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

Device Description

The CIARTIC Move is a mobile fluoroscopy C-arm x-ray system designed for the surgical environment. CIARTIC Move provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The CIARTIC Move consists of two major components: A. The C-arm with an 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 lifted vertically, shifted to the side and moved forward/ backward by an operator. All axes are motorized. B. The monitor trolley provides image processing, review, and patient data entry. The monitor trolley supports an optional hardcopy printer and navigational equipment. The trolley is connected to a mains power outlet or an optional data network.

AI/ML Overview

The provided text describes the Siemens CIARTIC Move (VB10) mobile X-ray system and its comparison to a predicate device, the Cios Spin (VA30). It focuses heavily on non-clinical performance testing and technical comparisons rather than a typical clinical study evaluating AI performance in a diagnostic context. Therefore, many of the requested points related to AI-specific study design (such as human reader improvement with AI assistance, type of ground truth for AI, training set details) are not directly applicable or explicitly detailed in the provided document, as the device itself is a medical imaging hardware system with software updates for enhanced functionality, not an AI diagnostic algorithm.

Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document outlines an array of non-clinical tests and a limited clinical study to demonstrate that the CIARTIC Move (VB10) meets its performance and safety requirements. The "acceptance criteria" are implied by the successful completion of these tests ("Passed").

Acceptance Criteria (Implied by Test Name/Objective)	Reported Device Performance
Software Update from VA30 to VB10A:	Passed
Functional, verification, and system validation testing	All test results met all acceptance criteria.
Updated Park Assist:	Passed
User can temporarily park Mobile C-arm Base Unit and restore previous position automatically.	Testing was conducted and passed.
Updated Position Assist:	Passed
User can position system to intended anatomical region via wired and wireless smart controls.	Testing was conducted and passed.
Updated Smart Control:	Passed
User can position system to intended anatomical region via wired and wireless smart controls.	Testing was conducted and passed.
Updated ISO Assist:	Passed
User can adjust distance (patient-to-detector) while maintaining iso-center (for zooming or operating space).	Testing was conducted and passed.
Updated Touch Sensitive Handle on C-Arm Mobile Base:	Passed
User can prepare system for intervention and drive C-arm base unit to anatomical region at OR table.	Testing was conducted and passed.
Updated Touch Sensitive handles on FD:	Passed
Additional controls for up/down, orbital, and angular movement of C-arm and C-Arm Mobile Base Functionality.	Testing was conducted and passed.
Updated Display to 32" Touch Sensitive:	Passed
Monitor resolution and refresh rate, touch function, mechanical interface of monitor mount to trolley.	Testing was conducted and passed.
Updated Touch User Interfaces (TUI):	Passed
Steps surgeons and OR staff perform during specific procedures (fracture reduction, pedicle screw placement).	Testing was conducted and passed.
Added Collision Detection and Avoidance:	Passed
System behavior during collision detection/avoidance, correctness of wheel motor torque limits, manual risk mitigations.	Testing was conducted and passed.
Added Movement indicator to Monitor Trolley:	Passed
Correctness of the movement indicator.	Testing was conducted and passed.
Updated Retina 3D for optional enlarged FOV (25x25x16cm):	Passed
Defined cylinder phantom can be completely sampled and reconstructed for both regular and enlarged volume; demonstration of use for navigation based on universal navigation interface.	Testing was conducted and passed.
Updated C-Arm Mobile Base with 4 motorized Holonomic wheels:	Passed
Mobile C-arm base unit can be moved in all directions by motor, braking, stability on uneven floors, cable deflectors function.	Testing was conducted and passed.
Updated Collimator:	Passed
Collimator initialization, leaves not visible in image, rotation velocity, open/close behavior, home positioning, coupling/decoupling, timing, minimal opening, user formats, limiting X-ray beam to active image format.	Testing was conducted and passed.
Electrical Safety, Performance, and EMC Standards Compliance:	Passed
Compliance with 21 CFR 1020.30, 1020.32, 1040.10, AAMI ANSI 60601-1-2:2014, IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60825-1, IEC 62304, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, IEC 62366-1, ISO 14971, NEMA ps3.1:2022, ANSI UL 2900-1, ANSI UL 2900-2-1.	Certified to comply with all listed standards.
Human Factors Usability:	Passed
Addressed through design control verification and validation process, system tests, clinical use tests with customer reports and feedback forms.	Demonstrated as safe and effective for intended users, uses, and use environments.
Cybersecurity:	Passed
Process for preventing unauthorized access, modification, misuse, denial of use, or unauthorized use of information.	Cybersecurity statement provided, considering IEC 80001-1:2010.
Clinical Performance (Primary Endpoint: Intraoperative Imaging Time Saving):	Met expectation
Intraoperative imaging time (IIT) of CIARTIC Move VB10 compared to Cios Spin VA30.	CIARTIC Move VB10 performs comparably to the predicate device. Expected "time saving" from objective is not explicitly quantified as successful acceptance criteria in summary.

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

Test Set (Clinical Study): The document mentions a "cross-sectional two-arm, controlled, open-label, mono-center, exploratory study with human specimens (body donations)."
- Sample Size: The exact number of human body donations used as the sample size for the clinical study is not specified in the provided document.
- Data Provenance: "human body donations" were used "in order to avoid radiation exposure to living humans." The study was "mono-center," but the country of origin is not explicitly stated. Given Siemens Healthineers AG (Germany) as the manufacturing site and Siemens Medical Solutions USA, Inc. (USA) as the importer/distributor, the location could be either, or potentially another region where such body donation studies are conducted. The study design is prospective, as it's a planned evaluation.

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

This information is not provided in the document. The clinical study was focused on comparing imaging time and other parameters (procedural times, number of images, DAP) rather than a diagnostic accuracy study requiring expert adjudication of images. The "ground truth" for time-saving would be direct measurements.

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

An adjudication method specific to image interpretation or diagnostic findings is not applicable and therefore not mentioned, as the study primarily measured time-based and procedural metrics.

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 comparative effectiveness study was not done for AI assistance. The provided document describes the device as an "Image-Intensified Fluoroscopic X-Ray System" with updated software and hardware features, not an AI-powered diagnostic tool. The clinical study aimed to compare the time efficiency of the new device (CIARTIC Move VB10) against a predicate device (Cios Spin VA30), not to assess human reader performance improvements with AI assistance. Therefore, no effect size related to AI improvement is stated.

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

This question is not applicable as the document describes a hardware device (X-ray system) with integrated software for operational improvements, not a standalone AI algorithm for medical diagnosis.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, direct measurements, and compliance with recognized industry standards. The tests checked if the system's new functionalities (e.g., movement, display, collision detection, FOV) performed as designed and met technical requirements.
For the clinical study, the "ground truth" for the primary endpoint (intraoperative imaging time) was direct measurement of time in seconds during the procedures on human body donations. Other secondary endpoints like number of images and dose area product (DAP) would also be direct measurements from the system.

8. The sample size for the training set:

This information is not applicable as the document is about a hardware device with software updates, not an AI algorithm that undergoes a distinct "training set" process from ground-truthed clinical data. Software development and testing (functional, verification, system validation) are mentioned, which incorporate internal test data, but not a "training set" in the context of machine learning.

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

This information is not applicable for the same reason as point 8. The software verification and validation are described as being based on "engineering requirements specifications," "subsystem requirements specifications," and "risk management hazard keys," with test results successfully traced to these.

Summary

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March 15, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K233748

Trade/Device Name: CIARTIC Move (VB10) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: February 14, 2024 Received: February 14, 2024

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Gabriela M. Rodal -S

Digitally signed by Gabriela M. Rodal -S

for

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

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Indications for Use

510(k) Number (if known) K233748

Device Name CIARTIC Move (VB10)

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)

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Image /page/3/Picture/2 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

510(k) Summary: CIARTIC Move (VB10)

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

Date Prepared: February 14, 2024

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 Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens Healthineers AG ROENTGENSTRASSE 19-21 95478 KEMNATH, Germany Establishment Registration Number: 3002466018

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:

CIARTIC Move (VB10) Image-Intensified Fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II OWB, JAA, OXO

1. Legally Marketed Predicate Device Trade Name: Cios Spin (VA30) 510(k) Clearance K210054 Clearance Date February 5, 2021 Classification Name: Image-intensified fluoroscopic X-ray System Classification Panel: Radiology Regulation Number: 21 CFR §892.1650

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Image /page/4/Picture/2 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.

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

Class II OWB JAA. OXO

All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any applicable issues.

Reference Device Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Subsequent Product Codes:

Excelsius3D™ K210912 February 5, 2021 Image-intensified fluoroscopic X-ray System Radiology 21 CFR §892.1650 Class II OWB JAA, OXO

5. Device Description:

The CIARTIC Move consists of two major components:

A. The C-arm with an 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 lifted vertically, shifted to the side and moved forward/ backward by an operator. All axes are motorized.

B. The monitor trolley provides image processing, review, and patient data entry. The monitor trolley supports an optional hardcopy printer and navigational equipment. The trolley is connected to a mains power outlet or an optional data network.

The following modifications were made to the Predicate Device the Cios Spin Mobile X-ray System cleared under Premarket Notification K210054 on February 5, 2021. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device the CIARTIC Move VB10. The following modifications are incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:

	Software / Hardware changes specific to New System Software VB10A
1.	Updated system Software from VA30G to VB10A
A.	Updated Park Assist
B.	Updated Position Assist
C.	Updated Smart Control
D.	Updated ISO Assist

Table 1: Subiect Device Modifications

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Software / Hardware changes specific to New System Software VB10A
E.	Updated Touch Sensitive Handle on (C-Arm Mobile Base) with control panel for moving, transporting, braking, and positioning C-arm Mobile Base.
F.	Updated Touch Sensitive handles on Flat Detector (FD) by adding additional controls on the FP control panel for up/ down, orbital, and angular movement of C-arm and C-Arm Mobile Base itself
G.	Updated Display to 32" Touch Sensitive
H.	Updated Touch User Interface (TUI).
I.	Added Collision Detection and Avoidance to the CIARTIC Move System
J.	Added a Movement indicator to Monitor Trolley
K.	Updated Retina 3D for optional Field of View (FOV) 25cm x 25cm x 16cm
L.	Updated the C-Arm Mobile Base with 4 motorized Holonomic wheels, which allows the C-Arm Mobile Base to move straight ahead, sideways, diagonally, and 360o rotation
M.	Updated Collimator
2.	Updated PC
3.	Revised Indications for Use Statement
4.	Product Claims List
5.	Updated 510(k) information for the Primary Predicate Device

6. Indications for Use:

The CIARTIC Move is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patients 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.

Substantial Equivalence: 7.

The CIARTIC Move (VB10A) is within the same classification requlation with the same indications for use as the legally marketed predicate listed in Table 2. below:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary Predicate Device	K210054	2/5/2021	Indications for use Image processing Mechanical design Software
Cios Spin (VA30)Siemens			Collimator PC hardware Interactive User Touch Control Display C-Arm Mobile Base Monitor Trolley
Reference DeviceExcelsius3DTMGlobus Medical Inc.	K210912	08/12/2021	Holonomic Wheel

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

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1. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
  The Indications for Use Statement is exactly the same as the cleared Predicate Device "Cios Spin" with the exception of the trade name of the Subject Device "CIARTIC Move."

The CIARTIC Move with system software version VB10A contains the following modifications that were made to the predicate device. Provided in Table 3 is a summary of the comparison of Technological Characteristics to the Predicate Device. The following technological differences exist between the subject and predicate devices:

	Subject DeviceCIARTIC Move (VB10A) SystemModifications	Predicate DeviceCios Spin (VA30)K210054	ComparisonResults	The following non-clinical testing was conducted on the listed modifications and relied on:
1.	Software update from VA30 toVB10A to support the followingnew hardware and softwarefeaturesA. Updated Park AssistB. Updated Position AssistC. Updated Smart ControlD. Updated ISO AssistE. Updated Touch SensitiveHandle on C-Arm Mobile Basewith control panel for moving,transporting, braking, andpositioning C-arm MobileBase.F. Updated Touch Sensitivehandles on FD by addingadditional controls on the FDcontrol panel for up/ down,orbital, and angular movementof C-arm and C-Arm MobileBase.G. Updated Display to 32" TouchSensitiveH. Updated Touch UserInterfaces on the C-armsystem control panel (CCP),Trolley Control panel (TCP) onmonitor trolley, and optionalremote control panel (RCP)that can be placed on an	VA30 System SoftwareThe system can be moved toparking position manually.C-arm positions can be stored(angular/orbital angles); up to 3positions.Radiation release and imagesaving were possible with handswitch.The functionality of ISO Assistwas possible only when theangular/ orbital position of theC-arm is 0°.Handles on chassis (not touch-sensitive) for manualmovement.Handle (FD) (not touch-sensitive) for manualmovement.2 smaller 19" displaysSmaller 12.1" resistive touchtechnology, resolution of 1280x 800 pixels for all TUIs	Modified:System software VA30to VB10A whichincludes the followingsoftware andhardware changes. Allmodificationsdifferences betweenthe Subject Deviceand Predicate DeviceSoftware andHardware Functionswere evaluated insoftware VB10A.System Softwaremodifications listed in1A-2 conform to the"Guidance for theContent of PremarketSubmission for DeviceSoftware Functions."Software testing whichidentifies all testingpertinent to eachmodification isprovided.These software andhardware changes donot raise any newrisks or issuesregarding the safety oreffectiveness of thedevice. All test resultsmet all acceptancecriteria.	Modification	Conducted Test	Test Results
	Subject DeviceCIARTIC Move (VB10A) SystemModifications	Predicate DeviceCios Spin (VA30)K210054	ComparisonResults	Software update from VA30 to VB10Ato support the following newhardware and software features	Software functional, verification, and Systemvalidation testing were conducted for Softwareversion VB10A.	Passed
	optional cart close to thepatient table.			Updated Park Assist	Testing was conducted with the user temporarilyparking the Mobile C-arm Base Unit to a convenientposition in the OR, away from the table, andrestoring the previous position automatically.	Passed
I.	Added Collision Detection andAvoidance to the CIARTICMove System	Non existent. The user has totake care that the collision doesnot occur.		Updated Position Assist	Testing was conducted with the user positioning thesystem to the intended anatomical region via wiredand wireless smart controls.	Passed
J.	Added a Movement indicatorto Monitor Trolley	Rudimentary movementindicator to indicate thedeviation from target position(<1°, <5°,>5°)		Updated Smart Control	Testing was conducted with the user positioning thesystem to the intended anatomical region via wiredand wireless smart controls.	Passed
K.	Updated Retina 3D for optionalenlarged Field of View (FOV)25cm x 25cm x 16cm.	Retina 3D image chain with 3Dreconstruction mode 16 cm x16 cm x 16cm		Updated ISO Assist	Testing was conducted with the user to adjusting thedistance (patient-to-detector) while maintaining theiso-center. The purpose to change the distancebetween flat detector and patient may be to zoom inor out, or to gain more operating space betweendetector and patient.	Passed
L.	Updated the C-Arm MobileBase with 4 motorizedHolonomic wheels, whichallows the C-Arm Mobile Baseto move straight ahead,sideways, diagonally, and 360°rotation.	The system can be movedmanually with non-motorizedwheels.		Updated Touch Sensitive Handle onC-Arm Mobile Base with control panelfor moving, transporting, braking, andpositioning C-arm Mobile Base.	Testing was conducted with the user whenpreparing the system for the next intervention andwhen driving the mobile C-arm base unit to theintended anatomical region at the OR table.	Passed
M.	Updated CollimatorUpdated PC	CollimatorThe PC HW is W550 fromFujitsu with the followingfeatures:• CELSIUS W550power-L• Core i3-6100• Memory 8GB DDR4-2133 ECC• HDD SATA III 2000GB7.2k BC• Fixed Slot and SATA-Port for HDD and ODD• PCI-Boards and cardbrackets• DVD SuperMulti SATA• Input: 230 Vac		Updated Touch Sensitive handles onFD by adding additional controls onthe FD control panel for up/ down,orbital, and angular movement of C-arm and C-Arm Mobile Base.
3.	Revised the Indications for UseStatement	Indications for Use Statement	Modified:Added the SubjectDevice Trade name:"CIARTIC Move."	Updated Display to 32" TouchSensitive	Testing was conducted to check at systemintegration level the following aspects: the monitorresolution and refresh rate, the monitor touchfunction, the mechanical interface of the monitormount to the monitor trolley.	Passed
4.	Product Claims List is provided			Updated Touch User Interfaces onthe C-arm system control panel(CCP), Trolley Control panel (TCP)on monitor trolley, and optionalremote control panel (RCP) that canbe placed on an optional cart close tothe patient table.	Testing was conducted to check steps surgeons,and the OR staff perform during a fracture reductionwith joint involvement and during a pedicle screwplacement.	Passed
5.	Updated 510(k) information for the Primary Predicate Device is provided			Added Collision Detection andAvoidance to the CIARTIC MoveSystem	Testing was conducted to check OR staff performingwhen transporting the mobile C-arm base unit to theintended equipment storage area. Testing focusedon checking the operator's manual risk mitigations,correctness of system behavior during collisiondetection and avoidance, and correctness of wheelmotor torque limits upon collision detection.	Passed
Added a Movement indicator toMonitor Trolley	Testing was conducted to focus on checkingcorrectness of the movement indicator.	Passed

Table 3: Summary of Comparison of Technological Characteristics

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Image /page/7/Picture/2 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

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Image /page/8/Picture/2 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.

9. Nonclinical Performance Testing:

During product development the following non-clinical testing was conducted on the listed modifications provided in Table 4 in support of the substantial equivalence determination.

Table 4: Conducted Non-Clinical Testing

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Image /page/9/Picture/2 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots in a circular pattern.

The following non-clinical testing was conducted on the listed modifications and relied on:
Modification	Conducted Test	Test Results
Updated Retina 3D for optionalenlarged Field of View (FOV) 25cm x25cm x 16cm	Testing was conducted to focus on checking that adefined cylinder phantom can be completelysampled and reconstructed for both regular andenlarged volume. The objective of the test is todemonstrate that the enlarged volume of theCIARTIC Move can be used for navigation based ona universal navigation interface.	Passed
Updated the C-Arm Mobile Base with4 motorized Holonomic wheels, whichallows the C-Arm Mobile Base tomove straight ahead, sideways,diagonally, and 360° rotation.	Testing was conducted to focus on checking thefollowing functions:1. The mobile C-arm base unit can be moved in allpossible directions by a motor as well as brakingin different situations.2. The movement platform ensures stability againsttilting, also on uneven floor.3. The cable deflectors can deflect cables lying onthe floor when the mobile C-arm base unit ismoved.	Passed
Updated collimator	Testing was conducted to focus on checking thefollowing functions:1. Collimator initialization and general behavior2. Collimator leaves are not visible in the image forall C-arm positions.3. Rotation velocity of the rotation collimator4. Open/close behavior, home positioning, couplingand decoupling of 1st Slot Collimator5. Open/close timing, minimal opening and userformats of the rectangle collimator6. Rectangle collimator can limit the X-ray beam tothe active image format in overview, zoom1 andzoom2	Passed

The Siemens CIARTIC Move (VB10A) has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens CIARTIC Move (VB10A) complies with the following 21 CFR Federal Performance Standards.

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

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

The CIARTIC Move (VB10A) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance, and Electromagnetic Compatibility:

AAMI ANSI 60601-1-2:2014 [Including AMD 1:2021] ●
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION ●
IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION ●

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IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION ●
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 Edition 1.1 2020-06 CONSOLIDATED VERSION ●
ISO 14971:2019 ●
NEMA ps3.1:2022 ●
ANSI UL 2900-1:2023 .
. ANSI UL 2900-2-1:2023

Table 5: 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
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)sDocument 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 Off-The-Shelf Software Use inMedical DevicesDocument issued on September 27, 2019
8.	Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Device Software FunctionsDocument issued on June 14, 2023
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

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FDA Guidance Document and Effective Date
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
15.	Guidance for Industry and FDA Staff: Electronic Submission Template for MedicalDevice 510(k) SubmissionDocument issued on October 2, 2023

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

Verification and Validation:

Software Documentation for a Basic Documentation Level software per FDA's Guidance Document "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance for medical devices containing software. Nonclinical tests were conducted on the Subject Device CIARTIC Move with software version VB10A 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 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 CIARTIC Move, 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 CIARTIC Move with software (VB10A) 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

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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.

Clinical Study Title:

A prospective evaluation of clinical performance and safety of CIARTIC Move in comparison to Cios Spin in terms of timesaving in different clinical procedures were conducted.

Objective:

The primary objective of the study was to evaluate the intraoperative imaging time saving (IIT) of CIARTIC Move VB10 compared to Cios Spin VA30. Procedural times, number of images, and dose area product were evaluated as secondary objectives.

Study Design:

Cross-sectional two-arm, controlled, open-label, mono-center, exploratory study with human specimens (body donations).

Primary Endpoint:

The primary endpoint was the time difference in seconds of the duration of the intraoperative imaging. (Intraoperative Imaging Time IIT) performed under imaging control with Cios Spin VA30 compared to CIARTIC Move VB10.

Total Intraoperative imaging time in sec defined as sum of all park-to-image-times (PTI) and image-to-park times (IPT) per procedure. IIT Cios Spin VA30J - IIT CIARTIC Move VB10= Δ IIT The IIT was evaluated for each surgery, spine and radius separately. In addition, the total intraoperative imaging time to capture the 5 standard projections (AP, Lateral, Inlet, outlet, obturatory) at the pelvis was determined.

Clinical Report Summary:

The purpose of the study was to evaluate the CIARTIC Move VB10 compared to the Cios Spin VA30J in reqard to intraoperative imaging time saving and number of images and other parameters. The study was conducted on human body donations in order to avoid radiation exposure to living humans.

The clinical data demonstrate that the CIARTIC Move VB10 performs comparably to the predicate device that is currently marketed for the same intended use.

Clinical and Non-Clinical Summary:

Performance tests were conducted to evaluate the functionality of the CIARTIC Move (VB10A). 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 did not raise any new issues of safety or effectiveness.

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10. General Safetv and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device safely and effectively.

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 postprocessing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the CIARTIC Move (VB10A) 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.