Who is the manufacturer of ARTIS pheno (VE2)?

Siemens Medical Solution USA, Inc. filed the 510(k) submission for ARTIS pheno (VE2) (K201156).

What is the FDA product code for ARTIS pheno (VE2)?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ARTIS pheno (VE2)?

510(k) clearance (submission type: Traditional).

Does ARTIS pheno (VE2) use AI or machine learning?

Yes. ARTIS pheno (VE2) (K201156) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for ARTIS pheno (VE2)?

ARTIS icono (VE2) (K190768); ARTIS pheno (K163286); Artis zee/zeego & Artis Q/Q.zen (VD11D) (K181407).

Who can help prepare an FDA 510(k) submission like ARTIS pheno (VE2)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like ARTIS pheno (VE2) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

ARTIS pheno (VE2)

K201156 · Siemens Medical Solution USA, Inc. · OWB · Jun 29, 2020 · Radiology

Device Facts

Record ID	K201156
Device Name	ARTIS pheno (VE2)
Applicant	Siemens Medical Solution USA, Inc.
Product Code	OWB · Radiology
Decision Date	Jun 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Device Story

Multi-axis robotic angiography system for interventional radiology, cardiology, and hybrid surgery. Inputs: X-ray signals via flat panel detector. Processing: C-arm positioning, X-ray generation, and image post-processing via syngo software. Outputs: 2D/3D fluoroscopic/angiographic images displayed on ceiling-mounted monitors. Used in OR/clinic by physicians/technicians. Features include DynaCT (3D reconstruction), OPTIQ (CNR-based AEC), and roadmap workflows. Assists clinical decision-making by providing real-time visualization for navigation, surgery, and treatment follow-up. Benefits: improved image quality, dose reduction, and workflow efficiency.

Clinical Evidence

Bench testing only. Performance verified through electrical safety, EMC, and software validation testing per recognized standards (e.g., IEC 60601 series, IEC 62304). Human factors/usability validation conducted via clinical use tests and customer feedback. No clinical trial data required for this modification.

Technological Characteristics

Multi-axis robotic floor stand, C-arm, Trixell 3040CV (as40HDR) flat panel detector, high-voltage generator, X-ray tube, and patient table. Connectivity: DICOM/generic interface for data transfer. Software: syngo application suite. Sterilization: N/A (non-invasive). Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for diagnostic imaging and interventional procedures, including cardiac, neuro, general, rotational, and multipurpose angiography, and whole-body radiographic/fluoroscopic procedures. Suitable for pediatric and obese patients. Includes image-guided surgery and DynaCT 3D reconstruction for hard/soft tissue imaging.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

ARTIS icono (VE2) (K190768)
ARTIS pheno (K163286)
Artis zee/zeego & Artis Q/Q.zen (VD11D) (K181407)

Related Devices

K230949 — ARTIS pheno (VE30A) · Siemens Medical Solutions USA, Inc. · Dec 15, 2023
K220409 — ARTIS pheno (VE21) System · Siemens Medical Solutions USA, Inc. · Jun 29, 2022
K190768 — ARTIS icono · Siemens Medical Solutions USA, Inc. · Sep 12, 2019
K141574 — ARTIS ZEE/ZEEGO SW VC21 · Siemens Medical Solutions USA, Inc. · Sep 5, 2014
K221516 — ARTIS icono (Ceiling Configuration) · Siemens Medical Solutions USA, Inc. · Jul 19, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. Siemens Medical Solution USA, Inc. c/o Kimberly Rendon Director, SHS AM NAM QT Regulatory Affairs 40 Liberty Boulevard 65-1A MALVERN, PA 19355 June 29, 2020 Re: K201156 Trade/Device Name: ARTIS pheno (VE2) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA Dated: April 28, 2020 Received: April 30, 2020 Dear Kimberly Rendon: 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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) K201156 Device Name ARTIS pheno (VE2) #### Indications for Use (Describe) ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <div></div> | <div></div> | | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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}------------------------------------------------ # 510(k) Summary: K201156 # ARTIS pheno (VE2) Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Date Prepared: April 28, 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. #### General Information 1. #### Importer / Distributor Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869 #### Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1, 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person Kim Rendon Director, SHS AM NAM QT Regulatory Affairs Siemens Medical Solutions USA, Inc. #### Device Name and Classification 3. | Trade Name: | ARTIS pheno (VE2) | |-----------------------|---------------------------------------------| | Classification Name: | lmage-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1650 | | Device Class: | Class II | | Product Codes: | OWB, JAA | - 4. Legally Marketed Primary Predicate Device | Trade Name: | ARTIS icono (VE2) | |---------------------------|---------------------------------------------| | 510(k) Number: | K190768 | | Clearance Date: | September 12, 2019 | | Classification Name: | Image-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1650 | | Device Class: | Class II | | Product Code: | OWB | | Subsequent Product Codes: | IZI, JAA, JAK | | Total Product Life Cycle: | There are no Recalls nor MDR incidents for | | | this cleared device. | {4}------------------------------------------------ | Legally Marketed Secondary Predicate Device 1 | | |-----------------------------------------------|---------------------------------------------| | Trade Name: | ARTIS pheno | | 510(k) Number: | K163286 | | Clearance Date: | March 09, 2017 | | Classification Name: | Image-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1650 | | Device Class: | Class II | | Product Codes: | OWB | | Subsequent Product Codes: | JAA | | Total Product Life Cycle: | * | | Legally Marketed Secondary Predicate Device 2 | | | Trade Name: | Artis zee/zeego&Artis Q/Q.zen (VD11D | | 510(k) Number: | K181407 | | Clearance Date: | August 15, 2018 | | Classification Name: | Image-intensified fluoroscopic x-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1650 | | Device Class: | Class II | | Product Code: | OWB | | Subsequent Product Codes: | IZI, JAA, JAK | Total Product Life Cycle: *All product Recall incidents are considered during the Development Design Input phase to ensure the latest models will not be affected by any applicable issue. #### 5. Device Description The ARTIS pheno (VE2) system is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE2) system is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, available for the support of dedicated clinical workflows. The ARTIS pheno (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and radiographic/ fluoroscopic procedures. - 1) The following components are configured to create the ARTIS pheno VE2 system: Floor stand with C-arm, X-ray tube assembly and FD - 2) Patient table - 3) Display ceiling suspension with displays {5}------------------------------------------------ ARTIS pheno (VE2) - 4) Footswitch for releasing radiation - 5) Control console for controlling the stand, patient table, collimator and imaging system. Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts. Post processing can be done in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS pheno (VE2) System is capable of 2D and 3D imaging. Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS pheno (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room. The Subject Device, "ARTIS pheno with software version VE2," will support the following categories of modifications made to the Subject Device in comparison to the Predicate Devices: ### 1) Modified Software | Table 1: Overview - Software Modifications ARTIS pheno VE2 System | |-------------------------------------------------------------------| | NEW System Software Modifications “VE2” (VE20) | | 1. | Modified Indications For Use Statement | |----|------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | System Software VE2 (also known as VE20), software modification/features | | 3. | Improved Roadmap | | | A. Increased image quality dose ratio and faster workflow via new Architecture and Organ Program parametrization due to improved algorithms | | | B. Improved Image Quality due to improved algorithm | | | C. Subtracted fluoro mode: Dose, Time, and Contrast Agent Savings | | | D. Automap Integration in DSA Roadmap Workflow | | 4. | OPTIQ - New Marketing Terminology. | | | "OPTIQ" - marketing name for the following previously cleared features in K190768: | | | 1. CNR based AEC | | | 2. Improved Roadmap features | | 5. | 3D Imaging - syngo DynaCT Multiphase | | 6. | Improved ClearStent Live | | 7. | Updated User Interface (Pilot Module) | | | A. Case Flow | | | B. "Favorites" in Toolbars in control room | | | C. Direct position buttons to save and recall the positions of the C-arm | | | D. C-arm swivel buttons on the side of the joystick, instead of next to the joystick | - Generic Interface for 3rd parties for data transference {6}------------------------------------------------ #### Table 2: Overview - Hardware/Other Modifications ARTIS pheno VE2 System Hardware/Other Modifications ARTIS pheno VE2 System | Device Hardware Modifications | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 9. | New Flat Panel Detector Trixell 3040CV (as known as as40HDR) | | 10. | New Optional Touch Control Displays | | 11. | New Variations of Display Ceiling Mounts | | | A. DCS-2x32" Pivot (fixed) mounted or rail (movable) mounted Improved Image Quality due to improved algorithm | | | B. Large Display DCS with up to two (2) additional (Artis) displays on the rear side; or one (1) additional (Artis) display and one (1) ACUSON Freestyle display/system on the rear side | | 12. | New 3rd Party Accessory Heatable Mattress | | 13. | Additional Video Interface Inputs | | 14. | Updated Cockpit Solution | | Other Device Modifications | | | 15. | Product Claims for the ARTIS pheno VE2 (VE20) | | 16. | Update 510(k) Information | ### 6. Indications for Use ARTIS is a family of dedicated angiography systems developed for single and biplane Diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography. neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data svnthesis. The ARTIS family systems also include the software option DynaCT with the following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and {7}------------------------------------------------ ARTIS pheno (VE2) treatment follow-up. ## 7. Substantial Equivalence The ARTIS pheno (VE2) system is substantial equivalent to the legally marketed predicates listed in Table 3 below: | Table 3: Predicate Device Comparable Properties for Subject Device Modifications | | | | |----------------------------------------------------------------------------------|------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | Predicate Device Name (all Siemens) | 510(k) Number | Clearance Date | Comparable Properties | | Primary Predicate ARTIS Icono (VE2) | K190768 | 9/12/2019 | Indications for use Software Version VE2 Roadmap OPTIQ (Marketing terminology) 3D Imaging - syngo DynaCT Multiphase ClearStent Live + User Interface - Case Flow Generic Interface - 3rd party data transference 3rd Party Accessory Heatable Mattress Optional Touch Control Displays Variations of Display Ceiling Mounts Video Interface Inputs ARTIS Cockpit Solution | | Secondary Predicates ARTIS pheno | K163286 | 3/09/2017 | Pilot Module ARTIS Cockpit Solution | | Artis zee/zeego (VD11D)/Artis Q/Q zen | K181407 | 8/15/2018 | Flat Panel Detector 3040CV (aka - (as40HDR)) | ### 8. Summary of Technological Characteristics of the Subject Device, Compared to the Predicate Device The ARTIS pheno (VE2) System is designed as a set of components (floor stand, Carm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, etc.) that is combined to provide a specialized angiography system. Components used with ARTIS pheno (VE2) System are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in the Table 4 below for all modifications. ### Table 4: Summary of Comparison of Technological Characteristics | | Subject Device SW Modifications ARTIS pheno (VE2) System | Comparison Results to the Predicate | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Modified Indications for Use Statement | Same as Primary Predicate – K190768 | | 2. | ARTIS pheno System (VE2) SW Modifications | Same as Primary Predicate – K190768 The Subject Device software modifications (numbers: 2. – 7.B.) are the same software modifications as cleared in the Primary Predicate – K190768. There are no technological differences | | | | in the listed modifications when compared to the Primary Predicate Device. | | 3. | Improved Roadmap A. Increased image quality dose ratio and faster workflow via new Architecture and Organ Program parametrization due to improved algorithms B. Improved Image Quality due to improved algorithm C. Subtracted fluoro mode: Dose, Time, and Contrast Agent Savings D. Automap Integration in DSA Roadmap Workflow | Same as 2. | | 4. | OPTIQ - New Marketing Terminology. "OPTIQ" - marketing name encompassing the following previously cleared features in K190768. 1. CNR based AEC 2. Improved Roadmap features | Same as 2. | | 5. | 3D Imaging - syngo DynaCT Multiphase | Same as 2. | | 6. | Improved ClearStent Live | Same as 2. | | 7. | Updated User Interface (Pilot Module) A. Case Flow B. "Favorites" in Toolbars in control room C. Direct position buttons to save and recall the positions of the C-arm D. C-arm swivel buttons moved to the side of the joystick, instead of being next to the joystick | 7.C. Exactly the same as Primary Predicate - K190768 7.D. Modified button location only. Moved buttons from sitting next to the joystick, to the side of the joystick. Same button functionality as Secondary Predicate, ARTIS pheno K163286. | | 8. | Generic Interface for 3rd parties for data transference | Exactly the same system software features as the Primary Predicate – K190768. | | | Hardware/Software Modifications | | | 9. | New Flat Panel Detector Trixell 3040CV (aka - as40HDR) | Exactly the same detector as cleared in Secondary Predicate - K181407. There are no technological differences in the Flat Panel Detector 3040CV. | | 10. | New Optional Touch Control Displays | 10. - 12. Exactly the same modifications as cleared with the Primary Predicate - K190768. There are no technological differences in the listed modifications when compared to the Primary Predicate device. | | 11. | New Variations of Display Ceiling Mounts A. DCS-2x32" Pivot (fixed) mounted or rail (movable) mounted Improved Image Quality due to improved algorithm B. Large Display DCS with up to two (2) additional (Artis) displays on the rear side; or one (1) additional (Artis) display and one (1) ACUSON Freestyle display/system on the rear side | Same as 10. | | 12. | New 3rd Party Accessory Heatable Mattress | Same as 10. | | 13. | Additional Video Interface Inputs | Same number of external video inputs and the same functionality as the primary predicate - K190768. | | 14. | Updated Cockpit Solution | Modified: The architecture/hardware has changed. The hardware is now integrated into the system's own image system cabinet and not realized via 3rd- party component. The functionality is same as the Secondary Predicate Device. | | Other Device Modifications | | | | 15. | Product Claims for the Artis pheno (VE20) | Device claims with supporting information is included in this submission. | | 16. | Update 510(k) Information | Update 510(k) (changes to the Predicate Device since clearance) are included this submission. | {8}------------------------------------------------ # 510(k) SUMMARY - K201156 ARTIS pheno (VE2) {9}------------------------------------------------ # 510(k) SUMMARY - K201156 ARTIS pheno (VE2) #### 9. Nonclinical Performance Testing Non-clinical tests were conducted for the ARTIS pheno (VE2) during product development. The ARTIS pheno (VE2) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility: - AAMI ANSI ES60601-1:2005/(R)2012 ● - . IEC 60601-1-2:2014 - IEC 60601-1-3:2013 - IEC 60601-1-6:2010/A1:2013 . - IEC 60825-1:2007 • - TR 60878:2015 - . IEC 62304:2015 - IEC 80001-1:2010 • - IEC 60601-2-28:2017 ● - IEC 60601-2-43:2017 . - IEC 60601-2-54:2009/A1:2015 - ISO 10993-1:2009 ● - ISO 14971:2007 - IEC 62366-1:2015 {10}------------------------------------------------ ### Table 5: FDA Guidance Documents | FDA Guidance Document and Effective Date | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions 510(k) - Document issued on October 2, 2017 | | 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s. Document issued on September 13, 2019 | | 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Document issued on September 13, 2019 | | 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing device. Document issued on October 25, 2017 | | 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. Document Issued on July 28, 2014 | | 6. | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid State X-ray Imaging Devices. Document issued on September 1, 2016 | | 7. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software in Medical Devices. Document issued on May 11, 2005 | | 8. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical Devices. Document issued on September 27, 2019 | | 9. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices. Document issued February 3, 2016 | | 10. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications. Document issued on November 28, 2017 | | 11. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical devices. Document issued on October 2, 2014 | | 12. | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices. Document issued on September 14, 2018 | | 13. | Guidance for Industry and FDA Staff: Medical Device Accessories - Describing Accessories and Classification Pathways. Document issued on December 20, 2017 | | 14. | Guidance for Industry and FDA Staff: Recommended Content and Format of Non- Clinical Bench Performance Testing Information in Premarket Submissions. Document issued on December 20, 2019 | The modifications described in this Premarket Notification are supported with verification and validation testing. ### Verification and Validation Software Documentation for a Major 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 and "Off-The-Shelf Software Use in Medical Devices" 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 were conducted on ARTIS pheno System software (VE2) during product development. 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 {11}------------------------------------------------ # 510(k) SUMMARY - K201156 ARTIS pheno (VE2) acceptance criteria. Testing for the verification for the device was found acceptable to support the claims of substantial equivalence. ARTIS pheno System software (VE2) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment. Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. Compliance with IEC 80001-1-2010 is the responsibility of the hospital. Provided in the Software Section is the required cybersecurity information. ## Nonclinical Testing Summary Performance tests were conducted to test the functionality of ARTIS pheno (VE2) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness. ## 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. 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 evaluating and post processing of X-ray images. ## 11. Conclusion as to Substantial Equivalence The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the ARTIS pheno (VE2) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.