The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Description

The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (DVD, USB).

AI/ML Overview

The provided text describes a 510(k) summary for the Siemens Cios Select (VA20) mobile X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" discussed relate to passing engineering verification and validation tests against established standards and guidance documents.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria or reported device performance in the format of specific clinical metrics (e.g., sensitivity, specificity, AUC) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are related to compliance with consensus standards, regulatory guidance, and internal software/hardware validation.

Acceptance Criteria (Type)	Reported Device Performance
Conformity to 21 CFR Federal Performance Standards	Complies with 1020.30, 1020.32, 1040.10
Conformity to Voluntary FDA Recognized Consensus Standards	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62366-1, ISO 14971:2012, IEC 62304, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, NEMA PS 3.1 - 3.20 (DICOM), IEC 60825-1, IEC 61910-1
Software Specification Fulfillment (for new features)	All software specifications met the acceptance criteria and worked as intended.
Risk Management Hazard Mitigation	Risk analysis completed, risk control implemented, all test results passed.
Electrical Safety and EMC Testing	Complies with IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54, IEC 60601-1-2.
Human Factors and Usability Validation	Human factors addressed, acceptable results from system test (operator's manual) and clinical use tests (customer report & feedback). Customer employees trained.
Cybersecurity Requirements	Conforms to cybersecurity requirements, cybersecurity statement provided.
System Performance & Imaging Performance Evaluation (for SSXI)	Acceptable results performed with "X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards".

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

The document explicitly states that the tests conducted were non-clinical (bench testing, software verification, electrical safety, EMC, etc.). Therefore, there is no "test set" in the sense of patient data, clinical images, or human subject data. The provenance of such data, therefore, is not applicable.

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

Not applicable, as no clinical test set with corresponding ground truth established by experts is mentioned in the non-clinical testing section.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is mentioned.

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 MRMC comparative effectiveness study is mentioned. The submission focuses on the safety and effectiveness of the device as a standalone imaging system, not on its impact on human reader performance or the improvement provided by AI assistance.

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

This submission is for a medical imaging device (C-arm X-ray system) and its associated software and hardware updates. The "standalone" performance described refers to the device itself operating according to its technical specifications and regulatory standards. It is an "algorithm only" in the sense that the software processes images without human intervention, but the device's function is to acquire and display images for human interpretation. The non-clinical testing evaluates this standalone device performance.

7. The Type of Ground Truth Used

For the non-clinical testing performed, the "ground truth" refers to predefined technical specifications, regulatory standards, and expected functional outputs. For example:

Engineering Requirements Specifications keys: The device's output and behavior are compared against these internal design requirements.
Voluntary Conformance Standards (e.g., IEC, ISO, NEMA): The device's performance (e.g., electrical safety, EMC, software lifecycle processes, radiation protection) is measured against these established industry standards.
FDA Guidance Documents: The implementation and testing adhere to these regulatory expectations (e.g., software guidance, wireless guidance, SSXI guidance).
Hazard Analysis/Risk Management: Identification and mitigation of potential hazards serve as "ground truth" for safety assessments.

8. The Sample Size for the Training Set

No training set (in the context of machine learning or AI algorithm development) is mentioned. The submission describes updates to an existing X-ray device and its software based on traditional engineering development and testing, not AI-driven development.

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

Not applicable, as no training set (for AI) is mentioned in the document.

Summary

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August 17, 2018

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

Re: K181767

Trade/Device Name: Cios Select Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO Dated: July 02, 2018 Received: July 03, 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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 mediation-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.

Hol. 2. Nils

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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	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 below.
510(k) Number (if known)	K181767
Device Name	Cios Select
Indications for Use (Describe)	The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.
	The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
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)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.
	DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
	The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human Services
	Food and Drug Administration
	Office of Chief Information Officer
	Paperwork Reduction Act (PRA) Staff
	PRAStaff@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Section 7 510(k) Summary

The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website.

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510(k) Summary: Cios Select

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

Date Prepared: August 16, 2018

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 Reqistration Number: 2. 2240869

Manufacturing Site:

Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318, China Establishment Registration Number: 3003202425

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:	Cios Select
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1650
Submission Type:	Traditional 510(k)
Device Class:	Class II
Product Code:	OWB
Subsequent Product Code:	OXO

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SIEMENS Healthineers

1. Legally Marketed Predicate Device: Primarv Predicate: Cios Select Trade Name: K153232 510(k) #: Clearance Date: February 10, 2016 Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: Class II Product Code: OWB Subsequent Product Code: JAA, OXO Recall Information: No Recalls Secondary Predicate: Trade Name: Cios Fusion 510(k) #: K153244 March 07, 2016 Clearance Date: Classification Name: Image-intensified fluoroscopic x-ray svstem Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: Class II Product Code: OWB Subsequent Product Code: ОХО No Recalls Recall Information:

5. Device Description:

The new detector PaxScan 2121DXV is a new component to the subject device Cios Select. This is a hardware change that impacts the system software VA20. The essential performance of the detector is to generate (a sequence of) digital images in which the digital pixel values are representative of the intensity of the spatially distributed X-Ray radiation at the position of the detector. All the non-clinical performance data demonstrate that the detector PaxScan 2121DXV for Cios Select VA20 does not raise any new issues of safety or effectiveness and is as safe, and effective when compared to the secondary predicate devices Cios Fusion (K153244) that is currently marketed for the detector technology.

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Interfaces are provided for optional devices such as external monitors, thermal printers, as well as wired and wireless DICOM network interfaces.

The following modifications are incorporated to create the Subject Device the Cios Select (VA20):

1. Updated the Indications for Use Statement with minor changes
1. Upgraded software, from Version VA10 to Version VA20:
- a. New User Interface touch panel (software)
- b. New flat detector (PaxScan 2121DXV) (software)
- (OTS) software from Windows 7 to Windows 10. (software) C.
- d. Updated Image storage to a maximum of 300000 frames (software)
- e. Optional Metal Artifact Reduction Software (cleared in Secondary Predicate Cios Fusion K153244)
1. New user interface in-touch panel for navigating and operating the system. (Hardware)
1. New optional wireless LAN for network connectivity (Hardware)
1. New optional wireless footswitch in addition to the wired footswitch. (Hardware)
1. New flat detector (PaxScan 2121DXV) to replace image intensifier for image receptor.(Hardware)

6. Indication for Use:

7. Substantial Equivalence:

The Cios Select (VA20) is substantially equivalent to the commercially available primary predicate device Siemens Cios Select (VA10), cleared February 10, 2016, with K153232.

The Indications for Use was slightly modified, however, the change does not impact the Intended Use of the device. Table 1 provides primary and secondary Predicate Devices comparable information:

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The Cios Select is substantially equivalent to the following predicate devices:

Table 1: Predicate Device Comparable Properties:

Predicate Device(s) Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary Predicate DeviceCios Select (VA10)Product Code: OWB, OXO,JAASiemens Shanghai MedicalEquipment Ltd.	K153232	2/10/2016	●ndications for use●-ray technology●mage processing●echanical design
Secondary Predicate DeviceCios Fusion (VA20)Product Code:OWB, OXOSiemens Healthcare GmbH	K153244	3/07/2016	●etector Technology

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

The Subject device Cios Select design is based on the Siemens Cios Select(K153232) including the system control, mechanical design and image processing functions. The flat panel detector technology is based on the Cios Fusion (K153244).

The subject device has the same fundamental scientific technologies as the

predicate devices. The modifications do not affect the intended use of the device. Table 2 has Subject Device characteristics compared to the Predicate Device.

Modifications	Subject DeviceCios Select(VA20)	PrimaryPredicate DeviceCios Select(VA10) K153232	SecondaryPredicate DeviceCios Fusion(VA20) K153244	Comparison Results
SystemSoftware	Upgradedsoftware, fromVersion VA10 toVersion VA20.	Software VersionVA10	N/A	System Softwareupgraded to VA20 tosupport new software /hardware modificationsand tested per softwareand guidance and SSXIGuidance. All testresults passed.
UserInterface	New userinterface in atouch panel fornavigating andoperating the	Keyboard buttonbased Userinterface	N/A	The functionality of thedevice remains thesame as the predicatedevice except for thenew User Interface with
Modifications	Subject DeviceCios Select(VA20)	PrimaryPredicate DeviceCios Select(VA10) K153232	SecondaryPredicate DeviceCios Fusion(VA20) K153244	Comparison Results
	system.			Touchscreen panel.
WLAN	New optionalwireless LAN fornetworkconnectivity.	N/A	N/A	The WLAN networkconnectivity feature is incompliance with theWireless Guidancedocument.
Footswitch	WiredOptionalWirelessfootswitch	Wired Only	N/A	Optional wirelessfootswitch with the samefunctionality as a wiredfootswitch. Wirelessversion does not raiseany new safety oreffectiveness issue.This feature is incompliance with theWireless Guidancedocument.
ImageReceptor	New flatdetectorPaxScan(2121DXV)	Image Intensifier	DetectorPaxScanTM 2020Xand PaxScanTM3030X Detectorwas cleared in thepredicate	Detector technology iscomparable tosecondary predicatedevice Cios Fusion(K153244) per the SSXIGuidance document anddoes not raise any newsafety or effectivenessissues.
Off The ShelfSoftware	Upgraded Off-the-Shelf (OTS)software fromWindowsversion 10.	Windows 7	N/A	Tested per SoftwareGuidance and Off theShelf SoftwareGuidance.
ImageStorage	Updated Imagestorage to amaximum of300000 frames.	150000 frames	N/A	Increased systemcapability for imagestorage. Thismodification does notraise new issues ofsafety or effectiveness.

Table 2: Comparison of Technological Characteristics

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9. Non-Clinical Testing

The Siemens Cios Select has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select complies with the following 21 CFR Federal Performance Standards:

1020.30 Diagnostic X-Ray Systems and their major components 1020.32 Fluoroscopic equipment

1040.10Laser products

and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:

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Table 3: Voluntary Conformance Standards:

Recog-nitionNumber	ProductArea	Title of Standard	Reference Numberand Date	StandardsDevelopmentOrganization
19-4	General	Medical Electrical Equipment - Part1: General Requirements forSafety, 2005	60601-1:2012, ed. 3.1	IEC
19-8	General	Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral Standard:Electromagnetic disturbances -Requirements and tests	60601-1-2 Edition 4.02014-02	IEC
12-269	Radiology	Medical electrical equipment - Part1-3: General requirements for basicsafety and essential performance -Collateral Standard: Radiationprotection in diagnostic X-rayequipment	60601-1-3 Edition 2.12013-04	IEC
5-114	General	Medical devices - Part 1:Application of usability engineeringto medical devices [IncludingCORRIGENDUM 1 (2016)]	62366-1 Edition 1.02015-02	IEC
5-70	General I(QS/RM)	Medical devices – application ofrisk management to medicaldevices	14971:2012	ISO
13-32	Software	Medical device software - Softwarelife cycle processes	62304 Ed. 1.02006	IEC
12-204	Radiology	Medical electrical equipment - Part2-28: Particular requirements forthe basic safety and essentialperformance of X-ray tubeassemblies for medical diagnosis	60601-2-28 Edition2.0 2010-03	IEC
12-202	Radiology	Medical electrical equipment- Part2-43: Particular requirements forthe basic safety and essentialperformance of X-ray equipment forinterventional procedures	60601-2-432010	IEC
12-274	Radiology	Medical electrical equipment - Part2-	60601-2-54:	IEC
Recog-nitionNumber	ProductArea	Title of Standard	Reference Numberand Date	StandardsDevelopmentOrganization
		54: Particular requirements for thebasic safety and essentialperformance of X-ray equipment forradiography and radioscopy	2009
12-300	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1 - 3.20 (2011)	NEMA
12-273	Radiology	Safety of laser products - Part 1:Equipment classification, andrequirements	60825-1 Edition 2.02007-03	IEC
12-290	Radiology	Medical electrical equipment -Radiation dose documentation -Part1: Equipment for radiography andradioscopy	61910-1 Edition 1.02014-09	IEC

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Table 4: FDA Guidance Documents

FDA Guidance Documents 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 January 30, 2018
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(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 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 forSolid 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 Imaging DevicePremarket Notifications.Document issued on November 28, 2017
11.	Guidance for Industry and FDA Staff: Content of Premarket Submissions for

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FDA Guidance Documents and Effective Date
	Management of Cybersecurity in Medical devices.Document issued on October 2, 2014
12.	Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology inMedical DeviceDocument issued on August 14, 2007.
13.	Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical DevicesDocument issued on July 11, 2016

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select software version VA20 during product development.

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

Bench testing in the form of Unit, Subsystem and System Integration testing were performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Electrical safety and EMC testing were conducted on the Cios Select, consisting of the acquisition unit (C-arm system) and the image processing and display station. The system complies with the IEC 60601-1, IEC 60601- 2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 the standard for EMC.

The Cios Select software (VA20) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. All new software functions present in the Subject Device (New User Interface touch panel, New flat detector (PaxScan 2121DXV), (OTS) software from Windows 7 to Windows 10 and Updated Image storage to a maximum of 300000 frames) have been validated through detailed software testing and it was

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founded they worked as intended. 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. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.

Additional engineering bench testing was performed including the nonclinical testing identified in the guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation. X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed with acceptable results.

Summary:

Performance tests were conducted to test the functionality of the Cios Select (VA20). These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing and clinical assessments 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 and mechanical 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 postprocessing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The Cios Select has the same indications for use, operating environment, and mechanical design as the Primary and Secondary predicates. Siemens concludes via the documentation provided in this 510(k) submission that the Cios Select does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as the

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predicate devices even though the Subject Device is using a different detector.

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.