------------------------------------|----------------------------|----------------------------|------| | Pixel size | 148 μm | 148 μm | Same | | Semiconductor<br>Material | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Same | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | Acquisition depth | 16 bit | 16 bit | Same | | DQE (Detective<br>Quantum<br>Efficiency) | DQE @ 1 lp/mm (2 μGy), 50% | DQE @ 1 lp/mm (2 μGy), 50% | Same | | MTF<br>(Modulations<br>transfer function) | MTF @ 1 lp/mm, 61% | MTF @ 1 lp/mm, 61% | Same | ## Wireless Subject Detector Compared to the Wireless Primary Predicate Detector - | Technical<br>Specifications | Trixell Pixium<br>2430EZ detector<br>(wireless) (subject) | Varian PaxScan<br>4336W detector<br>(wireless) (primary predicate) | Comparison<br>Results | |-------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------|-------------------------------| | Dimensions | 228 mm x 284 mm | 356 mm x 427 mm | Smaller | | Resolution | 1560 x 1920 pixels | 3032 x 2520 pixels | Difference not<br>significant | | Pixel size | 148 μm | 139 μm | Larger | | Semiconductor<br>Material | Amorphous silicon, a-<br>Si | Amorphous silicon, a-<br>Si | Same | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | Acquisition depth | 16 bit | 16 bit | Same | | DQE (Detective<br>Quantum<br>Efficiency) | DQE @ 1 lp/mm (2<br>μGy), 50% | DQE @ 1 lp/mm (2<br>μGy), 54% | Difference not<br>significant | | MTF<br>(Modulations<br>transfer function) | MTF @ 1 lp/mm,61% | MTF @ 1 lp/mm,57% | Difference not<br>significant | ## Wireless Subject Detector Compared to the Wireless Reference Predicate Detector | Technical<br>Specifications | Trixell Pixium<br>2430EZ detector<br>(wireless) (subject) | Trixell Pixium<br>2430EZ detector<br>(wireless) (reference<br>predicate) | Comparison<br>Results | |------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------|-----------------------| | Dimensions | 228 mm x 284 mm | 228 mm x 284 mm | Same | | Resolution | 1560 x 1920 pixels | 1560 x 1920 pixels | Same | | Pixel size | 148 µm | 148 µm | Same | | Semiconductor<br>Material | Amorphous silicon, a-<br>Si | Amorphous silicon, a-<br>Si | Same | | Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same | | Acquisition depth | 16 bit | 16 bit | Same | | DQE (Detective<br>Quantum<br>Efficiency) | DQE @ 1 lp/mm (2 µGy), 50% | DQE @ 1 lp/mm (2 µGy), 50% | Same | | MTF (Modulations<br>transfer function) | MTF @ 1 lp/mm,61% | MTF @ 1 lp/mm,61% | Same | {10}------------------------------------------------ ## 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device The Multix Fusion Max is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available predicates. It uses the same or similar components cleared in the Multix Fusion (e.g. tube, generator, ceiling-mounted tube support, table, Bucky wall stand and imaging system) and the Ysio Max (wireless detectors). The components of the subject device have many of the same technological characteristics as the ones from the predicate devices. There are some 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 Fusion Max with all of its components are comparable to the predicate devices and therefore is substantially equivalent to the predicate devices. The modifications made to the subject device Multix Fusion Max do not affect the intended use of the device nor do they alter its fundamental scientific technology from the 510(k) cleared predicate devices. #### 9. Nonclinical Performance Testing Non-clinical tests were conducted for the Multix Fusion Max during product development. The modifications described in this Premarket Notification are supported with verification and validation testing. Multix Fusion Max conforms to the following standards: IEC 60601-1:2012, ed.3.1; IEC 60601-1-2 3rd 2007; IEC 60601-1-3:2008+A1:2013; IEC 62366: 2014; ISO 14971:2007; IEC 62304 Ed. 1.1 2015; IEC 60601-2-28 Edition 2.0 (2010); IEC 60601-2-54 Edition 1.1 2015; PS 3.1 - 3.20 (2011); IEC 60601-1-6: 2013 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 Fusion Max during product development. Detector integration testing consisted of functional and image quality tests. Functional tests included exposure workflow, detector sharing function and image resend functions. Image quality tests included flat field uniformity of the detector. 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 {11}------------------------------------------------ Multix Fusion Max 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, mechanical, 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 Fusion Max has the same indications for use as the predicate Multix Fusion. The operating environment and mechanical design are similar. It is Siemens opinion, that the Multix Fusion Max is substantially equivalent to the Multix Fusion, cleared 12/18/2014 in K142049. The predicate device was cleared based on non-clinical supportive information. Therefore, the subject device non-clinical data supports the safety of software with verification and validation testing. Verification and validation testing demonstrates that the Multix Fusion Max should perform as intended. The non-clinical test data demonstrate that the Multix Fusion Max 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 Fusion Max does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device.