(25 days)
No
The summary describes a remote access and collaboration tool for ultrasound systems, focusing on communication and remote control features. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML algorithms, or image analysis beyond basic review and consultation.
No.
The device is indicated for remote access of an ultrasound system for image review, consultation, guidance, support, and education; images reviewed remotely are not for diagnostic use. It facilitates remote service support, clinical training, education, and peer-to-peer collaboration. None of these uses are therapeutic.
No
The "Intended Use" explicitly states that "Images reviewed remotely are not for diagnostic use."
No
The device is described as a "new software feature integrated in Philips Epiq and Affiniti Diagnostic Ultrasound Systems". While it is a software feature, it is explicitly part of a larger hardware system (the ultrasound system) and its functionality is dependent on that hardware. It is not a standalone software application.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states, "Images reviewed remotely are not for diagnostic use." This is the most crucial factor in determining if a device is an IVD. IVDs are specifically intended for use in the diagnosis of disease or other conditions.
- Device Description: The description highlights its use for remote service support, clinical training and education, and non-diagnostic peer-to-peer collaboration. While it involves image review, the purpose is not for making a diagnosis based on those images.
- Lack of Diagnostic Claims: There are no claims or descriptions of the device being used to analyze biological samples, detect specific markers, or provide diagnostic information.
The device is a tool for remote collaboration and support related to ultrasound systems, but it is not intended to perform diagnostic tests or provide diagnostic results itself.
N/A
Intended Use / Indications for Use
Collaboration Live is indicated for remote console access of the Philips ultrasound system for image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, IYN, IYO
Device Description
Collaboration Live is a new software feature integrated in Philips Epiq and Affiniti Diagnostic Ultrasound Systems (K182857). Collaboration Live enables two-way communication of text, voice, image, and video information between an ultrasound system operator and a remote user on a Windows desktop or laptop computer. Collaboration Live facilitates: 1) remote service support, 2) remote clinical training and education, and 3) remote peer-to-peer collaboration (non-diagnostic). Collaboration Live functionality includes a remote control feature in which the ultrasound system operator may grant a qualified remote user control of all ultrasound system parameters via a virtual control panel and virtual touch screen. The ultrasound system operator maintains the ability to take back system control at any time. The remote user interacts with the ultrasound system using the Collaboration Live remote application, which is called Reacts.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Technologist operating the system, remote user.
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)
Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use. Collaboration Live did not require clinical testing to support a determination of substantial equivalence. The Collaboration Live software requirements have been successfully verified and cybersecurity vulnerability testing has been conducted to ensure product security.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GE Customer Remote Console K150193
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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February 18, 2020
Image /page/0/Picture/1 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.
Philips Healthcare % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K200179
Trade/Device Name: Collaboration Live Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, IYN, IYO Dated: November 25, 2019 Received: January 24, 2020
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200179
Device Name Collaboration Live
Indications for Use (Describe)
Collaboration Live is indicated for remote console access of the Philips ultrasound system for image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. 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 of Safety and Effectiveness (5)
Collaboration Live
The 510(k) summary of safety and effectiveness information is submitted in accordance with 21CFR $807.92. See Appendix D1.
-
- Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy
Bothell, WA 98021-8431
- Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy
| Contact person: | Paul Elias, Regulatory Affairs Specialist |
|---|---|
| Email: | Paul.Elias@philips.com |
| Tel: | 425-482-8396 |
| Fax: | 425-487-8666 |
| Secondary Contact: | Hebe Sun, Senior Regulatory Affairs Manage |
| Email: | Hebe.Sun@philips.com |
Date prepared: November 20, 2019
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Picture archiving and communications system Common name: Proprietary name: Collaboration Live
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| System, Image Processing, Radiological | ||
| Picture archiving and communications system | ||
| (PACS) | 892.2050 | LLZ |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
As stated in 21 CFR parts 892.2050, 892.1550, and 892.1560, each of these types of devices has been classified as Class II.
3. Substantially Equivalent Devices
Philips Ultrasound believes that Collaboration Live is substantially equivalent to the following predicate device:
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| Predicate Device | 510(k) |
|---|---|
| GE Customer Remote Console | K150193 |
4. Device Description
Collaboration Live is a new software feature integrated in Philips Epiq and Affiniti Diagnostic Ultrasound Systems (K182857). Collaboration Live enables two-way communication of text, voice, image, and video information between an ultrasound system operator and a remote user on a Windows desktop or laptop computer. Collaboration Live facilitates: 1) remote service support, 2) remote clinical training and education, and 3) remote peer-to-peer collaboration (non-diagnostic). Collaboration Live functionality includes a remote control feature in which the ultrasound system operator may grant a qualified remote user control of all ultrasound system parameters via a virtual control panel and virtual touch screen. The ultrasound system operator maintains the ability to take back system control at any time. The remote user interacts with the ultrasound system using the Collaboration Live remote application, which is called Reacts.
5. Indications for Use
Collaboration Live is indicated for remote console access of the Philips ultrasound system for image viewing, image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use.
6. Technological Comparison to Predicate Device
Collaboration Live employs the same fundamental scientific technology as the predicate GE Customer Remote Console (CRC). Like CRC, Collaboration Live is a software feature 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-to-peer collaboration. Collaboration Live also contains a remote control feature similar to CRC, in which a qualified remote user can control the system parameters when granted access by the system operator. Like CRC, remote control in Collaboration Live can be granted to only one remote user at a time and may be revoked at any time by the system operator.
7. Safety Considerations and Nonclinical Performance Testing
No performance standards for PACS systems or components have been issued under the authority of Section 514.
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Quality assurance measures applied to the product design and development included risk analysis, product specifications, design reviews, and verification testing.
Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use.
8. Clinical Data
Collaboration Live did not require clinical testing to support a determination of substantial equivalence.
9. Conclusion
The Collaboration Live software requirements have been successfully verified and cybersecurity vulnerability testing has been conducted to ensure product security. The differences between Collaboration Live and the predicate GE Customer Remote Console do not raise new questions of safety or effectiveness. With similar technology, features, and indications for use, Collaboration Live is substantially equivalent to the predicate GE Customer Remote Console (K150193).
514 Performance Standards
There are no Sec. 514 performance standards for Collaboration Live.
Prescription Status
Collaboration Live and the associated Epiq and Affiniti Diagnostic Ultrasound Systems are prescription devices. The prescription device statement appears in the labeling for the Collaboration Live feature and in the labeling for the Epiq and Affiniti Diagnostic Ultrasound Systems.
Sterilization Sites
Not applicable. Collaboration Live is a software feature.