(62 days)
Not Found
No
The document describes a remote control and protocol management system for medical imaging devices, focusing on KVM (Keyboard, Video, Mouse) sharing and software functionality. There is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms.
No
The ROCC Console is intended for remote scanning, support, review, monitoring, and standardization of imaging protocols of medical imaging devices, as well as for training medical personnel. It enables remote control and management of MR/CT scanners. It does not directly treat or diagnose a disease or condition in a patient, making it a medical device, but not a therapeutic one.
No
The device is intended for remote scanning, support, review, monitoring, and standardization of imaging protocols of medical imaging devices, and for training of medical personnel. It enables remote access and control of MR/CT scanners for operational support, protocol management, and harmonization. It does not perform diagnostic functions itself, but rather facilitates the use and management of medical imaging devices.
Yes
The device description explicitly states "ROCC Console is a software device". While it interacts with hardware (MR/CT scanners, computers, KVM switches), the device itself, as described, is the software component enabling remote control and protocol management. The description focuses on the software applications and connection methods.
Based on the provided information, the ROCC Console is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ROCC Console's intended use is for remote scanning, support, review, monitoring, and standardization of imaging protocols for medical imaging devices (MR/CT scanners). It facilitates the operation and management of these devices, not the analysis of biological samples.
- The device description focuses on software and hardware for remote control and management of imaging equipment. It describes KVM connections, software applications for transmitting and receiving video streams, and protocol management features. These are all related to the operation of the imaging scanner itself, not the analysis of patient specimens.
- The intended users are expert radiology users and technologists operating imaging devices. This aligns with the use of imaging equipment, not laboratory testing.
- The performance studies focus on software verification and validation and equivalence to a predicate device that is also a remote control system for imaging. There are no mentions of studies related to the accuracy or performance of analyzing biological samples.
In summary, the ROCC Console is a software device designed to remotely control and manage medical imaging equipment. Its function is entirely separate from the analysis of in vitro specimens, which is the defining characteristic of an IVD device.
N/A
Intended Use / Indications for Use
ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi-vendor solution allowing view-only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected medical imaging devices.
Product codes
LLZ
Device Description
This premarket notification addresses the Philips ROCC Console, a Medical Image Management and Processing System (MIMPS).
ROCC Console is a software device, which is part of the ROCC (Radiology Operations Command Center) system, a cloud-based solution which can connect expert radiology users located at a remote command center with onsite technologists operating an MR/CT scanner on-demand, while enabling real-time operational support/guidance for the scanner console. This ROCC system allows healthcare professionals to share expertise, even when they are not physically present in the same location. Expert users are working from remote office locations within a healthcare facility or from a home office.
ROCC Console is a multiple function device product. The medical device functions include the ability to console of a connected MR/CT scanner from a remote location, and a Protocol Management mode, which can be used to manage updates / harmonize scan protocols across connected MR/CT scanners.
ROCC Console is vendor neutral. It is intended to be used in healthcare environments including imaging modalities (MR or CT) with digital output (DP, DVI, and HDMI) which are either fixed to one location or are in mobile (truck) environments where medical imaging services are provided.
ROCC Console supports three connection methods to exchange the KVM (Keyboard, Video and Mouse) information between the expert user and the technologist. The proprietary software KVM connection includes two applications: a "Console Transmitter App" for use by the technologist on the scanner side, and a "Console Receiver App" for use by the remotely located expert user. The Console Transmitter App is a native Windows application installed on a desktop system, which sends the console video stream over the internet to the Console Receiver App. The Console Receiver App is a web-application that can run on a web browser, and receives and displays the video stream to the remotely located expert user edits the scanner console through mouse and keyboard entries, it sends these keyboard and mouse entries back to the Console Transmitter App, which subsequently sends the scanner console. Additionally, ROCC Console supports off-the-shelf HW/SW KVM switch or VNC. ROCC Console can be used with 3 MR/CT console connections concurrently.
When a patient is to be scanned, the on-site technologist must remain present at all times and retains full control over the MR/CT scanner console and can terminate the editing authorization at any time. For CT connections, full access is limited to what is available in the software associated with the modality workspace and is not applicable to physical switches controlling the radiation exposure.
The Protocol Management mode allows access to the MR/CT scanner console without a technologist on site. It is only intended for protocol management and harmonization and not for any remote imaging support.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR or CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Expert radiology users, onsite technologists, healthcare professionals. Remote office locations within a healthcare facility or home office.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated with non-clinical performance testing. V&V) activities were performed on the proposed ROCC Console and demonstrated that the predetermined acceptance criteria were successfully met and no different questions in terms of safety and effectiveness were raised. The non-clinical performance tests provided in this 510(k) submission demonstrate that the proposed ROCC Console is as safe and effective as the predicate device, the syngo Virtual Cockpit (VB10A) (K232744).
All pre-specified performance metrics have been met as demonstrated within the software verification and validation. The ROCC Console performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2024
Philips Medical Systems Nederland B.V. % Rob Vingerhoed Regulatory Affairs Manager Veenpluis 6 5684 Pc BEST, NETHERLANDS
Re: K242512
Trade/Device Name: ROCC Console Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 23, 2024 Received: August 23, 2024
Dear Rob Vingerhoed:
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 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-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 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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Indications for Use
Submission Number (if known)
K242512
Device Name
ROCC Console
Indications for Use (Describe)
ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi-vendor solution allowing view-only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected 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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510(k) Summary
Prepared on: 2024-10-23
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | Philips Medical Systems Nederland B.V. | ||
| Applicant Address | Veenpluis 6 5684 PC Best Netherlands | ||
| Applicant Contact Telephone | +31 622632404 | ||
| Applicant Contact | Mr. Rob Vingerhoed | ||
| Applicant Contact Email | rob.vingerhoed@philips.com | ||
| Correspondent Name | Philips Medical Systems Nederland B.V. | ||
| Correspondent Address | Veenpluis 6 5684 PC Best Netherlands | ||
| Correspondent Contact Telephone | +31 622632404 | ||
| Correspondent Contact | Mr. Rob Vingerhoed | ||
| Correspondent Contact Email | rob.vingerhoed@philips.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | ROCC Console | ||
| Common Name | Medical image management and processing system | ||
| Classification Name | Medical image management and processing system | ||
| Regulation Number | 892.2050 | ||
| Product Code(s) | LLZ | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | K232744 | ||
| Predicate Trade Name (Primary Predicate is listed first) | syngo Virtual Cockpit (VB10A) | ||
| Product Code | LLZ | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
This premarket notification addresses the Philips ROCC Console, a Medical Image Management and Processing System (MIMPS).
ROCC Console is a software device, which is part of the ROCC (Radiology Operations Command Center) system, a cloud-based solution which can connect expert radiology users located at a remote command center with onsite technologists operating an MR/CT scanner on-demand, while enabling real-time operational support/guidance for the scanner console. This ROCC system allows healthcare professionals to share expertise, even when they are not physically present in the same location. Expert users are working from remote office locations within a healthcare facility or from a home office.
ROCC Console is a multiple function device product. The medical device functions include the ability to console of a connected MR/CT scanner from a remote location, and a Protocol Management mode, which can be used to manage updates / harmonize scan protocols across connected MR/CT scanners.
5
ROCC Console is vendor neutral. It is intended to be used in healthcare environments including imaging modalities (MR or CT) with digital output (DP, DVI, and HDMI) which are either fixed to one location or are in mobile (truck) environments where medical imaging services are provided.
ROCC Console supports three connection methods to exchange the KVM (Keyboard, Video and Mouse) information between the expert user and the technologist. The proprietary software KVM connection includes two applications: a "Console Transmitter App" for use by the technologist on the scanner side, and a "Console Receiver App" for use by the remotely located expert user. The Console Transmitter App is a native Windows application installed on a desktop system, which sends the console video stream over the internet to the Console Receiver App. The Console Receiver App is a web-application that can run on a web browser, and receives and displays the video stream to the remotely located expert user edits the scanner console through mouse and keyboard entries, it sends these keyboard and mouse entries back to the Console Transmitter App, which subsequently sends the scanner console. Additionally, ROCC Console supports off-the-shelf HW/SW KVM switch or VNC. ROCC Console can be used with 3 MR/CT console connections concurrently.
When a patient is to be scanned, the on-site technologist must remain present at all times and retains full control over the MR/CT scanner console and can terminate the editing authorization at any time. For CT connections, full access is limited to what is available in the software associated with the modality workspace and is not applicable to physical switches controlling the radiation exposure.
The Protocol Management mode allows access to the MR/CT scanner console without a technologist on site. It is only intended for protocol management and harmonization and not for any remote imaging support.
Intended Use/Indications for Use
ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi-vendor solution allowing view-only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected medical imaging devices.
Indications for Use Comparison
The intended use / indications for use statements are near identical, except for a few minor differences in applied terminology (e.g., view-only vs read-only). As these differences have essentially the same meaning, these statements are substantially equivalent.
The description of the intended clinical users also differs in applied terminology. The description for the predicate device only refers to the user profiles as used in the accompanying Instructions for Use, whereas the description for the ROCC Console also describes the professional qualifications of the intended users. As both devices are only intended to be used by healthcare professionals with similar qualifications, and not by patients or lay persons, these statements are substantially equivalent.
The description of the intended use environment for ROCC Console is more specific, but substantially equivalent with the one for the predicate device. Both devices support flexibility in the location of use.
Therefore, it can be concluded that the intended use / indications for use for both the proposed ROCC Console are the same.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The technological characteristics are identical for the following aspects
- · Design (Software only)
- Multi-vendor compatibility
- · Remote use
· Remote accessibility (expert user can remotely access the supported scanner and/or only view/read the scanner console
- Length of the remote sessions
- Connectivity requirements
- · User interface functions
- · Operator interface
- · Operating system
- User authorization and authentication
- Image acquisition
- · Image processing, reporting and archiving.
The following technological characteristics are considered substantially equivalent:
• Multi-modality / Hardware: ROCC Console supports MR and CT modality which is a subset of what the predicate device supports. Because it is a subset, it is regarded substantially equivalent.
• Delay / latency: the specified maximum latency of ROCC console is slightly higher than the predicate maximum
6
latency of ROCC Console allows the performance and safety requirements of ROCC Console to be met. The difference with it's predicate is not significant.
• Connection protocols: both devices use VNC over TCP. ROCC Console also uses HW KVM over TCP for one of it's connection methods. This means the TCP protocol is used by both devices use HTTPS connection protocols even though the data being exchanged is different, the use of the protocol is identical. The predicate device uses different terminology for the same connection protocol (UDP versus WebRTC-UDP for ROCC Console). Therefore this is substantially equivalent. · Lastly: the ROCC system communication features offered are substantially equivalent.
Substantial equivalence was demonstrated with non-clinical performance testing. V&V) activities were performed on the proposed ROCC Console and demonstrated that the predetermined acceptance criteria were successfully met and no different questions in terms of safety and effectiveness were raised. The non-clinical performance tests provided in this 510(k) submission demonstrate that the proposed ROCC Console is as safe and effective as the predicate device, the syngo Virtual Cockpit (VB10A) (K232744).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Please see software verification and validation documents to support the performance of ROCC Console.
Not applicable.
All pre-specified performance metrics have been met as demonstrated within the software verification and validation. The ROCC Console performs as intended.