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.

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 pheno (VE30A) is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, and 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 (VE30A) 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, and available for the support of dedicated clinical workflows.

The ARTIS pheno (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, 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

lmages 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 (VE30A) is capable of 2D and 3D imaging.

Other systems and software synqo Application Software, syngo X Workplace, Sensis Vibe, and or third-party systems may also be integrated into the ARTIS pheno (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination room and the control room.

AI/ML Overview

The provided text describes modifications to an existing device, ARTIS pheno (VE21) to create ARTIS pheno (VE30A). The study is primarily a non-clinical performance evaluation focused on verifying that the changes introduced in VE30A do not negatively impact the safety and effectiveness compared to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of "acceptance criteria" alongside specific "reported device performance" values in a quantitative manner for most of the listed modifications. Instead, it generally states that "All testing results passed" and "All test results met all acceptance criteria" for various tests performed on the modifications.

However, based on the descriptions, we can infer some general acceptance criteria and the reported performance as "met" or "passed".

Acceptance Criteria (Inferred from descriptions)	Reported Device Performance
New System Software (VE30A)
Conformance to "Guidance for the content of Premarket submission for software in Medical Devices".	All System Software modifications conform to "Guidance for the content of Premarket submission for software in Medical Devices".
No new risks or issues regarding safety or effectiveness (implied for software/hardware changes).	These software and hardware changes do not raise any new risks or any issues regarding the safety or effectiveness of the device.
Software functional, verification, and system validation testing with passing results.	Software functional, verification, and System validation testing with passing results.
Optional Second Workplace	Functional as intended, without introducing new risks (implied by general statements).
Updated Memory Data Storage to 600K	Memory data storage updated to 600K (implied functional).
Updated NOMSIE DSA (IQ) for Perivision organ program	NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing conducted and passed. (Implies image quality is acceptable or improved).
Updated Roadmap Phase 3	Configuration, DSA Roadmap, Subtracted Fluoro and transfer images testing conducted and passed. (Implies functionality and image quality are maintained or improved).
Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, and Bismuth	CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing conducted for Structure Scout new elements for the Organ program. All testing results passed. (Implies accurate detection and display of these elements, and image quality is maintained).
Updated Usability Features (F.1 - F.12)	All test results met all acceptance criteria. Usability features were validated to ensure safe and effective operation. Human Factor Usability Validation showed human factors addressed according to operator's manual. Customer employees are trained in the use of this equipment. (Implies improvements are functional and intuitive).
New PC for Imaging System	Functionality maintained, without introducing new risks (implied by general statements).
NFJ-0157 and NFJ #0163 (Integration with other systems)	Functionality and safe integration confirmed (implied by general statements).
Compliance with electrical safety, performance, and EMC standards	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with a list of specified standards (e.g., AAMI ANSI ES60601-1:2005, IEC 60601-1-2:2020, etc.).
Software specifications met acceptance criteria.	The testing results support that all the software specifications have met the acceptance criteria.
Risk control implemented to mitigate identified hazards.	Risk analysis completed, and risk control implemented.
Cybersecurity requirements met.	Conforms to cybersecurity requirements, considering IEC 80001-1:2010.

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

The document does not specify a quantitative sample size for any test set (e.g., number of images, number of patients, number of cases). The testing appears to be primarily focused on system-level verification and validation of the software and hardware modifications rather than a clinical study involving patient data.

Test Set: Not explicitly stated as a distinct "test set" in the context of clinical data. The testing involved "software functional, verification, and System validation testing," "NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing," and "CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing." These are likely performed on test harnesses, simulated data, and potentially a limited number of test cases or phantoms.
Data Provenance: Not applicable in the context of clinical data. The testing is non-clinical.

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

This information is not provided. Since the study is a non-clinical performance evaluation, it did not involve clinical experts establishing ground truth in the traditional sense for a diagnostic AI device. The "ground truth" for the non-clinical tests would be the expected functional and performance outcomes defined by engineering specifications.

4. Adjudication method for the test set

Not applicable. There is no indication of multiple readers or an adjudication method for establishing ground truth from human experts, as this was not a clinical study involving diagnostic interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an image-intensified fluoroscopic x-ray system, and the changes are related to system software, hardware, and workflow features, not a diagnostic AI component intended for human reader assistance.

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

The device itself is an imaging system. The "algorithms" mentioned (e.g., NOMSIE, Structure Scout) are integrated parts of the overall imaging functionality. While these algorithms perform specific tasks (like image quality enhancement, reconstruction, element identification), their "standalone" performance isn't described in isolation from the system's output. The performance evaluation is inherently within the context of the ARTIS pheno system. It's not an AI model providing a separate diagnostic output.

7. The type of ground truth used

The ground truth used for these non-clinical tests would be based on:

Engineering specifications and requirements for software functionality.
Expected image quality parameters (e.g., CNR for Structure Scout) as measured by phantoms or controlled test conditions.
Defined operational workflows for usability features.
Compliance with recognized standards for electrical safety, performance, and EMC.

It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The document describes modifications to an existing x-ray system, implying traditional software and hardware development and testing, not the training of a machine learning model from a distinct "training set" of data.

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

This information is not applicable and not provided as no machine learning training set is mentioned.

Summary

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December 15, 2023

Image /page/0/Picture/1 description: The image shows the text "Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard". The text appears to be an address or contact information for Siemens Medical Solutions USA, Inc. with Patricia Jones listed as a Regulatory Affairs Professional. The address is 40 Liberty Boulevard.

Re: K230949

MALVERN, PA 19355

Trade/Device Name: ARTIS pheno (VE30A) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA 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 (OS) 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).

Sincerelv.

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

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Indications for Use

510(k) Number (if known) K230949

Device Name ARTIS pheno (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.

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 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 cluster of orange dots.

510(k) Summary: ARTIS pheno (VE30A) 510(k) #: K230949

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

December 7, 2023 Date Prepared:

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

2. Contact Person:

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

3. Device Name and Classification:

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

ARTIS pheno (VE30A)

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

Legally Marketed Primary Predicate Device 4.

Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: Regulation Number: Device Class:
ARTIS pheno (VE21) K220409 June 29, 2022 Image-intensified fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II

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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

The 510(k) submission, Subject Device "ARTIS pheno with software version VE30A" will support the following modifications made to the Subject Device in comparison to the Predicate Device:

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Table 1. Modifications for ARTIS pheno (VE30A)
List of Modifications:
1.	Updated system Software from VE21A to VE30A
A.	Added an optional Second Workplace
B.	Updated memory data storage to 600K
C.	Updated NOMSIE DSA (IQ) for Perivision organ program
D.	Updated Roadmap Phase 3
E.	Added new elements for Organ Program "Structure Scout": Calcium, Gadolinium, andBismuth
F.	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 Favorites 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 the system restarts.
2.	New PC for imaging System due to obsolescence

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. 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 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 three-dimensional image format.

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Image /page/6/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. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

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.

7. Substantial Equivalence:

The ARTIS pheno (VE30A) is substantially equivalent to the legally marketed predicate listed in Table 2 below:

Predicate Device Nameand Manufacturer	510(k) Number	Clearance Date	Comparable Properties
Primary PredicateARTIS pheno (VE21)	K220409	06/29/2022	Indications for use Software Version VE21 PC Usability Features Image Quality (NOMSIE) Workplace Station Data Memory Storage Roadmap Feature Structure Scout

Table 2: Predicate Device Comparable Properties for Subject Device Modifications

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

The ARTIS pheno (VE30A) is designed as a set of components (floor stand, C-arm, the 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 (VE30A) 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
Modifications	Subject DeviceARTIS pheno (VE30A)	Predicate DeviceARTIS pheno (VE21A)K220409	ComparisonResults
New SystemSoftware/HardwareChanges	1. Updated system Softwarefrom VE21A to VE30A	System software versionVE21	System softwareVE30A was updatedto supportmodifications 1A – 2.
	A. Added an optional 2ndWorkplace	ARTIS pheno offeredonly 1 Workplace	All System Softwaremodifications conformto "Guidance for thecontent of Premarketsubmission forsoftware in MedicalDevices"
	B. Updated memory datastorage to 600K	Memory data storage is400K
	C. Updated NOMSIE DSA(IQ) for Perivisionorgan program	NOMSIC customizationof contrast in DSAimages
	D. Updated of RoadmapPhase 3	Roadmap with 4 phases
	E. Added new elements forOrgan Program"Structure Scout":	Structure Scout clearedelements are platinum,tantalum, iron, iodine.	These software andhardware changes do
Modifications	Subject DeviceARTIS pheno (VE30A)	Predicate DeviceARTIS pheno (VE21A)K220409	ComparisonResults
	Calcium, Gadolinium,and Bismuth	steel and nitinol, and CO2	not raise any newrisks or any issuesregarding the safety oreffectiveness of thedevice.
	F. Updated Usability Features:
	1) Updated CaseFlow feature toinclude Editing	Editing of the Case Flowwas not available.
	2) Updated BodyRegion to includeEditing	Editing of the BodyRegion was notavailable.	All test results met allacceptance criteria.
	3) UpdatedProcedure Nameto include Editing	Editing of the ProcedureName was not available.
	4) On ScreenDisplayReconfiguration	Reconfiguring of the On-Screen Display was notavailable.
	5) UpdatedFavorites on thePilot Module toinclude protocols,frame and pulserates	Favorites on PM did notinclude protocols, frame,and pulse rates.
	6) Updated DirectAccess Bar onthe Pilot Moduleto include Editing	Editing of the DirectAccess Bar was notavailable.
	7) Updated Favoriteon the PilotModule to includeList & Icon View	Favorites on PM with list& Icon View were notavailable.
	8) Updated ARTISProfiles toinclude UserProfile	ARTIS Profiles toinclude user Profile wasnot available.
	9) Updated PilotModule to lock	Locking PM was notavailable.
	10) Updated ImageDirectory toinclude CustomFilter possible asdefault	Image Directory toinclude Custom Filtersas default was BodyRegion was notavailable.
	11) AdditionalDisplay Layoutsfor Cockpit	Additional DisplayLayouts for cockpit werenot available.
	12) Added "Inactive"as a function forDynamic Viewerduring PTregistration andafter systemrestarts.	Dynamic Viewer wasActive during PTregistration and aftersystem restarts. Inactivewas not available.
New PC	2. New PC for Imaging Systemdue to obsolescence	PC for Imaging System
	3. NFJ- 0157: Modifications forthe ARTIS pheno for	NFJ- 0157:Modifications for the
Modifications	Subject DeviceARTIS pheno (VE30A)	Predicate DeviceARTIS pheno (VE21A)K220409	ComparisonResults
	inclusion of the new ARTISTransfer Solution incombination with MR NexarisDockable Table for systemMAGNETOM Vida / Sola	ARTIS pheno forinclusion of the newARTIS Transfer Solutionin combination with MRNexaris Dockable Tablefor system MAGNETOMVida / Sola
	4. NFJ #0163-Introduction ofoptional AVVIGOTMGuidance 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.	NFJ #0163-Introductionof optional AVVIGOTMGuidance System II tothe Artis Family ofMedical Devices. TheAVVIGO GuidanceSystem II is a 3rd Party510(k) cleared device(K212490) that isintegrated (connected)with the ARTIS system.

Summary of Comparison of Technological Characteristics

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Nonclinical Performance Testing: 9.

Non-clinical tests were conducted for the ARTIS pheno (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. NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing were conducted for the Updated NOMSIE DSA (IQ) for the Perivision. 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 pheno (VE30A) 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 60601-1-2:2020 ●
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 ●

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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 ●

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

Verification and Validation:

Non-clinical tests were conducted on ARTIS icono 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 pheno software (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 trained in the use of this equipment.

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.

Summarv:

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

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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 familiar with and responsible for the evaluation and postprocessing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. Non-clinical test results demonstrate that the ARTIS pheno (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.