(104 days)
Not Found
No
The description focuses on communication and remote control features, with no mention of AI/ML algorithms for image analysis, decision support, or other functions.
No
Explanation: This device is a communication software for remote consultation, guidance, support, and training related to CT systems. It does not directly treat or diagnose medical conditions, which are characteristics of therapeutic devices.
No
The "Intended Use / Indications for Use" section explicitly states, "Images reviewed remotely are not for diagnostic use." The device is intended for communication, consultation, guidance, support, and training, not for making diagnostic interpretations of images.
No
The device is described as a software application integrated into Philips CT systems. While it is software, its functionality is directly tied to and integrated with the hardware of the CT system, including remote control of system parameters. It is not a standalone software application that operates independently of specific medical device hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that "Images reviewed remotely are not for diagnostic use." This is a key indicator that the device is not intended for making diagnoses based on in vitro samples or images.
- Device Description: The device is described as a software application for communication, consultation, guidance, support, and training related to CT systems. While it involves image sharing, the primary function is communication and remote assistance, not diagnostic analysis of images or biological samples.
- Lack of IVD-specific elements: The description does not mention any interaction with biological samples, reagents, or diagnostic assays, which are characteristic of IVD devices.
The device is clearly focused on facilitating communication and remote interaction with a CT system for operational and training purposes, not for performing diagnostic tests or interpreting images for diagnostic purposes.
N/A
Intended Use / Indications for Use
CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screen sharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.
Product codes
LLZ, JAK
Device Description
The proposed CT Collaboration Live is a software application integrated in Philips Computed Tomography (CT) X-Ray CT 5300 Systems. CT Collaboration Live enables two-way communication of text, voice, image, and video information between a CT system operator and a remote user on a Windows device. CT Collaboration Live facilitates: 1) peer-to-peer consultation and training, 2) system-level remote sharing & operation, 3) access to live image feed and 4) remote expert user(s) and physician consultation. CT Collaboration Live functionality includes a remote-control feature in which the CT system operator may grant a qualified remote user control of the CT system parameters via a virtual control panel and virtual touch screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified remote clinical user, CT technologist/system operator, Philips Clinical Application Specialist, expert user(s), physician.
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)
Non-clinical performance software verification testing has been performed on the proposed CT Collaboration Live. All tests were used to support substantial equivalence of the proposed CT Collaboration Live and to demonstrate that CT Collaboration Live: Complies with international and FDA-recognized consensus standards and/or FDA device Specific guidance document, and; Meets the acceptance criteria and is adequate for its intended use. Design Verification planning and testing against Software Requirements Specification (SRS), was conducted. Software verification activities demonstrate that the CT Collaboration Live software application meets the design input requirements. Software requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes risk analysis/risk mitigation testing. The traceability between the requirements and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement. The summary and conclusion of results are provided in the System Verification Test Report. The proposed CT Collaboration Live did not require a clinical study since substantial equivalence to the predicate device Collaboration Live (K200179) was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness.
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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November 18, 2024
Philips Healthcare (Suzhou) Co., Ltd % Yael Curtz Regulatory Affairs Team Lead No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou Jiangsu, 215024 CHINA
Re: K242329
Trade/Device Name: CT Collaboration Live Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, JAK Dated: October 30, 2024 Received: October 30, 2024
Dear Yael Curtz:
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
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
Indications for Use
Submission Number (if known)
Device Name
CT Collaboration Live (728290)
Indications for Use (Describe)
CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screen sharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.
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
| This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92 | ||
|---|---|---|
| Date Prepared: | August 5, 2024 | |
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |
| No. 258, Zhongyuan Road, Suzhou Industrial Park, | ||
| Suzhou Jiangsu, CHINA, 215024 | ||
| Establishment Registration Number: 3009529630 | ||
| Primary Contact Person: | Yael Curtz | |
| Regulatory Affairs Team Lead | ||
| Phone: (972) 54-7282285 | ||
| E-mail: yael.curtz@philips.com | ||
| Secondary Contact | ||
| Person: | Carmit Shmuel | |
| Regulatory Affairs Manager and Site Lead | ||
| Phone: (972) 54-2109054 | ||
| E-mail: Carmit.shmuel@philips.com | ||
| Device: | Trade Name: | CT Collaboration Live |
| Common name: | Picture archiving and communications system | |
| Classification Name: | System, Image Processing, Radiological | |
| Picture archiving and communications system | ||
| (PACS) | ||
| Classification Regulation: | 21 CFR 892.2050 | |
| 21 CFR 892.1750 | ||
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | LLZ | |
| JAK | ||
| Primary Predicate | ||
| Device: | Trade Name: | Collaboration Live |
| Manufacturer: | Philips Ultrasound, Inc. | |
| 510(k) Clearance: | K200179 (Predicate) | |
| Classification Name: | System, Image Processing, Radiological | |
| Picture archiving and communications system | ||
| (PACS) | ||
| Classification Regulation: | 21 CFR 892.2050 | |
| 21 CFR 892.1550 | ||
| 21 CFR 892.1560 | ||
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | LLZ | |
| Secondary Product Code: | JYN, JYO |
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the primary focus of the image and is presented against a white background.
- Device Description: The proposed CT Collaboration Live is a software application integrated in Philips Computed Tomography (CT) X-Ray CT 5300 Systems. CT Collaboration Live enables two-way communication of text, voice, image, and video information between a CT system operator and a remote user on a Windows device. CT Collaboration Live facilitates: 1) peer-to-peer consultation and training, 2) system-level remote sharing & operation, 3) access to live image feed and 4) remote expert user(s) and physician consultation. CT Collaboration Live functionality includes a remote-control feature in which the CT system operator may grant a qualified remote user control of the CT system parameters via a virtual control panel and virtual touch screen.
- Intended Use: CT Collaboration Live is a solution with on-console chat, audio and video call, screen sharing and remote access functionality to facilitate collaboration between CT users and between CT user and Philips Clinical Application Specialist.
Contraindications are not known.
- Indications for Use: CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screensharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.
- Technological The proposed CT Collaboration Live has the same fundamental design Characteristics characteristics as the predicate Collaboration Live (K200179). CT Collaboration Live is a software application that enables remote image viewing and real-time communication between the system operator and a remote user (on a laptop or desktop computer) for the purposes of service, training/education, and peer-topeer collaboration. CT Collaboration Live also contains a remote-control feature similar to Collaboration Live, in which a qualified remote user can control the system parameters when granted access by the system operator. Like Collaboration Live, remote control in CT Collaboration Live can be granted to only one remote user at a time and may be revoked at any time by the system operator. Based on the information provided above, the CT Collaboration Live is
considered substantially equivalent to the primary currently marketed and predicate device Collaboration Live (K200179) in terms of fundamental design technology.
The following table 1 lists the technological characteristics differences for the proposed CT Collaboration Live:
| Table 1 – Technological Characteristics Comparison | |||
|---|---|---|---|
| Design | |||
| Feature | Cleared to | ||
| Market | |||
| Predicate | |||
| Device: | |||
| Collaboration | |||
| Live (K200179) | Proposed | ||
| Device: CT | |||
| Collaboration | Conclusion | ||
| Regulation | |||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical, therefore |
| substantially | |||
| equivalent. |
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| Regulation
Name | System, Image
processing,
Radiological-
Picture
Archiving and
Communications
System (PACS) | System, Image
processing,
Radiological-
Picture
Archiving and
Communications
System (PACS) | Identical, therefore
substantially
equivalent. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | LLZ | LLZ | Identical, therefore
substantially
equivalent. |
| Features | Remote service
support,
Remote clinical
training and
education,
Remote peer to
peer
collaboration
(non-diagnostic) | Peer to peer
consultation and
training,
System level
remote sharing
and operation,
Access to live
image feed,
Remote expert
user(s) and
physician
consultation | Features were
elaborated for
clarity. Equivalent,
no impact to safety
and effectiveness,
therefore
substantially
equivalent. |
| Remote
Access
Control | Granted by
technologist at
system | Granted by
technologist at
system | Identical, therefore
substantially
equivalent. |
| Remote
privileges | Secure
credentials | Secure
credentials | Identical, therefore
substantially
equivalent. |
| Number of
remote
users per
session | 1 | 1 | Identical, therefore
substantially
equivalent. |
| Diagnostic
use | Remote images
are not for
diagnostic use | Remote images
are not for
diagnostic use | Identical, therefore
substantially
equivalent. |
Based on the above, the proposed CT Collaboration Live is considered substantially equivalent to the predicate device Collaboration Live (K200179), in terms of technological characteristics.
Summary of Non-Clinical Non-clinical performance software verification testing has been performed on Performance Data: the proposed CT Collaboration Live.
All tests were used to support substantial equivalence of the proposed CT Collaboration Live and to demonstrate that CT Collaboration Live:
• Complies with international and FDA-recognized consensus standards and/or FDA device Specific guidance document, and;
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, CT Collaboration Live is substantially equivalent to the predicate device Collaboration Live (K200179) in terms of safety and effectiveness.
Design Verification planning and testing against Software Requirements Specification (SRS), was conducted. Software verification activities demonstrate
7
that the CT Collaboration Live software application meets the design input requirements. Software requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes risk analysis/risk mitigation testing.
The traceability between the requirements and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement. The summary and conclusion of results are provided in the System Verification Test Report.
Summary of Clinical The proposed CT Collaboration Live did not require a clinical study since Performance Data: substantial equivalence to the predicate device Collaboration Live (K200179) was demonstrated with the following attributes:
- Indication for use; ●
- Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness.
Substantial Equivalence The proposed CT Collaboration Live is substantially equivalent to the predicate device Collaboration Live (K200179) in terms of indications for use, Conclusion: technological characteristics and safety and effectiveness.
Additionally, substantial equivalence was demonstrated by verification tests provided in this 510(k) premarket notification. These tests demonstrate that CT Collaboration Live complies with the requirements specified in the international and FDA-recognized consensus standards and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.