ARTIS is a family of dedicated angiography systems developed for single-plane 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.

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

The ARTIS systems 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 soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up.

Device Description

The ARTIS icono (VE30A) is a medical device that allows visualization of vessels within the human body. It is of the utmost importance to find the right projections so physicians can navigate catheters and other devices safely. The ARTIS icono (VE30A) consists of a patient table and a multi-axis motorized c-arm that can be positioned around the patient and angulated in a double-oblique fashion iso-centering the region of interest between the x-ray tube and the flat panel detector. The X-ray generator is placed separately. The displays for visualizing the X-ray images are mounted at the ceiling with a movable display suspension system. System operation is executed via control modules table side so that the physician can move and position the table and c-arm adequately for best imaging while manipulating catheters or other devices during the x-ray. X-ray release is tableside via a footswitch.

The ARTIS icono (VE30A), modular angiography systems are designed as sets of components that may be combined into two different configurations (Biplane or Floor) to provide specialized angiography systems. In general, they are equipped with a Carm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing.

The ARTIS icono (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical multipurpose rotational angiography, angiography, angiography. radiographic/fluoroscopic procedures.

The following components are configured to create a Floor or Biplane 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, and imaging system

Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE30A) configuration, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information contained in various layouts are used.

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 icono (VE30A) is capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor and the ceiling. Other systems and software syngo Application Software, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination and control rooms.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ARTIS icono (VE30A) device, a medical imaging system. The submission aims to establish substantial equivalence to a predicate device (ARTIS icono (VE21)). However, the document primarily focuses on explaining modifications to the software and hardware, and the general testing conducted to support safety and effectiveness.

Crucially, the document does NOT contain specific acceptance criteria tables or detailed study results that prove the device meets those criteria in the way typically expected for a clinical performance study of AI/algorithm performance (e.g., Sensitivity, Specificity, AUC values).

The "Nonclinical Performance Testing" section mentions general types of testing performed (e.g., "Software functional, verification, and System validation testing with passing results," "CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed."). This indicates that the device's technical specifications and intended functionality were verified, but it doesn't provide the type of performance metrics usually associated with proving diagnostic accuracy or clinical effectiveness.

Given the information provided, I cannot fulfill all parts of your request as the specific data on acceptance criteria and a detailed study proving the device meets those criteria (especially regarding AI/algorithm performance or human-in-the-loop studies) are absent. This document is a 510(k) summary, which often focuses on demonstrating substantial equivalence through technological comparison and non-clinical engineering/software validation, rather than extensive clinical efficacy trials.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "All test results met all acceptance criteria" and "The testing results support that all the software specifications have met the acceptance criteria." However, it does not enumerate these criteria or provide quantitative performance results (e.g., sensitivity, specificity, accuracy, or metrics specific to imaging quality beyond qualitative "passing results"). The focus is on demonstrating that the modified components function as intended and do not introduce new risks, aligning with the "substantial equivalence" claim.

2. Sample size used for the test set and the data provenance

Cannot be provided for the type of performance testing you are asking for. The document mentions "non-clinical tests" and "software functional, verification, and System validation testing." This testing typically involves engineering samples, simulated data, or phantoms, rather than a clinical patient test set with a specific sample size and geographic provenance for evaluating diagnostic performance. The document does not describe a clinical "test set" in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Cannot be provided. Since no specific clinical test set for diagnostic performance evaluation is detailed, there's no mention of experts establishing ground truth for such a set. The document focuses on technical verification and validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Cannot be provided. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. There is no mention of an MRMC study or AI assistance improving human readers. The device described is an X-ray imaging system, and the modifications mentioned are related to software features, usability, and hardware updates (e.g., updated memory, new PC, new elements for "Structure Scout" organ program, usability features). While a "software option DynaCT" is mentioned, the evaluation here focuses on the modifications to the core system and its software, not on a specific AI algorithm for diagnostic interpretation that would typically necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No specific standalone algorithm performance study is detailed. The described tests are for the overall system's functionality and safety, not for a distinct algorithm's diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for diagnostic purposes. For engineering and software validation, ground truth would likely refer to system specifications, known inputs, and expected outputs, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set

Not applicable/Cannot be provided. This document does not describe the development or evaluation of a machine learning model that would require a "training set." The software updates are described as functional enhancements and system improvements, not as new AI algorithms trained on specific datasets.

9. How the ground truth for the training set was established

Not applicable/Cannot be provided. As above, no training set information is present.

In summary, the provided document is a regulatory submission focused on demonstrating the substantial equivalence of a modified imaging system (ARTIS icono (VE30A)) to a previously cleared predicate device (ARTIS icono (VE21)). It highlights engineering verification and validation, software testing, and compliance with performance and safety standards, rather than clinical performance studies of diagnostic accuracy or AI assistance.

Summary

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December 14, 2023

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

Re: K230950

Trade/Device Name: ARTIS icono (VE30A) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, IZI, JAA, JAK Dated: November 30. 2023 Received: December 1, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic 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) K230950

Device Name ARTIS icono (VE30A)

Indications for Use (Describe)

ARTIS is a family of dedicated angiography systems developed for single-plane 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 angtography, 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.

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

The ARTIS systems 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 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/0 description: The image shows the Siemens Healthineers logo. 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.

510(k) Summary: ARTIS icono (VE30A) 510(K) #: K230950

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

Date Prepared: December 7, 2023

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, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

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

Contact Person: 2.

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

Device Name and Classification: 3.

Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:

ARTIS icono (VE30A)

Image-intensified fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II OWB, IZI, JAA, JAK

Legally Marketed Primary Predicate Device: 4. Trade Name: ARTIS icono (VE21) 510(k) Clearance K220432 Clearance Date June 29, 2022 Classification Name: Image-intensified fluoroscopic X-ray System Classification Panel: Radiology

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Requlation Number: Device Class: Product Code: Subsequent Product Codes: 21 CFR §892.1650 Class II OWB IZI, JAA, JAK

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 a Floor or Biplane 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, and imaging system

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The Subject device ARTIS icono with software version VE30A supports the following modifications.

Software / Hardware changes specific to New System Software VE30A
1.	Updated system Software from VE21A to VE30A
A.	Added an optional Second Workplace
B.	Updated memory data storage to 600K
C.	Updated of Roadmap Phase 3
D.	Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, and Bismuth
E.	Updated Usability Features:
	1) Updated Case Flow feature to include Editing
	2) Updated Body Region to include Editing
	3) Updated Procedure Name to include Editing
	4) On Screen Display Reconfiguration
	5) Updated Favorites on the Pilot Module to include protocols, frame, and pulse rates
	6) Updated Direct Access Bar on the Pilot Module to include Editing
	7) Updated Favorite on the Pilot Module to include List & Icon View
	8) Updated ARTIS Profiles to include User Profile
	9) Updated Pilot Module to lock
	10) Updated Image Directory to include Custom Filter possible as default
	11) Additional Display Layouts for Cockpit
	12) Added "Inactive" as a function for Dynamic Viewer during PT registration and after system restarts.
2.	New PC for imaging System due to obsolescence

Table 1: Modification for ARTIS icono (VE30A)

6. Indications for Use:

ARTIS is a family of dedicated angiography systems developed for single-plane 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.

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Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. 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.

The examination table as an integrated part of the system can be used for X-ray imaging, surgery, and interventions.

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

The ARTIS systems include also 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 icono (VE30A) is substantially equivalent to the legally marketed predicate listed in the table below:

Predicate Device Nameand Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateARTIS icono (VE21)Siemens	K220432	06/29/2022	Indications for use Software Version VE21 PC Usability Features Workplace Station Data Memory Storage Roadmap Feature Structure Scout

Table 2: Predicate Device Comparable Properties for Subject Device Modifications

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

The ARTIS icono (VE30A) is designed as a set of components (C-arm, X-ray tube, housing, flat panel detector, digital imaging system, collimator, generator, etc.) that may be combined into two different configurations (Floor & Biplane to provide specialized angiography systems. Components used with ARTIS icono (VE21) are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device are provided in Table 3 below for all modifications.

Table 3: Summary of Comparison of Technological Characteristics

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Modifications	Subject DeviceARTIS icono (VE30A)	Predicate DeviceARTIS icono (VE21A)K220432	Comparison Results
New SystemSoftware/HardwareChanges	1. Updated system Software from VE21A to VE30A	System software version VE21	Comparable:System software VE30A was updated to support modifications 1A-2. All System Software modifications conform to "Guidance for the content of Premarket submission for software in Medical Devices"
	A. Added an optional 2nd Workplace	ARTIS icono offered only 1 Workplace
	B. Updated memory data storage to 600K	Memory data storage is 400K
	C. Updated Roadmap Phase 3	Roadmap with 4 phases	These software and hardware changes do not raise any new risks or any issues regarding the safety or effectiveness of the device.
	D. Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, and Bismuth	Structure Scout cleared elements are platinum, tantalum, iron, iodine, steel and nitinol, and CO2
	E. Updated Usability Features:
	1) Updated Case Flow feature to include Editing	Editing of the Case Flow was not available.	All test results met all acceptance criteria.
	2) Updated Body Region to include Editing	Editing of the Body Region was not available.
	3) Updated Procedure Name to include Editing	Editing of the Procedure Name was not available.
	4) On Screen Display Reconfiguration	Reconfiguring of the On-Screen Display was not available.
	5) Updated Favorites on the Pilot Module to include protocols, frame and pulse rates	Favorites on PM did not include protocols, frame and pulse rates.
	6) Updated Direct Access Bar on the Pilot Module to include Editing	Editing of the Direct Access Bar was not available.
	7) Updated Favorite on the Pilot Module to include List & Icon View	Favorites on PM with list & Icon View was not available.
	8) Updated ARTIS Profiles to include User Profile	ARTIS Profiles to include user Profile was not available.
	9) Updated Pilot Module to lock	Locking PM was not available.
	10) Updated Image Directory to	Image Directory to include Custom Filters as default
Modifications	Subject DeviceARTIS icono (VE30A)	Predicate DeviceARTIS icono (VE21A)K220432	ComparisonResults
	include CustomFilter possibleas default	was Body Region was notavailable.
	11) AdditionalDisplayLayouts forCockpit	Additional Display Layoutsfor cockpits were notavailable.
	12) Added"Inactive" as afunction forDynamicViewer duringPT registrationand aftersystemrestarts.	Dynamic Viewer was Activeduring PT registration andafter system restarts.Inactive was not available.
New PC	2. New PC for ImagingSystem due toobsolescence	PC for Imaging System
	3. NFJ- 0157: Modificationsfor the ARTIS icono (floor &biplane) for inclusion of thenew ARTIS TransferSolution in combinationwith MR Nexaris DockableTable for systemMAGNETOM Vida / Sola	NFJ- 0157:Modificationsfor the ARTIS icono (floor &biplane) for inclusion of thenew ARTIS TransferSolution in combinationwith MR Nexaris DockableTable for systemMAGNETOM Vida / Sola
	4. NFJ #0163-Introduction ofoptional AVVIGO™Guidance System II to theArtis Family of MedicalDevices. The AVVIGOGuidance System II is a3rd Party 510(k) cleareddevice (K212490) that isintegrated (connected)with the ARTIS system	NFJ #0163-Introduction ofoptional AVVIGO™Guidance System II to theArtis Family of MedicalDevices. The AVVIGOGuidance System II is a 3rdParty 510(k) cleared device(K212490) that is integrated(connected) with the ARTISsystem family

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9. Nonclinical Performance Testing:

Non-clinical tests were conducted for the ARTIS icono (VE30A) during product development. The following non-clinical testing was conducted on the presented modifications and relied on: Software functional, verification, and System validation testing with passing results. Configuration, DSA Roadmap, Subtracted Fluoro and transfer images testing was conducted in support of the Updated roadmap Phase 3. CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed.

The ARTIS icono (VE30A) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

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AAMI ANSI ES60601-1:2005/(R)2012 ●
IEC 60601-1-2:2020 ●
IEC 60601-1-3:2013 ●
IEC 60825-1:2014 ●
TR 60878:2015
IEC 62304:2015 ●
IEC 80001-1:2010 ●
IEC 60601-2-28:2017 ●
IEC 60601-2-43:2019 ●
IEC 60601-2-54:2018 ●
ISO 10993-1:2018 ●
ISO 14971:2019 ●
ISO 15223-1:2021 ●
ISO 17664:2018
ISO 17664-2:2021
IEC 60601-2-35:2020 ●
IEC 62366-1:2020 ●
IEC 62563-1:2021 ●
NEMA PS 3.1:2022 .
ANSI UL 2900-1:2017
ANSI UL 2900-2-1:2017 ●
AAMI TIR57:2016 ●
ISO 14155:2020

Verification and Validation:

Non-clinical tests were conducted on ARTIS icono System software (VE30A) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.

The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

ARTIS icono (VE30A) 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.

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. The responsibility for compliance with

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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 the ARTIS icono (VE30A). These tests have been performed to assess the functionality of the subject device. The results of all conducted testing and clinical assessments were found acceptable and did 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 safely and effectively.

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 practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals who are trained and responsible for evaluating the postprocessing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. Nonclinical test results demonstrate that the ARTIS icono (VE30A) 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 Device 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.