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 anglography, 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 Description

The ARTIS pheno (VE21) 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 (VE21) 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 (VE21) 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.

The following components are configured to create the floor configuration:

(1) Floor stand with C-arm, X-ray tube assembly and FD
(2) Patient table
(3) Display ceiling suspension with displays
(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 (VE21) 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 (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

AI/ML Overview

This document, K220409, concerns the Siemens Medical Solutions USA, Inc. ARTIS pheno (VE21) System, an image-intensified fluoroscopic X-ray system. The submission seeks to demonstrate substantial equivalence to the previously cleared ARTIS pheno (VE20) system. The modifications in the VE21 system include updated system software (from VE20 to VE21) to support NOMSIE DSA (IQ) customization of contrast in DSA images and an optional new generator (Polydoros ACX).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a summary of comparison of technological characteristics was performed. However, it does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it offers a qualitative statement about the testing results.

Acceptance Criteria Category	Reported Device Performance (Summary)
System Software Modifications	All test results met all acceptance criteria.
Safety & Effectiveness	Test results demonstrate that the ARTIS pheno (VE21) System acceptance criteria are adequate for the intended use of the device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.
Electrical Safety	Complies with 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 60601-2-28:2017, IEC 60601-2-43:2017, IEC 60601-2-54:2009/A1:2015.
EMC	Complies with IEC 60601-1-2:2014.
Software Validation	Performance data demonstrates continued conformance with special controls for medical devices containing software. Risk analysis was completed, and risk control implemented to mitigate identified hazards. All software specifications have met the acceptance criteria.
Usability	Human Factor Usability Validation showed that human factors are addressed in the system test according to the operator's manual.
Cybersecurity	Conforms to cybersecurity requirements, considering IEC 80001-1:2010.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size (e.g., number of images, or patient cases) used for the test set for image quality or clinical performance evaluations related to the software updates.

Regarding data provenance, the document mentions "non-clinical tests" and "bench test summaries." The nature of these tests suggests they are primarily technical and engineering validations rather than studies involving patient data from a specific country of origin or a retrospective/prospective design. The modifications are described as "software and hardware changes [that] do not raise any new risks or any issues regarding the safety nor effectiveness of the device."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts or the establishment of ground truth for a test set in the context of the software or hardware modifications. The testing described focuses on technical compliance, verification, and validation, rather than clinical efficacy studies involving expert review of patient data.

4. Adjudication Method for the Test Set

Since there is no mention of a clinical test set requiring expert ground truth establishment, there is no adjudication method described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence through technical and functional testing of modifications rather than comparative clinical performance with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone performance study in the context of an algorithm's diagnostic accuracy without human intervention. The "NOMSIE DSA (IQ) Customization of Contrast in DSA images" is a software modification related to image quality customization, and its performance is assessed through verification and validation testing, not typically as an AI algorithm in a standalone diagnostic capacity as might be reported for a disease detection or quantification algorithm.

7. Type of Ground Truth Used

The "ground truth" for the testing performed appears to be based on:

Engineering Specifications and Standard Compliance: For electrical safety, EMC, software functionality, and other technical aspects, ground truth is conformity to established industry standards (e.g., IEC 60601 series, IEC 62304) and internal product specifications.
Verification and Validation Testing Results: The software specifications are considered met based on the outcomes of verification and validation tests.
Risk Analysis: Ground truth for safety is established by mitigating identified hazards through risk control measures.

There's no indication of ground truth based on expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy for an algorithm.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is consistent with the nature of the submission, which focuses on modifications to an existing device (ARTIS pheno VE20 to VE21) and the associated technical validation, rather than the development and training of a novel machine learning algorithm requiring a distinct training dataset.

9. How the Ground Truth for the Training Set was Established

Since no training set is mentioned for a new machine learning algorithm, there is no information provided on how ground truth for a training set would have been established.

Summary

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June 29, 2022

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: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K220409

Trade/Device Name: ARTIS pheno (VE21) System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA Dated: June 15, 2022 Received: June 17, 2022

Dear Patricia Jones:

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

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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 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220409

Device Name ARTIS pheno (VE21) System

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.

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.

510(k) Summary: ARTIS pheno (VE21)

Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355

Date Prepared: June 28, 2022

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 Systems USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Reqistration Number: 2240869

Manufacturing Site:

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

Contact Person: 2.

Ms. Patricia D. Jones Requlatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-Healthineers.com

1. Device Name and Classification:
  Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Codes:

ARTIS pheno (VE21) Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB. JAA

4. Legally Marketed Primary Predicate Device

Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: Requlation Number: Device Class:

ARTIS pheno (VE20) K201156 June 29, 2020 Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II

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Image /page/4/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 text is a cluster of orange dots arranged in a circular pattern.

Product Code: Subsequent Product Code : OWB, JAA

Total Product Life Cycle:

All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.

5. Device Description:

The following components are configured to create the floor configuration:

(1) Floor stand with C-arm, X-ray tube assembly and FD
(2) Patient table
(3) Display ceiling suspension with displays
(4) Footswitch for releasing radiation

(5) Control console for controlling the stand, patient table, collimator, and imaging system

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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. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

The 510(k) submission, Subject Device "ARTIS pheno with software version VE21" will support the following modifications made to the Subject Device in comparison to the Predicate Device:

Table 1.	Modifications for ARTIS pheno (VE21) System
----------	---------------------------------------------

Software/Hardware modifications specific to New System Software VE21
1. Updated system Software from VE20 to VE21
A. NOMSIE DSA (IQ Customization of Contrast in DSA images
B. Optional New Generator
2. Updated 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.

ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

The ARTIS family also include the software option DynaCT with 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 treatment follow-up.

Substantial Equivalence: 7.

The ARTIS pheno (VE21) system is substantial equivalent to the legally marketed predicate listed in the Table 2 below:

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Predicate Device Nameand Manufacturer	510(k) Number	ClearanceDate	Comparable Properties
Primary PredicateARTIS pheno (VE20)	K201156	06/29/2020	• Indications for use• Software VersionVE20• Image Quality• Generator

Table 2: Predicate Device Comparable Properties for Subject Devic

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The ARTIS pheno (VE21) System is designed as a set of components (floor stand, C-arm, 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 (VE21) 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 3 below for all modifications.

Modifications	Subject DeviceARTIS pheno (VE21)	Predicate DeviceARTIS pheno (VE20)K201156	ComparisonResults
New SystemSoftwareChanges	1. Updated system Softwarefrom VE20 to VE21A. NOMSIE DSA (IQ)Customization ofContrast in DSAImagesB. Optional NewGenerator(Polydoros ACX)	System Software VersionVE20Classical edge enhancementwith filters and automaticwindowing was used.Generator (PolydorosA100G)	Comparable:System software VE21 wasupdated to supportNOMSIE DSA (IQ)Customization of Contrastin DSA Images and a newGenerator. SystemSoftware modificationsconforms to "Guidance forthe content of Premarketsubmission for software inMedical Devices". Providedis all required softwaretesting. Provided in thissubmission are Bench TestSummaries. Thesesoftware and hardwarechanges do not raise anynew risks or any issuesregarding the safety noreffectiveness of the device.All test results met allacceptance criteria.
Update 510(k)Information	2. Updated 510(k) information for the Primary Predicate Device is provided.

Table 3: Summary of Comparison of Technological Characteristics

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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 below it. To the right of the word "Healthineers" is a graphic of orange dots.

9. Nonclinical Performance Testing:

Non-clinical tests were conducted for the ARTIS pheno (VE21) during product development.

The ARTIS pheno (VE21) 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 ●

The modifications described in this Premarket Notification are supported with verification and validation testing.

Verification and Validation:

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, 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 (VE21) 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 acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

ARTIS pheno System software (VE21) 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. Customer employees are adequately trained in the use of this equipment.

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Image /page/8/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 in a circular pattern.

Siemens conforms to the cybersecurity requirementing 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. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of ARTIS pheno (VE21) 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 (VE21) 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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.