The Cios Spin 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 Spin (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin 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 the image 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 is a 510(k) summary for the Siemens Cios Spin X-ray system, specifically concerning modifications to its software (VA30 version). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that the device meets specific patient outcome or diagnostic performance acceptance criteria typical for AI/ML devices or new medical technologies.

Therefore, the document does not contain the information requested in most of the points about acceptance criteria and study design for proving device performance in terms of clinical accuracy or effectiveness (e.g., accuracy metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details).

This 510(k) serves to show that the modified Cios Spin (VA30) is as safe and effective as its predicate devices, primarily through nonclinical performance testing, software verification/validation, and compliance with recognized standards. The modifications listed are largely related to user interface enhancements and software security, not core image acquisition or diagnostic capabilities that would require extensive clinical accuracy studies.

However, I can extract information related to the testing performed to demonstrate substantial equivalence for the listed software modifications.

Here's a breakdown based on the available information:

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

The document does not provide a table of acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human reader improvement with AI assistance, as it is a 510(k) for a modified X-ray system, not a new diagnostic AI algorithm.

Instead, the acceptance criteria for these modifications appear to be:

Software Functionality: The new software features (Target Pointer, Interactive User Touch Control, Dose Regulation Indicator, Sound Radiation Delay, Product Software Security, Screw removal button) function as intended and do not introduce new safety or effectiveness issues.
Compliance with Standards: The device complies with relevant electrical safety, performance, electromagnetic compatibility (EMC), and software standards (e.g., AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, etc.).
Risk Mitigation: Identified risks are mitigated through design controls, verification, and validation.
Human Factors/Usability: The device is safe and effective for intended users and use environments, and human factors are adequately addressed.

The "reported device performance" for these criteria is stated as:

"The Cios Spin (VA30) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards..." (lists standards).
"The performance data demonstrates continued conformance with special controls for medical devices containing software."
"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."
"The Cios Spin 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."
"Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness."

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

Sample Size: The document does not specify a sample size for a "test set" in the context of diagnostic performance (e.g., number of images, number of patients). The testing described is primarily non-clinical verification and validation of software functionality and compliance with standards. It mentions "system test" and "clinical use tests with customer report and feedback," but no specific numerical sample sizes for these.
Data Provenance: Not applicable as there's no diagnostic performance test set described. The testing described would be performed internally by Siemens (e.g., "Siemens Healthcare GmbH Corporate Testing Laboratory").

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

Not Applicable. This document describes modifications to an X-ray imaging system's software features (e.g., user interface, security) and not a diagnostic AI algorithm that would require human expert ground truth for its performance evaluation (e.g., radiologists labeling findings).

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

Not Applicable. See point 3.

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, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for the software modifications described for this X-ray system. The document focuses on the system's functionality and safety.

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

Not Applicable. The described "modifications" are software features integrated into an X-ray system, meant to be used by a human operator (e.g., "Target Pointer", "Interactive User Touch Control"). There isn't a standalone diagnostic algorithm being evaluated.

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

Not Applicable. For the software modifications, "ground truth" would be the functional specification and expected safe operation of the software feature itself, verified through engineering tests and user testing, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set:

Not Applicable. There is no mention of a "training set" as this is not an AI/ML device that requires machine learning for its primary function. The software modifications are deterministic functional changes.

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

Not Applicable. See point 8.

Summary

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February 5, 2021

Siemens Medical Systems USA, Inc. % Mr. Cordell Fields, Esq. Technical Specialist, Regulatory Submissions 40 Liberty Blvd., 65-1A MALVERN PA 19355

Re: K210054

Trade/Device Name: Cios Spin Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: January 7, 2021 Received: January 8, 2021

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. 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/cfpmp/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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210054

Device Name Cios Spin

Indications for Use (Describe)

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."

FORM FDA 3881 (6/20)

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510(k) Summary: Cios Spin

K210054

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

Date Prepared: January 07, 2021

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 Roentgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018

2. Contact Person:

Mr. Cordell Fields, Esq. 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 Spin Image-intensified fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO JAA

Legally Marketed Primary Predicate Device Trade Name: Cios Spin 510(k) Clearance K181550 Clearance Date October 30, 2018

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Classification Name:	Image-intensified fluoroscopic x-ray System
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 theDesign Input phase of development to ensure the latestmodels will not be affected by any of the applicableissue.

Legally Marketed Secondary Predicate Device
Trade Name:	Cios Flow
510(k) Clearance	K203504
Clearance Date	December 22, 2020
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 thDesign Input phase of development to ensure the latestmodels will not be affected by any of the applicableissues

4. 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.
b) The second unit is the image display station with a moveable trolley for the image 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 Spin (K181550). Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device Cios Spin (VA30) for the following device modifications made to the Predicate Device Cios Spin (VA30 - K181550).

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

Modified Software:

Table 1: Overview of Software Modifications supported by Software Version VA30 .

Table 1. Software Modifications for Cios Spin

Software changes specific to New System Software VA30
Device Software Modification
1.	Target Pointer
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.	Screw removal button for Screw Scout

Other Device Modifications
7.	Update 510(k) Information

6. Indications for Use:

7. Substantial Equivalence:

The Cios Spin (VA30) system is substantial equivalent to the legally marketed predicates listed in Table 2 below:

Table 2: Predicate Device Comparable Properties for Subject Device Modifications:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary Predicate

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Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Siemens' Cios Spin	K181550	10/30/2018	• Indications for use• System for Image Acquisition• Post-processing Software• Examination Settings• Screw Scout
Secondary PredicateSiemens' Cios Flow	K203504	12/22/2020	• Target Pointer• Interactive User Touch Control• Dose Regulation Indicator• Sound Radiation Delay• Product Software Security

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

The Cios Spin (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. Components used with Cios Spin (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 3 below for all modifications.

	Subject DeviceCios Spin (VA30)Modifications	Primary Predicate DeviceCios SpinK181550Secondary Predicate DeviceCios FlowK203504(modifications 1 to 5 derivedfrom secondary predicatedevice Cios Flow)	ComparisonResults
1.	Target Pointer	Target Pointer	Same: Target Pointer has thesame functionality as cleared inthe Secondary PredicateDevice Cios Flow K202504.There are no technologicaldifferences in these featuresand the functionality of thesefeatures have not changed.
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 (Dose regulation with	Interactive User Touch ControlA. Collimation ControlsB. Brightness Contrast ControlsC. Rotate and Flip ControlsD. Zoom and Pan ControlsE. Spot Adapt (Dose regulation with	Same: 2.A-E has the samefunctionality as cleared in theSecondary Predicate device.The functionality of thesefeatures has not changed fromthe Secondary Predicatedevice Cios Flow K203504.
	movable circle)	movable circle)

Table 3: Summary of Comparison of Technological Characteristics

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	Comparison of Modifications to Predicate Devices
3.	New Dose Regulation Indicator	Dose Regulation Indicator	Same:The Dose regulation is equal tothe Secondary PredicateCios Flow K203504
4.	New Sound during Radiation Delay	Sound during Radiation Delay	Same:The Sound during RadiationDelay is equal to theSecondary Predicate CiosFlow K203504
5.	New Product Software Security	Product Software Security	Same:The updated Product SoftwareSecurity functionality is thesame as cleared in theSecondary Predicate deviceCios Flow K203504.
6.	Screw removal button for Screw Scout	Primary Predicate DeviceCios SpinK181550Screw Scout without Screwremoval button	Similar: The feature ScrewScout provides the samefunctionality as cleared in thePrimary Predicate deviceCios Spin K181550. Only abutton has been madeavailable to remove recognizedscrews.

Nonclinical Performance Testing: 9.

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

The Cios Spin (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 60601-2-28:2010 ●
IEC 60601-2-43:2010
IEC 60601-2-54:2009/A1:2015 ●
ISO 14971:2019 ●
IEC 62366-1:2015/ Cor.1:2016 .

Table 4: 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 Accept Policyfor 510(k)sDocument issued on September 13, 2019

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FDA Guidance Document and Effective Date
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 Spin (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 acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

The Cios Spin 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

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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 Spin (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 Spin (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.