roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, ...) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.

rTOP is not indicated for any specific disease, or condition.

rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).

Device Description

roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP 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. rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.

The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times.

The full-control accessibility to higher risk modalities with physical switches ( CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.

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

rTOP allows full control of the connected devices, but for higher risk devices (e.g. LINACS, ...) rTOP only provides read-only access.

AI/ML Overview

The provided document is a 510(k) summary for the rTOP device, which is a medical image management and processing system. The summary describes the device, its intended use, and a comparison to a predicate device (syngo Virtual Cockpit).

This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed "acceptance criteria" for performance metrics in the way one might find for a diagnostic AI algorithm. Instead, the acceptance criteria are implicitly met by demonstrating that the rTOP device performs comparably to the predicate device and that any differences do not raise new questions of safety or effectiveness.

Therefore, the response below will present the information based on the available content, highlighting that specific quantitative "acceptance criteria" and a "study that proves the device meets (these) acceptance criteria" in terms of explicit performance metrics are not provided in this 510(k) summary. The document focuses on demonstrating comparable functionality and safety during remote operation.

Here's the information extracted from the provided text:

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

As explicitly stated in the document, no specific quantitative acceptance criteria or corresponding reported device performance metrics were necessary to claim substantial equivalence in the context of this 510(k) submission. The submission focuses on demonstrating that the rTOP device performs "comparably to the predicate device in terms of safety and effectiveness" and that "any differences do not raise new questions of safety or effectiveness."

The closest aspect to performance comparison is related to delay/latency and functionality.

Acceptance Criteria (Implicitly compared to predicate)	Reported Device Performance (rTOP)
Functional Equivalence	Performs remote operation, assistance, review, monitoring, and standardization of medical imaging/diagnostic devices with video and optional USB interface, similarly to the predicate.
Safety and Effectiveness	Does not raise new questions of safety or effectiveness compared to the predicate. Hardware inclusion (rC) and its testing (IEC 60601-1, 60601-1-2) increases safety.
Multi-Monitor Control	Allows connection of 2 monitors.
Delay/Latency	Latencies up to 100 ms. Bench testing and usability testing show adequate reactivity.
Operating System Compatibility	Independent of OS (browser-based for remote user, own OS on rC).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a sample size for a "test set" in the context of traditional clinical performance or diagnostic accuracy. The testing mentioned refers to "Software verification and validation testing," "bench testing," and "usability testing," which are typically internal development and validation activities.

No specific sample size for a test set is reported.
No details on data provenance (country of origin, retrospective/prospective) are provided for any testing mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The concept of "ground truth" and "experts establishing ground truth" is typically associated with diagnostic performance studies, especially for AI/ML devices. Since this submission is for a medical image management and processing system for remote operation and does not involve AI for diagnosis, there is no mention of experts establishing ground truth for a test set.

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

Similarly to point 3, as there isn't a diagnostic performance "test set" with ground truth established by experts, an adjudication method for such a test set is not applicable and not mentioned in the document.

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.
The device (rTOP) is a teleoperation platform for remote operation/assistance; it is not an AI assistance tool for human readers in the context of improving diagnostic accuracy. Therefore, the effect size of human readers improving with AI assistance is not relevant to this device and not reported.

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

Not applicable in the context of diagnostic performance. The rTOP device's primary function is to facilitate human-in-the-loop remote operation, assistance, and training of medical devices. It is not an algorithm designed for standalone diagnostic or analytical tasks.

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

As mentioned, the device is not for diagnostic purposes, and therefore, the concept of "ground truth" in the context of diagnostic accuracy (e.g., expert consensus, pathology, outcomes data) does not apply. The validation focuses on functional performance, safety, and effectiveness of the remote operation capabilities.

8. The sample size for the training set

The document makes no mention of a "training set" or a sample size for one. This is consistent with the device not being an AI/ML algorithm that requires training data.

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

As there is no mention of a training set, the establishment of ground truth for such a set is also not discussed or applicable.

Summary

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February 4, 2025

roclub GmbH % Mario Schrenk Regulatory Affairs & QM Manager Bismarckstraße 10-12 Berlin, Berlin 10625 GERMANY

Re: K243333

Trade/Device Name: rTOP Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: January 10, 2025 Received: January 10, 2025

Dear Mario Schrenk:

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.

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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 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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

Enclosure

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Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Indications for Use

Submission Number (if known)

K243333

Device Name

rTOP

Indications for Use (Describe)

roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaginc or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices. ...) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.

rTOP is not indicated for any specific disease, or condition.

rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).

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

Contact Information

Company Name	roclub GmbH
Address	Bismarckstraße 10-12, 10625 Berlin
Phone Number	00436703593947
Company Representative	Mario Schrenk, Regulatory Affairs & QMManager
Email	mario.schrenk@roclub.com
Primary Correspondent	Mario Schrenk, Regulatory Affairs & QMManager
Primary CorrespondentEmail	mario.schrenk@roclub.com
Date Summary Prepared	23. Oct. 2024

Device Information

Trade Name	rTOP
Common Name	teleoperation platform
Product Code	LLZ
Classification Name	Medical image management and processing system
Regulation Number	§892.2050
Class	Class II
Panel	Radiology

Predicate Device Information

Predicate Device Name	syngo Virtual Cockpit (VB10A).
Predicate Device K Number	K232744
Product Code	LLZ

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Regulation Number	§892.2050
Class	Class II
Panel	Radiology

Device Description

based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.

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

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rTOP allows full control of the connected devices, but for higher risk devices (e.g. LINACS, ...) rTOP only provides read-only access.

Indications for Use

rTOP is not indicated for any specific disease, or condition.

rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).

Substantial Equivalence Discussion

In this chapter the differences between the predicate device and rTOP are discussed.

Predicate Device Indications for 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. synqo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.

Subject Device Indications for Use

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Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, ...) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.

Indications for Use Equivalence Discussion

The Indications for Use for syngo Virtual Cockpit (predicate device) and TeleOperationPlatform (rTOP) are essentially equivalent. rTOP like syngo Virtual Cockpit does allow read-only or full access to the connected devices for a manifold of purposes. The two differences will be discussed in detail in chapter and leads to increased safety and effectiveness of rTOP.

Device Comparison Table

The following table describes the attributes of rTOP and the predicate device syngo Virtual Cockpit. Additionally in the comments column a comparison between rTOP and the predicate device is given. All attributes "Identical" will be discussed subsequently in chapter "Substantial Equivalence Discussion" in regards with new questions concerning safety and efficacy.

Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744 )	Comments
General Information
Type ofSoftware	SaMD + Hardware	SaMD	Hardware is part ofrTOP
Device	System, ImageProcessing,Radiological	System, ImageProcessing,Radiological	Identical
Regulation	§ 892.2050 Medicalimagemanagement andprocessing system	§ 892.2050 Medicalimagemanagement andprocessing system	Identical
Product Code	LLZ	LLZ	Identical
Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744 )	Comments
ClinicalCharacteristics
Clinicalconditionthe device isintended todiagnose, treat,or manage	roclubTeleOperationPlatformis not indicated for anyspecific disease, orcondition.	syngo VirtualCockpit is notindicated for anyspecificdisease, orcondition.	Identical
Intended patientpopulation	roclubTeleOperationPlatformdoes not have alimitation concerningthe patient population(e.g., age, weight,health, condition).	syngo VirtualCockpit does nothave a limitationconcerning thepatientpopulation (e.g.,age, weight, health,condition).	Identical
Site of the bodythe device isintended to beused	No limitationconcerning thesite of the body thedevice is intended tobe used.	No limitationconcerning the siteof the body thedevice is intendedto be used.	Identical
DeviceLimitations	roclubTeleOperationPlatformis not to be used asthe basis for medicaldiagnosis.roclubTeleOperationPlatformis not to be usedwithout clinicalpersonnel at thecontrolled medicaldevice who are trainedaccording to locallaws & regulations.roclubTeleOperationPlatformis not suitable for use	syngo VirtualCockpit is not to beused as the basisfor medicaldiagnosis.syngo VirtualCockpit is not to beused without clinicalpersonnel at themedical imagingdevice who aretrained according tolocal laws &regulations.syngo VirtualCockpit is notsuitable for use in	IdenticalIdenticalIdentical
Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744 )	Comments
stable and reliableinternet connection isnot available.	stable and reliableinternet connectionis not available.syngo VirtualCockpit is not to beused to connect tomedical deviceswhichrequire control oftwomonitors whenusing KVMSwitchesfor connecting.	allows connection of2 monitors, thereforethe limitation is notgiven.
Intended use	roclub TOP is asystem (softwareapplication andhardware component)intended for remoteoperation, assistance,review, monitoring andstandardization ofmedical device withvideo and optionalUSB interface for HID.lt is a vendor neutralsolution allowingreadonly or full accesscontrol to connecteddevices. roclub TOP isalso intended fortraining of medicalpersonnel working onthe medical imagingdevices.	syngo VirtualCockpit is asoftware applicationintended for remoteoperation,assistance, review,monitoring andstandardization ofmedical imagingdevices. It is avendor neutralsolution allowingreadonly or fullaccess control toconnected devices.syngo VirtualCockpit is alsointended for trainingof medicalpersonnel workingon the medicalimaging devices.	rTOP includesHardware and has ageneric definition oftheconnected/controlleddevices.
Intended useenvironment	Healthcare facilities	Healthcare facilities	Identical
Intended user(s)	roclubTeleOperationPlatform	syngo VirtualCockpit is intended	Identical
Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744 )	Comments
TechnicalCharacteristics	is intended for thefollowing userprofiles/user roles:• SteeringTechnologist• ModalityTechnologist• Physician• IT Administrator• ApplicationSpecialist• Service Technician• ImplementationEngineer• ProductVendor/Business Unit	for the followinguser profiles/userroles:• SteeringTechnologist• ModalityTechnologist• Physician• IT Administrator• ApplicationSpecialist• ServiceTechnician• ImplementationEngineer• ProductVendor/BusinessUnit

Supportedradiologicaldevices	medical devices withvideo and optionalUSB interface for HID	- medical imagingdevices- Radiotherapeuticdevices (linac), readonly	Generic definition ofthe connecteddevices.
Supportedvendors	Vendor neutral	Vendor neutral	Identical
Remote Use	Yes	Yes	Identical
Connectivityrequirements	Secured clinicalnetwork	Secured clinicalnetwork	Identical
Accessibility	Read only and fullaccess	Read only and fullaccess	Identical
Length ofremote sessions	Remote sessionremainsactive until manualdisconnections. Theconnection	Remote sessionremainsactive until manualdisconnections. Theconnection	Identical
Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744 )	Comments
	automatically timesout after a userdefined idle time.	automaticallytimes out after auser defined idletime.
User InterfaceFunctions	PC-based	PC-based	Identical
OperatorInterface	Keyboard, Mouse,Video	Keyboard, Mouse,Video	Identical
Delay/latency	Minimum requirementswith one modality:latencies up to 100 ms(warning above thislevel)	Minimumrequirements withone modality:Response time: ≤ 30ms (Expert-i) / 60ms (KVM)	Equivalent
Connectionprotocols	HTTPS over TCPUDP (for WebRTC)	VNC over TCPHTTPS over TCPUDP (for chat, VoIP)	Identical (VNCfunctionality ofpredicate included inWebRTC of rTOP)
Hardware	Hardware (KVM,computer hardware) isincluded.Requires only networkinterfaces for accessto the roclub cloud.	Software onlysolution.Requires standardcomputer andnetwork hardware.KVM switch isrequired as ageneralnetwork hardwarefor the connectionto 3rd partyscanners andradiotherapeuticequipment usingKVM switchmethod.	Equivalent
Operatingsystem for App	Independent of OS(browser based)	Microsoft Windows	Equivalent
UserAuthorization	Device requires userauthentication and log	Device requires userauthentication and	Identical
Attribute	rTOP	syngo VirtualCockpit (VB10A)(K232744)	Comments
andAuthentication	on capabilities. Userauthorization isrequired for remoteconnection.	log on capabilities.Userauthorization isrequired for remoteconnection.
Communicationfeatures	Screen sharingUSB cameras for livevideo, audio calls andchat.	Screen sharingIP cameras for livevideo, Audio callsandchat.	Identical
Imageacquisition	Yes. Depending oncontrolled medicaldevice.	Yes. Limitation totrigger radiationexposure of CTscanners remotely.	Identical
Imageprocessing,reporting andarchiving	No image processing,reporting andarchivingfunctionalities.	No imageprocessing,reporting andarchivingfunctionalities.	Identical

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Substantial Equivalence Discussion

In this chapter the differences between the predicate device and rTOP are discussed in detail.

"Intended Use" and "Supported radiological devices"

There is two differences in the intended use:

predicate: "software application" rTQP:": This is discussed extensively in the chapter "Type of software" and "Hardware"
predicate: "of medical imaging devices" rTOP: "medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device)":

The predicate device restricts its use to medical imaging devices in the indications for use, but lists "Radiotherapeutic devices (linac), read only" under supported radiological devices (see Device Comparison Table). rTOP allows control over medical imaging or diagnostic devices with video and optional USB

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interface. This allows a slightly wider range of application. For higher risk devices this means "read only" as particular standards of the 60601 series do not allow remote control of devices like Linacs (see IEC 60601-2-64 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment). Essentially this leads to the same use of both the predicate device and rTOP, which raises no new questions regarding safety and effectiveness.

"Type of software" and "Hardware"

rTOP is a vendor independent solution and as the predicate device needs hardware to be connected to medical devices. The predicate device needs a KVM switch as a general network hardware for the connection to 3rd party scanners and radiotherapeutic equipment using KVM switch method. This functionality is included in rTOP. The roclub Connector (rC) allows the functionality of the KVM.

The hardware is fully tested according to 60601-1 for electrical and mechanical safety. As discussed in the highest risks of rTOP are connected to electromagnetic compatibility. This is mitigated by testing according to 60601-1-2.

For normal KVM switches as needed by the predicate device this testing is not exectuted, therefore rTOP increases the safety of the user and the healthcare facility environment in general.

Additionally, because rTOP integrates the hardware, all verification and validation tests are executed including the necessary hardware. This leads to a higher expected effectiveness and less downtime of the full system.

The executed bench testing allows rTOP to increase the safety and effectiveness compared to the predicate device.

"Device limitations"

rTOP does not have the limitation to only control one monitor. This is a further benefit of the tailor made hardware of rTOP. This does not raise new questions regarding safety and effectiveness. The effectiveness of rTOP is increased, because the included hardware allows controll of devices, which use two monitors.

"Delay/latency"

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The delay/latency of rTOP is comparable to the predicate device. Bench testing and usability testing show, that reactivity of rTOP is adequate. The comparable delay/latency of rTOP does not lead to new questions regarding safety of effectivenessy.

"Operating system for App"

rTOP does use its own OS on the rC and on the side of the remote user is not dependent on an operating system as it is used browser based. This does not raise any new questions regarding safety and leads to better effectiveness, because of fewer limitations and compatibility issues to access rTOP.

Conclusion

rTOP is substantially equivalent to the identified predicate device syngo Virtual Cockpit (VB10A) (K232744 ). Specifically, rTOP has similar intended use and technological characteristics compared to the previously cleared predicate device.

The differences, which were found comparing rTOP to the predicate device, have been discussed extensively. These differences in technological characteristics do not raise any new questions of safety and effectiveness and have been properly verified and validated through testing.

Therefore, rTOP is substantially equivalent to the predicate device.

Performance Data

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by 2023 FDA Guidance "Content of Premarket Submissions for Device Software Functions".

The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.

As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is

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evidence that the rTOP performs in an equivalent manner to the syngo Virtual Cockpit (VB10A).

Clinical Performance Testing

No clinical performance data was necessary to claim substantial equivalence.

Conclusion

The rTOP shares similar technological characteristics, intended use, and functionality with the predicate device. There are no differences between the devices that raise new questions of safety and effectiveness.

Furthermore, non-clinical performance test data and software verification and validation demonstrate that rTOP performs comparably to the predicate device in terms of safety and effectiveness.

Based on the device comparisons and the acceptable testing results, it is determined that rTOP is substantially equivalent 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).