The Cios Flow is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

Device Description

The Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Flow provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:

a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
b) The second unit is the image display station with a moveable trolley for t processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.

AI/ML Overview

The provided text describes modifications to an existing medical device, the Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System, and seeks substantial equivalence to previously cleared predicate devices. The documentation focuses on demonstrating that the new features and changes do not introduce new safety or effectiveness concerns, primarily through a comparison of technological characteristics and compliance with recognized standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Key Takeaway: The submission leverages a "Special 510(k)" pathway, implying that the changes made to the device are primarily modifications to existing features or the incorporation of features already cleared in other Siemens devices. Therefore, the "study" demonstrating performance is primarily a comprehensive set of non-clinical tests and verification/validation activities rather than a traditional large-scale clinical trial with human-in-the-loop assessments of diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating that the modified device remains as safe and effective as its predicate devices, complying with relevant electrical safety, performance, and electromagnetic compatibility standards, and that all software specifications meet their defined criteria.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance/Compliance
Electrical Safety	Compliance with AAMI ANSI ES60601-1:2005/(R)2012	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Performance	Compliance with IEC 60601-1-3:2013, IEC 60601-2-28:2017, IEC 60601-2-43:2017, IEC 60601-2-54:2009/A1:2015	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Electromagnetic Comp.	Compliance with IEC 60601-1-2:2014	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Software General	Compliance with IEC 62304:2015	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Software Usability	Compliance with IEC 62366-1:2015	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Laser Safety	Compliance with IEC 60825-1:2014 (for optional laser light localizer)	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply.
Risk Management	Compliance with ISO 14971:2014	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply; "Risk analysis was completed, and risk control implemented to mitigate identified hazards."
Software Specific	All software specifications met, verification & validation, human factors addressed, cybersecurity.	"Testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device acceptable to support the claims of substantial equivalence. The Cios Flow software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form." Conforms to cybersecurity requirements by implementing processes; cybersecurity statement considers IEC 80001-1:2010.
Functionality	Functionality tests of Cios Flow (VA30) System.	"Performance tests were conducted to test the functionality of Cios Flow (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness."

Study Information (Based on the provided text):

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or image datasets with a defined sample size for evaluating AI/algorithm performance. It focuses on non-clinical performance testing of the device's components and integrated system.
- The provenance of data for these non-clinical tests is internal to Siemens (e.g., Siemens Healthcare GmbH Corporate Testing Laboratory). There is no mention of external data or patient data being used for a clinical performance evaluation of the new features that would typically involve a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the submission relies on non-clinical testing and comparison to predicate devices, not on a new clinical study requiring ground truth established by medical experts for diagnostic accuracy.
- For the Human Factor Usability Validation, it mentions "customer employees are adequately trained in the use of this equipment" and "clinical use tests with customer report and feedback form." This implies user feedback, but not expert ground truth for interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable (None specified). No clinical study for diagnostic accuracy (e.g., using images interpreted by humans) is described, hence no adjudication method is detailed.
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 evidence of an MRMC study outlined for this submission. The changes described (software features like Target Pointer, DCM, Cios OpenApps, interactive touch control, new sound radiation delay, etc., and hardware like new detector, wireless footswitch, anti-microbial coating) are functional enhancements or component upgrades rather than a new AI diagnostic algorithm. Therefore, an MRMC study is not relevant to this submission as described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implicitly, standalone functional testing was done for the software components. The document states, "Performance tests were conducted to test the functionality of Cios Flow (VA30) System," and "Software Documentation for a Moderate Level of Concern software... The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Flow (VA30) during product development." This describes testing the software and hardware components (including functions like Target Pointer, DCM, interactive controls) to ensure they operate as intended and meet specifications, but not in the context of an "algorithm only" diagnostic accuracy study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is adherence to engineering specifications, regulatory standards (e.g., electrical safety, EMC, software standards), and functional requirements. There is no mention of ground truth based on medical diagnoses, pathology, or outcomes data, as this is not a diagnostic AI device submission but a modification to an existing X-ray system.
The sample size for the training set:
- Not applicable (None specified). The document does not describe a machine learning model that would require a distinct training set for diagnostic classification or prediction. The software modifications enhance the system's operational capabilities, not its diagnostic interpretation.
How the ground truth for the training set was established:
- Not applicable. As no training set for a diagnostic AI model is discussed, the method for establishing its ground truth is not relevant to this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 22, 2020

Siemens Medical Solutions USA, Inc. % Cordell Fields, Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K203504

Trade/Device Name: Cios Flow Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: November 25, 2020 Received: November 30, 2020

Dear Mr. Fields:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use	See PRA Statement on last page.

510(k) Number ( if known )	K203504
Device Name
Cios Flow
Indications for Use ( Describe )
The Cios Flow is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

Type of Use ( Select one or both, as applicable )
☑ Prescription Use (Part 21 CFR 801 Subpart D)Subpart C)	□ Over-The-Counter Use (21 CFR 801

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
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information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1
	PSC Publishing Services (301)443-6740 EF

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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

510(k) Summary: Cios Flow

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

Date Prepared: November 25, 2020

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

General Information: 1. lmporter / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Röntgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018

2. Contact Person:

Mr. Cordell Fields Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 306-3167 Email: cordell.fields@siemens-Healthineers.com

3. Device Name and Classification:

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

Cios Flow Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO JAA

Legally Marketed Primary Predicate Device 4.

Trade Name:	Cios Fusion
510(k) Clearance	K153244
Clearance Date	March 07, 2016
Classification Name:	Image-intensified fluoroscopic x-ray System

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Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.

Classification Panel: Requlation Number: Device Class: Product Codes: Subsequent Product Code: Total Product Life Cycle:

Radiology 21 CFR §892.1650 Class II OWB, OXO JAA

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:	Cios Alpha
510(k) Clearance	K181560
Clearance Date	October 24, 2018
Classification Name:	Image-intensified fluoroscopic x-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1650
Device Class:	Class II
Product Codes:	OWB, OXO
Subsequent Product Codes:	JAA
Total Product Life Cycle:	All product Recall incidents are considered during theDesign Input phase of development to ensure the latestmodels will not be affected by any of the applicable

Legally Marketed Secondary Predicate Device Trade Name: Cios Spin 510(k) Clearance K181550 Clearance Date October 30, 2018 Image-intensified fluoroscopic x-ray System Classification Name: Classification Panel: Radiology Regulation Number: 21 CFR §892.1650 Device Class: Class II Product Code: OWB, OXO Subsequent Product Codes: 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

issue.

issues.

5. Device Description:

a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.

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Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

b) The second unit is the image display station with a moveable trolley for t processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The main unit is connected to the main power outlet and the trolley is connected to a data network.

The following modifications were made to the predicate device the Cios Fusion. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device Cios Flow (VA30) for the following device modifications made to the Predicate Device (Cios Fusion (VA20).

This 510(k) submission, Subject Device "Cios Flow" with software version VA30" will support the following categories of modifications made to the Subject Device in comparison to Predicate Devices:

1. Modified Software:
Table 1: Overview of Software Modifications supported by Software Version VA30 ●
1. Modified Hardware/Software:
- Table 2: Overview of Hardware Modifications supported by Software Version VA30 ●
1. Modified Hardware changes
- . Table 3: Overview of Hardware Modifications

Table 1. Software Modifications for Cios Flow

Software changes specific to New System Software VA30
Device Software Modification
1.	System Software VA30 software modifications/features
	A. Target Pointer
	B. Digital Cine Mode (DCM)
	C. Cios OpenApps
2.	Interactive User Touch Control (Software component of VA30)
	A. Collimation Controls
	B. Brightness Contrast Controls
	C. Rotate and Flip Controls
	D. Zoom and Pan Controls
	E. Spot Adapt
3.	Dose Regulation Indicator
4.	New Sound Radiation Delay
5.	New Product Software Security
6.	Upgrade to Windows 10 Operating System

Table 2: Hardware/Software Modifications for Cios Flow

Software/Hardware changes specific to New System Software VA30
Device Hardware/Software Modifications
7.	System Software VA30 software/hardware modifications/features
	A. New CMOS Flat Panel Detector
	B. Wireless Foot Switch

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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

Table 3. Hardware Modifications

Device Hardware Modifications
8.	Optional Laser Light Localizer green
9.	Optional Cart for Remote Control Unit
10.	Anti-microbial Coating on C-Arm and Trolley
Other Device Modifications
11.	Update 510(k) Information

6. Indications for Use:

7. Substantial Equivalence:

The Cios Flow (VA30) system is substantial equivalent to the legally marketed predicates listed in Table 3 below:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateSiemens' Cios Fusion	K153244	03/07/2016	● Indications for use● System for Image Acquisition● Post-processing Software● Examination Settings● Cyber Security Information
Secondary PredicatesSiemens' Cios Alpha	K181560	10/24/2018	● CMOS Flat Panel Detector- Large Detector:Xineos-30 cm x 30 cm- Small detectorXineos-20 cm x 20 cm● Wireless Foot Switch● Cart for Remote Control Unit● Anti-Microbial Coating● Target Pointer● Digital Cine Mode● Cios Open Apps● Windows 10
Secondary PredicatesSiemens' Cios Spin	K181550	10/30/2018	● Laser Light Localizer green

Table 3: Predicate Device Comparable Properties for Subject Device Modifications:

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

The Cios Flow (VA30) System is designed as a set of components (floor stand, C-arm, Xray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that is combined to provide a mobile Interventional Fluoroscopic X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

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Image /page/7/Picture/0 description: The image contains the logos for Siemens and Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

Components used with Cios Flow (VA30) System are either commercially available with current Siemens systems or include updated modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in Table 4 below for all modifications.

Table 4. Summary of Comparison of Technological CharacteristicsComparison of Modifications to Predicate Devices
	Subject DeviceCios Flow (VA30Modifications	Primary Predicate DeviceCios FusionK153244	ComparisonResults
1.	System Software VA30 softwaremodifications/featuresA. Target PointerB. Digital Cine Mode (DCM)C. Cios OpenApps	Secondary Predicate DeviceCios Alpha K181560Target PointerDigital Cine Mode (DCM)Cios OpenApps	Comparable: 1.A-C have thesame functionality as cleared inthe Secondary PredicateDevice Cios Alpha K181560.The functionality of TargetPointer has not changedexcept for better visualizationof moving k-wires
2.	Interactive User Touch Control(Software components of VA30)A. Collimation ControlsB. Brightness Contrast ControlsC. Rotate and Flip ControlsD. Zoom and Pan ControlsE. Spot Adapt	Primary Predicate DeviceCios FusionK153244Collimation ControlsBrightness Contrast ControlsRotate and Flip ControlsZoom and Pan ControlsSpot Adapt	Comparable: 2.A-E has thesame functionality as cleared inthe Primary Predicate device,with exception to user interfaceis with Touch Control. Thefunctionality of these featureshas not changed from thePrimary Predicate deviceCios Fusion K153244.
3.	New Dose Regulation Indicator	New Dose Regulation Indicator	Comparable:The Dose regulation is equal tothe primary predicate CiosFusion. While dose regulationremains the same, added is avisual feedback to the operator
4.	New Sound Radiation Delay	New Sound Radiation Delay	Comparable:Comparable to the primarypredicate Cios Fusion typicallythere is a delay after press ofbutton until the radiation starts.While the delay will be similar,there is now an acousticalfeedback to the user that thebutton has been pressed, butradiation has not yet started.
5.	New Product Software Security	New Product Software Security	Comparable: This Productsoftware provides additionalcybersecurity feature to protectproduct security. The softwarefunctionality is the same exceptfor inclusions of additionalsoftware security features.The updated functionality is thesame as cleared in the PrimaryPredicate device, CiosFusion K153244.
6.	Upgrade to Windows 10 OperatingSystem	Upgrade to Windows 10 OperatingSystem	Same: The WindowsOperating System is the sameas cleared in the PrimaryPredicate Device with
Image: Healthineers logo
Comparison of Modifications to Predicate Devices
7.	System Software VA30software/hardwaremodifications/features	Secondary Predicate DeviceCios Alpha K181560	exception to an upgradedversion Windows 10. Theupgraded functionality is thesame as cleared in the PrimaryPredicate device Cios FusionK153244.
	A. CMOS Flat Panel Detector	CMOS Flat Panel Detector	Same: The CMOS Flat PanelDetector is the exact samedetector cleared in theSecondary Predicate DeviceCios Alpha K181560.
	B. Wireless Foot Switch	Wireless Foot Switch	Same: The Wireless FootSwitch is the same as in theSecondary Predicate DeviceCios Alpha K181560.
8	Optional Laser Light Localizer, green	Secondary Predicate DeviceCios Spin K181550Optional Laser Light Localizer,green	Same: The Optional GreenLaser Light Localizer is thesame aimer cleared in theSecondary Predicate DeviceCios Spin K181550
9	Optional Cart for Remote Control Unit	Secondary Predicate DeviceCios Alpha K181560Optional Cart for Remote ControlUnit	Same: The Optional Cart forRemote Control Unit is thesame cart cleared in theSecondary Predicate DeviceCios Alpha K181560.
10	Anti-microbial Coating on C-Arm andTrolley	Anti-microbial Coating on C-Armand Trolley	Same: The Anti-microbialCoating on C-Arm and Trolleyis the same cart cleared in theSecondary Predicate DeviceCios Alpha K181560.

Table 4: Summary of Comparison of Technological Characteristics

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Image /page/8/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 pattern.

Nonclinical Performance Testing: 9.

Non-clinical tests were conducted for the Cios Flow (VA30) during product development.

The Cios Flow (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

AAMI ANSI ES60601-1:2005/(R)2012 ●
IEC 60601-1-2:2014 ●
IEC 60601-1-3:2013 ●
IEC 60601-1-6:2010/A1:2013 ●
IEC 60825-1:2014 ●
IEC 62304:2015 ●
IEC 60601-2-28:2017 ●
IEC 60601-2-43:2017 ●
IEC 60601-2-54:2009/A1:2015 ●
ISO 14971:2014 ●
. IEC 62366-1:2015

Table 5: FDA Guidance Documents

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Healthine

	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 Accept Policyfor 510(k)sDocument issued on September 13, 2019
3.	Guidance for Industry and FDA Staff: The Special 510(k) ProgramDocument issued on September 13, 2019
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a changeto 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 SolidState 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 27, 2019
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 Imaging DevicePremarket 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: Appropriate Use of Voluntary ConsensusStandards in Premarket Submission for Medical DevicesDocument issued on September 14, 2018
13.	Guidance for Industry and FDA Staff: Medical Device Accessories - DescribingAccessories and Classification PathwaysDocument issued on December 20, 2017
14.	Guidance for Industry and FDA Staff: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket SubmissionsDocument issued on December 20, 2019

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

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on Cios Flow (VA30) during product development.

The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the

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Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

acceptance criteria. Testing for verification and validation for the device acceptable to support the claims of substantial equivalence.

The Cios Flow software (VA30) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.

Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. Compliance with IEC 80001-1-2010 is the responsibility of the hospital. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of Cios Flow (VA30) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.

10. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore, the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Flow (VA30) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.