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, 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 Cios Select (VA21C) with Flat Panel Detector Mobile X-ray System is designed for the surgical environment. The Cios Select FD (VA21) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K210309 on March 5, 2021.

The Cios Select consists of two major units:

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 (USB).

AI/ML Overview

The provided text is a 510(k) summary for the Siemens Cios Select (VA21C) with Flat Panel Detector. It describes modifications made to an existing device (Cios Select (VA21) Flat Panel, cleared under K210309) and argues for its substantial equivalence to the predicate device.

Crucially, this document focuses on demonstrating substantial equivalence of a modified medical device to its predicate, rather than providing a detailed study proving the de novo performance of a new device against specific acceptance criteria for a clinical task (e.g., detecting a disease).

The "acceptance criteria" discussed in this document refer to adherence to regulatory standards, successful completion of non-clinical bench testing, software verification and validation, and human factors validation, all geared towards demonstrating that the modified device is as safe and effective as the original, and performs as expected.

Therefore, many of the requested points regarding clinical study design, expert ground truth, MRMC studies, and training set details are not applicable or not explicitly provided in this type of regulatory submission because the demonstrated equivalence is primarily based on engineering and performance testing, not direct clinical efficacy studies for a new diagnostic or therapeutic capability.

Here's a breakdown based on the provided text, addressing the points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a "Special 510(k)" for modifications, the "acceptance criteria" are primarily related to conforming to recognized standards and ensuring the modifications do not introduce new safety or effectiveness concerns, rather than specific clinical performance metrics. The "reported device performance" is framed in terms of successful completion of tests demonstrating compliance and functional equivalence to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (as stated in the document)
Non-Clinical Performance Testing & Standards Compliance	Compliance with relevant FDA performance standards for diagnostic x-ray systems and fluoroscopic equipment (21 CFR 1020.30, 1020.32, 1040.10).	"The Siemens Cios Select (VA21C) with Flat Panel Detector has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select (VA21C) with Flat Panel Detector complies with the following 21 CFR Federal Performance Standards: 1020.30, 1020.32, 1040.10."
	Compliance with electrical safety, performance, and electromagnetic compatibility (EMC) standards: 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 60601-2-43:2019, IEC 60601-2-54:2018, IEC 62366-1:2015, ISO 14971:2019.	"The Cios Select (VA 21C) with Flat Panel Detector 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 [and others listed above]... 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 standard for EMC."
Software Verification & Validation	Conformance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and "Off-The-Shelf Software Use in Medical Devices." All software specifications meet acceptance criteria. Successful unit, subsystem, and system integration testing. Successful regression testing.	"Software Documentation for a Moderate Level of Concern software... is also included as part of this submission. The performance data demonstrate continued conformance with special controls for medical devices containing software. ...The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. ...All testable requirements... have been successfully verified and traced... The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria..."
Risk Management	Identified hazards mitigated through risk control implementation.	"The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. ...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."
Cybersecurity	Implement processes preventing unauthorized access, modifications, misuse, or denial of use of information.	"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."
Human Factors/Usability	Device is safe and effective for intended users, uses, and use environments. Human factors addressed in system testing and clinical use tests.	"The Cios Select with Flat Panel Detector software VA21(C) 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 reports and feedback forms."
Overall Equivalence	Device performs as well as the predicate device and does not introduce new safety or effectiveness issues.	"The results of all conducted testing and clinical assessments were found acceptable and do not raise any new safety or effectiveness issues." "The Cios Select (VA21C) with Flat Panel Detector does not introduce any new potential safety risks and is substantially equivalent and performs as well as the predicate devices."

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

Sample Size: Not specified in terms of clinical images or patient data. The testing described is primarily engineering bench testing, software verification/validation, and human factors validation.
Data Provenance: Not applicable in the context of clinical images/patient data for performance evaluation. Testing was conducted internally by Siemens Healthcare GmbH Corporate Testing Laboratory and through internal product development processes. It is not mentioned whether the human factors validation included users from specific countries.

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

Not Applicable. This submission does not involve assessment against a "ground truth" for a specific diagnostic task or clinical condition, as it's a submission for modifications to an existing X-ray system, not a new AI-based diagnostic algorithm.

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

Not Applicable. No adjudication method is mentioned as there's no diagnostic ground truth being established by experts.

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 conducted as this is an X-ray imaging system, not an AI-assisted diagnostic tool for interpretation.

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

Not Applicable. This is an X-ray imaging system, not an AI algorithm.

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

Ground truth in this context refers to the specifications and requirements the device is designed to meet, as well as adherence to recognized industry standards for medical device safety and performance. No disease-specific "ground truth" derived from expert consensus, pathology, or outcomes data is relevant for this type of submission.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device that requires a training set of data.

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

Not Applicable. As above, no training set or associated ground truth is relevant.

In summary: The K223410 510(k) submission for the Cios Select (VA21C) with Flat Panel Detector focuses on demonstrating that minor modifications (software update, new collimator, new PC hardware) to an already cleared X-ray system do not raise new safety or effectiveness concerns and maintain substantial equivalence to its predicate. The "study" referenced in the document is a compilation of engineering bench tests, software verification and validation activities, and human factors validation, all ensuring compliance with regulatory standards and functional performance of the device's hardware and software components. It does not involve a clinical efficacy study or AI performance evaluation.

Summary

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December 7, 2022

Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K223410

Trade/Device Name: Cios Select (VA21) Flat Panel 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 4, 2022 Received: November 9, 2022

Dear Patricia Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

2022.12.07
17:26:25
Lu Jiang
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223410

Device Name Cios Select (VA21) Flat Panel

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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: Cios Select (VA21) Flat Panel System Submission Number: K223410

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: December 5, 2022

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

1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

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

2. Contact Person:

Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-healthineers.com

3. Device Name and Classification:

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

Cios Select (VA21) Flat Panel

Image-Intensified Fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO, JAA

1. Legally Marketed Predicate Device Cios Select (VA21) Flat Panel Trade Name: 510(k) Clearance K210309 Clearance Date March 5, 2021 Classification Name: Image-intensified fluoroscopic x-ray System Classification Panel: Radiology

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

21 CFR §892.1650 Class II OWB JAA. OXO There are no Recalls nor MDR incidents for this cleared device.

5. Device Description:

The Cios Select consists of two major units:

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 (USB).

The following modifications were made to the predicate device the Cios Select (VA21) Flat Panel mobile X-ray System cleared under Premarket Notification K210309 on March 5, 2021. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21C) with Flat Panel Detector in comparison to the Predicate Device.

1. Updated Software from VA21(B) to VA21(C) to support the following hardware changes.
- a. New collimator
- b. New PC hardware
1. Updated 510(k) Information

6. Indications for Use:

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

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pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Substantial Equivalence: 7.

The Cios Select (VA21C) with Flat Panel Detector system is substantially equivalent to the legally marketed predicates listed in Table 1 below:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Predicate DeviceCios Select (VA21) FlatPanelSiemens Shanghai MedicalEquipment Ltd.	K210309	3/5/2021	Indications for use X-ray technology Image processing Mechanical design Cybersecurity Software Collimator PC Hardware

Table 1: 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 Select (VA21C) with Flat Panel Detector System is designed as a set of components (floor stand, C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator etc.) that is combined to provide a specialized angiography system. Components used with Cios Select (VA21C) with Flat Panel Detector System are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device are provided in Table 2 below for all modifications.

Table 2: Summary of Comparison of Technological Characteristics

	Subject DeviceCios Select (VA 21C) with Flat PanelDetector SystemModifications	Predicate DeviceCios Select (VA21B) FlatPanelK210309	ComparisonResults
1.	Software update from VA21(B) toVA21(C) to support the followingnew hardware, no new features	VA21B System Software	Comparable:There are no new functionalitieswhen compared to the PredicateDevice Cios Select (VA21) FlatPanel cleared in K210309. Thesystem software update tosupport the new hardware doesnot raise any new safety oreffectiveness issues.
A.	Replaced Collimator	Collimator	Comparable:There are no new functionalitieswhen compared to the PredicateDevice Cios Select (VA21) FlatPanel cleared in K210309. The

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	Subject DeviceCios Select (VA 21C) with Flat PanelDetector SystemModifications	Predicate DeviceCios Select (VA21B) FlatPanelK210309	ComparisonResults
			new collimator does not raise anynew safety or effectiveness.
B.	Updated PC hardware"Mini-PC"	PC hardware	Comparable:There are no new functionalitieswhen compared to the PredicateDevice Cios Select (VA21) FlatPanel cleared in K210309. Thenew mini-PC does not raise anynew safety or effectiveness issues

9. Nonclinical Performance Testing:

Non-clinical tests were conducted for the Cios Select (VA21C) with Flat Panel Detector during product development. The Siemens Cios Select (VA21C) with Flat Panel Detector has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select (VA21C) with Flat Panel Detector complies with the following 21 CFR Federal Performance Standards.

Code of Federal Requlations Title 21 Subchapter J- Radiological Health, applicable sections include:

1020.30 Diagnostic X-Ray Systems and their major components ●
1020.32 Fluoroscopic Equipment .
1040.10 Laser products ●

The Cios Select (VA 21C) with Flat Panel Detector 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 60601-2-43:2019 ●
IEC 60601-2-54:2018 ●
IEC 62366-1:2015 ●
ISO 14971:2019

Provided in Table 4 is a list of relevant Guidance Documents that were used in the development of the 510(k) content.

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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 AcceptPolicy for 510(k)sDocument issued on January 30, 2018
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 achange to an existing device.Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014
6.	Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s 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 ImagingDevice Premarket Notifications.Document issued on November 28, 2017
11.	Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014
12.	Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically Powered Medical DevicesDocument issued on July 11, 2016
13.	Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology inMedical DevicesDocument issued on August 14, 2007
14.	Guidance for Industry and Food and Drug Administration Staff: Pediatric Informationfor X-ray Imaging Device Premarket NotificationsDocument issued on November 28, 2017.
15.	Guidance for Industry and FDA Staff: Appropriate Use of Voluntary ConsensusStandards in Premarket Submission for Medical devicesDocument issued on September 14, 2018
16.	Guidance for Industry and FDA Staff: Medical Device Accessories – DescribingAccessories and Classification PathwaysDocument issued on December 20, 2017
17.	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.

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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 demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select with Flat Panel Detector software version VA21(C) during product development.

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

Bench testing in the form of Unit, Subsystem, and System Integration testing was 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 standard for EMC.

The Cios Select with Flat Panel Detector software VA21(C) 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 reports and feedback forms. 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 non-clinical testing identified in the guidelines for submission of 510(k)s for Solid State X-Ray Imaging

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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 (VA21C) with Flat Panel Detector. These tests have been performed to assess the functionality of the Subject Device. The results of all conducted testing and clinical assessments were found acceptable and do not raise any new safety or effectiveness issues.

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 practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and post-processing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The Cios Select (VA21C) with Flat Panel Detector has the same indications for use, operating environment, and mechanical design as the predicate. Siemens concludes via the documentation provided in the 510(k) submission that the Cios Select (VA21C) with Flat Panel Detector does not introduce any new potential safety risks and is substantially equivalent and performs as well as the predicate devices.

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.