YSIO X.pree

{0}------------------------------------------------ October 21, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. % Mr. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355 Re: K201670 Trade/Device Name: YSIO X.pree Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 17, 2020 Received: September 21, 2020 Dear Mr. Turner: 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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) K201670 Device Name YSIO X.Pree Indications for Use (Describe) The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. Generic clinical benefits of radiographic examinations within the intended use are applicable for this device. YSIO X.pree is not for mammography examinations. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------|---------------------------------------------------------| | <span></span> | <span></span> | | <div></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div></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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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 words is a graphic of orange dots. Below the words is the text "K201670". ## 510(k) Summary: YSIO X.pree Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 #### Date Prepared: August 5, 2020 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 Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Andrew Turner Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Stop 65-1A Malvern, PA 19355, USA Phone: 610-850-5627 Email: andrew.turner@siemens-healthineers.com #### 3. Device Name and Classification: Trade Name: YSIO X.pree System, X-Ray, Stationary Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR § 892.1680 Device Class: Class II Product Code: KPR #### 4. Legally Marketed Predicate Device Trade Name: Ysio Max 510(k) #: K181270 Classification Name: System, X-Ray, Stationary Classification Panel: Radiology {4}------------------------------------------------ Image /page/4/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 word "Healthineers" is a graphic of orange dots. Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: KPR #### 5. Device Description: The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. The following modifications have been made to the cleared predicate device: - New image system with touch user interface o - Added a camera at collimator to support clinical workflow o #### Indications for Use: 6. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. Generic clinical benefits of radiographic examinations within the intended use are applicable for this device. YSIO X.pree is not for mammography examinations. #### 7. Substantial Equivalence: The YSIO X.pree with VA10 is substantially equivalent to the commercially available Ysio Max VF10 ( K181270 ). ### 8. Summary of Technological Characteristics of the Subiect Device as Compared with the Predicate Devices: The YSIO X.pree is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available Ysio Max. It uses the same or similar components cleared with Ysio Max (e.g. tube, collimator, table, wallstand, detector or generator). Many components of the subject device have the same technological characteristics as those from the predicate device. Testing and validation have been successfully completed and test results show that the subject device YSIO X.pree with all of its components is comparable and therefore substantially equivalent to the predicate device. The modifications made to the subject device YSIO X.pree are within the scope of intended use of 510(k) cleared predicate device Ysio Max (tomographic exposure is no longer available) and they also don't alter the fundamental scientific technology compared to predicate device. {5}------------------------------------------------ Image /page/5/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 words is a graphic of orange dots arranged in a circular pattern. ## Table 1: Comparison of the Subject to the Predicate | Attribute | Subject Device<br>YSIO X.pree | Predicate Device<br>Ysio Max K181279 | Comparison /<br>Remarks | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | YSIO X.pree is a device<br>intended to visualize<br>anatomical structures by<br>converting an X-ray<br>pattern into a visible<br>image. YSIO X.pree<br>enables radiographic<br>exposures of the whole<br>body and may be used on<br>pediatric, adult and<br>bariatric patients. It can<br>also be used for<br>emergency applications.<br>YSIO X.pree is not for<br>mammography<br>examinations. | Ysio Max is a device<br>intended to visualize<br>anatomical structures by<br>converting an X-ray pattern<br>into a visible image. Ysio<br>Max enables radiographic<br>and tomographic exposures<br>of the whole body and may<br>be used on pediatric, adult<br>and bariatric patients. It can<br>also be used for emergency<br>applications.<br>Ysio Max is not for<br>mammography<br>examinations. | The option for<br>tomographic<br>exposures is not<br>available for the<br>subject device<br>due to low<br>customer use in<br>previous devices.<br>Ysio X.pree was<br>initially developed<br>without this<br>feature and<br>therefore this<br>does not alter the<br>safety and<br>effectiveness. | | Product Code | KPR | KPR | same | | X-Ray | | | | | Generator | Polydoros R80<br>65/80 kW | Polydoros R80<br>65/80 kW | same | | X-Ray tube | OPTITOP<br>150/40/80/HC-100 | OPTITOP<br>150/40/80/HC-100 | same | | X-ray<br>techniques | Radiography | Radiography | same | | Collimator | Digital Multileaf<br>Collimator N | Digital Multileaf<br>Collimator N | same | | Air kerma | Kerma X | Kerma X | same | | CARE | Combined<br>Applications to<br>Reduce Exposure | Combined<br>Applications to<br>Reduce Exposure | same | | Touch user<br>interface on<br>tube<br>suspension | New touchscreen in<br>landscape format | Touchscreen in portrait<br>format. | New touchscreen | | Digital Imaging | | | | | Fixed detector<br>for table and<br>wall stand | Trixell Pixium 4343RC<br>"Max Static" | Trixell Pixium 4343RC<br>"Max Static" | same | | Large mobile<br>detector | Trixell Pixium<br>3543EZh "MAX wi-D" | Trixell Pixium<br>3543EZh "MAX wi-D" | same | | Small mobile<br>detector | Pixium 2430EZ "MAX<br>mini" | Pixium 2430EZ "MAX mini" | small changes in<br>DQE and MTF,<br>see table below,<br>does not affect<br>safety and<br>effectiveness. | | | | | effectiveness | | Digital imaging<br>system | syngo XR | Fluorospot Compact | Different, new<br>imaging system | | | Operating system<br>Windows 10 | Operating system Windows<br>10 | same | | | Operated via touch screen | Operated with mouse and<br>keyboard | Different, does<br>not affect safety<br>or effectiveness | | | Image processing with<br>MyExam IQ | Image processing with<br>Diamond View Plus | Slightly different,<br>based on same<br>processing<br>software. Does<br>not affect safety<br>or effectiveness | | | Al-based Auto Cropping | Auto Cropping | New Algorithm,<br>does not affect<br>safety or<br>effectiveness | | | Acquisition and Image<br>processing parameters<br>selected via clinical<br>protocols | Acquisition and Image<br>processing parameters<br>selected via Organ<br>Programs | Improved, does<br>not affect safety<br>or effectiveness | | Other Features and Components | | | | | | Table with fixed detector<br>and table with bucky | Table with fixed detector<br>and table with bucky | same | | Patient table | Standard tabletop and flat<br>tabletop | Standard tabletop | Additional flat<br>tabletop for easier<br>patient<br>positioning, does<br>not affect safety<br>or effectiveness | | Wall stand | Wall stand with fixed<br>detector and wall stand<br>with bucky | Wall stand with fixed<br>detector and wall stand with<br>bucky | same | | Camera | Live camera for patient<br>positioning and collimation | N/A | New, does not<br>affect safety or<br>effectiveness | | Wireless<br>Remote<br>Control | Yes, same type | Yes, same type | same | {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. # Table 2: Comparison of detector parameters for detector Pixium 2430EZ | Mobile Rad detector | YSIO X.pree | Ysio Max / K181279 | |--------------------------|-------------------|--------------------| | Siemens Name | MAX mini | MAX mini | | Trixell name | Pixium 2430EZ | Pixium 2430EZ | | Dimensions (active area) | 28.4 cm x 22.5 cm | 28.4 cm x 22.5 cm | {7}------------------------------------------------ Image /page/7/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 word "Healthineers" are a series of orange dots arranged in a circular pattern. | Matrix size | 1920 x 1520 | 1920 x 1520 | |-----------------|--------------------|--------------------| | DQE in %; 2 µGy | 70 % at 0.05 lp/mm | 66 % at 0.05 lp/mm | | | 51 % at 1 lp/mm | 50 % at 1 lp/mm | | | 42 % at 2 lp/mm | 40 % at 2 lp/mm | | | 29 % at 3 lp/mm | 24 % at 3 lp/mm | | | 19 % at Nyquist | 17 % at Nyquist | | MTF in % | 63 % at 1 lp/mm | 61 % at 1 lp/mm | | | 35 % at 2 lp/mm | 31 % at 2 lp/mm | | | 19 % at 3 lp/mm | 15 % at 3 lp/mm | | | 15 % at Nyquist | 12 % at Nyquist | The MAX mini has now the same image performance as the MAX Wi-D. #### 9. Summary of Non-Clinical Tests: The YSIO X.pree was tested and complies with the voluntary standards listed in the table below: | Reference Number and Date | Title of Standard | |----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1<br>Edition 3.1 (IEC 60601-1:2005<br>+ Cor.:2006 + Cor.:2007 +<br>A1:2012) | Medical Electrical Equipment - Part 1: General Requirements<br>for Safety | | IEC 60601-1-2<br>Edition 4.0<br>(IEC 60601-1-2:2014) | Medical Electrical Equipment - Part 1-2: General requirements<br>for basic safety and essential performance - Collateral<br>Standard: Electromagnetic Compatibility -- Requirements and<br>Tests | | IEC 60601-1-3<br>Edition 2.1<br>(IEC 60601-1-3:2008 +<br>A1:2013) | Medical electrical equipment - Part 1-3: General requirements<br>for basic safety and essential performance - Collateral<br>Standard: Radiation protection in diagnostic X-ray equipment | | IEC 60601-2-28 Edition 3.0<br>(IEC 60601-2-28: 2017) | Medical electrical equipment - Part 2-28: Particular<br>requirements for the basic safety and essential performance of<br>X-ray tube assemblies for medical diagnosis | | IEC 60601-2-43<br>Edition 2.1<br>(IEC 60601-2-43:2010 +<br>A1:2017) | Medical electrical equipment - Part 2-43: Particular<br>requirements for the safety of X-ray equipment for<br>interventional procedures | | IEC 60601-2-54<br>Edition 1.2<br>(IEC 60601-2-54:2009 +<br>Cor.:2010 + Cor.:2011 +<br>A1:2015 + A2:2018) | Medical electrical equipment - Part 2-54: Particular<br>requirements for the basic safety and essential performance of<br>X-ray equipment for radiography and radioscopy | ## Table 3: Non-clinical performance testing {8}------------------------------------------------ | IEC 62366-1<br>Edition 1.0<br>(IEC 62366-1:2015) | Medical devices - Application of usability engineering to<br>medical devices | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 14971:2019 | medical devices - application of risk management to medical<br>devices | | IEC 62304<br>Edition 1.1<br>(IEC 62304:<br>2006 + A1:2015) | Medical device software - Software life cycle processes | | IEC 61910-1<br>Edition 1.0<br>(IEC 61910:<br>2014) | Medical electrical equipment - Radiation dose documentation -<br>Part 1: Radiation dose structured reports for radiography and<br>radioscopy (IEC 61910-1:2014) | | PS 3.1 - 3.20 2016 | Digital Imaging and Communications in Medicine (DICOM) Set | | ISO 10993-1: 2013 | Biological evaluation of medical devices -- Part 1: Evaluation<br>and testing within a risk management process | The following quality assurance measures were applied to the development of the system: - . Risk Analysis - Requirement Specification Reviews ● - . Design Reviews - Integration testing (System verification and validation) ● #### 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 YSIO X.pree is continuously monitored and if an error occurs the system functions will be blocked and an error message will be displaved. 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. #### 11. Conclusion as to Substantial Equivalence: The YSIO X.pree has the same fundamental scientific technology and performance characteristics as the predicate, Ysio Max (K181270). The YSIO X.pree has the same intended use and a simplified indications for use. Therefore, the YSIO X.pree is substantially equivalent to the predicate Ysio Max #### 12. Guidance documents The following FDA guidance documents were utilized in this Premarket Notification: {9}------------------------------------------------ Image /page/9/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. - Content of Premarket Submissions for Management of Cyberse ● Devices Guidance for Industry and Food and Drug Administration Staff Document lssued 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 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 - 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