syngo Virtual Cockpit (VB10A)

K232744 · Siemens Healthcare GmbH · LLZ · Dec 21, 2023 · Radiology

Device Facts

• Record ID: K232744
• Device Name: syngo Virtual Cockpit (VB10A)
• Applicant: Siemens Healthcare GmbH
• Product Code: LLZ · Radiology
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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 Story

Software-based remote access system for medical imaging and radiotherapeutic devices; enables geographically distant technologists or radiologists to assist with equipment operation. Input: remote control signals (KVM/proprietary tools), live video, audio, and text chat. Operation: client-server architecture; Steering client connects to modality consoles (up to 3) via KVM switch or proprietary tools; Physician client provides expert assistance. Output: real-time visualization of modality console screens; remote control of scanning protocols (full-control or read-only). Used in healthcare facilities by trained professionals (technologists, physicians, specialists). Benefits: enables cross-organizational collaboration, standardization of scans, and remote expert support to increase productivity. Healthcare providers use output to guide on-site staff during image acquisition; does not perform diagnostic image processing or reporting.

Clinical Evidence

No clinical studies performed. Bench testing only. Verification and validation conducted in simulated clinical environments using representative modality scanners to assess system configuration, connectivity, compatibility, and safety-critical functions.

Technological Characteristics

Software-only solution (SaMD) running on standard PC hardware. Connectivity via secured clinical network using VNC over TCP, HTTPS over TCP, and UDP. Integrates with modality consoles via KVM switches or proprietary tools. Conforms to IEC 62366-1, ISO 14971, IEC 62304, IEC TR 80001-2-2, and IEC 82304-1. Cybersecurity controls implemented to prevent unauthorized access.

Indications for Use

Indicated for remote operation, assistance, review, monitoring, and standardization of medical imaging devices and training of medical personnel. No specific patient population, disease state, or contraindications defined.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Customer Remote Console (K150193)

Reference Devices

• syngo Expert-i (K052423)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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/1 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 cluster of orange dots.

# 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: [phone] Email: [e-mail]

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 Device<br>Customer Remote Console<br>K150193 | Reference Device<br>syngo Expert-I<br>K052423 | Subject Device<br>syngo 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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Image /page/5/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. To the right of the word "Healthineers" is a cluster of orange dots.

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

| technologist operating the<br>system. The remote access is<br>only available for systems<br>supporting GE remote<br>connectivity capability. Images<br>reviewed remotely are not for<br>diagnostic use. | network of the MRI (i.e. the<br>network of the radiology) can<br>log onto the MR main or satellite<br>console. | Cockpit is also intended for<br>training of medical personnel<br>working on the medical imaging<br>devices. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|

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 Device<br>Customer Remote Console<br>K150193 | Reference Device<br>syngo Expert-i<br>K052423 | Subject Device<br>syngo Virtual Cockpit<br>VB10A | Equivalency<br>Analysis with<br>predicate device |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Information | | | | |
| Type of<br>Software | Software in a Medical Device<br>(SiMD) | Software in a Medical Device<br>(SiMD) | Software as a Medical<br>Device (SaMD) | equivalent |
| Device | System, Image Processing,<br>Radiological | System, Nuclear Magnetic<br>Resonance Imaging | System, Image Processing,<br>Radiological | Identical |
| Regulation | § 892.2050 Medical image<br>management and processing<br>system | § 892.1000 Magnetic<br>resonance diagnostic device | § 892.2050 Medical image<br>management and processing<br>system | Identical |
| Product Code | LLZ | LNH | LLZ | Identical |
| Clinical Characteristics | | | | |
| Attribute | Predicate Device<br>Customer Remote Console<br>K150193 | Reference Device<br>syngo Expert-i<br>K052423 | Subject Device<br>syngo Virtual Cockpit<br>VB10A | Equivalency<br>Analysis with<br>predicate device |
| Clinical condition<br>the device is<br>intended to<br>diagnose, treat, or<br>manage | Customer Remote Console is<br>not indicated for any specific<br>disease, or condition. | syngo Expert-i is not<br>indicated for any specific<br>disease, or condition. | syngo Virtual Cockpit is not<br>indicated for any specific<br>disease, or condition. | Identical |
| Intended<br>patient<br>population | Customer Remote Console<br>does not have a limitation<br>concerning the patient<br>population (e.g., age, weight,<br>health, condition). | syngo Expert-i does not have<br>a limitation concerning the<br>patient population (e.g., age,<br>weight, health, condition). | syngo Virtual Cockpit does<br>not have a limitation<br>concerning the patient<br>population (e.g., age, weight,<br>health, condition). | Identical |
| Site of the body<br>the device is<br>intended to be<br>used | No limitation concerning the<br>site of the body the device is<br>intended to be used. | No limitation concerning the<br>site of the body the device is<br>intended to be used. | No limitation concerning the<br>site of the body the device is<br>intended to be used. | Identical |
| Device Limitations | Not publicly available | syngo Expert-i is not to be<br>used as the basis for medical<br>diagnosis.<br>syngo Expert-i is not to be<br>used without clinical<br>personnel at the medical<br>imaging device who are<br>trained according to local<br>laws & regulations.<br>syngo Expert-i is not suitable<br>for use in facilities where a<br>stable and reliable internet<br>connection is not available. | syngo Virtual Cockpit is not<br>to be used as the basis for<br>medical diagnosis.<br>syngo Virtual Cockpit is not<br>to be used without clinical<br>personnel at the medical<br>imaging device who are<br>trained according to local<br>laws & regulations.<br>syngo Virtual Cockpit is not<br>suitable for use in facilities<br>where a stable and reliable<br>internet connection is not<br>available.<br>syngo Virtual Cockpit is not<br>to be used to connect to<br>medical devices which<br>require control of two<br>monitors when using KVM-<br>Switches for connecting. | Equivalent to<br>reference device.<br>sVC provides a<br>solution to<br>connect to<br>Siemens<br>Healthineers MR<br>scanners and<br>show two screens<br>in the similar way<br>as the reference<br>device. |
| Intended use<br>environment | Healthcare facilities | Healthcare facilities | Healthcare facilities | Identical |
| Intended user(s) | Radiologist, Expert<br>Technologist | persons with the certified<br>specialist knowledge<br>according to country-specific<br>regulations, for example,<br>physicians, trained<br>radiologists or trained<br>technologists, after an<br>appropriate application<br>training. | syngo Virtual Cockpit is<br>intended for the following<br>user profiles/user roles:<br>Steering Technologist<br>Modality Technologist<br>Physician<br>IT Administrator<br>Application Specialist<br>Service Technician<br>Implementation<br>Engineer<br>Product<br>Vendor/Business Unit | Identical.<br>Described in<br>different verbiage<br>but identical in<br>contents. |
| Attribute | Predicate Device<br>Customer Remote Console<br>K150193 | Reference Device<br>syngo Expert-i<br>K052423 | Subject Device<br>syngo Virtual Cockpit<br>VB10A | Equivalency<br>Analysis with<br>predicate device |
| Technical Characteristics | | | | |
| Supported<br>radiological<br>devices | medical imaging devices | • MR | • medical imaging<br>devices<br>• Radiotherapeutic devices<br>(linac), read only | equivalent |
| Supported<br>vendors | GE | Siemens Healthineers | Vendor neutral | Different. sVC<br>supports more<br>vendors. |
| Remote Use | Yes | Yes | Yes | Identical |
| Connectivity<br>requirements | Secured clinical network | Secured clinical network | Secured clinical network | Identical |
| Accessibility | Read only | Read only and full access | Read only and full access | Identical to<br>reference device |
| Length of<br>remote sessions | Not publicly available | Remote session remains<br>active until manual<br>disconnections. The<br>connection automatically<br>times out after a user defined<br>idle time. | Remote session remains<br>active until manual<br>disconnections. The<br>connection automatically<br>times out after a user defined<br>idle time. | Identical to<br>reference device |
| User Interface<br>Functions | PC-based | PC-based | PC-based | Identical |
| Operator<br>Interface | Keyboard, Mouse, Video | Keyboard, Mouse, Video | Keyboard, Mouse, Video | Identical |
| Delay/latency | Not publicly available | Response time: <30 ms | Minimum requirements with<br>one modality:<br>Response time: ≤ 30 ms<br>(Expert-i) / 60 ms (KVM) | Equivalent to<br>reference device |
| Connection<br>protocols | Not publicly available | VNC over TCP<br>HTTPS over TCP | VNC over TCP<br>HTTPS over TCP<br>UDP (for chat, VolP) | Equivalent to<br>reference device |
| Hardware | Software only solution.<br>Requires standard computer<br>and network hardware | Software only solution.<br>Requires standard computer<br>and network hardware | Software only solution.<br>Requires standard computer<br>and network hardware. KVM<br>switch is required as a general<br>network hardware for the<br>connection to 3rd party<br>scanners and radiotherapeutic<br>equipment using KVM switch<br>method. | Equivalent. The<br>major deference is<br>sVC requires a<br>general IT<br>network hardware<br>KVM switch for<br>its vendor neutral<br>solution. |
| Operating<br>system | Microsoft Windows | Microsoft Windows | Microsoft Windows | Identical |
| User<br>Authorization<br>and<br>Authentication | Device requires user<br>authentication and log on<br>capabilities. User<br>authorization is required for<br>remote connection. | Device requires user<br>authentication and log on<br>capabilities. User<br>authorization is required for<br>remote connection. | Device requires user<br>authentication and log on<br>capabilities. User<br>authorization is required for<br>remote connection. | Identical |
| Attribute | Predicate Device<br>Customer Remote Console<br>K150193 | Reference Device<br>syngo Expert-i<br>K052423 | Subject Device<br>syngo Virtual Cockpit<br>VB10A | Equivalency<br>Analysis with<br>predicate device |
| Communication<br>features | Screen sharing | Screen sharing | Screen sharing<br>IP cameras for live video,<br>Audio calls and<br>chat | Equivalent. sVC<br>has improved<br>communication<br>features. |
| Image<br>acquisition | No. | Yes. | Yes. Limitation to trigger<br>radiation exposure of CT<br>scanners remotely. | Equivalent to<br>reference device.<br>The capability of<br>MRI acquisition<br>in sVC is the<br>same as reference<br>device. |
| Image<br>processing,<br>reporting and<br>archiving | No image processing,<br>reporting and archiving<br>functionalities | No image processing,<br>reporting and archiving<br>functionalities | No image processing,<br>reporting and archiving<br>functionalities | Identical |

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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. 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/7/Picture/0 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.

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.