syngo Virtual Cockpit is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices. It is a vendor neutral solution allowing read-only or full access control to connected devices. syngo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.

Device Description

syngo Virtual Cockpit (sVC) is a software solution for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. sVC provides a private, secure communication platform for real-time image visualization and crossorganizational collaboration between healthcare professionals across multiple sites. sVC enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. sVC is based on a client server architecture, with sVC server as the backbone and 3 different variants of client, based on the user roles, Modality client & Physician client. Modality client as two flavors one windows based client and a web client which can be hosted in a web browser. Steering client establishes remote connection to Modality console / Modality acquisition workplace through KVM (Keyboard, Video and Mouse) switch or Siemens proprietary accessing tool, syngo Expert-i. Steering client can establish connections to more than one (up to 3) Modality console applications. Physician client is the third client for Physician that can be contacted either by Steering technologist or by Modality technologist for assistance regarding scanning in more complex cases, or the Physician can provide expert radiologist knowledge. The connection is possible in full control or read-only mode. The full-control accessibility to CT scanners is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. The connection to radiotherapeutic equipment is limited to be read-only. In addition to enabling remote access and control of the modality scanners, sVC also supports common communication methods including live videos at the modality site, audio calls and text chats among users.

AI/ML Overview

The provided FDA 510(k) summary for syngo Virtual Cockpit (VB10A) focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. As such, it does not contain the typical elements of an acceptance criteria table or a comparative effectiveness study (such as MRMC) that would be expected for a diagnostic AI device requiring a clinical performance evaluation.

The device, "syngo Virtual Cockpit (VB10A)," is categorized as a "Medical Image Management And Processing System" (MIMPS) with product code LLZ and is a software-only solution intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices, and for training medical personnel. It is explicitly stated that "Images reviewed remotely are not for diagnostic use." This indicates it is not a diagnostic AI device that would produce specific diagnostic outputs requiring performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, the information typically requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study effect sizes, standalone performance, type of ground truth) is not present in this document because the device's function does not necessitate such a clinical performance evaluation.

Here's an analysis based on the information available in the document:

Acceptance Criteria and Device Performance (as inferred from the document's V&V approach):

Instead of clinical performance metrics, the acceptance criteria are focused on the functional validity, safety, and effectiveness of the remote management system compared to its predicate and the general requirements for medical device software.

Acceptance Criteria Category	Description (Inferred from document)	Reported Device Performance / Evidence
Functional Equivalence & Intended Use	Demonstrate that syngo Virtual Cockpit (sVC) enables remote access, assistance, review, monitoring, and standardization of medical imaging devices, similar to or expanded from the predicates, without raising new questions of safety or effectiveness.	"The intended use... is equivalent in that they all enable remote access to medical imaging devices and provide assistance... The subject, predicate and reference devices all allow remote users to help and assist modality technologist to display and review scanning protocols, observe and monitor the image acquisition and therefore help standardize scans in one institution."
Technical Performance (Latency)	For remote operation, the system should demonstrate acceptable delay/latency for real-time interaction.	Response time: ≤ 30 ms (for Expert-i method) / 60 ms (for KVM method with one modality). This is stated as "Equivalent to reference device."
Connectivity & Compatibility	Ensure stable and secure connections to supported medical imaging devices (including third-party via KVM switch) over a secured clinical network.	"The verification testing demonstrates that the sVC connection to modality scanners via KVM switch can perform as intended, meeting all of the design inputs." Supported modalities include medical imaging devices and radiotherapeutic devices (read-only). Supports multiple vendors.
Communication Features	Support essential communication methods for remote collaboration.	Includes "Screen sharing, IP cameras for live video, Audio calls and chat." Stated as "Equivalent. sVC has improved communication features."
Software Verification & Validation (V&V)	All software specifications must be met, and risks associated with clinically relevant functions assessed in a simulated clinical environment. Conformity to relevant consensus standards.	"Software validation is performed using externally sourced representative modality scanners... at the Siemens Healthineers training center and at the clinical collaborating site. The system configuration, connectivity, compatibility and operation... are assessed to validate the safety and effectiveness of the system in the simulated clinical environment." "All the software specifications have met the acceptance criteria."
Cybersecurity	Address cybersecurity considerations, including prevention of unauthorized access, modification, misuse, denial of use, or unauthorized use of information.	"Siemens Healthineers conforms to cybersecurity requirements by implementing a means to prevent unauthorized access..."
Risk Management	Identification and mitigation of identified hazards in compliance with ISO 14971.	"Risk Analysis... was completed and risk control implemented to mitigate identified hazards."
Safety and Effectiveness	The device should be safe and effective, performing as well as the predicate device without introducing new safety and effectiveness concerns. Output evaluated by clinicians to identify and intervene in case of malfunction.	"Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device." "The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction."

Details Regarding the Study (as per provided text):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the traditional sense of a clinical study for diagnostic performance. The testing involved "externally sourced representative modality scanners" and "the entire system."
- Data Provenance: The testing was conducted "in the Siemens Healthineers training center and at the clinical collaborating site." This suggests controlled, simulated environments and potentially real clinical settings, but the origin of any "data" would be the performance of the system itself during validation, not pre-existing patient data. It was effectively a prospective functional validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the traditional sense. There is no "ground truth" established by experts for diagnostic purposes because the device does not make diagnostic claims or generate diagnostic outputs. The "ground truth" for this device would be its ability to correctly perform its intended functions (remote control, video, audio, chat, latency, etc.) and comply with safety and cybersecurity standards. The "evaluation by clinicians" refers to their use of the system and their ability to detect malfunctions during its operation, not a judgmental "ground truth" on diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used to resolve discrepancies in expert readings or interpretations when establishing ground truth for diagnostic studies. This device's validation focused on functional performance and compliance.
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 explicitly NOT done. The document states: "No clinical studies were carried out for syngo Virtual Cockpit (Version VB10A). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This device is not designed to assist with human reading of images but rather with operating and managing the imaging process remotely.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. The device, by its nature, is a human-in-the-loop system for remote operation. Its functionality is the human-in-the-loop performance (e.g., remote control inputs, video/audio communication). "Stand-alone" performance would refer to diagnostic output generation without human intervention, which is not what this device does.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense for diagnostic performance. The "ground truth" relevant to this device's validation is the successful execution of its defined functional requirements and user stories, compliance with design inputs, and adherence to relevant safety and regulatory standards (e.g., IEC 62366-1, ISO 14971, IEC 62304). This is assessed through structured verification and validation testing rather than comparison to a clinical gold standard for disease.
The sample size for the training set:
- Not Applicable. This device is a software application for remote operation and management, not a machine learning or AI algorithm that trains on a dataset to learn patterns or make predictions. Therefore, there is no "training set" in the context of an AI model.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI model, there is no ground truth associated with it.

In summary: The K232744 submission for syngo Virtual Cockpit (VB10A) is a 510(k) for a Medical Image Management and Processing System, not a diagnostic AI device. Its validation focuses on functional performance, safety, cybersecurity, and substantial equivalence to a predicate device based on those characteristics, rather than clinical performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the questions regarding clinical study design, ground truth, and AI model training are not relevant to this specific device submission.

Summary

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December 21, 2023

Siemens Healthcare GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL, MN 55114

Re: K232744

Trade/Device Name: syngo Virtual Cockpit (VB10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 18, 2023 Received: December 18, 2023

Dear Prithul Bom:

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/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.

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).

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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 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 (QS) 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 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic 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

Submission Number (if known)

K232744

Device Name

syngo Virtual Cockpit (VB10A)

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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510(k) Summary syngo Virtual Cockpit (Version VB10A)

K232744

In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.

SUBMITTER I.

21CFR § 807.92(a)(1)

Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany

Contact: Dr. Jiayan Liu Phone: +1 (734) 604-7870 Email: jiayan.liu@siemens-healthineers.com

Date Prepared: July 4, 2023

II. DEVICE

21CFR § 807.92(a)(2)

Device Trade Name	syngo Virtual Cockpit (VB10A)
Classification Name	Medical image management and processing system
Common Name	System, Image Processing, Radiological
Classification Panel	Radiology
Regulation Number	§892.2050 Medical image management and processing system
Product Code	LLZ

III. LEGALLY MARKETED PREDICATE DEVICES

21CFR § 807.92(a)(3)

Predicate Device
Device Trade Name	Customer Remote Console
510(k) Number	K150193
Product Code	LLZ
This predicate has not been subject to a design-related recall.

Reference Device

Device Trade Name	syngo Expert-i
510(k) Number	K052423

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

Product Code

LNH

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION SUMMARY

21CFR § 807.92(a)(4)

This premarket notification addresses the Siemens Healthineers syngo Virtual Cockpit (Version VB10A) Medical Image Management and Processing System (MIMPS).

syngo Virtual Cockpit (sVC) is a software solution for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.

sVC provides a private, secure communication platform for real-time image visualization and crossorganizational collaboration between healthcare professionals across multiple sites. sVC enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.

sVC is based on a client server architecture, with sVC server as the backbone and 3 different variants of client, based on the user roles, Modality client & Physician client. Modality client as two flavors one windows based client and a web client which can be hosted in a web browser. Steering client establishes remote connection to Modality console / Modality acquisition workplace through KVM (Keyboard, Video and Mouse) switch or Siemens proprietary accessing tool, syngo Expert-i. Steering client can establish connections to more than one (up to 3) Modality console applications. Physician client is the third client for Physician that can be contacted either by Steering technologist or by Modality technologist for assistance regarding scanning in more complex cases, or the Physician can provide expert radiologist knowledge. The connection is possible in full control or read-only mode. The full-control accessibility to CT scanners is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. The connection to radiotherapeutic equipment is limited to be read-only.

In addition to enabling remote access and control of the modality scanners, sVC also supports common communication methods including live videos at the modality site, audio calls and text chats among users.

V. INTENDED USE/INDICATIONS FOR USE

21CFR § 807.92(a)(5)

Indications for Use Comparison

Predicate DeviceCustomer Remote ConsoleK150193	Reference Devicesyngo Expert-IK052423	Subject Devicesyngo Virtual Cockpit VB10A
The Customer Remote Console	The syngo Expert-i feature	syngo Virtual Cockpit is a
Software Option allows remote	allows the local user of the MRI	software application intended for
access for viewing/review of	(e.g. tech) to get help and	remote operation, assistance,
images as well as the ability to	assistance from other personnel	review, monitoring and
remotely provide real time	of the radiology department (e.g.	standardization of medical
guidance to the technologist	other tech or physician) to	imaging devices. It is a vendor
operating GE Healthcare	perform scans faster and with	neutral solution allowing read-
medical imaging devices. This	better quality. For this purpose, a	only or full access control to
access must be granted by the	remote user within the local	connected devices. syngo Virtual

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syngo Virtual Cockpit (Version VB10A) Traditional 510(k) Submission

technologist operating thesystem. The remote access isonly available for systemssupporting GE remoteconnectivity capability. Imagesreviewed remotely are not fordiagnostic use.	network of the MRI (i.e. thenetwork of the radiology) canlog onto the MR main or satelliteconsole.	Cockpit is also intended fortraining of medical personnelworking on the medical imagingdevices.
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The intended use of subject device syngo Virtual Cockpit (version VB10A), predicate device Customer Remote Console and reference device syngo Expert-i is equivalent in that they all enable remote access to medical imaging devices and provide assistance to on-site technologists (Table 2). The subject, predicate and reference devices all allow remote users to help and assist modality technologist to display and review scanning protocols, observe and monitor the image acquisition and therefore help standardize scans in one institution. The intended use of the subject, predicate and reference devices to work with modality scanners is equivalent.

None of the subject, predicate and reference devices is indicated for any specific disease, condition, or patient population, and all are intended to support healthcare professionals in the healthcare institutions' environment. This similarity indicates that they share a broad scope of application and are not intended for a specific subset of patients or clinical scenarios. They can be considered substantially equivalent in their clinical versatility.

Indications for Use/Intended Use Comparison Summary and Conclusion

The Indications for Use were assessed in accordance with the following FDA Guidance Documents:

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] ●
The results of this evaluation determined that the Indications for Use for the subject, device and the predicate device are similar with expanded capability of intended use. As such, Siemens Healthineers is of the opinion that the Intended Use and Indications for Use are similar to the predicate device.

VI. COMPARISON OF FEATURES AND SPECIFICATIONS WITH 21CFR § 807.92(a)(6) THE PREDICATE DEVICE

Attribute	Predicate DeviceCustomer Remote ConsoleK150193	Reference Devicesyngo Expert-iK052423	Subject Devicesyngo Virtual CockpitVB10A	EquivalencyAnalysis withpredicate device
General Information
Type ofSoftware	Software in a Medical Device(SiMD)	Software in a Medical Device(SiMD)	Software as a MedicalDevice (SaMD)	equivalent
Device	System, Image Processing,Radiological	System, Nuclear MagneticResonance Imaging	System, Image Processing,Radiological	Identical
Regulation	§ 892.2050 Medical imagemanagement and processingsystem	§ 892.1000 Magneticresonance diagnostic device	§ 892.2050 Medical imagemanagement and processingsystem	Identical
Product Code	LLZ	LNH	LLZ	Identical
Clinical Characteristics
Attribute	Predicate DeviceCustomer Remote ConsoleK150193	Reference Devicesyngo Expert-iK052423	Subject Devicesyngo Virtual CockpitVB10A	EquivalencyAnalysis withpredicate device
Clinical conditionthe device isintended todiagnose, treat, ormanage	Customer Remote Console isnot indicated for any specificdisease, or condition.	syngo Expert-i is notindicated for any specificdisease, or condition.	syngo Virtual Cockpit is notindicated for any specificdisease, or condition.	Identical
Intendedpatientpopulation	Customer Remote Consoledoes not have a limitationconcerning the patientpopulation (e.g., age, weight,health, condition).	syngo Expert-i does not havea limitation concerning thepatient population (e.g., age,weight, health, condition).	syngo Virtual Cockpit doesnot have a limitationconcerning the patientpopulation (e.g., age, weight,health, condition).	Identical
Site of the bodythe device isintended to beused	No limitation concerning thesite of the body the device isintended to be used.	No limitation concerning thesite of the body the device isintended to be used.	No limitation concerning thesite of the body the device isintended to be used.	Identical
Device Limitations	Not publicly available	syngo Expert-i is not to beused as the basis for medicaldiagnosis.syngo Expert-i is not to beused without clinicalpersonnel at the medicalimaging device who aretrained according to locallaws & regulations.syngo Expert-i is not suitablefor use in facilities where astable and reliable internetconnection is not available.	syngo Virtual Cockpit is notto be used as the basis formedical diagnosis.syngo Virtual Cockpit is notto be used without clinicalpersonnel at the medicalimaging device who aretrained according to locallaws & regulations.syngo Virtual Cockpit is notsuitable for use in facilitieswhere a stable and reliableinternet connection is notavailable.syngo Virtual Cockpit is notto be used to connect tomedical devices whichrequire control of twomonitors when using KVM-Switches for connecting.	Equivalent toreference device.sVC provides asolution toconnect toSiemensHealthineers MRscanners andshow two screensin the similar wayas the referencedevice.
Intended useenvironment	Healthcare facilities	Healthcare facilities	Healthcare facilities	Identical
Intended user(s)	Radiologist, ExpertTechnologist	persons with the certifiedspecialist knowledgeaccording to country-specificregulations, for example,physicians, trainedradiologists or trainedtechnologists, after anappropriate applicationtraining.	syngo Virtual Cockpit isintended for the followinguser profiles/user roles:Steering TechnologistModality TechnologistPhysicianIT AdministratorApplication SpecialistService TechnicianImplementationEngineerProductVendor/Business Unit	Identical.Described indifferent verbiagebut identical incontents.
Attribute	Predicate DeviceCustomer Remote ConsoleK150193	Reference Devicesyngo Expert-iK052423	Subject Devicesyngo Virtual CockpitVB10A	EquivalencyAnalysis withpredicate device
Technical Characteristics
Supportedradiologicaldevices	medical imaging devices	• MR	• medical imagingdevices• Radiotherapeutic devices(linac), read only	equivalent
Supportedvendors	GE	Siemens Healthineers	Vendor neutral	Different. sVCsupports morevendors.
Remote Use	Yes	Yes	Yes	Identical
Connectivityrequirements	Secured clinical network	Secured clinical network	Secured clinical network	Identical
Accessibility	Read only	Read only and full access	Read only and full access	Identical toreference device
Length ofremote sessions	Not publicly available	Remote session remainsactive until manualdisconnections. Theconnection automaticallytimes out after a user definedidle time.	Remote session remainsactive until manualdisconnections. Theconnection automaticallytimes out after a user definedidle time.	Identical toreference device
User InterfaceFunctions	PC-based	PC-based	PC-based	Identical
OperatorInterface	Keyboard, Mouse, Video	Keyboard, Mouse, Video	Keyboard, Mouse, Video	Identical
Delay/latency	Not publicly available	Response time: <30 ms	Minimum requirements withone modality:Response time: ≤ 30 ms(Expert-i) / 60 ms (KVM)	Equivalent toreference device
Connectionprotocols	Not publicly available	VNC over TCPHTTPS over TCP	VNC over TCPHTTPS over TCPUDP (for chat, VolP)	Equivalent toreference device
Hardware	Software only solution.Requires standard computerand network hardware	Software only solution.Requires standard computerand network hardware	Software only solution.Requires standard computerand network hardware. KVMswitch is required as a generalnetwork hardware for theconnection to 3rd partyscanners and radiotherapeuticequipment using KVM switchmethod.	Equivalent. Themajor deference issVC requires ageneral ITnetwork hardwareKVM switch forits vendor neutralsolution.
Operatingsystem	Microsoft Windows	Microsoft Windows	Microsoft Windows	Identical
UserAuthorizationandAuthentication	Device requires userauthentication and log oncapabilities. Userauthorization is required forremote connection.	Device requires userauthentication and log oncapabilities. Userauthorization is required forremote connection.	Device requires userauthentication and log oncapabilities. Userauthorization is required forremote connection.	Identical
Attribute	Predicate DeviceCustomer Remote ConsoleK150193	Reference Devicesyngo Expert-iK052423	Subject Devicesyngo Virtual CockpitVB10A	EquivalencyAnalysis withpredicate device
Communicationfeatures	Screen sharing	Screen sharing	Screen sharingIP cameras for live video,Audio calls andchat	Equivalent. sVChas improvedcommunicationfeatures.
Imageacquisition	No.	Yes.	Yes. Limitation to triggerradiation exposure of CTscanners remotely.	Equivalent toreference device.The capability ofMRI acquisitionin sVC is thesame as referencedevice.
Imageprocessing,reporting andarchiving	No image processing,reporting and archivingfunctionalities	No image processing,reporting and archivingfunctionalities	No image processing,reporting and archivingfunctionalities	Identical

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syngo Virtual Cockpit (Version VB10A) Traditional 510(k) Submission

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Image /page/8/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

1go Virtual Cockpit (Version VB10A) Traditional 510(k) Submission

The subject and predicate devices are both remote access technologies enabling remote collaborations and real-time communications between the onsite technologist and remote user. They share significant technological similarities in connectivity capabilities, network requirements, cybersecurity, software (operating systems) and hardware environment.

The major different technological characteristics resides in the sVC remote access by interfacing with a general IT infrastructure hardware, KVM switch. The verification testing demonstrates that the sVC connection to modality scanners via KVM switch can perform as intended, meeting all of the design inputs. KVM switch connection related risks are mitigated to as far as possible. The technological difference with the subject device sVC does not constitute any new intended use and does not raise new questions of safety and effectiveness. Despite other differences in supported vendors, communication features, and other technical aspects, sVC has expanded device support, compatibility with multiple vendors, and enhanced communication features to address the evolving needs of healthcare settings, advancements in technology, or to provide additional functionality without compromising its intended use and purpose. The observed differences do not undermine the overall similarity and equivalence between the devices, as they can be explained by design improvements, expanded capabilities, or adaptations to meet evolving healthcare requirements.

Therefore, Siemens is of the opinion that syngo Virtual Cockpit VB10A does not raise new or different questions of safety or effectiveness and is substantially equivalent to the currently marketed predicate device Customer Remote Console.

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VII. PERFORMANCE DATA

The following performance data were provided in support to demonstrate similarities to the predicate / previously cleared device.

Clinical Testing

No clinical studies were carried out for syngo Virtual Cockpit (Version VB10A). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.

Summary of Non-Clinical Testing

No performance standards for MIMPS have been issued under the authority of Section 514. Nonclinical testing was conducted for the device syngo Virtual Cockpit (Version VB10A) during product development. The features described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthineers claims conformance to the following recognized consensus standards:

IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
ISO 14971 Third Edition 2019-12 ●
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC TR 80001-2-2 Edition 1.0 2012-07 ●
IEC 82304-1 Edition 1.0 2016-10 ●

Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Software validation is performed using externally sourced representative modality scanners for the entire system in the Siemens Healthineers training center and at the clinical collaborating site. The system configuration, connectivity, compatibility and operation as well as risks associated with clinically relevant functions are assessed to validate the safety and effectiveness of the system in the simulated clinical environment and to validate the appropriateness and implementation of the intended use. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.

Cybersecurity considerations related to syngo Virtual Cockpit are included within this submission. Siemens Healthineers conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

Risk Analysis, in compliance with ISO 14971 Third Edition, for syngo Virtual Cockpit (Version VB10A) 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 in support to determine similarities to the predicate /previously cleared device.

VIII. CONCLUSIONS

21CFR § 807.92(b)(3)

21CFR § 807.92(b)(1)

21CFR § 807.92(b)(2)

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syngo Virtual Cockpit (Version VB10A) Traditional 510(k) Submission

Performance tests were conducted to test the functionality of the device syngo Virtual Cockpit (Version VB10A). These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.

Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.

The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.

Siemens Healthineers believes that syngo Virtual Cockpit (Version VB10A) is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

Substantial Equivalence Conclusion

The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo Virtual Cockpit is safe, effective and performs as well as the predicate device.

In summary, Siemens Healthineers is of the opinion that syngo Virtual Cockpit (Version VB10A) does not introduce any new significant potential safety risks and is similar to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).