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, 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.

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 systems include also the software option DynaCT with following IFU:

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 Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software.

Siemens currently markets the Artis zee / zeego (K141574) and the Artis Q / Q.zen (K123529). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen (K123529). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality.

Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.

The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions.

This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 (K141574) and Artis Q / Q.zen SW Version VD10 (K123529). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."

AI/ML Overview

The provided document does not contain the detailed acceptance criteria and performance study outcomes typically found in a clinical or standalone performance study report for AI-powered diagnostic devices.

Instead, this document is a 510(k) summary for Siemens Medical Solution USA, Inc.'s Artis zee/zeego & Artis Q/Q.zen angiographic X-ray systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for hardware and software modifications, rather than evaluating a novel AI algorithm's diagnostic performance against ground truth.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

Acceptance Criteria and Device Performance

No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) are provided for an AI component.
The document mentions "acceptance criteria" in the context of verification and validation testing for the software specifications and that "all software specifications have met the acceptance criteria," but these criteria are not detailed in terms. This likely refers to system-level tests for functionality, safety, and effectiveness of the updated X-ray system software, not a diagnostic performance metric.

Study Details (as far as can be inferred/is absent)

A table of acceptance criteria and the reported device performance:
- Absent. There is no table detailing acceptance criteria for diagnostic performance or reported performance metrics like sensitivity, specificity, or F1-score for any AI component. The document discusses regulatory standards compliance and software verification/validation, but not diagnostic accuracy.
Sample size used for the test set and the data provenance:
- Absent. The document does not describe a test set in the context of diagnostic performance evaluation for an AI algorithm. It refers to "non-clinical test data" and "clinical images and data" used for evaluating the predicate devices, but doesn't specify a test set for the modifications or an AI component.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Absent. No information is provided regarding expert readers or ground truth establishment for a test set, as no diagnostic performance study for an AI algorithm is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Absent. Not applicable, as there's no mention of a diagnostic test set for an AI algorithm.
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:
- Absent. There is no mention of an MRMC study or any evaluation of human reader improvement with AI assistance. The submission is about modifications to an X-ray imaging system, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Absent. No standalone AI algorithm performance study is indicated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Absent. No ground truth type is specified, as no diagnostic performance study is detailed.
The sample size for the training set:
- Absent. There is no mention of a training set, indicating that this submission is not for an AI/ML algorithm that requires training. The "DynaCT" software option mentioned is for 3D reconstruction from 2D images, not a learned diagnostic pattern recognition system in the sense of modern AI/ML.
How the ground truth for the training set was established:
- Absent. Not applicable, as no training set is mentioned.

Summary of What the Document Does Provide:

The document is a 510(k) submission for modifications to existing angiography systems. The modifications primarily involve:

Revised Indications for Use (clarification, not new uses).
New software version (VD11D) to support hardware.
Support for an existing detector (Pixium 3040CV) on an additional system (Artis zee/zeego).
A new tube cooling unit.
Updated product claims.
Configuration updates for the "Miyabi Angio-CT" (now "nexaris Angio-CT"), including improved collision calculation.

The regulatory review concluded that the device is "substantially equivalent" to predicate devices, based on:

Non-clinical tests for electrical safety, performance, electromagnetic compatibility, and compliance with various international standards (listed in Table 3 on page 10).
Software verification and validation testing, addressing the FDA's guidance documents for software in medical devices and cybersecurity. These tests demonstrated that the software modifications met acceptance criteria and did not raise new safety or effectiveness issues.
Human Factors Usability Validation.

Key Missing Information: This document is NOT about an AI-powered diagnostic device in the modern sense that would require performance metrics like sensitivity, specificity, or a comparison against a human expert ground truth. It focuses on demonstrating the safety and effectiveness of updated hardware and software components within an imaging system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solution USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K181407

Trade/Device Name: Artis zee/zeego & Artis O/O.zen Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, IZI, JAA, JAK Dated: May 26, 2018 Received: May 30, 2018

Dear Ms. 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.

August 15th, 2018

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Baffaro

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181407

Device Name Artis zee / zeego & Artis Q / Q.zen

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 systems include also the software option DynaCT with following IFU:

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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SIEMENS

510(k) Summary: Artis zee / zeego & Artis Q / Q.zen

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

August 15, 2018 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: lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

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

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.jones@siemens-Healthineers.com

3. Device Name and Classification:

Trade Name:	Artis zee / zeego
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1650
Device Class:	Class II
Product Codes:	OWB, IZI, JAA, JAK
Trade Name:	Artis Q and Artis Q.zen
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1650
Device Class:	Class II

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SIEMEN

Product Codes:

OWB, JAA, IZI

1. Legally Marketed Primary Predicate Device
- Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Subsequent Product Codes: Total Product Life Cycle:

Artis zee/zeego SW VC21 K141574 September 05, 2014 Image-intensified fluoroscopic x-ray system Radiology 21 CFR §892.1650 Class II OWB IZI, JAA, JAK 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.

Legally Marketed Secondary Predicate Device

Trade Name:	Artis Q and Artis Q.zen
510(k) Clearance	K123529
Clearance Date	February 26, 2013
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1650
Device Class:	Class II
Product Codes:	OWB,
Subsequent Product Codes:	IZI, JAA
Total Product Life Cycle:	All product Recall incidents are consideredduring the Design Input phase ofdevelopment to ensure the latest modelswill not be affected by any of the applicableissues.

5. Device Description:

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SIEMENS

Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.

The following modifications/features do not impact any new usage of Contrast Agents.

Proposed Device Modifications for the Artis zee / zeego and the Artis Q / Q.zen Systems:

Revised Indication for Use Statement applicable to both systems 1. (Artis zee / zeego and Artis Q / Q.zen)
1. New system software version VD11D supports hardware for both systems (Artis zee / zeego and Artis Q / Q.zen)
New detector pixium 3040CV (also known as "as40HDR") 3. Software and Hardware modification applicable to the Artis zee / zeego system only. (This detector is already cleared for use in the Predicate Device for the Artis Q /Q.zen System).
1. New Tube cooling unit for both systems (Artis zee / zeego and Artis Q / Q.zen)
Product Claims List modification applicable for both systems (Artis 5. zee / zeego and Artis Q / Q.zen)
Update 510(k) Information provided for all predicate devices. 6.

This 510(k) submission also includes the following modification made to the "Miyabi Angio-CT" configuration, which consists of Artis zee / zeego or Artis Q /Q.zen and a CT system (SOMATOM Family Sliding Gantry). The Miyabi Angio-CT configuration that will include these Subject Device modifications will be marketed as "nexaris Angio-CT."

Proposed Device Modifications for the nexaris Angio-CT configuration:

Note: These modifications are only applicable when the Artis zee / zeego or Artis Q / Q.zen and a CT system (SOMATOM Family Sliding Gantry) are

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configured in the nexaris Angio-CT configuration. The nexaris Angio-CT is only an environment which may contain an Angio and CT system in close proximity.

New software version VD11D interface software component with 7. Angio and CT systems.
- Improved Collision calculation between the Artis zee / zeego or Artis Q / Q.zen and CT Systems.
- .

6. Indications for Use:

Artis zee / zeego Indications for Use Statement:

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 angjography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image-quided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery, and interventions.

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

The Artis systems include also the software option DynaCT with following IFU:

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.

Artis Q / Q.zen Indications for Use Statement:

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 anqiography;

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multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

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

The Artis systems include also the software option DynaCT with following IFU:

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.

7. Substantial Equivalence:

The Artis zee / zeego and Artis Q / Q.zen SW VD11D is substantially equivalent to the legally marketed predicates listed in the table below:

This Tradition Bundled 510(k) Submission Contains Two Angiographic Systems
Artis zee / zeego VD11D comparable properties:
Predicate Device Nameand Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateArtis zee/zeego SW VC21	K141574	09/05/2014	• Indications for use• System for Image Acquisition• System for post-processing
Secondary PredicatesArtis Q and Q.zen - ModularAngiographic System	K123529	02/12/2013	• Detector Pixium 3040CV(as40HDR)• Product Claims
Artis Q / Q.zen VD11D comparable properties:
Primary PredicateArtis Q and Q.zen - ModularAngiographic System	K123529	02/12/2013	• Indications for use• System for Image Acquisition• System for post processing• Detector Pixium 3040CV(as40HDR)• Product Claims

		Table 1: Predicate Comparable Properties
--	--	------------------------------------------	--

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SIEMENS

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

Artis zee / zeego and Artis Q / Q.zen Systems are designed as a set of components (C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that may be combined into different configurations to provide specialized angiography systems. Components used with Artis zee / zeego and Artis Q / Q.zen 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 the table below for all modifications.

Modification	Subject Device	Primary Predicate Device	Secondary Predicate Device	Comparison Results
IndicationsFor UseStatement	IFU statementrevised to simplifyand improve clarityof content.	Cleared IFUStatement forK141574	Not applicable	See row belowfor results
ComparisonResult	The revised IFU statement is within the scope of the Intended Use for Interventionalfluoroscopic X-Ray Systems per 21 CFR §892.1650. The minor modification of the clearedIFU statement has no impact on the intended use of the device.
SoftwareVersion	New SoftwareVD11D supportsArtis zee / zeegoSystem with Pixium3040CV 30cm x40cm 16 bit detectoralso known as(as40HDR)	Software VC21 forArtis zee/zeego	Not applicable	Compatible forboth Artis zee /zeego and ArtisQ / Q.zensystemsmeets criteriaas tested perSoftware andSSIX Guidance
Flat PanelDetector	Pixium 3040CV(as40HDR)30cm x 40cm16 bit	Not applicable	Pixium 3040CV30cm x 40cm16 bit also known as(as40HDR)	Same detectoras cleared withArtis Q / Q.zenwill be usedwith Artis zee /zeego meetscriteria astested perSoftware andSSIX Guidance
Tube CoolingUnit	New Tube CoolingUnit: SMC Tube onefor all	Tube Cooling Unit:Kluever cooling unitor Lytron coolingsystem.	Not applicable	Samefunctionality
Modification	Subject DeviceArtis Q / Q.zen Systems withSW VD11D	Primary Predicate DeviceArtis Q and Artis Q.zen ModularAngiography System VD10(K123529)	ComparisonResults
IndicationsFor UseStatement	IFU statement revised tosimplify and improve clarity ofcontent.		Cleared IFU Statement for K123529	See row belowfor results
ComparisonResult	The revised IFU statement (applicable to both Artis zee / zeego and Artis Q / Q.zensystems) fall within the scope of the Intended Use for Interventional fluoroscopic X-RaySystems per 21 CFR §892.1650. The minor modification of the cleared IFU statement hasno impact on the intended use of the device.
SoftwareVersion	New Software VD11D supportsArtis zee / zeego System withPixium 3040CV 30cm x 40cm16 bit detector also known as(as40HDR)		Software Version VD10 cleared withArtis Q / Q.zen	Compatible forboth Artis zee /zeego and ArtisQ / Q.zensystems meetscriteria astested perSoftware andSSIX Guidance
Tube CoolingUnit	New Tube Cooling Unit: SMCTube one for all		Lytron cooling unit	Samefunctionality
Miyabi Angio CT Configuration new marketing name is the nexaris Angio-CT Configuration which is anenvironment configured with Angio - CT Systems in close proximity previously marketed as Miyabi AngioCT.
Modifications	Subject DeviceConfigurationnexaris Angio-CTConfigurationwith Artis zee /zeego or Artis Q /Q.zen	Predicate DeviceConfigurationMiyabi Angio CTConfiguration withArtis zee / zeego	Predicate DeviceConfigurationMiyabi Angio CTConfiguration withArtis Q / Q.zen.	ComparisonResults
Miyabi Angio-CT SystemConfiguration	New nexaris AngioCT Configurationwith Artis zee /zeego or Artis Q /Q.zen Systems	Miyabi Angio CTConfiguration withArtis zee / zeego	Miyabi Angio CTConfiguration withArtis Q / Q.zen	New marketingname for theprevious MiyabiConfiguration willbe known as thenexaris Angio-CTConfiguration withthe Artis zee /zeego or Artis Q /Q.zen system andCT Systems withsliding gantry.
CollisionCalculation	Collisioncalculation (SmartCollision) of theCT gantry now isbased on a CTmodel	Collision calculation ofthe CT gantry isbased on a simulatedmoving wall	Collision calculationof the CT gantry isbased on asimulated movingwall	Collisioncalculation hasbeen improvedand meetscriteria astested perSoftware

Table 2: Comparison of Technological Characteristics

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9. Nonclinical Performance Testing:

Non-clinical tests were conducted for Artis zee / zeego and Artis Q / Q.zen during product development.

The Artis zee / zeego and Artis Q / Q.zen were certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

ES60601-1:2005/(R)2012
60601-1-2:2007 ●
60601-1-3:2008 ●
60601-1-6:2010/A1:2013 ●
60825-1:2007 ●
TR 60878:2015 ●
62304:2006
80001-1:2010
60601-2-28:2010 ●
60601-2-43:2010 ●
60601-2-54:2009/A1:2015 ●
10993-1:2009
14971:2007 ●

Table 3: FDA Guidance Documents

FDA Guidance Document and Effective Date
1.	Guidance for Industry and FDA Staff - User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to AcceptPolicy for 510(k)sDocument issued on January 30, 2018
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated510(k)s - Guidance for Industry and FDA StaffDocument issued on August 12, 2005
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for achange to an existing device.Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014
6.	Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for

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SIER

	Solid State X-ray Imaging DevicesDocument issued on September 1, 2016
7.	Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005
8.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use inMedical DevicesDocument issued on September 9, 1999
9.	Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016
10.	Guidance for Industry and FDA Staff: Pediatric Information for X-ray ImagingDevice Premarket Notifications.Document issued on November 28, 2017
11.	Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014
12.	Guidance for Industry and FDA Staff: Bundling Multiple Devices or MultipleIndications in a Single Submission.Document issued on June 27, 2007

Verification and Validation:

Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The modifications of the Artis zee / zeego and Artis Q / Q.zen, software version VD11D are supported with non-clinical information that demonstrates the software safety through verification and validation testing. Verification and validation testing demonstrate that Artis zee / zeego and Artis Q / Q.zen perform as intended. The non-clinical test data demonstrate that Artis zee / zeego and Artis Q / Q.zen device performance is comparable to the predicate device. Software supports all old and modified hardware components for both subject devices with respect to the intended use. The testing supports that all software specifications have met the acceptance criteria. The verification and validation testing support the claims of substantial equivalence.

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 and do not raise any new issues of safety or effectiveness.

Artis zee / zeego and Artis Q / Q.zen software VD11 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

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tests according to the operator's manual and in clinical use tests with customer report and feedback form.

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 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 zee / zeego and Artis Q / Q.zen software VD11D. 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 zee / zeego and Artis Q / Q.zen SW VD11D 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 Devices are 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.