(103 days)
Not Found
No
The document describes a teleoperation platform for remote control and monitoring of medical imaging and diagnostic devices. It focuses on secure communication, real-time visualization, and remote access/control. There is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
Explanation: The rTOP is intended for remote operation, assistance, review, monitoring, and standardization of medical imaging or diagnostic devices. While it can be used with therapeutic devices in a read-only capacity, its primary function is not to deliver therapy itself.
No
The rTOP device is a system for remote operation, assistance, review, monitoring, and standardization of medical imaging or diagnostic devices. It does not directly perform diagnostic functions itself but rather facilitates the use of other diagnostic devices remotely.
No
The device description explicitly states that rTOP is a "medical device (including hardware and software)" and mentions the "roclub connector (rC) including a video splitter and emulation of mouse and keyboard," which are hardware components.
Based on the provided information, the roclub TeleOperationPlatform (rTOP) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of rTOP is for the remote operation, assistance, review, monitoring, and standardization of medical imaging or diagnostic devices. It is also intended for training medical personnel working on these devices. This focus is on the operation and management of diagnostic equipment, not on performing tests on biological samples to diagnose disease.
- Device Description: The description reinforces that rTOP is a system for remote access and control of modality consoles and communication between healthcare professionals. It facilitates the use of imaging equipment, but it does not itself perform diagnostic tests on patient samples.
- Lack of Mention of Biological Samples: There is no mention of rTOP interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
- Focus on Imaging and Therapeutic Devices: The device is intended for use with medical imaging and diagnostic devices, and in a read-only capacity with therapeutic devices. These are distinct from IVD devices.
In summary, rTOP is a system designed to facilitate the use and management of medical devices, primarily imaging and diagnostic equipment. It does not perform diagnostic tests on biological samples, which is the defining characteristic of an IVD device.
N/A
Intended Use / Indications for Use
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).
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
No limitation concerning the site of the body the device is intended to be used.
Indicated Patient Age Range
rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Intended User / Care Setting
Intended use environment: Healthcare facilities
Intended user(s):
- Steering Technologist
- Modality Technologist
- Physician
- IT Administrator
- Application Specialist
- Service Technician
- Implementation Engineer
- Product Vendor/Business Unit
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical Performance Testing: No clinical performance data was necessary to claim substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
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.
1
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
2
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
3
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Indications for Use
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
Contact Information
| Company Name | roclub GmbH |
|---|---|
| Address | Bismarckstraße 10-12, 10625 Berlin |
| Phone Number | 00436703593947 |
| Company Representative | Mario Schrenk, Regulatory Affairs & QM |
| Manager | |
| mario.schrenk@roclub.com | |
| Primary Correspondent | Mario Schrenk, Regulatory Affairs & QM |
| Manager | |
| Primary Correspondent | |
| 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 |
5
| Regulation Number | §892.2050 |
|---|---|
| Class | Class II |
| Panel | Radiology |
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.
6
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
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).
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
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
7
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 Virtual
Cockpit (VB10A)
(K232744 ) | Comments |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| General Information | | | |
| Type of
Software | SaMD + Hardware | SaMD | Hardware is part of
rTOP |
| Device | System, Image
Processing,
Radiological | System, Image
Processing,
Radiological | Identical |
| Regulation | § 892.2050 Medical
image
management and
processing system | § 892.2050 Medical
image
management and
processing system | Identical |
| Product Code | LLZ | LLZ | Identical |
| Attribute | rTOP | syngo Virtual
Cockpit (VB10A)
(K232744 ) | Comments |
| Clinical
Characteristics | | | |
| Clinical
condition
the device is
intended to
diagnose, treat,
or manage | roclub
TeleOperationPlatform
is not indicated for any
specific disease, or
condition. | syngo Virtual
Cockpit is not
indicated for any
specific
disease, or
condition. | Identical |
| Intended patient
population | roclub
TeleOperationPlatform
does not have a
limitation concerning
the patient population
(e.g., age, weight,
health, condition). | syngo Virtual
Cockpit does not
have a limitation
concerning the
patient
population (e.g.,
age, weight, health,
condition). | Identical |
| Site of the body
the device is
intended to be
used | No limitation
concerning the
site of the body the
device is intended to
be used. | No limitation
concerning the site
of the body the
device is intended
to be used. | Identical |
| Device
Limitations | roclub
TeleOperationPlatform
is not to be used as
the basis for medical
diagnosis.
roclub
TeleOperationPlatform
is not to be used
without clinical
personnel at the
controlled medical
device who are trained
according to local
laws & regulations.
roclub
TeleOperationPlatform
is not suitable for use | syngo Virtual
Cockpit is not to be
used as the basis
for medical
diagnosis.
syngo Virtual
Cockpit is not to be
used without clinical
personnel at the
medical imaging
device who are
trained according to
local laws &
regulations.
syngo Virtual
Cockpit is not
suitable for use in | Identical
Identical
Identical |
| Attribute | rTOP | syngo Virtual
Cockpit (VB10A)
(K232744 ) | Comments |
| stable and reliable
internet connection is
not available. | stable and reliable
internet connection
is not available.
syngo Virtual
Cockpit is not to be
used to connect to
medical devices
which
require control of
two
monitors when
using KVMSwitches
for connecting. | allows connection of
2 monitors, therefore
the limitation is not
given. | |
| Intended use | roclub TOP is a
system (software
application and
hardware component)
intended for remote
operation, assistance,
review, monitoring and
standardization of
medical device with
video and optional
USB interface for HID.
lt is a vendor neutral
solution allowing
readonly or full access
control to connected
devices. roclub TOP is
also intended for
training of medical
personnel working on
the medical imaging
devices. | 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
readonly or full
access control to
connected devices.
syngo Virtual
Cockpit is also
intended for training
of medical
personnel working
on the medical
imaging devices. | rTOP includes
Hardware and has a
generic definition of
the
connected/controlled
devices. |
| Intended use
environment | Healthcare facilities | Healthcare facilities | Identical |
| Intended user(s) | roclub
TeleOperationPlatform | syngo Virtual
Cockpit is intended | Identical |
| Attribute | rTOP | syngo Virtual
Cockpit (VB10A)
(K232744 ) | Comments |
| Technical
Characteristics | is intended for the
following user
profiles/user roles:
• Steering
Technologist
• Modality
Technologist
• Physician
• IT Administrator
• Application
Specialist
• Service Technician
• Implementation
Engineer
• Product
Vendor/Business Unit | for the following
user profiles/user
roles:
• Steering
Technologist
• Modality
Technologist
• Physician
• IT Administrator
• Application
Specialist
• Service
Technician
• Implementation
Engineer
• Product
Vendor/Business
Unit | |
| | | | |
| Supported
radiological
devices | medical devices with
video and optional
USB interface for HID | - medical imaging
devices
- Radiotherapeutic
devices (linac), read
only | Generic definition of
the connected
devices. |
| Supported
vendors | Vendor neutral | Vendor neutral | Identical |
| Remote Use | Yes | Yes | Identical |
| Connectivity
requirements | Secured clinical
network | Secured clinical
network | Identical |
| Accessibility | Read only and full
access | Read only and full
access | Identical |
| Length of
remote sessions | Remote session
remains
active until manual
disconnections. The
connection | Remote session
remains
active until manual
disconnections. The
connection | Identical |
| Attribute | rTOP | syngo Virtual
Cockpit (VB10A)
(K232744 ) | Comments |
| | automatically times
out after a user
defined idle time. | automatically
times out after a
user defined idle
time. | |
| User Interface
Functions | PC-based | PC-based | Identical |
| Operator
Interface | Keyboard, Mouse,
Video | Keyboard, Mouse,
Video | Identical |
| Delay/latency | Minimum requirements
with one modality:
latencies up to 100 ms
(warning above this
level) | Minimum
requirements with
one modality:
Response time: ≤ 30
ms (Expert-i) / 60
ms (KVM) | Equivalent |
| Connection
protocols | HTTPS over TCP
UDP (for WebRTC) | VNC over TCP
HTTPS over TCP
UDP (for chat, VoIP) | Identical (VNC
functionality of
predicate included in
WebRTC of rTOP) |
| Hardware | Hardware (KVM,
computer hardware) is
included.
Requires only network
interfaces for access
to the roclub cloud. | Software only
solution.
Requires standard
computer and
network hardware.
KVM switch is
required as a
general
network hardware
for the connection
to 3rd party
scanners and
radiotherapeutic
equipment using
KVM switch
method. | Equivalent |
| Operating
system for App | Independent of OS
(browser based) | Microsoft Windows | Equivalent |
| User
Authorization | Device requires user
authentication and log | Device requires user
authentication and | Identical |
| Attribute | rTOP | syngo Virtual
Cockpit (VB10A)
(K232744) | Comments |
| and
Authentication | on capabilities. User
authorization is
required for remote
connection. | log on capabilities.
User
authorization is
required for remote
connection. | |
| Communication
features | Screen sharing
USB cameras for live
video, audio calls and
chat. | Screen sharing
IP cameras for live
video, Audio calls
and
chat. | Identical |
| Image
acquisition | Yes. Depending on
controlled medical
device. | Yes. Limitation to
trigger radiation
exposure of CT
scanners remotely. | Identical |
| Image
processing,
reporting and
archiving | No image processing,
reporting and
archiving
functionalities. | No image
processing,
reporting and
archiving
functionalities. | Identical |
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9
10
11
12
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
13
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"
14
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.